Life Sciences Sector Skill Development Council (LSSSDC) recently hosted “SkillVerse 2026 – A National Skill Summit for the Life Sciences Sector” at Le Méridien, Gachibowli, Hyderabad, bringing together more than 100 senior leaders and key stakeholders from the life sciences ecosystem. The summit focused on addressing skill gaps, strengthening training ecosystems, building industry-aligned talent and preparing India’s workforce for the future needs of the rapidly evolving life sciences sector.

Organised around the theme “Shaping the Skilled Future of Life Sciences,” the national summit brought together representatives from the Central and State Governments, pharma and life sciences industries, academia, skill development organisations, policymakers and other ecosystem partners. Express Pharma was the media partner for this event.

The summit commenced with the welcome of dignitaries, followed by the ceremonial lighting of the lamp and the National Anthem. Shri Gautam Bhattacharya, Chief Executive Officer, LSSSDC, delivered the welcome address. Shri Anil Matai, Chairman, LSSSDC and Director General, OPPI, shared his perspectives through a video message.

Special addresses were delivered by Shri Aman Sharma, IAS, Department of Pharmaceuticals; Shri Chakravarthi AVPS, LSSSDC Board Member; Ms. Nidhi Satiija, ISS, Director, Ministry of Skill Development & Entrepreneurship (MSDE); Dr. K. Narendran, Deputy Drugs Controller, CDSCO; Dr. Sarvesh Singh, CEO, Telangana Life Sciences; and Prof. Shailendra Saraf, Director, NIPER Hyderabad, among other distinguished speakers.

More than 100 senior industry leaders participate

A major highlight of SkillVerse 2026 was the participation of more than 100 senior leaders, CXOs, industry experts and decision-makers from the life sciences sector. The summit provided a high-level platform for meaningful dialogue between industry, government, academia and the skill development ecosystem.

The industry ecosystem represented at the summit included leading pharmaceutical, biotechnology and life sciences organisations such as Dr. Reddy’s Laboratories, Sun Pharma, Cadila, Biological E, Aurobindo Pharma, Hetero Labs, Granules India, Natco Pharma, MSN Laboratories, Eisai Pharmaceuticals India, Sahajanand Medical Technologies, Alkem Laboratories, Sekhmet Pharmaventures, Cohance Life Sciences, Agappe Diagnostics, Sandoz, Aragen Life Sciences , Bharath Biotech, Biozeen, Sai Life Sciences, Gland Pharma, Vimta Labs, Sai Parenterals.

Strong representation across government, academia and industry associations

The summit witnessed strong representation and participation from key Government Departments and organisations, including the Ministry of Skill Development & Entrepreneurship (MSDE), National Skill Development Corporation (NSDC), Central Drugs Standard Control Organisation (CDSCO), Telangana Life Sciences, Telangana Academy for Skill and Knowledge (TASK), Department of Employment and Training, Government of Andhra Pradesh, Department of Technical Education, Government of Andhra Pradesh, Regional Directorate of Skill Development & Entrepreneurship (RDSDE), Andhra Pradesh Pharmacy Council, Department of Pharmaceuticals and TICEL Bio Park.

The academic and knowledge ecosystem was represented by institutions and organisations including IIT Hyderabad, National Institute of Pharmaceutical Education and Research (NIPER), CSIR, GITAM, SRM, Punjab Biotech Incubator, PAGE and VIPER, reflecting the strong commitment of academia and knowledge partners towards building a future-ready life sciences workforce.

Industry associations and ecosystem bodies, including FOPE, BDMAI, MDP TG and FABA, also participated in the summit, contributing to discussions on industry requirements, skill development priorities and collaborative models for strengthening the life sciences skill ecosystem.

Key discussions on skill gaps and industry needs

The first panel discussion, “Identifying Skill Gaps in Life Sciences Sector,” examined the current skill requirements of the industry, changing demands in the employment market and the need to build a workforce that is industry-ready from day one.

The second panel, “NeeV Initiatives – Industry-led Models for Strengthening Skill Development Centres (SDCs),” explored practical models for strengthening Skill Development Centres through deeper industry participation, infrastructure support and outcome-oriented training.

Government initiatives and industry partnership

The third panel discussion on “Government Initiatives for Skilling” focused on aligning government-led skill development programmes with industry requirements, improving training quality and expanding employment opportunities for young talent.

The fourth panel, “Future-Ready Workforce for Life Sciences – Preparing for Industry 5.0,” brought together industry experts to discuss emerging skills, advanced technologies, innovation, digital transformation and the human capabilities required to prepare the life sciences workforce for the Industry 5.0 era.

Key partnerships to strengthen skill development

The summit also witnessed important partnership initiatives aimed at strengthening the skill development ecosystem. An MoU exchange took place between LSSSDC and Biological E Limited for a new Corporate Social Responsibility (CSR)-supported Skill Development Initiative for FY 2026–27.

LSSSDC also entered into an understanding with Medical Devices Park to strengthen industry collaboration for multiple skill development initiatives. In addition, Oxygen Pharmatech Private Limited was associated as a Knowledge Partner for various skill development initiatives.

Building a future-ready life sciences workforce

Speakers and participants unanimously emphasised that as India’s life sciences and pharmaceutical sectors continue to grow rapidly, sustained investment in industry-aligned skilling, industry–academia collaboration, government support and awareness of emerging technologies will be critical.

The discussions highlighted that bridging skill gaps can not only improve employment opportunities for young talent but also strengthen India’s ability to compete globally by building a highly skilled, adaptable and future-ready workforce.

A strong national platform for collaboration

In his concluding remarks, Gautam Bhattacharya, CEO, LSSSDC, outlined key recommendations and the way forward, while thanking the distinguished guests, industry leaders, government representatives, academic institutions, partners and other stakeholders for their valuable participation and support.

All participating stakeholders appreciated the LSSSDC team for successfully organising this useful and timely national event for the Life Sciences Sector Skill Ecosystem. Participants acknowledged the summit as a valuable platform for meaningful dialogue, knowledge sharing, collaboration and collective action towards addressing skill gaps and strengthening India’s life sciences talent pipeline.

With the shared objectives of “Bridging Skill Gaps – Strengthening Training Ecosystems – Driving Innovation & Future-Ready Talent – Building a Competitive Global Workforce,” SkillVerse 2026 emerged as a significant national platform that brought together industry, government, academia and the wider skill ecosystem to collectively shape the future of talent development in India’s life sciences sector.

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Available models include cabinets with two doors and one or two drawers, five-drawer configurations, and Cart-Mate carts with varying drawer and door configurations. Specific models are offered in Clinton Classic Laminate, with select models also available in Fashion Finish or with molded tops. 

Clinton Industries Inc.

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Zydus Lifesciences announces the receipt of final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP, 25,000 mg/50 mL (500 mg/mL) and 5,000 mg/10 mL (500 mg/mL). The product is primarily used for the short-term treatment of scurvy in adult and paediatric patients aged 5 months and older for whom oral administration is not possible, insufficient or contraindicated.

Zydus’ Ascorbic Acid Injection is the generic equivalent of the reference listed drug (RLD), Ascor Injection, 25,000 mg/50 mL (500 mg/mL). The USFDA has designated the ANDA for the product as a Competitive Generic Therapy (CGT). Eligibility for the 180-day exclusivity available to certain competitive generic therapies is determined by the USFDA and, where applicable, the period runs from the date of first commercial marketing of the product.

The product will be manufactured at the group’s USFDA-approved injectable manufacturing plant at Jarod, near Vadodara in Gujarat, and will be marketed in the US market by Zydus Pharmaceuticals (US) Inc.

The brand product had annual sales of approximately $11.6 million in the US (IQVIA MAT June-2026).

The Group now has 448 approvals and has so far filed 513* ANDA with the USFDA. (*As on 30-June-2026)

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Over the last five years, more than 1,300 WellSpan patients at 12 cancer sub-specialties have received support from the partnership, which includes physician consultations, multidisciplinary tumour conferences, and access to subspecialty expertise.

Around 500 WellSpan patients have enrolled in clinical trials that are being by Johns Hopkins Medicine.

WellSpan Health president and CEO Roxanna Gapstur said: “When we expanded this collaboration five years ago, we shared a vision of bringing together the strengths of a leading academic medical centre and a nationally recognised community-based cancer programme to better serve patients across our region.

“Today, that vision continues to deliver meaningful benefits for our patients and it reflects our shared commitment to ensure more people can access world-class cancer care while remaining close to home and surrounded by their support systems.”

Johns Hopkins Health System president and Johns Hopkins Medicine executive vice-president Kevin Sowers said: “Our collaboration with WellSpan Health reflects a shared belief that every patient deserves access to the highest level of cancer expertise, regardless of where they live.

“Over the years, we have built strong clinical and research relationships that support healthcare professionals, advance innovation and improve patient experience.”

The extended collaboration will reach patients in areas, including the Central Susquehanna Valley, where WellSpan is investing in a programme for oncology at WellSpan Evangelical Community Hospital.

Starting this autumn, phased improvements will introduce local oncology, infusion, and eventually radiation oncology and advanced cancer services.

Earlier this year, WellSpan collaborated with Cancer Care Associates of York to support cancer care efforts in York County.

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The agreement aims to accelerate the progression of the new enterovirus vaccine.

It seeks to leverage the global expertise that Charles River provides in areas, including biologics testing, virology, non-clinical development, and regulatory science.

The collaboration is intended to align development with global regulatory expectations and advance the vaccine programme.

Medigen Vaccine Biologics has previously secured approval for its Envacgen Enterovirus 71 Vaccine in Taiwan and Vietnam.

Based on this prior regulatory experience, the company is moving forward with the development of a next-generation vaccine to address broader enterovirus strains.

As part of this process, Charles River has been selected to supply the necessary analytical, testing, and regulatory support.

Charles River global manufacturing corporate senior vice-president Kerstin Dolph said: “We are excited to collaborate with MVC and apply our testing and NGS expertise for vaccine development.

“By leveraging our experience in biologics, analytics, and safety, we are proud to partner with companies like MVC to achieve key milestones and drive innovation in the industry.”

The two companies plan to integrate Charles River’s biologics testing and non-clinical development capabilities with Medigen’s research in order to accelerate development and support investigational new drug (IND)-enabling non-clinical studies.

The partnership also seeks to generate data for global IND applications and future clinical pathways. They have indicated a shared interest in exploring further vaccine development opportunities in response to global infectious diseases.

Charles River has recently enhanced its NGS testing capabilities through the acquisition of Pathoquest. The company’s biologics testing solutions offer expertise and regulatory support across the entire developmental life cycle for clients worldwide.

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Glenmark Pharmaceuticals, USA (Glenmark) has announced the launch of Calcium Gluconate Injection USP in the US in 1,000 mg/10 mL (100 mg/mL) Single-Dose Vials, 5,000 mg/50 mL (100 mg/mL) Single-Dose Vials and 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package.

Glenmark’s Calcium Gluconate Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug, Calcium Gluconate Injection, 1,000 mg/10 mL (100 mg/mL), 5,000 mg/50 mL (100 mg/mL) and 10,000 mg/100 mL (100 mg/mL), of Fresenius Kabi USA, LLC [NDA 208418].

According to IQVIA sales data for the 12-month period ending June 2026, the Calcium Gluconate Injection, 1,000 mg/10 mL (100 mg/mL), 5,000 mg/50 mL (100 mg/mL) and 10,000 mg/100 mL (100 mg/mL) market achieved annual sales of approximately $69.9 million*.

Commenting on the launch, Marc Kikuchi, President & Business Head, North America, said, “The launch of Calcium Gluconate Injection USP marks another important step in strengthening Glenmark’s U.S. injectables business and expanding our hospital portfolio. It reflects the disciplined execution of our strategy to build a differentiated and sustainable injectables business – one that addresses institutional needs, supports greater supply resilience and deepens Glenmark’s relevance across the U.S. healthcare system,” he added.

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Lupin has announced that VISUfarma B.V. (VISUfarma), a wholly owned subsidiary of Lupin, has entered into an exclusive licensing agreement with Visus Therapeutics Inc., U.S.A., a wholly owned subsidiary of Tenpoint Therapeutics Holding Limited (Tenpoint).

Under the agreement, VISUfarma will hold exclusive rights to undertake regulatory activities, commercialisation, marketing, promotion, distribution and sale of YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution) 2.75 per cent/0.1 per cent for the treatment of presbyopia in adults across the European Union, the United Kingdom, Switzerland, Norway and Iceland (Licensed Territories).

VISUfarma will make a strategic investment in Visus under the agreement. Tenpoint and Visus, individually or collectively, will also be eligible to receive regulatory and commercial milestone payments, as well as tiered royalties based on net sales.

Vinita Gupta, Chief Executive Officer, Lupin, said, “We are delighted to partner with Tenpoint Therapeutics to bring a novel ophthalmic therapy that advances our Specialty Care strategy. Building on the strategic acquisition of VISUfarma, this partnership further strengthens our vision care franchise and expands our presence across key European markets. The addition of YUVEZZI underscores our commitment to broadening access to differentiated therapies, improving patient outcomes, and reinforcing our leadership in eye care across the Licensed Territories.”

“This exciting partnership marks an important step for Tenpoint as we continue our work to make YUVEZZI available for the millions of patients with presbyopia and eye care professionals around the world,” said Henric Bjarke, Chief Executive Officer, Tenpoint. “Lupin’s strong commercial operations span major European markets, and its specialty ophthalmology company VISUfarma’s longstanding presence in eyecare makes them an excellent partner. We look forward to working together as we bring YUVEZZI to Europe.”

YUVEZZI is the first and only approved once-daily, dual-agent eye drop for presbyopia. The addition of YUVEZZI expands Lupin’s ophthalmology portfolio and supports its strategy to expand its specialty care business through therapies addressing patient needs.

Tenpoint is advancing the commercialisation of YUVEZZI in the United States following its U.S. FDA approval. Tenpoint has submitted an MMA in the UK through the MHRA’s International Recognition Procedure and will continue its plans for regulatory applications for YUVEZZI in other regions. 

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GSDIa is a rare genetic metabolic disorder caused by a deficiency in the enzyme required for releasing glucose from the liver into the bloodstream.

This deficiency impairs the liver’s ability to manage glucose levels, leading to a risk of severe hypoglycaemia and requiring continuous nutritional monitoring, often involving frequent intake of raw cornstarch as oral glucose replacement.

The FDA granted accelerated approval for Genglycos, also known as DTX401, based on data from a 48-week double-blind, randomised, placebo-controlled Phase III study involving 46 participants who were treated with either DTX401 or a placebo.

The GlucoGene study demonstrated a statistically significant reduction in cornstarch requirements among those who received the gene therapy.

According to the trial’s protocol, participants who completed 48 weeks were able to cross over to the alternate treatment, and follow-up analyses are planned at weeks 96 and 144.

As part of the approval, Ultragenyx will provide two years of efficacy and safety data from an open-label commercial treatment group comprising 50 patients.

This will be conducted alongside 20 control patients who are unable to receive Genglycos due to anti–adeno-associated virus serotype 8 (AAV8) antibodies.

Data collection will occur via the GSDIa Disease Monitoring Program, which will track both new commercial patients and previous trial participants for up to ten years.

Ultragenyx chief medical officer Dr Eric Crombez said: “The approval of Genglycos fulfills our commitment to provide the first therapy that directly targets the root cause of GSDIa.

“The reduced reliance on cornstarch, experienced by patients in our clinical studies, demonstrates this gene therapy’s ability to establish the normal breakdown of glycogen to produce glucose during fasting or episodes of metabolic stress.

“This ability to regulate glucose has alleviated the disease burden and has the potential to mitigate the risk of severe or life-threatening hypoglycaemia for these patients.”

Genglycos is set to be distributed through a network of Qualified Treatment Centers and manufactured at the company’s facility in Bedford, Massachusetts.

In July 2025, Ultragenyx received a complete response letter from the FDA concerning its biologics licence application for UX111 (ABO-102), an adeno-associated virus gene therapy aimed at treating Sanfilippo syndrome type A (MPS IIIA).

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ISHRAE Thane Chapter, along with ISHRAE Mumbai Chapter, successfully hosted PharmaConnect 2026 – Cleanroom Conclave, a knowledge-sharing and networking platform bringing together professionals from the pharma, biopharma, cleanroom, HVAC, engineering, consultancy and allied industries.

Held at Hotel Ramada, Navi Mumbai, the conclave was organised around the theme “Transcending Frontiers in Pharma: Evolution of Biologics & Facility Adaptation for Next-Gen Sustainable Manufacturing.”

The programme served as a platform for industry leaders, pharma professionals, consultants, technology providers, HVAC experts and facility specialists to discuss the rapidly evolving requirements of the pharma manufacturing ecosystem. The pharmaceutical industry is undergoing significant transformation with the growth of biologics, advanced therapies and next-generation manufacturing technologies — developments that are creating new challenges and opportunities in facility design, cleanroom technology, HVAC systems, contamination control, energy efficiency, sustainability and regulatory compliance.

The gathering was addressed by Tejas Gawde, President, ISHRAE Thane Chapter; Mukesh Suthar, President, ISHRAE Mumbai Chapter; and Manoj Khati, Convener, PharmaConnect 2026, whose remarks set the tone for the event.

PharmaConnect 2026 addressed these emerging requirements through a combination of technical presentations, keynote sessions, expert discussions and a panel discussion, enabling participants to exchange experiences and perspectives.

The event featured eminent industry professionals, including Shyam Khante, President, Shyam Khante & Associates; Ajit Kadam, Director, Spectrum Pharmatech Consultant; and Bhupeshkumar Patil, Associate Vice President, Knexir Consultant, along with other experts from the pharma and engineering ecosystem.

A key highlight of the programme was a panel discussion moderated by Gautam Baliga, which brought together industry experts including Prashant Kavale, Shyam Khante, RV Kulkarni, Adnan Khan and Ajit Kadam. The panel discussed the challenges associated with evolving pharma facilities, sustainability, technology adoption and the changing needs of next-generation manufacturing. The discussion underscored the need for future pharma facilities to balance product quality, patient safety, regulatory compliance, operational reliability, energy efficiency and environmental sustainability.

Speaking on the occasion, the organisers highlighted the need for stronger collaboration between pharmaceutical manufacturers, consultants, technology providers and HVAC professionals to develop facilities that are not only compliant but also energy-efficient, resilient, sustainable and future-ready.

Recognising industry excellence

PharmaConnect 2026 also provided an opportunity to recognise and acknowledge the contribution of professionals and organisations supporting the growth and advancement of the pharmaceutical industry. The event witnessed strong participation from professionals across the pharma and allied sectors, creating opportunities for knowledge exchange, professional networking and collaboration.

The success of PharmaConnect 2026 reflects the commitment of ISHRAE Thane Chapter to promoting technical excellence and creating meaningful platforms for interaction between the HVAC&R and pharma industries.

Looking ahead

With the pharma industry moving towards biologics, advanced manufacturing technologies and increasingly sustainable operations, the role of cleanroom engineering, HVAC, contamination control and energy-efficient facility design will become even more critical. PharmaConnect 2026 highlighted the importance of bringing stakeholders together to share knowledge, address emerging challenges and explore solutions for the pharma facilities of tomorrow.

ISHRAE Thane Chapter extended its appreciation to all speakers, panelists, sponsors, supporting organisations, delegates and volunteers whose contribution helped make the conclave a successful industry gathering

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It enables drug discovery teams to computationally assess and rank how strongly candidate molecules are likely to interact with specific disease targets.

Unlike established computer methods that require detailed structural data about the target molecule, AQPotency does not rely on existing structural maps.

This capability allows researchers to evaluate potential drug compounds even for targets that lack structural information, which has typically limited access to traditional computational screening.

SandboxAQ stated that early-stage drug discovery often involves selecting which molecules to assess experimentally, a process that can be both costly and time-consuming if unsuitable candidates are chosen.

Existing computational narrowing techniques are described as slow and expensive, and restricted to cases where a detailed structure is available.

AQPotency addresses these shortcomings by providing rapid ranking of molecule-target pairs and delivering results in seconds using standard computing resources.

The model reports both the predicted activity and a confidence assessment, indicating whether a target falls within its reliable performance range.

The tool is also designed to support analysis in the opposite direction.

Researchers can input a molecule and receive a prioritised list of proteins that the compound may interact with, which could be useful when a molecule demonstrates effects whose mechanisms are not yet clear.

SandboxAQ drug discovery vice-president Andrea Bortolato said: “AQPotency has given us and our customers a faster, scalable and reliable way to prioritise compounds in the workflows we already run, without needing a 3D crystal structure of the target. This opens up programmes that structure-based methods simply couldn’t reach.

“The confidence intervals make the output actionable for biopharma companies, and the model has already been successfully used in eight customer programmes with experimentally validated impact.”

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Mankind Pharma has entered into an exclusive in-licensing and marketing agreement with Chongqing Chenan Biopharmaceutical Co., Ltd., China, for the commercialisation of two insulin analogues, Insulin Degludec and Insulin Degludec + Aspart Combination, in India.

The partnership marks a step in Mankind Pharma’s strategy to strengthen its presence in diabetes care and broaden its portfolio of injectable therapies. The addition of these products will further enhance Mankind Pharma’s position in the injectable diabetes segment, contributing to a more comprehensive portfolio and reinforcing its commitment to addressing the evolving needs of patients.

The partnership further reinforces the company’s commitment to expanding its diabetes portfolio and bringing a broader range of treatment options to patients in India.

Commenting on the partnership, Atish Majumdar, Senior President – Sales and Marketing, Mankind Pharma, said, “China is rapidly emerging as a hub for innovative biopharmaceutical assets. Building on our partnerships for Insulin Aspart and Insulin Degludec, we remain focused on expanding our in-licensing pipeline from China. This partnership reinforces our commitment to expanding access to advanced therapies for patients in India while further strengthening our presence in the injectable diabetes segment.”

The partnership with Chongqing Chenan Biopharmaceutical is also aligned with Mankind Pharma’s broader strategy of leveraging global innovation through strategic partnerships and in-licensing opportunities. China’s developing biopharmaceutical ecosystem presents opportunities for Indian pharmaceutical companies to access differentiated and innovative assets that can complement their existing portfolios.

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Strides Pharma Science has announced that its flagship manufacturing facility in Bengaluru, India, has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA), indicating the closure of the inspection conducted at the facility.

The USFDA conducted a current Good Manufacturing Practices (cGMP) inspection of the facility from May 12 to May 20, 2026. As previously disclosed to the stock exchanges on May 20, 2026, the inspection concluded with the issuance of a Form 483 containing five observations. The company submitted a response addressing all observations within the stipulated timeline.

Based on the company’s response and the corrective and preventive actions implemented, the USFDA classified the inspection outcome as Voluntary Action Indicated (VAI) and issued the Establishment Inspection Report (EIR), thereby concluding the inspection.

The facility is Strides’ flagship manufacturing site and serves regulated and other international markets. The facility manufactures pharmaceutical dosage forms, including tablets, capsules and oral liquids, supporting existing commercial products and future growth opportunities.

The closure of the inspection further strengthens Strides’ regulatory track record and reinforces the company’s commitment to supplying pharmaceutical products to patients across global markets.

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Glenmark Pharmaceuticals has announced the receipt of U.S. FDA approval for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray. Glenmark’s Fluticasone Propionate Nasal Spray USP is bioequivalent and therapeutically equivalent to the reference listed drug, Flonase Nasal Spray, 0.05 mg/spray of Haleon US Holdings LLC [NDA 020121], and will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIA sales data for the 12-month period ending June 2026, the Flonase Nasal Spray market achieved annual sales of approximately $295.2 million.

Commenting on the approval, Marc Kikuchi, President & Business Head, North America, said, “The approval of Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray marks another step in expanding our respiratory portfolio in the U.S. and builds on the strong foundation we have established in this therapeutic area. We remain committed to broadening access to quality, affordable treatment options that address the evolving needs of patients and healthcare providers.”

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Eppendorf has introduced a new addition to its Eppendorf Research 3 neo single-channel pipette line, launched in 2025. From today, laboratories worldwide can order 3-pack and 6-pack bundles at a special rate, making it easier and more cost-effective to upgrade to the latest Eppendorf pipetting technology.

The 3-pack bundles are available in three sets, each designed for common laboratory needs. Option 1 includes 10 µL, 100 µL and 1000 µL pipettes. Option 2 includes 20 µL, 200 µL and 1000 µL pipettes, while Option 3 includes 1000 µL, 5 mL and 10 mL pipettes.

The 6-pack bundle includes 2.5 µL, 10 µL, 20 µL, 100 µL, 200 µL and 1000 µL pipettes, along with a Pipette Carousel 2 for convenient and safe storage.

Eppendorf said all multi-packs include an original Eppendorf pipette pen as a bonus item.

The Research 3 neo pipettes address key pain points for scientists, including faster and easier volume adjustment with a lock to prevent accidental volume changes during pipetting, improved ergonomics with a shorter pipetting button, flexible labelling options, and the reliability and ergonomics Eppendorf is known for.

Further information about the Eppendorf Research 3 neo pipettes and value packs is available at www.eppendorf.link/research3neo.

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Invesco Mutual Fund has announced the launch of the Invesco India Pharma and Healthcare Fund, an open-ended equity scheme investing in pharma, healthcare and allied sectors.

The fund seeks to capitalise on India’s evolving healthcare ecosystem, which is being shaped by favourable demographics, expanding healthcare access, rising insurance penetration, growing global pharmaceutical leadership and emerging innovation-driven opportunities across healthcare and life sciences. The scheme will invest across pharmaceutical companies, hospitals, diagnostics, contract development and manufacturing organisations (CDMOs), contract research organisations (CROs), medical devices, healthcare services, insurance and other allied healthcare segments.

India today occupies a position in the global healthcare ecosystem, supported by its scale, talent pool, manufacturing capabilities and growing innovation footprint. Structural drivers such as increasing healthcare expenditure, ageing demographics, rising lifestyle diseases, expanding health insurance coverage, infrastructure development and growing global outsourcing trends are expected to create long-term opportunities across the healthcare value chain.

The fund will be managed by Aditya Khemani and will be benchmarked against the BSE Healthcare TRI.

Speaking at the launch, Aditya Khemani, Head of Equity & Fund Manager, Invesco Mutual Fund, said “India’s healthcare sector is undergoing a structural transformation. The country is not only witnessing rising healthcare consumption driven by favourable demographics and increasing affordability but is also strengthening its position as a global pharmaceutical and healthcare innovation hub. We see attractive opportunities across domestic pharma, hospitals, diagnostics, CDMOs and emerging healthcare segments that can potentially benefit from this multi-year growth cycle. Our investment approach will focus on identifying quality businesses with sustainable competitive advantages and strong growth visibility across the healthcare ecosystem.”

The minimum lumpsum investment amount during the NFO is ₹1,000 and in multiples of ₹1 thereafter. For SIP investments, the minimum application amount is ₹100 and in multiples of ₹1 thereafter. The fund will charge an exit load of 0.50 per cent for units redeemed or switched out on or before three months from the date of allotment. No exit load will be charged if units are redeemed or switched out after three months.

The New Fund Offer (NFO) is open for subscription from August 18, 2026 and will close on September 1, 2026.

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Device History Record (DHR)

A Device History Record (DHR) is a collection of records demonstrating that an individual medical device was manufactured, tested, inspected, and released in accordance with approved procedures and specifications. The DHR provides complete traceability for a specific device and serves as objective evidence that manufacturing activities were performed as required.

DHRs are most commonly used for devices that are individually identified and traceable through a unique serial number. Since each device can be distinguished from every other device, manufacturing and quality records are maintained at the individual device level rather than at a batch level.

A typical DHR may include:

• Device serial number
• Manufacturing date
• Components and material lots used
• Assembly records
• Inspection and test results
• Calibration verification records
• Nonconformance and rework records
• Final release authorization

Examples of Devices Commonly Managed Through DHRs

• Infusion Pumps
• Ventilators
• Patient Monitors
• Dialysis Machines
• Surgical Navigation Systems
• Medical Lasers
• Imaging Equipment
• ECG Machines

For example, an infusion pump with Serial Number IP-2026-000145 would have its own manufacturing, testing, and release records maintained within a dedicated DHR specific to that device.

Batch Production Record (BPR)

A Batch Production Record (BPR) documents the manufacturing activities performed for a defined batch or lot of medical devices produced under the same manufacturing conditions. Rather than maintaining records for each individual unit, the BPR captures information applicable to all devices within the batch.

BPRs are typically used when large quantities of identical devices are manufactured together and assigned a common batch number or lot number. In such cases, production controls, inspections, testing, and material usage are recorded at the batch level.

A typical BPR may include:

• Batch or lot number
• Manufacturing dates
• Raw material lot numbers
• Equipment used
• Process parameters
• In-process inspection results
• Final inspection results
• Yield calculations
• Scrap and reject quantities
• Batch release authorization

Examples of Devices Commonly Managed Through BPRs

• Syringes
• IV Administration Sets
• Blood Collection Tubes
• Catheters
• Surgical Gloves
• Wound Dressings
• Extruded Medical Tubing
• Diagnostic Test Strips

For example, a manufacturer may produce 10,000 PVC catheters under Batch Number CT-250801. Material consumption, yield calculations, scrap quantities, inspection results, and release activities for all 10,000 units would be documented within a single BPR associated with that batch.

DHR vs BPR: Are They Different?

Although the terms Device History Record (DHR) and Batch Production Record (BPR) are sometimes used interchangeably, they are often applied to different manufacturing scenarios. The primary distinction lies in the level of traceability required for the product being manufactured.

Why Yield Calculations Are Required

Yield calculations are used to demonstrate material accountability throughout the manufacturing process. Every component, raw material, subassembly, or consumable issued to production should be traceable to a documented outcome, such as acceptable finished product, scrap, rejects, samples, rework, or returned inventory.

Without yield calculations, manufacturers may be unable to explain differences between the quantity of materials issued to production and the quantity of finished devices produced. Such discrepancies can indicate process inefficiencies, material losses, documentation errors, inventory inaccuracies, equipment problems, or other manufacturing issues that require investigation.

Yield analysis also provides an objective measure of manufacturing performance. By comparing expected and actual production outputs, organizations can identify trends, monitor process efficiency, evaluate manufacturing controls, and detect unusual losses that may affect product quality or operational performance.

From a quality and regulatory perspective, yield calculations help demonstrate that:

• Materials issued to production have been appropriately accounted for.
• Manufacturing losses are identified and documented.
• Scrap, rejects, samples, and rework activities are traceable.
• Production processes remain within expected operating limits.
• Significant deviations are investigated and addressed when necessary.

For batch-manufactured medical devices, yield calculations are often performed as part of the Batch Production Record (BPR) and become an important element of production review and batch release activities. The resulting calculations provide evidence that manufacturing outputs are consistent with the quantities of materials introduced into the process and that all material dispositions have been properly documented.

Fundamental Material Accountability Terms

Understanding Overage

Overage refers to the additional quantity of materials intentionally issued to production above the theoretical quantity required to manufacture a planned number of devices. Overage is a planned and controlled manufacturing practice used to compensate for expected material losses that occur during routine production operations.

In an ideal manufacturing process, the exact quantity of materials required would be sufficient to produce the planned output. In reality, however, manufacturing activities frequently involve setup losses, process waste, inspection sampling, trimming operations, machine adjustments, and other unavoidable material consumption. To ensure that sufficient materials are available to achieve the intended production quantity, manufacturers often issue an additional quantity known as the overage.

Why Overage is Required

Overages may be established to compensate for:

• Equipment setup and start-up losses
• Process-related material waste
• Cutting and trimming losses
• Extrusion start-up scrap
• Inspection and testing samples
• Expected reject rates
• Validation or qualification samples
• Historical manufacturing losses

The amount of overage is typically determined using historical production data, process capability studies, engineering evaluations, or established manufacturing procedures.

Practical Example

A manufacturer plans to produce:

10,000 PVC Catheters

Historical production data indicates:

To ensure that 10,000 acceptable catheters can be produced, the manufacturer issues:

10,400 Catheter Components

The additional 400 components represent the planned overage.

Key Principle

An overage is not a manufacturing loss. It is an intentionally planned quantity issued to production to accommodate anticipated losses and ensure that the required production target can be achieved.

However, all overage quantities must ultimately be accounted for through documented outcomes such as:

• Finished goods
• Scrap
• Rughage
• Rejects
• Samples
• Rework
• Returned inventory

Any unexplained differences between issued quantities and recorded dispositions should be investigated through the organization's quality management system.

Relationship Between Overage and Yield

Although overage does not directly reduce yield, it influences the quantity of materials issued to production and therefore affects how manufacturing efficiency is evaluated. Excessive overages may indicate poor process capability, unstable manufacturing operations, or inadequate process controls, while well-controlled processes generally require smaller overage allowances.

Consequently, overage planning and yield analysis are closely related activities within Batch Production Records (BPRs) and play an important role in material accountability and production reconciliation. Once materials have been issued to production, manufacturers must determine how efficiently those materials were converted into acceptable finished devices. This assessment is performed through yield calculations, which compare production outputs against the quantities of materials introduced into the manufacturing process.

Understanding Yield

Yield is a measure of manufacturing efficiency that indicates how effectively materials issued to production are converted into acceptable finished products. It is one of the most important metrics documented within Batch Production Records (BPRs) because it provides objective evidence of material utilization and process performance.

In simple terms, yield answers the following question:

A high yield generally indicates an efficient manufacturing process with minimal losses, whereas a low yield may indicate excessive scrap, rejects, process waste, equipment issues, operator errors, or other manufacturing inefficiencies.

Why Yield is Important

Yield calculations help manufacturers:

• Evaluate manufacturing efficiency.
• Monitor process performance.
• Identify excessive material losses.
• Detect abnormal production trends.
• Support material accountability.
• Investigate unexpected process deviations.
• Improve production planning and overage estimates.

Practical Example

A manufacturer issues:

At the end of production, the following quantities are recorded:

All materials issued to production have been accounted for through documented dispositions. The quantity of acceptable finished products produced from the materials issued forms the basis of the yield calculation.

Basic Yield Formula

Example Yield Calculation

This means that approximately 95.24% of the materials issued to production were successfully converted into acceptable finished catheters.

Interpreting Yield Results

The yield formula presented above represents the most basic approach to yield calculation. In practice, organizations may use different methodologies depending on how they treat approved samples, reworked units, returned inventory, or planned process losses. Understanding these variations is important when comparing yield values across products, manufacturing sites, or production processes.

Gross Yield vs Net Yield

Although yield is often expressed as a single percentage, manufacturers may calculate yield using different methodologies depending on their procedures and reporting requirements. The two most common approaches are Gross Yield and Net Yield (Adjusted Yield).

The difference between these calculations lies in how certain material dispositions, such as approved samples, are treated during the yield calculation.

Gross Yield

Gross Yield considers only the quantity of acceptable finished product released from the manufacturing process. Any units consumed during testing, validation activities, or other approved uses are excluded from the acceptable output.

Net Yield (Adjusted Yield)

Net Yield recognizes that some units are intentionally removed from production for approved quality control activities, validation testing, sterility testing, retention programs, or other authorized purposes. Because these units were successfully manufactured and did not fail the process, some organizations include them when evaluating overall manufacturing performance.

Example Calculation

Assume the following production results:

Gross Yield Calculation

Net Yield Calculation

Comparison

Yield Reconciliation

Yield calculations provide an indication of manufacturing efficiency, but they do not by themselves demonstrate complete material accountability. To verify that all materials issued to production have been properly tracked and documented, manufacturers perform a process known as yield reconciliation or material reconciliation.

Yield reconciliation is the process of accounting for every unit, component, or quantity of material introduced into the manufacturing process by assigning it to a documented disposition category. The objective is to ensure that no material remains unexplained at the completion of production.

Fundamental Reconciliation Principle

For a batch to be considered fully reconciled, the total quantity issued to production should equal the total quantity accounted for through documented outcomes.

Common Material Disposition Categories

Practical Reconciliation Example

Assume a production batch receives:

Reconciliation Verification

Special Considerations for Moulding Operations

In injection moulding, compression moulding, and blow moulding processes, rughage often represents a significant proportion of total material consumption. Common examples include runners, sprues, gates, purging material, setup waste, color change material, and flash removal.

In some moulding operations, rughage may exceed the quantity of actual rejects. Consequently, manufacturers frequently track rughage separately from scrap and rejects to better understand process efficiency and material utilization.

GM2 gangliosidosis is a rare genetic disorder that leads to the progressive loss of nerve cells in the brain and spinal cord. The most common form begins during infancy, although other forms can appear later in life.

The condition belongs to the group of lysosomal storage disorders and results from genetic mutations that impair lysosomal function, leading to harmful accumulation within cells and severe neurological symptoms.

Andelyn Biosciences will implement a multi-phase programme using its Curator Platform, which features a cell line and a modular approach intended to adapt manufacturing processes to specific programme needs.

Andelyn Biosciences chief commercial officer Matt Niloff said: “We are proud to partner with Queen’s University to advance this gene therapy candidate for the benefit of patients and families facing the challenges of GM2 gangliosidoses.

“Our deep expertise in AAV development and production allows us to support Queen’s University with the scale and quality rigour necessary to bring this life-changing therapy one step closer to reality.”

Queen’s University medical geneticist and department of paediatrics professor Dr Jagdeep Walia said: “This partnership with Andelyn is very strategic as they have the established expertise of producing vectors for many gene therapy programmes.

“Their track record and ability to manufacture the viral vector for the upcoming GM2 programme gives us confidence that the participants in the clinical trial will be receiving the highest quality, safe product.”

In August 2025, Andelyn Biosciences entered a collaboration with Amplo Biotechnology to manufacture adeno-associated virus (AAV) gene therapies to address conditions affecting the neuromuscular junction.

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This partnership, which began in 2023, has so far provided Brukinsa to more than 300 CLL patients in Armenia, Ethiopia, and Nepal. The figure surpassed the programme’s initial goal by around 150 patients.

The initiative is aimed at improving access to CLL therapy in regions where advanced treatments have previously been limited or unavailable.

Support for the project involves donated Brukinsa from BeOne Medicines and a $1m BeOne Care Foundation grant, which together help underpin patient care, physician involvement, and operational needs for the next two years.

The Max Foundation leads implementation efforts based on its experience with oncology access programmes.

BeOne Medicines co-founder, chairman and CEO John Oyler said: “From the beginning, our goal has been to ensure that where a person lives does not determine whether they can access high-quality cancer care.

“Renewing this partnership with The Max Foundation reflects both the impact we have already achieved together and our commitment to reaching many more patients who otherwise may have limited treatment options.”

The agreement will maintain support in Armenia, Ethiopia, and Nepal, and may include additional countries such as Côte d’Ivoire, Malawi, Mongolia, Mozambique, Togo, and Zambia, depending on future capacity and priorities.

The model includes provisions for ongoing treatment for enrolled patients beyond 2028 if clinically required.

Earlier this month, BeOne Medicines signed a multi-part collaboration with Revolution Medicines to develop and commercialise targeted oncology therapies.

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Dr Ashok Kumar Mittal, Rajya Sabha MP and Founder-Chancellor of Lovely Professional University, has been elected by 245 Members of Parliament from the Rajya Sabha as a member of the governing body of the All India Institute of Medical Sciences (AIIMS), Bathinda.

Dr Mittal is among the Rajya Sabha members recently elected to the governing bodies of various AIIMS institutions across the country. His election to AIIMS Bathinda adds an institutional responsibility to his parliamentary role and places him within the governance framework of a public healthcare and medical education institution in Punjab.

AIIMS Bathinda combines patient care, medical education and research. Its development is relevant to healthcare capacity and access to medical services in Punjab and the wider region.

Institutional governance supports healthcare institutions in advancing their academic, clinical and research objectives. In Punjab, medical education, healthcare capacity, research and innovation are areas of focus for developing public healthcare infrastructure.

Speaking on his election, Dr Ashok Kumar Mittal said, “ I am honoured to have been entrusted with this responsibility, having been elected by 245 Members of the Rajya Sabha. This appointment holds special significance for me: I was previously nominated by the Vice President of India as a member of the School of Planning and Architecture, and of the Jawaharlal Nehru University (JNU) Court — both central institutions located in Delhi. AIIMS Bathinda, though also a central institution, is located in Bathinda, in my own home state of Punjab. ”

He added, “ The Bathinda region faces a significant health burden linked to water table issues, with cancer being the most serious of these challenges. AIIMS Bathinda, with its clinical experience, its team of doctors, and the infrastructure it is building, can make a major contribution towards addressing the cancer burden faced by the people of Punjab, and particularly by those in the Bathinda region. I am especially glad that, as a member of AIIMS Bathinda, I may be able to contribute meaningfully to the health and well-being of the people of Punjab, and I look forward to strengthening Punjab’s healthcare ecosystem. ”

He further said, “ Healthcare and education are fundamental pillars of social and economic development. As we work towards a healthier and more developed Punjab, we must continue to strengthen institutions that can deliver quality healthcare while also creating the knowledge, talent and research capabilities needed for the future. My endeavour will be to bring a constructive and public-interest-oriented perspective to this responsibility. ”

The election comes as healthcare institutions are expected to integrate patient care with medical education, research, technology and innovation. AIIMS Bathinda can contribute to this ecosystem in Punjab.

Dr Mittal’s participation in the governing body provides an opportunity to contribute his perspective on institution-building and capacity development while supporting objectives related to medical education, healthcare accessibility, research and innovation. No specific initiatives or policy measures have been announced by Dr Mittal in connection with his new role at this stage.

As Punjab continues to strengthen its healthcare infrastructure and human-resource capabilities, institutions such as AIIMS Bathinda will remain relevant to healthcare access and the development of medical professionals and researchers. Institutional systems, academic excellence and public-oriented healthcare remain areas of focus for the state’s long-term development.

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India-US pharma ties are entering a new phase. The two countries already have a strong pharma relationship, India supplies 40 per cent of US generic pharma. Now, both sides are looking at what comes next.

The message came through at the Indo-American Chamber of Commerce (IACC) National Convention 2026 in Mumbai. Sergio Gor, US Ambassador to India and Devendra Fadnavis, Chief Minister, Government of Maharashtra spoke about taking the wider India-US partnership deeper.

The timing is significant. Gor said trade in goods and services between the two countries has grown 12-fold to $240 billion. The two countries are targeting $500 billion in bilateral trade by 2030.

“The reason we get 40 per cent of our generic pharma from India, that’s an incredible number, is because we trust India,” said Gor.

He sees scope to take that trust further. “Simply put, when the US and India work together, we integrate value chains, accelerate breakthroughs in critical technologies, and strengthen supply chain resilience,” he said.

The bigger opportunity

Fadnavis wants Maharashtra to play a central role.

“The next chapter of the India-US partnership must move from strategic convergence to economic execution. And when that happens, Maharashtra wants to be at the center of that story.”

His message to industry is simple. Do more together.

He said, “It means moving towards co-investment, co-innovation, co-development and co-creation. It means American technology meeting Indian scale. American capital meeting Indian entrepreneurship. American research meeting Indian talent.”

For pharma, this could open up new areas of collaboration. Fadnavis pointed to joint research, technology transfer, global capability centres and manufacturing partnerships.

He also described a bigger ambition for India-US manufacturing.

“Not merely made in India but increasingly designed together, developed together, manufactured together and taken to the world together.”

That is a clear step beyond the traditional generics model.

Gor also made a direct pitch to Indian companies.

“So here’s my ask of every company in this room. If you’re weighing your next overseas investment, choose the US. Bring your regional project, your R&D center, your manufacturing lines to American soil.

If you’ve already invested in America, deepen that commitment further. This is the moment.”

He cited Natco Pharma and Aurobindo Pharma among Indian pharma companies that have expanded their operations in the US.

He also highlighted Mumbai-based LMAC Packages. The company has partnered with North Carolina-based Aylward to build high-speed pharma packaging equipment.

So, what will it take?

Deeper partnerships will need a supportive business environment, Gor said.

“We need predictable taxation and regulatory frameworks that allow business to thrive. We need candid, trust-based engagement on export controls and technology flows. And we need rock-solid intellectual property protections, giving every innovator in this room the confidence to invest, create and scale without fear.”

Maharashtra is making its own pitch to US companies.

“Look at Maharashtra as a platform for your India and global growth. Partner with Maharashtra for your manufacturing. Partner with Mumbai for your financial operations. Utilise our talent for your global capability centers. Utilise our technology ecosystem for innovation. Utilise our healthcare ecosystem for research and medical innovation.”

Thus, the IACC National Convention brought larger ambition into focus. Anup Acharya, National President, IACC, and Raghavendra Ponkshe, Regional Director–West, IACC, highlighted, the India-US relationship has grown beyond traditional trade and investment.

IACC has spent decades building bridges between the two business communities. The next chapter, its leadership said, will be about ideas, investment and partnerships.

lakshmipriya.nair@expressindia.com 

laxmipriyanair@gmail.com 

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Following completion of the merger, the new entity will focus on developing Slate’s pipeline of migraine treatments, with SLTE-1009 as its lead candidate.

This clinical-stage subcutaneous anti- pituitary adenylate cyclase-activating peptide / vasoactive intestinal peptide (PACAP/VIP) monoclonal antibody is intended for the prevention of migraine and other headache disorders.

The financing is expected to support operations through 2029, enabling progress of SLTE-1009 through Phase I studies in healthy volunteers and a Phase II dose-range finding study in patients with migraine.

Also in development is SLTE-2100, a bispecific antibody targeting PACAP/VIP and calcitonin gene-related peptide (CGRP), which remains in the lead optimisation stage.

SLTE-2100 is scheduled to enter clinical trials in the second half of 2027 and has secured funding for a Phase IIa study in migraine.

The transaction, unanimously supported by the boards of both companies, is targeted to close in the fourth quarter of 2026, pending regulatory and shareholder approvals, as well as satisfaction or waiver of customary closing conditions.

Upon completion, pre-merger Fulcrum stockholders are expected to own 5% of the new company while pre-merger Slate stockholders and pre-closing financing investors are expected to hold 95%.

Fulcrum is anticipated to contribute net cash of nearly $20.3m and issue a cash dividend estimated at $270m, to be paid immediately prior to closing, to Fulcrum stockholders.

Slate Medicines CEO Gregory Oakes will lead the merged entity.

Oakes said: “Migraine remains one of the most prevalent and disabling neurological diseases, yet millions of patients continue to be underserved by existing therapies.

“This merger and the related financing are expected to provide the resources to advance SLTE-1009, along with the rest of our pipeline, through potentially meaningful clinical milestones.”

Slate’s management team includes president and chief operating officer Neil Buckley, chief medical officer Dr Roger Cady, and chief financial officer John Umstead.

The new company’s board of directors will include representatives from RA Capital Management, Forbion, Foresite Capital, and a former executive of Verona Pharma.

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It also applies to those who have previously undergone platinum-based chemotherapy and an immune checkpoint inhibitor.

Faeth Therapeutics is currently conducting a Phase II trial of this treatment approach, known as Study FTH-PIK-201, in second-line advanced endometrial cancer.

The company anticipates releasing top line results from this trial by the end of this year.

Faeth Therapeutics CEO Anand Parikh said: “Fast track designation for PIKTOR reflects the significant unmet need in advanced endometrial cancer for patients whose disease has progressed despite platinum-based chemotherapy and an immune checkpoint inhibitor.

“We believe PIKTOR’s multi-node approach to the PI3K/AKT/mTOR pathway is well suited to this population as our preclinical data suggests that PIKTOR can resensitise patients to chemotherapy.”

PIKTOR is described as an investigational, all-oral combination therapy and is designed to inhibit several nodes of the PI3K/AKT/mTOR pathway, which, according to published literature, is altered in up to half of all solid tumours.

In addition to the endometrial cancer trial, PIKTOR is being tested in a Phase Ib/II study for hormone receptor positive / human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer, referred to as Study FTH-PIK-101.

The first patient in this study was dosed in April, with interim results expected in 2027.

Faeth Therapeutics focuses on multi-node therapies for cancer, with PIKTOR as its leading development programme.

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Godavari Biorefineries has secured a patent from the European Patent Office for its invention, “Pharmaceutical Composition and a Process to Prepare the Same”. The patent covers a pharmaceutical composition that combines anti-cancer compounds with a solubilising agent, along with the process to prepare it.

The composition is designed to enhance the solubility and bioavailability of the active compounds, thereby improving their therapeutic potential. It has applications in the treatment of various cancers, including breast and prostate cancers, particularly through oral administration.

The patent adds to Godavari Biorefineries Limited’s oncology-focused intellectual property portfolio.

“In oncology research, identifying a promising compound is only one part of the challenge. How that compound is formulated can determine how effectively it can be developed for therapeutic use. Our research has focused on improving the solubility and bioavailability of these compounds, and the grant of this European patent is an important recognition of that work,” said Dr Sangeeta Srivastava, Executive Director, Godavari Biorefineries Limited.

Commenting on the achievement, Samir Somaiya, Chairman and Managing Director, Godavari Biorefineries Limited said, “Our approach to innovation has always been guided by a larger purpose, to advance health, wellbeing and sustainability while creating lasting value for all. The Sanskrit mantra ‘सर्वे सन्तु निरामयाः’, meaning ‘Health for All’, reflects this purpose and reminds us that the true value of innovation lies in its ability to improve lives. As we look beyond our traditional businesses, our investments in R&D are enabling us to build capabilities in areas where science and technology can address meaningful societal needs. This European patent is an important milestone in that journey, strengthening our intellectual property and opening possibilities for developing solutions with potential applications in healthcare. For us, innovation is meaningful when it creates sustainable opportunities for the business while also contributing to a healthier and more sustainable future for society.”

The European grant further expands Godavari Biorefineries’ international intellectual property footprint as the company continues to protect its research across major markets worldwide.

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This article draws on peer-reviewed research conducted at SP Jain School of Global Management and published in Bioengineering (2025, 12, 35). The study develops a novel machine learning methodology for diabetes prediction that outperforms existing algorithms when clinical data suffer from class imbalance.

The clinical stakes of getting prediction right

Diabetes remains one of the most consequential public health challenges worldwide. According to the International Diabetes Federation’s Diabetes Atlas (11th edition, 2025), an estimated 589 million adults aged 20–79 are living with diabetes, and that figure is projected to reach 853 million by 2050. 

Early detection is critical: when clinicians can identify at-risk individuals before the disease takes hold, lifestyle interventions and targeted treatment can slow or even reverse its progression. Machine learning offers a powerful tool for this purpose, sifting through biological and social indicators to flag patients who might otherwise be missed.

Yet a persistent technical obstacle undermines many predictive models. Real-world clinical datasets are frequently imbalanced: healthy patients vastly outnumber diabetic ones. In the widely used PIMA Indians Diabetes Dataset, for example, roughly two thirds of observations are non-diabetic. A classifier trained on such data can achieve deceptively high overall accuracy simply by predicting the majority class, while failing to identify the very patients who most need attention. The consequences in a clinical setting are serious: missed diagnoses, delayed treatment, and poorer health outcomes for the most vulnerable.

A simpler path to better predictions

Our research, conducted at SP Jain School of Global Management in collaboration with Sofia University, set out to address this class imbalance problem without resorting to computationally expensive deep learning architectures or elaborate feature selection procedures. The methodology we propose introduces two straightforward preprocessing steps—resampling and random shuffling—before applying a standard support vector machine classifier with balanced class weights and k-fold cross validation.

Resampling supplements the minority class so that both classes are represented more evenly in the training data. Random shuffling then rearranges the order of observations, preventing the model from learning spurious patterns tied to the sequence of the data rather than the genuine relationships among variables. These steps are combined with Python’s built-in balanced class weighting and tested under both standard k-fold and stratified k-fold cross validation. The entire pipeline is simple to implement, fast to execute, and requires no specialist hardware.

Results that rival deep learning

The results are striking. Our proposed methodology achieved a classification accuracy of 95.5 per cent on the PIMA dataset, with 100 per cent specificity and over 91 per cent sensitivity. By comparison, the classical approach—shuffling and balanced class weights alone, without resampling—yielded accuracies between 83 and 85 per cent and notably lower sensitivity scores. The proposed methodology also outperformed published results from several other research groups using Random Forest, Naive Bayes, Adaboost, and SHAP-based ensemble methods on the same dataset.

Perhaps most remarkably, our simple machine learning pipeline came within roughly 2.5 percentage points of the best reported deep neural network accuracies, while achieving a perfect specificity of 100 per cent—a result none of the deep learning benchmarks matched. This means our model correctly identified every non-diabetic patient in the test set, producing zero false positives. In clinical terms, that translates to fewer unnecessary follow-up procedures and reduced patient anxiety, while still detecting over 91 per cent of diabetic cases.

Why it matters for healthcare

The practical implications extend well beyond a single dataset. The methodology avoids feature selection, which eliminates an entire source of researcher bias and saves considerable analytical time. It is agnostic to the type of cross validation, performing comparably under both k-fold and stratified k-fold approaches, which suggests robustness across datasets of different sizes and structures. And because it relies on standard Python libraries rather than bespoke deep learning frameworks, it can be deployed in resource-constrained clinical environments where computational infrastructure is limited.

For public health professionals and policymakers, this work offers an accessible, evidence-based tool for diabetes prescreening. By improving the identification of at-risk individuals, clinicians can allocate preventive resources more effectively, tailor interventions to individual risk profiles, and ultimately reduce the burden of a disease that exacts an enormous toll on patients, families, and health systems.

Looking ahead

Future work at SP Jain School of Global Management will extend this methodology to larger diabetes datasets, multiclass classification problems, and datasets with high-dimensional feature spaces. We also plan to incorporate additional evaluation metrics such as the Matthews Correlation Coefficient and nested stratified cross validation to further strengthen model reliability. As artificial intelligence becomes increasingly embedded in healthcare decision-making, ensuring that predictive models are not only accurate but also simple, interpretable, and ethically sound is an imperative that this research directly serves.

This research was conducted at SP Jain School of Global Management, Dubai.

Reference: Toleva, B.; Atanasov, I.; Ivanov, I.; Hooper, V. An Effective Methodology for Diabetes Prediction in the Case of Class Imbalance. Bioengineering 2025, 12, 35.

https://doi.org/10.3390/bioengineering12010035

https://idf.org/news-and-resources/news/idf-diabetes-atlas-11th-edition/

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ACG has appointed Lalit Kasliwal as Group Chief Financial Officer, with responsibility for the company’s global finance function across its pharmaceutical and nutraceutical manufacturing businesses.

In his new role, Kasliwal will lead financial strategy, treasury, governance, capital allocation and risk management to support ACG’s long-term ambitions.

Kasliwal brings more than 27 years of global leadership experience across financial strategy, treasury, capital allocation and structuring, governance, enterprise transformation and risk management in the pharmaceutical, manufacturing and international trading sectors.

He joins ACG from Tata International Limited, where he served as Chief Financial Officer and Company Secretary, leading the global finance function for operations across more than 29 countries. Before this, he served as CFO – Group Manufacturing and Head of Group Insurance at Reliance Industries Limited. Earlier in his career, he held senior finance leadership positions with Vedanta Group, including Hindustan Zinc Limited and Sterlite Technologies Limited, Ruia Group and IPCA Laboratories Limited.

Karan Singh, Managing Director at ACG, commented; “We are delighted to welcome Lalit to ACG. He brings a wealth of global experience, a strong track record of financial leadership and a deep understanding of complex international businesses. His expertise will be invaluable as we continue to strengthen our operations and pursue the next phase of our growth strategy.”

Lalit Kasliwal added; “I am delighted to be joining ACG at an exciting stage of its global growth journey. I look forward to partnering with colleagues across the organisation to strengthen financial performance, enhance governance and support sustainable long-term value creation for our customers, partners and stakeholders.”

The appointment comes as ACG continues to expand its global presence and invest in technologies and solutions that support pharmaceutical and nutraceutical manufacturers worldwide.

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ACG has appointed Rajesh Bhogavalli as Group Chief Commercial Officer as the company continues its international growth, operational excellence and commercial transformation across its pharmaceutical and nutraceutical manufacturing businesses.

As Group Chief Commercial Officer, Bhogavalli will lead the Group’s global commercial strategy, strengthen strategic partnerships, drive cost-optimisation initiatives and support market expansion.

Bhogavalli brings more than 30 years’ experience in commercial strategy, global supply chain and business transformation. Before joining ACG, he spent almost 12 years with EPL Limited, formerly Essel Propack Ltd., most recently as President – Supply Chain & Sustainability (Global), leading operations across 11 countries. He has also held senior leadership positions with BASF India and Asian Paints.

Bhogavalli holds an MBA in Operations Management from IGNOU and an MSc in Physical Chemistry from Andhra University.

Karan Singh, Managing Director at ACG, said: “We are delighted to welcome Rajesh to ACG. He brings a wealth of global experience, a strong track record in commercial strategy and operations, and a deep understanding of complex international businesses. His expertise will be invaluable as we continue to strengthen our operations and pursue the next phase of our growth strategy.”

Rajesh Bhogavalli said: “ACG has built an outstanding reputation across the pharmaceutical manufacturing ecosystem, and I’m excited to join the business at such an important stage of its growth. I look forward to further strengthening our commercial strategy, deepening customer relationships and supporting the company’s continued global expansion.”

The appointment comes as ACG continues to expand its global presence and invest in technologies and solutions that support pharmaceutical and nutraceutical manufacturers worldwide.

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Optimus Pharma, a subsidiary of Sekhmet Pharmaventures, has become the first company in India to receive permission from the Drugs Controller General of India (DCGI) to manufacture and market Tapinarof Cream 1 per cent w/w and the tapinarof bulk drug.

Tapinarof Cream 1 per cent w/w is a non-steroidal topical treatment for plaque psoriasis in adults.

Psoriasis is a chronic, non-communicable skin condition that the World Health Organization estimates affects at least 100 million people worldwide. Indian studies place prevalence in the country between 0.44 and 2.8 percent, with plaque psoriasis the most common presentation. Many patients depend on long-term topical therapy, where options beyond corticosteroids have remained limited. Tapinarof, a topical aryl hydrocarbon receptor agonist, provides a non-steroidal option for the management of plaque psoriasis in adults.

Optimus’ clinical study in India enrolled 213 patients with moderate-to-severe plaque psoriasis. Tapinarof Cream 1 per cent w/w demonstrated statistically significant superiority over placebo in achieving Physician Global Assessment (PGA) success at Week 12.

Significant improvements compared with placebo were also observed in the Psoriasis Area and Severity Index (PASI ≥50), percentage reduction in Body Surface Area (%BSA) involvement, the Peak Pruritus Numeric Rating Scale (PP-NRS) and Psoriasis Symptom Diary (PSD) scores. Numerical improvements were observed in higher PASI response rates (PASI ≥75 and PASI ≥90). Additionally, significant improvements were seen in Dermatology Life Quality Index (DLQI) scores.

Tapinarof Cream 1 per cent w/w was well tolerated in Indian patients, and no immunogenicity concerns were identified during the study.

Tapinarof Cream 1% w/w and its bulk drug are manufactured at facilities operating cGMP-compliant quality systems. These facilities have undergone inspections by regulatory agencies including the US FDA and European authorities, and are designed to ensure product quality, reliability and patient safety through controls across manufacturing, testing and supply operations.

With both the bulk drug and the finished formulation produced in-house, Optimus maintains control across the end-to-end manufacturing journey, from drug substance to finished dosage form, supporting consistency, traceability and quality at every stage.

The approval reflects the company’s capabilities in the development and manufacture of complex and differentiated formulations, enabling early launch through its strategic partners and making products available to Indian patients.

Sumit Kumar, Chief Commercial Officer, Sekhmet Pharmaventures, said: “The approval for Tapinarof Cream 1 per cent w/w and its bulk drug is a significant milestone for Sekhmet and a testament to the strength of our R&D, regulatory, quality and manufacturing capabilities. The group is backed by more than 250 scientists, reinvests over 12 percent of revenue into R&D, and has filed more than 300 patents and secured over 170 grants. Being the first company in India to receive this permission reflects our commitment to bringing differentiated pharmaceutical products to patients while maintaining the highest standards of quality and compliance.”

Optimus’ Tapinarof Cream 1 per cent w/w is a prescription-based drug. Patients are advised to consult their doctors for more details.

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Spevatamig is a bispecific antibody targeting claudin 18.2 and cluster of differentiation 47 (CD47), designed to function as an innate immunity enhancer (I₂E).

The fast track designation for BTC follows other recent regulatory milestones for spevatamig.

In 2024, the antibody received the designation for metastatic claudin 18.2-positive pancreatic adenocarcinoma, and orphan drug status for metastatic pancreatic cancer in 2022.

Phanes Therapeutics expanded a clinical trial partnership with Merck & Co (MSD) last month to examine spevatamig in combination with pembrolizumab as a first-line treatment for BTC.

The companies began their collaboration in 2023 to study this combination therapy.

Phanes Therapeutics CEO Ming Wang said: “Spevatamig has the potential to be a transformational treatment option for patients with BTC.

“Following the successful completion of enrolment in our Phase II clinical trial of spevatamig in combination with chemotherapy for the front-line treatment of metastatic pancreatic ductal adenocarcinoma, we are making significant progress in the Phase II study of the molecule in BTC.”

The company is conducting three separate Phase II studies of its pipeline assets, notably spevatamig, peluntamig, and mavrostobart.

Both spevatamig and peluntamig are described as first-in-class bispecific antibodies and secured fast track and orphan drug status from the FDA.

The company’s pipeline is built using its PACbody, SPECpair and ATACCbody technology platforms, with the aim of addressing significant unmet needs in cancer treatment.

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The submission is supported by efficacy and safety data from the Phase III VALOR clinical trial, which enrolled 9,437 participants aged five years and above across the US, Canada, and Europe.

In the study, PF-07307405 showed efficacy of more than 70% in preventing Lyme disease. The vaccine candidate was found to be well tolerated with no identified safety concerns, according to the companies.

Pfizer senior vice-president and chief vaccines officer Annaliesa Anderson said: “I’m proud of the progress we have made with our Lyme disease vaccine candidate and excited about the opportunity to potentially bring the first vaccine of its kind to Europe. I look forward to collaborating with the EMA as this vaccine candidate advances through the review cycle.”

“Lyme disease remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year. When left untreated, it can lead to serious and potentially long-lasting complications involving the skin, joints, nervous system, and heart.

“We believe vaccination has the potential to provide an important new layer of protection against this debilitating disease and help people continue to enjoy the outdoors with greater confidence.”

Pfizer and Valneva began collaborating on PF-07307405 in April 2020, with the former holding exclusive manufacturing and commercialisation rights if regulatory approval is achieved.

The vaccine is a 6-valent outer surface protein A (OspA)-based protein subunit, targeting six Borrelia OspA serotypes found in North America and Europe.

Currently, no approved human vaccines exist for Lyme disease.

In June 2026, Pfizer received approval from the US Food and Drug Administration for an expanded indication of Hympavzi (marstacimab-hncq) to treat haemophilia A or B.

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Tata Consultancy Services (TCS) has launched TCS ADD AgentHub, a role-based, enterprise-ready and trusted AI platform that enables the use of agentic AI in drug development at scale. The platform is designed to transform clinical trials and pharmacovigilance services while maintaining regulatory and audit requirements.

Pharmaceutical companies operate in regulated environments and face challenges related to trust, governance and scalability when applying AI across functions. Growing data volumes, fragmented systems and increasing regulatory expectations across clinical development and pharmacovigilance are adding complexities across the R&D value chain.

TCS ADD AgentHub provides a framework to address these challenges. Within the framework, AI agents can operate with clear roles, defined oversight and built-in auditability. Pharmaceutical companies can custom build their AI agent hub and deploy it across clinical workflows. The platform enables integration with minimal effort to accelerate adoption while maintaining regulatory compliance.

Built on the TCS ADD framework, TCS ADD AgentHub delivers operational benefits across drug development and drug safety functions. Solutions powered by the platform have demonstrated up to 40 per cent efficiency gains in clinical data management activities, up to 30 per cent reduction in clinical study build effort through metadata-driven automation and up to 30 per cent cost savings in end-to-end safety case processing. AI-powered safety agents can also reduce quality control effort by as much as 50 per cent.

Built on the TCS ADD agentic AI architecture, TCS ADD AgentHub enables pharmaceutical companies to deploy a Human + AI Operating Model in which AI agents are embedded into enterprise workflows, with humans retaining responsibility for governing and decision-making.

Debashis Ghosh, President, Lifesciences and Healthcare, TCS, said, “TCS ADD AgentHub, is a role-based, enterprise-ready, and trusted AI platform that will enable our customers to accelerate drug development using agentic AI at scale. It enables a shift from reactive to proactive, scalable, and audit-ready operations amidst an ever-changing regulatory environment. TCS’ strategy is to move towards autonomous enterprise functions where AI agentic workforce operates alongside humans driving innovation in drug development and improving patient safety.”

TCS ADD AgentHub supports workflows across clinical development and pharmacovigilance through AI workers for ICSR intake, data entry, coding, review and literature analysis; study design, protocol digitisation and clinical data review; SDTM (Study Data Tabulation Model) transformation; and medical monitoring assistance, among others.

The platform has an evolving catalogue of AI agents that can be deployed based on specific requirements and the existing landscape. These agents can be deployed progressively with minimal integration and implementation effort. By standardising how AI agents are deployed across these processes, the platform helps organisations improve productivity and enables scientific teams to focus on higher-value work.

TCS said its “AI-first” culture, exemplified by TCS ADD AgentHub, supports its aspiration to become the world’s largest AI-led technology services company. By leveraging the proprietary cognitive intelligence of the TCS ADD suite, TCS enables tangible, predictive and secure digital ecosystems for its customers.

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The 75th Indian Pharmaceutical Congress (IPC) will be held from 18-20 December 2026 at the Yashobhoomi Convention Centre, Sector 25, Dwarka, New Delhi. The Platinum Jubilee edition is being organised by the Indian Pharmaceutical Congress Association (IPCA) and the Indian Pharmacy Graduates’ Association (IPGA).

The theme of IPC 2026 is “Transforming India from Pharmacy of the World to Pharma Powerhouse @2047”, aligned with the national vision of Viksit Bharat – Viksit Pharmacy.

According to the event documents, the Congress will bring together scientists, academicians, industry leaders, regulators, healthcare professionals, researchers, policymakers, entrepreneurs and students from India and other countries to exchange knowledge, foster collaborations and discuss the future of pharmaceutical science and the profession.

The programme will include plenary lectures, keynote addresses, scientific sessions, symposia, workshops, Continuing Professional Development (CPD) programmes, panel discussions and a CEO Conclave. It will also include a pharmaceutical expo, oral and poster presentations, student competitions, innovation challenges, a job fair and career development opportunities.

The Congress will focus on pharma education, research, industry, healthcare and professional practice. The event documents also identify innovation, advanced research, artificial intelligence, biotechnology, precision medicine, sustainable manufacturing, resilient supply chains and globally harmonised regulatory systems as areas relevant to the sector’s development towards 2047.

The 75th IPC will also include discussions involving industry, academia, research institutions, government and healthcare professionals. The documents state that the Congress will provide a platform for scientific deliberations, technology exchange, business networking and collaborative partnerships.

The event will feature PharmaExpo 2026. The documents also list Pharma PowderTech Expo 2026, covering powder processing, particle engineering and pharmaceutical manufacturing technologies. The expo will include areas covering filling, blending, granulation and drying; nutraceutical powder supplement systems; laboratory testing and quality-control equipment; stainless steel equipment and process components; plant engineering and turnkey project solutions; contract manufacturing and processing services; excipients, pharmaceutical ingredients and specialty materials; research, consultancy, validation and regulatory services; and research laboratories, academic institutions, government departments, regulatory organisations, trade organisations, investors, innovators and start-ups.

The event documents also outline sponsorship opportunities for the 75th IPC. The listed sponsorship categories are Principal Sponsor at Rs 100 lakh, Platinum Sponsor at Rs 75 lakh, Gold Sponsor at Rs 50 lakh and Silver Sponsor at Rs 25 lakh.

Sponsorship opportunities also include hospitality, scientific sessions, resource persons from abroad, entertainment programmes, delegate kit bags, uniforms and caps for student volunteers, gifts in kit bags, mementos, scientific schedule booklets, stationery for delegates and cosmetics items in kit bags.

The documents state that the Congress has been held since 1948, with the first Indian Pharmaceutical Congress held at Kota, West Bengal, in December 1948. The IPGA was established in 1971 and has branches across more than 20 states and 10 local chapters, according to the event material.

The event will be held at Yashobhoomi Convention Centre, Sector 25, Dwarka, New Delhi, from Friday, 18 December to Sunday, 20 December 2026.

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Lupin has received final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pitolisant Tablets, 4.45 mg and 17.8 mg.

The U.S. FDA has approved Lupin’s Pitolisant Tablets, 4.45 mg and 17.8 mg, as bioequivalent to Wakix for the indications in the approved labelling.

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Aurobindo Pharma said the United States Food and Drug Administration (USFDA) has classified its Raleigh plant in North Carolina, USA, as “Voluntary Action Indicated” (VAI) following an inspection conducted in 2025.

Pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, the company said the USFDA inspected the Raleigh plant from March 24, 2025, to April 10, 2025. The facility is owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the company, and is established for manufacturing inhalers, dermatology and transdermal products.

At the end of the inspection, Form 483 was issued with a total of 11 observations.

The unit has now received the Establishment Inspection Report (EIR), which classifies the facility as “Voluntary Action Indicated” (VAI). The USFDA has concluded that the inspection is now closed.

The company said that as the unit is classified as VAI, pending applications for multiple inhalers and other dosage forms filed from the facility can now progress through the USFDA’s review process.

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The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Government of India, has directed all State and Union Territory (UT) Drugs Controllers to take action against the manufacture and marketing of drug products containing Enclomiphene and its combinations without approval from the Central Licensing Authority (CLA).

In a letter dated 10 August 2026, issued by the Enforcement & Intelligence Cell of CDSCO, the Directorate said it had been brought to its notice that certain manufacturers were manufacturing and/or marketing drug products containing Enclomiphene and its combinations without obtaining the requisite permission from the CLA, despite such products falling within the definition of a “New Drug” under the New Drugs and Clinical Trials Rules, 2019.

As per Rule 2(1)(w) read with Rule 19 of the New Drugs and Clinical Trials Rules, 2019, no new drug shall be manufactured for sale or distribution unless it has been granted permission by the CLA.

Further, under Rule 80 of the Rules, any person intending to manufacture a new drug, whether as an Active Pharmaceutical Ingredient (API) or as a pharmaceutical formulation for sale or distribution, is required to obtain prior permission from the CLA by submitting an application in Form CT-21, along with the prescribed fee specified in the Sixth Schedule.

The Directorate said it had observed that Enclomiphene and its combinations had not been approved by the CLA for manufacture and marketing in the country.

Accordingly, it stated that any manufacture, sale, distribution or marketing of such products without prior approval from the CLA would be treated as non-compliance with the provisions of the New Drugs and Clinical Trials Rules, 2019, and the Drugs and Cosmetics Act, 1940.

The State and UT Drugs Controllers have been requested to immediately identify manufacturers, marketers, distributors and retailers dealing with drug products containing Enclomiphene and its combinations without the requisite approval from the CLA.

They have also been directed to initiate appropriate regulatory action under the provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder, including cancellation or suspension of manufacturing permissions, wherever applicable.

The Controllers have further been asked to ensure that such unapproved products are not manufactured, sold, distributed or marketed within their respective jurisdictions.

CDSCO has also sought an action taken report, including details of manufacturers identified, regulatory action initiated and the present status of compliance, at the earliest.

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The Life Sciences Sector Skill Development Council (LSSSDC), operating under the aegis of the Ministry of Skill Development & Entrepreneurship (MSDE), Government of India, will organise ‘LSSSDC Skillverse 2026’, a National Skill Summit for the Life Sciences sector, on 21st August 2026 at Hotel Le Méridien, Hyderabad.

The summit will bring together CXOs, Managing Directors, CEOs, HR Leaders, Manufacturing Heads, R&D Leaders, CSR Heads, academia, government officials, policymakers, industry associations and skill development experts to deliberate on building a future-ready workforce for India’s Life Sciences ecosystem.

As India’s Life Sciences industry expands across Pharmaceuticals, Biotechnology, Medical Devices, Clinical Research and Allied Healthcare, the demand for industry-ready talent has become more critical. LSSSDC Skillverse 2026 has been conceptualised as a platform to bridge the gap between industry expectations and workforce capabilities while promoting collaborative solutions for skill development.

The summit will feature keynote addresses, panel discussions, industry presentations and networking opportunities focused on workforce challenges and emerging opportunities in the sector.

The key themes of Skillverse 2026 will include identifying skill gaps and workforce requirements in the Life Sciences sector; NeeV initiatives and industry-led models for strengthening Skill Development Centres (SDCs); preparing a future-ready workforce for Industry 5.0; strengthening talent, innovation and global operations in Life Sciences through Global Capability Centres (GCCs); and government initiatives for skill development and workforce transformation.

The event will provide a platform for industry leaders to share best practices, discuss emerging trends and contribute towards shaping India’s national skilling agenda for the Life Sciences sector.

Skillverse 2026 reflects LSSSDC’s commitment to creating a skilled, globally competitive workforce by fostering collaboration between industry, academia, government and training institutions. The summit is expected to generate actionable insights and strategic partnerships that will accelerate talent development across the Life Sciences value chain.

LSSSDC has invited organisations, industry leaders, training institutions and stakeholders from the Life Sciences ecosystem to participate in Skillverse 2026 and contribute towards building a skilled, future-ready workforce for India.

The event, titled LSSSDC Skillverse 2026 – National Skill Summit for the Life Sciences Sector, will be held on Friday, 21st August 2026 at Hotel Le Méridien, Hyderabad. It is being organised by the Life Sciences Sector Skill Development Council (LSSSDC) under the Ministry of Skill Development & Entrepreneurship (MSDE), Government of India.

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Zenbexus is said to be the first cereblon E3 ligase modulator (CELMoD) therapy approved by the FDA for MM treatment. Continued approval for this indication may depend on confirmation of clinical benefit in ongoing trials.

In combination with ZDd, Zenbexus received the agency’s decision following results from the Phase III EXCALIBER-RRMM trial.

The study compared Zenbexus, ZDd (n=207) with daratumumab, bortezomib and dexamethasone (n=213) in patients with relapsed or refractory MM.

After a median follow-up of 16 months, 41% of patients treated with ZDd achieved minimal residual disease (MRD)-negative complete response compared to 21% receiving the comparator regimen.

Safety data indicated that 7.8% of patients discontinued ZDd because of adverse reactions.

Serious infections and severe neutropenia were observed, with neutropenia and infections occurring in 90.2% and 78.9% of patients, respectively.

Fatal adverse reactions occurred in 4.9% of patients treated with Zenbexus, with sepsis as the only event affecting more than one individual. Other observed reactions included upper respiratory tract infection, pneumonia, diarrhoea and fatigue.

Bristol Myers Squibb chief medical officer and development head Cristian Massacesi said: “Today’s approval of Zenbexus represents meaningful progress for patients living with multiple myeloma and underscores the power of our targeted protein degradation platform, particularly our CELMoD programmes.

“As the first approved CELMoD, Zenbexus marks the arrival of a new treatment class and is an important milestone in our efforts to expand what is possible for patients with multiple myeloma. And we believe this is only the beginning.

“This approval validates years of scientific research and strengthens our confidence in the potential of this approach as we continue to advance our innovative pipeline on behalf of patients with significant unmet needs.”

This review was conducted under the FDA’s Project Orbis, enabling concurrent regulatory assessment in several other countries.

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The project combines Xanadu’s algorithms team and the University of Alberta chemistry professor Alex Brown.

They will work jointly to create a quantum computing framework that addresses the challenges involved in the discovery of novel photosensitisers.

Existing approaches to identifying effective photosensitisers rely on experimental methods or classical simulations, which the partners say are either slow, costly, or limited in their capacity to account for critical molecular interactions.

Recent results released by Xanadu have used quantum computers to simulate light-matter interactions in photosensitiser compounds, focusing on characteristics such as sensitivity to specific wavelengths and the efficiency of triggering cancer cell death.

Xanadu founder and CEO Dr Christian Weedbrook said: “Current methodologies for developing effective photosensitisers are hampered by a variety of hurdles.

“By leveraging early fault-tolerant quantum computers to model critical light-matter interactions within photosensitisers, we are positioning quantum computing as a highly competitive method for accelerating photodynamic drug discovery.”

Brown said: “Photosensitisers are challenging systems because their performance depends on excited-state processes that are difficult to capture accurately with standard computational methods.

“By combining Xanadu’s quantum algorithm expertise with our experience in modelling photodynamic therapy systems, we’re excited to explore how fault-tolerant quantum computing could provide new tools for understanding and designing more effective light-activated cancer treatments.”

The collaboration is intended to strengthen Xanadu’s quantum-based drug design workflow, with the goal of expanding its use to more complex problems in photosensitiser development.

Brown’s role will include identifying mechanisms that influence therapeutic effectiveness in photodynamic therapy.

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Gulfstream Intelligence has announced the launch of a regulatory intelligence and execution platform for pharmaceutical, biotechnology and life science organisations.

Developed by Gulfstream Life Science, the platform was created by regulatory professionals with more than 25 years of experience in the pharmaceutical and biotechnology industry. Gulfstream Intelligence was developed from experience managing global development programmes, health authority interactions, submissions, labelling, regulatory strategy and regulatory team activities.

Gulfstream Intelligence said regulatory teams have access to information and technology, but their work can remain disconnected across systems, documents, spreadsheets, email and presentations. Regulatory intelligence may be maintained in one system, submission plans in another and labelling in separate documents and spreadsheets, while health authority preparation, gap assessments and programme decisions may be managed through email, presentations and individual files.

Gulfstream Intelligence was built to bring these activities together and help regulatory professionals move from finding information to understanding its implications for a programme and determining the actions required.

The platform brings together global regulatory intelligence and policy, global labelling, global regulatory gap assessments, health authority preparation and simulation, submission planning and critical path management, regulatory document intelligence and decision-ready deliverables.

The global regulatory intelligence and policy function enables teams to monitor guidance, legislation, policy changes and health authority developments across global markets and assess how these changes may affect development programmes.

The global labelling function supports the development and lifecycle management of product labelling, including Core Data Sheets and regional labels such as US Prescribing Information, EU Summary of Product Characteristics and Canadian Product Monograph. Teams can compare regional labelling, identify differences, evaluate new safety and efficacy information and maintain consistency between global and local labelling positions.

The global regulatory gap assessment function enables teams to evaluate programmes and regulatory documentation against regional health authority expectations to identify gaps, risks and actions that may be required before an interaction or submission.

The health authority preparation and simulation function supports preparation for meetings and interactions with the FDA, EMA, MHRA, PMDA, Health Canada and other global authorities by identifying likely questions, areas of concern and issues that may require additional justification.

The submission planning and critical path management function enables teams to develop submission plans, timelines, dependencies and deliverables for INDs, BLAs, NDAs, MAAs and other regulatory milestones, while maintaining visibility into activities that may affect submission timelines.

The regulatory document intelligence function reviews regulatory documents to identify inconsistencies, missing information, potential risks and areas requiring attention. The platform also converts regulatory analysis into structured reports, summaries and editable presentations that can be shared with regulatory teams, development teams and leadership.

“The problem is not simply finding regulatory information. It is what happens after the information is found,” said Scott Morvay, Founder of Gulfstream Intelligence. “After more than 25 years working in regulatory affairs, we have seen how quickly important context can become disconnected as information moves between systems, documents and teams. We built Gulfstream around the way regulatory professionals actually work, from understanding an issue to deciding what it means for the program and ultimately doing something about it.”

Gulfstream Intelligence aims to maintain the connection between the regulatory source, professional interpretation of that information, its impact on the development programme, the resulting actions and the final regulatory deliverable.

For larger pharmaceutical organisations, Gulfstream Intelligence provides a way to maintain continuity across programmes, functions, regions and health authorities. Regulatory intelligence, labelling, health authority preparation, submission planning and document review can remain connected rather than being managed as separate workstreams across multiple systems.

For emerging and mid-sized biotechnology companies, Gulfstream provides the same capabilities in one environment. The company said this can support regulatory teams managing broad responsibilities with limited internal resources.

Gulfstream Intelligence was built from the experience of regulatory professionals rather than by adapting a general technology platform to regulatory affairs. The company said this experience informed the platform and how its capabilities work together.

Gulfstream uses artificial intelligence to assist with research, comparison, analysis, planning and drafting, while qualified regulatory professionals remain responsible for reviewing information, interpreting regulatory requirements and making regulatory decisions.

“AI can help us work faster, but regulatory affairs is not simply an information problem,” Morvay said. “Experience matters. Judgment matters. Understanding the development program matters. Gulfstream was built to give regulatory professionals better tools to apply that experience.”

The platform does not replace professional judgment, provide legal advice or independently submit materials to health authorities.

Gulfstream Intelligence is designed to support regulatory teams throughout development, from monitoring changes in the global regulatory environment and assessing programme readiness to preparing for health authority interactions, developing global labelling and planning submissions.

As programmes progress, information generated through these activities can remain connected rather than becoming isolated across separate systems and documents. The platform is designed to provide teams with visibility into what has changed, what it means for their programme, what requires attention and what needs to happen next.

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What is the extent of counterfeiting in India’s pharma supply chain? 

Counterfeit medicines continue to pose a significant risk to patient safety and the integrity of India’s pharmaceutical supply chain. According to the CRISILASPA State of Counterfeiting in India 2025 Report, 28 per cent of consumers reported encountering a counterfeit healthcare product at least once during the last 12 months. The report uses the broader category “healthcare products,” which includes pharmaceuticals, OTC medicines, nutraceuticals, and medical devices following a nomenclature update. 

ASPA believes the threat extends beyond economic losses. Counterfeit medicines directly endanger patient safety, undermine treatment outcomes, erode consumer confidence, and damage the reputation of legitimate pharmaceutical manufacturers.

What are the common modus operandi of such counterfeit operations? 

ASPA observes that counterfeiters have become increasingly sophisticated. Rather than producing obvious imitations, they now: 

• Closely replicate genuine packaging and labels. 
• Attempt to imitate certain security features. 
• Exploit fragmented distribution networks. 
• Use online marketplaces and e-pharmacies to reach consumers. 
• Introduce products containing incorrect ingredients, substandard formulations, harmful substances, or sometimes no active pharmaceutical ingredient at all. 

These evolving tactics make visual inspection alone insufficient and reinforce the need for authentication combined with end-to-end traceability.

What has been the reaction of pharma companies to such incidents? Has it been adequately addressed to prevent future incidents? 

Pharma companies are increasingly strengthening their anti-counterfeiting efforts. ASPA cites examples such as Mankind Pharma, which has adopted authentication and traceability solutions to enhance product security and consumer trust. 

Manufacturers are increasingly viewing authentication not merely as a compliance requirement but as a strategic investment in patient safety and brand protection. 

That said, ASPA’s position is that more needs to be done. Counterfeiters continue to evolve, making isolated security measures insufficient. The association advocates integrated authentication ecosystems combining serialisation, traceability, physical security features, digital verification, and stakeholder collaboration. 

What has been the reaction from policymakers like the CDSCO? 

ASPA welcomes the Government of India’s efforts to strengthen oversight within the pharma packaging ecosystem, including initiatives aimed at improving accountability and traceability. This is a step in the right direction and reflects growing regulatory recognition of the problem. 

At the same time, ASPA believes oversight measures need to evolve into enforceable standards. The association is advocating for the next phase of policy to include mandatory adoption of multi-layered Authentication and Traceability Solutions (ATS) for high-risk drug categories, stricter penal action against counterfeiters and those enabling them, and a national track-and-trace mandate that gives visibility across the entire supply chain, not just at the point of packaging.

The CDSCO has mandated expansion of QR codes to vaccines. What are ASPA’s views, given that QR codes have proven unsuccessful in preventing counterfeiting? 

ASPA welcomes this as a step in the right direction. Extending QR code requirements to vaccines shows the regulator’s intent to improve traceability in a high stakes category. 

However, the solution is complete only when QR codes are combined with other visible and invisible security features. A standard QR code, on its own, carries the risk of being copied or reprinted by counterfeiters just as easily as the genuine one, since it does not by itself authenticate the product. Layering it with tamper-evident features, holograms, and covert or nonclonable markers is what actually closes that gap and gives both regulators and consumers a way to verify authenticity with confidence.

At the 69th Drugs Consultative Committee (DCC) meeting, held virtually on last month on June 24, it was recommended to constitute a subcommittee to evaluate the feasibility of the proposal to introduce an online registration framework for manufacturers/suppliers of printed pharma packaging materials used for drugs. Why does ASPA feel that the printer registration initiative is a meaningful first step, but insufficient on its own? 

ASPA sees printer registration as a welcome and meaningful first step. It strengthens oversight, accountability, and transparency at the packaging stage of the supply chain, an area that has traditionally seen limited scrutiny. However, registration of printers does not, by itself, authenticate a product or track it once it leaves the printing facility. Counterfeiters operating outside registered networks can still replicate packaging design. ASPA’s ask is for this initiative to be paired with clear enforcement mechanisms, such as periodic audits of registered printers and a defined compliance timeline, alongside a broader push for product-level authentication so that oversight extends beyond who printed the packaging to whether the product itself can be verified as genuine. 

Where are the gaps even after printer registration is in place? 

The real gap lies beyond the printing stage. Once a product moves through manufacturing, warehousing, distribution, and retail, visibility drops sharply. There is currently no reliable way to confirm that the medicine reaching a patient at the last mile is the same one that left the manufacturing facility. 

This is a supply chain visibility problem as much as a packaging problem. Diverted stock, parallel distribution channels, and unregulated online sellers can all introduce counterfeit or tampered products at any point after packaging, well outside the reach of printer oversight. Closing this gap requires giving every product a verifiable identity that can be checked at each handoff, not just at the point of origin. 

What kind of authentication technology is essential to close those gaps? 

ASPA’s position is that no single technology can eliminate pharma counterfeiting on its own. 

What is needed is a multilayered Authentication and Traceability Solution (ATS): serialisation for unique product identity, secure or non-clonable QR codes, tamper-evident packaging, holograms and covert security features, RFID/NFC for automated tracking, cloud based verification, and AI-enabled monitoring for anomaly detection. 

This “phygital” approach, combining physical security with digital verification, is what allows a product to be authenticated and tracked through its entire lifecycle, rather than relying on any single checkpoint. 

What do such counterfeiting operations mean for India’s credibility as a global pharma exporter? 

Counterfeiting poses a serious threat to India’s reputation as one of the world’s largest pharmaceutical manufacturers and exporters. Even isolated incidents can undermine confidence among international regulators, healthcare providers, and global buyers, leading to increased scrutiny and affecting trust in the country’s pharmaceutical supply chain. 

As the Pharmacy of the World, India must continue strengthening supply chain integrity through robust product authentication, end -to-end traceability, and advanced anti-counterfeiting technologies. These measures will not only safeguard patient safety but also reinforce India’s credibility as a trusted global supplier of high-quality medicines and support seamless international trade. 

viveka.r@expressindia.com 

viveka.roy3@gmail.com 

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By Lindsey Coulter

• $252 million investment: The new St. Luke’s Heart Hospital represents the largest construction project in St. Luke’s University Health Network’s history.
• 355,000 square feet of space: The five-story facility will significantly expand the St. Luke’s Anderson Campus in Bethlehem, Pennsylvania, adding 140 beds.
• Purpose-built for cardiovascular care: The hospital will include four heart operating rooms, a hybrid operating room, 10 interventional suites, a dedicated cardiac intensive care unit and advanced imaging and life-support capabilities.
• Designed around clinical operations: The facility incorporates dedicated staff circulation routes, expanded support spaces and a rooftop helipad to facilitate efficient patient care and emergency access.
• Opening in October 2026: The Heart Hospital is scheduled to open this fall, expanding St. Luke’s cardiovascular services while adding educational and research opportunities, including a cardiac fellowship program.

BETHLEHEM, Pa. — St. Luke’s University Health Network is preparing to open a new heart hospital at its Anderson Campus in October, adding 140 beds and nearly doubling the size of the campus.

The $252 million St. Luke’s Heart Hospital represents the largest construction project in the health system’s more than 150-year history, both by investment and square footage. The five-story facility encompasses approximately 355,000 square feet and was constructed entirely with American steel. Construction began in 2024 and employed hundreds of skilled workers.

The project expands the Anderson Campus’ capacity for cardiovascular care while consolidating a broad range of specialized services within a purpose-built facility. The hospital will include four dedicated heart operating rooms, one hybrid operating room and 10 advanced interventional suites supporting cardiac catheterization, electrophysiology and interventional radiology.

A dedicated cardiac intensive care unit will provide specialized care for high-acuity cardiac patients. The facility also will feature advanced imaging equipment, heart-lung machines used during open-heart surgery and extracorporeal membrane oxygenation, or ECMO, equipment for patients requiring extended cardiopulmonary support.

Designed Around Clinical Workflow

The Heart Hospital was designed with operational efficiency and patient care in mind. A central corridor on each of the upper floors extends approximately 330 feet, while internal service corridors give staff access to supplies and support areas without relying on primary patient circulation routes.

The facility also includes a rooftop helipad and a larger cafeteria, improvements intended to support both the new hospital and the broader Anderson Campus.

The hospital’s design also supports St. Luke’s educational and research mission. Expanded teaching space and a new cardiac fellowship program are intended to strengthen clinical education while providing additional opportunities for learning and innovation.

The project is part of St. Luke’s broader expansion of cardiovascular services. The health system has built five full-service acute care hospitals in recent years, which it says is more than any other health system in Pennsylvania.

Expanding the Anderson Campus

Located on a 500-acre site overlooking the Lehigh River, St. Luke’s Anderson Campus opened 15 years ago as Pennsylvania’s first new full-service acute care hospital in four decades. The campus has subsequently expanded through several major projects.

A $26 million Specialty Pavilion opened in 2017, adding specialty services and an ambulatory surgery center. In 2020, a $90 million Women & Babies Pavilion added labor and delivery services, a neonatal intensive care unit, graduate medical education space and a simulation teaching center.

The new Heart Hospital will again substantially increase the campus footprint and capabilities. Once fully operational, the facility also is expected to support hundreds of permanent health care jobs.

For St. Luke’s, the project represents a significant investment in both cardiovascular care and the physical infrastructure needed to support a growing regional health system. The Heart Hospital is scheduled to open in October 2026.

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Since acquiring Bassetti Architects in 2025, HMC has been building upon the Portland and Seattle studios’ longstanding strengths in education, civic, and community-focused design. The addition of Brooks and Kruse establishes dedicated healthcare leadership in the region, pairing their local relationships and experience with HMC’s decades of expertise in designing hospitals, outpatient facilities, specialty care, and other complex healthcare environments.

Brooks brings more than 20 years of experience designing healthcare, research, workplace, and civic environments. His portfolio includes Legacy Health Randall Children’s Hospital in Portland, Oregon; the UCSF Nancy Friend Pritzker Psychiatry Building; and the Stanford University Biomedical Innovation Building. His work is grounded in a human-centered design approach that supports healing while balancing patient and staff needs, operational performance, environmental responsibility, and a strong response to place. His experience with mass timber and other high-performance design strategies also complements Bassetti’s longstanding commitment to architecture that is both enduring and sustainable.

As principal-in-charge, Brooks will guide the strategic growth of HMC’s Pacific Northwest healthcare practice, cultivate client relationships, and connect regional opportunities with the firm’s healthcare leaders and resources across the organization.

“The Pacific Northwest’s healthcare organizations are navigating tremendous change, from evolving models of care and workforce pressures to aging infrastructure and growing community needs,” Brooks said. “HMC brings the depth and specialized knowledge to help address those challenges, while our Portland-based team brings an understanding of the region and the people who call it home. We are building a practice that combines firmwide healthcare expertise with deep regional knowledge, a focus on long-term relationships, and design that genuinely improves the human experience.”

Kruse brings 28 years of architectural experience, with extensive work in healthcare planning, design, technical documentation, and project delivery. Throughout her career, she has led projects for hospitals, clinics, behavioral health facilities, emergency departments, pharmacies, imaging suites, and other technically demanding care environments across Oregon, Washington, and beyond.

Her recent work includes projects for Legacy Silverton Medical Center, Samaritan Health Services, Mercy Medical Center, and Snoqualmie Valley Hospital. She has also been an active member of regional healthcare organizations, including the Oregon Society for Healthcare Engineering, Washington State Society for Healthcare Engineering, Women in Healthcare, and The Center for Health Design.

“Advancing health and healing through architecture is more than a professional philosophy for me; it is what motivates me every day,” Kruse said. “The work begins with careful listening and grows through close collaboration and trust. I am excited to bring HMC’s healthcare expertise to the Pacific Northwest and help create environments where patients, families, care teams, and communities can flourish.”

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Momentum

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Ivonescimab is described as an investigational bispecific antibody. The latest marketing authorisation is based on data from the HARMONi-6 multi-centre Phase III study that was conducted in China.

Data for the study were generated, managed, and analysed solely by Akeso.

The HARMONi-6 trial compared ivonescimab in combination with platinum-based chemotherapy against a regimen of the programmed cell death protein 1 (PD-1) inhibitor tislelizumab with platinum-based chemotherapy.

It included patients with locally advanced or metastatic squamous NSCLC, regardless of PD-L1 expression.

The study showed that the combination with ivonescimab produced statistically significant and clinically meaningful improvements in both progression-free survival and overall survival when compared to the PD-1 inhibitor-based regimen.

The safety profile observed was said to be consistent with earlier studies of ivonescimab combined with chemotherapy.

Summit Therapeutics chairman and co-CEO Bob Duggan said: “Today’s approval in China marks another extraordinary milestone for ivonescimab and reinforces the strength of the clinical evidence generated to date.

“HARMONi-6 is the first known Phase III study in NSCLC — or any tumour type — to demonstrate a statistically significant and clinically meaningful overall survival benefit over an anti-PD-(L)1 antibody plus chemotherapy regimen in a head-to-head setting.”

Ivonescimab, which is also referred to as SMT112 in Summit Therapeutics’ licence regions, remains an investigational therapy and is not approved by regulatory authorities in the US or Europe.

As noted by Akeso, more than 4,000 patients have been treated with ivonescimab in clinical studies worldwide, and over 70,000 in a commercial setting in China.

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The latest funding brings the total capital raised by the company to $62m.

The Series A round was led by OG Venture Partners and M Ventures, Merck KGaA, Darmstadt, Germany’s corporate strategic venture arm.

Other new and existing backers include NFX, Qumra Capital, Tadmor Group, TechAviv, and Vine Ventures.

Remepy develops Hybrid Drugs through partnerships with pharmaceutical companies.

These drugs combine prescription medicines with personalised, AI-driven therapeutic applications, aiming to integrate pharmacology with adaptive physical, cognitive, and behavioural interventions into a single treatment regimen.

The company stated that the Hybrid Drug model has gained traction, supported by evolving US regulatory frameworks for drug-software combination products.

Remepy recently disclosed a strategic partnership with Merck KGaA, Darmstadt, Germany to develop hybrid drugs for multiple indications, beginning with rare tumours.

Hybridopa, it’s lead programme for Parkinson’s disease, has reported positive Phase IIa clinical data regarding both motor and non-motor symptom improvement.

It remains an investigational product and has not received approval from the US Food and Drug Administration.

Remepy co-CEOs Michal Tsur and Or Shoval said: “We believe medicine is entering a new era, where every breakthrough drug will be paired with personalised intelligence to maximise its impact for every patient.

“Over the past year, we’ve demonstrated that this vision is achievable through clinical validation, peer-reviewed science, regulatory alignment, and partnerships with leading pharmaceutical companies.

“This financing allows us to advance Phase III of Hybridopa for Parkinson’s disease, and expand the hybrid drug model across multiple therapeutic areas.”

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BASF’s Personal Care business has introduced Floragenist, a range of floral active ingredients developed to address consumer demand for natural beauty with performance supported by scientific studies. Floragenist Rose and Floragenist Blossom are derived from Damask Rose (Rosa damascena) and Bitter Orange blossom (Citrus aurantium var. amara), respectively, and are sourced from Morocco.

BASF said the ingredients are designed to enhance skin radiance and support the skin’s ability to adapt to daily stress. The botanicals are sourced with traceability and responsible sourcing practices.

BASF said the development of Floragenist combines its AquaGenesis extraction technology with epigenetic science. AquaGenesis uses coconut water as a natural solvent to extract bioactive compounds without aggressive solvents. According to BASF, the technology preserves phytochemicals while increasing the concentration of key active molecules. Compared with conventional extraction methods, it delivers enhanced levels of flavonoids for skin care applications.

BASF researchers combined the extraction technology with epigenetic science to develop flower extracts that support the epidermis.

Floragenist Rose is designed to enhance skin radiance by supporting the skin’s expression of “surface optics” proteins. BASF said these proteins are involved in maintaining skin structure and light-reflecting properties, supporting skin cohesion and visible luminosity. Floragenist Rose also addresses the effects of oxidative stress and supports an even-looking complexion. Clinical studies using VISIA imaging reported a 2.7-fold improvement in the appearance of skin luminosity and a 22 per cent decrease in redness at a concentration of 0.4 per cent of the ingredient compared with the placebo group.

Floragenist Blossom is designed to support the skin’s adaptive capacity in response to environmental and lifestyle-related stress. BASF said it supports skin resilience by helping the skin express key skin integrity proteins. This contributes to maintaining the skin’s natural barrier function, improving the appearance of epidermal cohesion and helping the skin cope with external stressors such as mechanical stress, over-cleansing and microbial imbalance. An in vivo study found that harsh cleansing of skin pre-treated with 0.1 per cent Floragenist Blossom for 28 days resulted in 52 per cent lower variation in transepidermal water loss (TEWL) than placebo.

BASF said the development of the Floragenist range is guided by the principles of its Responsibly Active programme for cosmetic bioactives, which focuses on transparency, ethical conduct and environmental responsibility. The ingredients are derived from certified organically cultivated Damask Rose and Bitter Orange, hand harvested in Morocco and traceable to the source. BASF said the Damask Rose originates from a supply chain verified against a sustainable sourcing standard, supporting agricultural practices and creating impacts for local communities.

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The Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Enterprise of the Department of Biotechnology (DBT), Government of India, is showcasing its innovation and start-up ecosystem at a pavilion during the Bharatiya Vyapar Mahotsav (BVM) 2026, being held from August 12–15 at Bharat Mandapam, Pragati Maidan, New Delhi.

Organised jointly by the Confederation of All India Traders (CAIT) and India Trade Promotion Organisation (ITPO), BVM 2026 brings together traders, MSMEs, manufacturers, institutions, investors and policymakers under the theme “Made in India, Made for India, Made for the World”.

The BIRAC pavilion allows visitors, investors, industry leaders and the public to engage with biotech and medtech innovators and understand BIRAC’s schemes, funding instruments and infrastructure supporting the development of laboratory research into market-ready products.

Since its establishment, BIRAC has worked as an interface between India’s scientific research base and industry, supporting the conversion of research into enterprises and products. As an industry–academia interface agency under DBT, BIRAC has developed a network of incubators, bioclusters, accelerators and funding schemes supporting entrepreneurs from proof-of-concept to commercialisation.

BIRAC’s support includes seed and early-stage funding for validating ideas and developing prototypes, access to risk capital through venture funds and co-investment mechanisms, technology transfer and intellectual property (IP) support, bioincubation infrastructure, and regulatory and market-access support.

Its bioincubation network provides lab space, mentorship and technical support, including in tier 2 and tier 3 regions. BIRAC also runs social innovation programmes supporting technologies for affordable healthcare, assistive devices, and solutions for underserved and marginalised communities.

According to BIRAC, these programmes have supported start-ups and MSMEs across therapeutics, diagnostics, medical devices, agri-biotech, industrial biotechnology and clean energy.

A share of the start-ups featured at the BIRAC pavilion are working on medical technology and social impact, including prosthetics, robotic rehabilitation systems and assistive devices for persons with disabilities.

“BIRAC’s role has always gone beyond funding — to de-risk the innovation journey for India’s biotech entrepreneurs, connecting them to capital, infrastructure, mentorship and markets at every stage. The start-ups showcased at our pavilion this year, many of them working on assistive technologies and rehabilitation solutions, are a powerful example of how Indian innovation can be both cutting-edge and deeply inclusive. Platforms like the Bharatiya Vyapar Mahotsav allow us to bring these home-grown solutions closer to industry, investors and the public, and to reaffirm BIRAC’s commitment to building a self-reliant, globally competitive Indian bio-economy.” Stated Dr. Dhananjay Kumar Tiwary, Managing Director, BIRAC.

Reconstructive Healthcare Solutions  (RHS), founded in 2018 by a maxillofacial surgeon, is an ISO 13485-certified medtech company specialising in virtual surgical planning and 3D-printed anatomical models, surgical guides, splints, and dental and orthopaedic implants. Operating from a GMP facility at IMT Faridabad, Haryana, RHS combines imaging, software integration and manufacturing for patient-specific surgical care and healthcare education.

GenElek Technologies, an IIT Delhi-incubated medical robotics company, develops robotic exoskeletons for gait training and mobility rehabilitation. Its Sencibel Robotic Gait Trainer is a lower-limb robotic exoskeleton with multiple training modes, real-time monitoring and analytics for individuals with neurological and musculoskeletal impairments.

Exobot Dynamics Pvt. Ltd., incubated at IIT Delhi and backed by BIRAC, AIC, IHFC, SACC, NCPEDP, DST and FICCI-Mercedes Benz, develops upper-limb prosthetics and wearable robotic systems. Its GripX product is a myoelectric prosthetic hand designed for Indian clinical workflows. The company is also developing X1, a bionic hand, as part of its “Human Physical AI” vision.

Rymo Technologies Pvt. Ltd., founded in 2020, has developed a neuro-rehabilitation ecosystem combining robotics, VR, AI and electrical stimulation. Its product suite includes Mobi-L, Mend, Nudge, Aura XR and Pulse FES. The company said its products have been installed at 779 sites across 612 clinics and hospitals, including AIIMS, Apollo, Sakra and Manipal.

Translead Medtech Pvt. Ltd., a Bengaluru-based medical device company, has developed Stand at Eaze, an unpowered assistive chair that helps users sit and stand using a compliant hinge mechanism licensed exclusively from biomechanics research at the Indian Institute of Science. The device is CDSCO-registered as a Class A medical device, with clinical evaluation underway at partner hospitals.

Torchit, a social technology company, develops assistive technologies including the Saarthi Smart Mobility Aid, the Jyoti AI ecosystem, AI Vision Glasses and AI Reader, braille technologies and the Saksharta Inclusive Education Kit. The company works with government bodies, NGOs, hospitals and CSR partners and has impacted over 2 million lives across India and other emerging markets.

Visitors, media representatives, investors and potential industry partners can connect with BIRAC and the participating start-ups at the BIRAC pavilion at Bharat Mandapam through August 15, 2026, for information on BIRAC’s funding schemes and eligibility for start-ups and SMEs, bioincubation and infrastructure support, technology transfer, licensing and IP-related assistance, regulatory and market-access guidance, and partnership, collaboration and investment opportunities with the participating start-ups.

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In pharmaceutical manufacturing, contamination control begins long before products reach final packaging. Raw materials are blended, milled and granulated before being compressed into tablets or filled into capsules. At each stage, there is potential for metal contamination arising from broken sieves, worn equipment, magnets or foreign material introduced with ingredients.

Metal detection forms part of the control strategy applied during these processes. By identifying and removing metal contaminated products while they are still in production, it aids compliance with regulations plus supports quality management within validated and documented systems. 

Why are metal detectors used in pharmaceutical production?

As medications are used directly by individuals, even a small metal contaminant within a tablet, capsule or powder can present a risk to patient safety and product quality. Applicable Good Manufacturing Practice (GMP) requirements, including 21 CFR Parts 210 and 211, require manufacturers to establish appropriate controls to prevent contamination and deliver product quality. Where automated systems are used, GAMP 5 (Good Automated Manufacturing Practice) provides guidance on validation and lifecycle management.

Metal detection provides an automated inspection method capable of identifying stainless steel, ferrous and non-ferrous metal contaminants, including very small particles. In pharmaceutical applications, stainless steel detection sensitivity can reach down to 0.3 mm test spheres, depending on the product and configuration. At this level of sensitivity, inspection plays a vital role in physical contamination control.

Inspection before compression: powders and granules

Active Pharmaceutical Ingredients (APIs) and excipients are handled as powders or granules before tableting or encapsulation. During blending, milling or granulation, metal contaminants may be introduced through equipment wear or raw material handling.

Pharma Gravity Fall (GF-PRO) metal detection systems are designed specifically to inspect these free-flowing materials at vertical transfer points. As powders move by gravity through an enclosed chute, they pass through the detector aperture. If metal contamination is identified, a fast-acting reject mechanism diverts only the affected material from the product stream.

By positioning inspection before compression, metal contaminated material can be removed early in the process, reducing the likelihood of a full batch being affected.

Inspection after compression: tablets and capsules

Once powders have been compressed into tablets or filled into capsules, inspection shifts to the finished dosage form before packaging.

Tablex-PRO is a pharmaceutical metal detection system from Mettler-Toledo designed specifically for solid-dose applications. It integrates directly with tablet presses or encapsulators and de-dusters, to inspect products immediately after formation. As tablets discharge from these machines, they pass through the metal detector and are automatically separated into accepted and rejected streams.

Inspection can take place at speeds of up to 300,000 tablets per hour, depending on the application. If a metal contaminant is detected, a minimal number of tablets or capsules are diverted into the reject container by the fast-acting reject device. This rejection approach helps minimise product loss while maintaining tight process control. A lift flap diverter reject mechanism offers straight-line product flow for delicate products; a side diverter reject mechanism is ideal when inspection height space is restricted.

Blister packs are not typically inspected using conventional metal detectors at this stage because aluminium foil interferes with the detection field. For that reason, inspection is generally focused on unpackaged powders, tablets and capsules.

How do pharmaceutical metal detectors work?

Pharmaceutical metal detectors operate using balanced coil technology. A high-frequency electromagnetic field is generated within the inspection aperture. When metal passes through this field, it disturbs the signal and is detected by the system electronics.

Ultra-high tuned frequency operation, combined with an optimised aperture size, enhances sensitivity particularly for non-magnetic stainless steel contaminants, which can be more difficult to detect. 

When contamination is identified, visual alarms are activated and the reject mechanism diverts the affected product. These events are recorded to provide documented evidence of removal.

Compliance, validation and lifecycle control

In pharmaceutical environments, detection capability alone is not sufficient. Inspection systems must operate within validated frameworks and be supported by documented performance. Metal detection equipment is supplied with documentation to support Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) as part of the wider Equipment Qualification (EQ) process. Ultimately, the EQPac documentation from Mettler-Toledo allows the manufacturer to have a traceable procedure for implementing the metal detection system into their production line. 

Validation and verification activities continue throughout the system lifecycle. Regular sensitivity checks, including Performance Monitoring Routine (PMR) testing, annual performance verification and scheduled revalidation form part of standard site procedures. Systems also maintain controlled records of user access, configuration changes and test results, with reports available via Ethernet or USB to support audit readiness and traceability.

Trained service engineers can also support installation, validation and ongoing maintenance, helping manufacturers maintain consistent inspection performance over time.

Design considerations in pharmaceutical environments

Pharmaceutical production areas are tightly controlled and often space is constrained. Metal detection systems must combine compact design with flexibility to integrate with different tablet presses, de-dusters and transfer points. Adjustable configurations allow the system to accommodate varying tablet sizes and product formats. Flexibility is enhanced with adjustable aperture / reject device height and castors which allow the system to be easily repositioned to integrate with other in-process equipment.

Hygienic design in pharmaceutical environments focuses on cleanability. Mirror-polished, stainless steel construction, smooth surfaces and simplified strip-down procedures support controlled cleaning processes. Touchscreen interfaces and password-protected access contribute to ease of use and controlled operation.

Conclusion

Metal detection remains a core inspection technology within pharmaceutical manufacturing. By inspecting APIs, excipients, tablets and capsules at critical stages, manufacturers can detect and remove metallic contamination before products progress further through production.

In an industry defined by compliance, documentation and patient protection, metal detection supports reliable inspection, validated performance and controlled process management across the system lifecycle.

For more information view: www.mt.com/md-pharma-basics-pr

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By Lindsey Coulter

Michael Ream is a Director of Sales for Enterprise and Healthcare Solutions at ABM, where he draws on nearly 18 years of experience across healthcare operations, environmental services, medical equipment and infrastructure development. He began his career as a janitorial supervisor and advanced through operational leadership roles supporting healthcare facilities and environmental services across the Midwest. 

Today, Ream focuses on enterprise-wide solutions for healthcare clients, combining operational expertise with strategic business development. He holds an MBA and an Infection Prevention certification from the American Hospital Association.  

In this Q&A, Ream discusses the evolving relationship between infection prevention, regulatory compliance, workforce stability and organizational culture—and why proactive safety practices can be more effective than reacting to deficiencies after they occur.  

Hear more from Ream and fellow ABM experts Brian Maiden, Engineering Manager, and Chris Giannotta, Director of Sales for Enterprise and Healthcare Solutions, at the free webinar “Beyond the Hospital: Facility Compliance Challenges in Non-Acute Healthcare” Sept. 1 at 9 a.m. PST.  

Q: How have compliance expectations changed over the last two decades? 

Michael Ream: There will always be new and emerging pathogens. Our understanding of those pathogens—and how they are transmitted from host to host—will continue to evolve. 

COVID-19 is a good example. Our response evolved from initially comparing it to the flu, to implementing social distancing, masking and extensive disinfection protocols, and then adapting those practices as our understanding of the virus changed. That demonstrated how quickly healthcare organizations must respond to emerging information. 

We have seen a similar evolution in life safety and building operations. The industry has moved away from a “replace it when it breaks” mentality toward preventive and increasingly predictive maintenance. The goal should be to develop a preventive and predictive state of mind across the organization. 

Surveys should be more than checking a compliance box. They reinforce best practices in infection prevention, life safety and building maintenance. When those practices are part of everyday operations, organizations remain continuously prepared rather than scrambling when a surveyor arrives. 

Q: How closely connected are infection prevention and regulatory compliance? 

Ream: The goal should always be for patients to leave a healthcare facility in better health than when they entered. 

Healthcare-associated infections remain a serious threat to that goal. According to the CDC, on any given day, approximately one in 38 hospital patients has at least one healthcare-associated infection. 

At its core, regulatory compliance is about patient and staff safety. We have a duty to protect patients, colleagues and everyone who enters the healthcare environment. For that reason, infection prevention and regulatory compliance are completely intertwined. 

When organizations follow, and seek to exceed, recommended best practices from organizations such as APIC, the CDC and AORN, compliance becomes a natural outcome. More importantly, patients and staff are safer. 

Q: Where do organizations struggle to build accountability around compliance? 

Ream: One of the clearest examples is hand hygiene. It can be difficult for employees to see something and feel comfortable saying something, particularly when workplace hierarchies are involved. 

I once witnessed a physician yell at a nurse in front of a patient after the nurse reminded him that he needed to wash his hands when entering the room. The physician then reported the nurse to administration. During the follow-up meeting, the Chief Nursing Officer did an excellent job of removing titles, hierarchy and personal dynamics from the conversation. She brought the discussion back to what mattered: keeping patients and staff safe. The physician ultimately acknowledged that his actions went against policy and established best practices. 

That experience reinforced an important lesson: no person’s title, authority or responsibilities place them above the fundamental goal of patient wellness and safety. A true culture of accountability exists when every employee, regardless of position, is expected and empowered to speak up when safety is at risk. 

Q: What impact does workforce instability have on compliance? 

Ream: The impact is massive. In environmental services, the majority of the budget is labor. However, the solution is not simply to reduce staffing. The key is to recruit and retain great people who are well compensated, well coached, properly equipped and connected to a larger purpose. 

Employees need to see themselves as more than housekeepers, maintenance technicians or support staff. They should see themselves as caregivers and essential members of the broader patient-care team. 

When employees receive the right training and resources—and feel heard, respected and connected to a purpose—they produce better results. Lower turnover creates greater consistency, and greater consistency produces better quality and efficiency. 

Q: How can healthcare leaders become more proactive instead of reactive? 

Ream: There is an important difference between compliance and commitment. Compliance means, “I will do what I have to do to meet the minimum requirement.” Commitment means, “I am bought in, and I am here to help complete the mission.” 

Becoming proactive is ultimately about creating the right culture. Leaders can wear themselves out trying to write enough rules to keep everyone compliant. A stronger approach is to establish a clear culture, a shared goal and a genuine understanding of the organization’s mission, vision and values. 

Training people on the “why” is critical. Employees need to understand that a process is not being followed merely because leadership wants it or because a policy requires it. It is being followed because it protects patients, coworkers and themselves. 

That understanding creates commitment, which motivates people to identify risks earlier and develop proactive, preventive and predictive solutions. 

Q: What is one practical step organizations can take today? 

Ream: Organizations need to create, reinforce and continually drive the right culture. Training should never become a check-the-box exercise. Every process and every decision should begin with safety in mind. 

When safety becomes the foundation of the culture, the organization moves beyond basic compliance toward high performance. Compliance should not be viewed as an “A” rating. Meeting the minimum standard is closer to earning a “C.” An “A” means people are working ahead, anticipating risks and preventing future issues. 

In a high-performing organization, compliance is not the primary activity. It is the natural result of people consistently doing the right things every day. 

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While specific financial terms have not been disclosed, the deal is subject to customary conditions, including relevant regulatory clearances.

It will bring Nordic Pharma’s rheumatoid arthritis business, led by the Nordimet methotrexate franchise, into Alfasigma’s rheumatology portfolio.

This portfolio currently includes Jyseleca, approved for second-line treatment in inflammatory and autoimmune diseases such as rheumatoid arthritis and ulcerative colitis, and marketed by Alfasigma in the EU, EEA, and UK.

In addition, the acquisition covers Nordic Pharma’s products in women’s health, critical care, and ophthalmology.

Following the deal, Alfasigma will operate directly in 18 European countries, and extend its commercial activities to Canada and Japan.

The addition of Nordic Pharma will see approximately 265 new employees join Alfasigma.

Alfasigma CEO Francesco Balestrieri said: “Alfasigma is pursuing a deliberate strategy to identify the right opportunities to build our global specialty and rare disease business, focused on areas of significant unmet need in gastroenterology and immunology.

“The acquisition of Nordic Pharma marks a decisive step forward in that journey, strengthening our European presence and expanding our rheumatology portfolio. By combining our portfolios, scientific expertise and talented teams, we are better positioned to deliver meaningful innovation and value for patients and shareholders.”

Nordic Group CEO Charlotte Phelps said: “Alfasigma is the right partner for Nordic Pharma as we enter our next phase of growth. Both companies are patient-focused, rooted in science and entrepreneurial. We look forward to combining our experience to support patients.”

Alfasigma is a privately owned pharmaceutical company headquartered in Italy, distributing products in more than 100 markets and employing around 4,000 people.

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Under the deal, Mereo BioPharma will receive a non-refundable option fee from Sentynl.

If Sentynl exercises the option, Mereo BioPharma will be eligible for $40m in upfront and research and development payments, and up to $435m in regulatory and commercial milestone payments, along with double-digit tiered royalties on net sales in the US.

Sentynl will have a global licence to manufacture the therapy for AATD-LD and provide funding for the Phase III development programme, which might commence in early 2027.

The companies will jointly streamline the Phase III study design during the option period.

Mereo BioPharma CEO Denise Scots-Knight said: “We are very pleased to have the opportunity to partner with Sentynl to advance alvelestat for patients with AATD-LD. We have been preparing alvelestat for a global Phase III study, backed by positive efficacy data from two Phase II studies.

“We believe Sentynl’s commitment to rare diseases and established commercial infrastructure make them the ideal partner for alvelestat and look forward to collaborating with them during the option period, when we plan to refine the global Phase III study design.”

Alvelestat is designed to inhibit neutrophil elastase, an enzyme linked to inflammation and lung tissue damage. Its tolerability and safety have been assessed in trials involving more than 1,000 patients across several respiratory conditions.

The therapy has secured orphan drug designation for AATD-LD from both the European Commission and the US Food and Drug Administration (FDA), along with FDA fast track designation.

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India’s pharmaceutical exports grew by 6.80 per cent to USD 8.10 billion during April–June FY 2026-27, compared with USD 7.58 billion in the corresponding period of the previous financial year, according to data released by the Pharmaceuticals Export Promotion Council of India (Pharmexcil).

Pharmaceutical shipments increased by 7.13 per cent to USD 2.81 billion in June FY27, compared with USD 2.62 billion in June FY26. June exports were also 6.86 per cent higher than the USD 2.63 billion recorded in May FY27.

Drug formulations and biologicals contributed USD 5.98 billion during the quarter, accounting for 73.85 per cent of total pharmaceutical exports. The category recorded growth of 4.14 per cent over the corresponding period last year.

Bulk drugs and drug intermediates, the second-largest export category, grew by 13.84 per cent to USD 1.36 billion. Vaccine exports rose by 35.68 per cent to USD 0.39 billion, while surgical product exports increased by 11.95 per cent to USD 0.21 billion during the quarter.

NAFTA (North American Free Trade Agreement), Europe, Africa, and Latin America & the Caribbean (LAC) remained the key destinations for India’s pharmaceutical exports during the quarter, collectively accounting for nearly 75 per cent of total pharmaceutical exports. NAFTA accounted for 34.28 per cent of India’s overall pharmaceutical exports.

The United States remained India’s largest pharmaceutical export destination during April–June FY27, followed by Brazil, the United Kingdom, the Netherlands and France. The top 25 export destinations accounted for nearly 70% of India’s pharmaceutical exports, with shipments valued at USD 5.65 billion. Exports to these 25 countries recorded year-on-year growth of 5.50 per cent during April–June FY27.

Commenting on the performance, Mr Namit Joshi, Chairman, Pharmexcil, said, “India’s pharmaceutical export performance demonstrates that the sector continues to combine scale in established markets with growing momentum across a wider set of geographies. The United States remains our largest export destination, with shipments valued at USD 2.50 billion and a 30.89 per cent share, while the strong performance of Brazil, the Netherlands, France and several emerging markets reflects the expanding global footprint of Indian pharmaceutical companies. The double-digit growth recorded across Europe, Africa, Latin America, ASEAN and South Asia is particularly important in the present global trade environment. India must continue consolidating its leadership in generics while building a stronger presence in complex generics, biosimilars, peptides and other innovation-led segments. Our ability to combine quality, regulatory credibility, manufacturing scale and market diversification will determine the strength of India’s next phase of pharmaceutical export growth.”

Mr Bhavin Mehta, Vice Chairman, Pharmexcil, said, “The growth recorded across vaccines, bulk drugs and drug intermediates reflects the increasing depth of India’s capabilities across the pharmaceutical value chain. Vaccine exports increased by 35.68 per cent, while bulk drugs and drug intermediates grew by 13.84 per cent during the quarter. Sustaining this momentum will require continued investments in advanced manufacturing, stronger quality systems, specialised production capabilities and regulatory preparedness. It will also be important to enable Indian MSMEs to upgrade their capabilities, meet international compliance requirements and participate more meaningfully in regulated and emerging global markets.”

Pharmexcil said it will continue to work with the Government of India, the pharmaceutical industry, overseas regulators and international stakeholders to strengthen market access, regulatory cooperation and the global competitiveness of Indian pharmaceutical exporters.

The Council will also support efforts to expand India’s presence across established and emerging markets and enable the industry to move towards higher-value and innovation-led pharmaceutical exports.

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From 12 August 2026, new requirements will begin to apply to packaging placed on the EU and EU associated market countries, with further measures being introduced gradually through to 2040 and beyond . For businesses selling products into Europe, understanding these changes and preparing early will be essential.

What is PPWR?

PPWR (Regulation (EU) 2025/40) aims to reduce packaging waste across Europe by creating harmonised rules around packaging design, sustainability, labelling, recyclability and recycled content requirements.

The regulation has been introduced to:

• Reduce unnecessary packaging
• Improve recyclability and recycling rates
• Increase the use of recycled materials
• Standardise packaging requirements across EU member states
• Support the transition towards a more circular economy

Unlike previous directives, PPWR is a regulation, meaning its requirements apply directly across all EU member states, creating greater consistency for businesses trading across borders.

What Happens on 12 August 2026?

From 12 August 2026, manufacturers placing packaging on the EU market will need to undertake the applicable conformity assessment, prepare the required technical documentation and, where conformity has been demonstrated, draw up an EU declaration of conformity in accordance with Article 39

However, it is important to note that many of the detailed technical requirements relating to recyclability criteria, harmonised labelling and recycled content methodologies are still being developed by the European Commission and are expected to be clarified over the coming years.

This means that while the direction of travel is clear, some aspects of compliance will continue to evolve between now and 240 and beyond.

Who will be Responsible for PPWR Compliance?

One of the biggest questions surrounding PPWR is: who is responsible?

In most cases, responsibility for ensuring compliance will sit with the economic operator placing the packaged product on the EU market. This is typically the brand owner, packer/filler, importer or distributor, depending on the supply chain structure.

As a packaging supplier, Origin’s role is to support our customers by providing relevant product information and documentation where applicable. However, the final responsibility for assessing compliance of the finished packaging configuration will remain with the organisation placing that packaging onto the market.

This is because compliance assessments are expected to require knowledge of:

• The final packaging format
• Product contents
• Labelling and artwork
• Combined packaging components
• Intended end use and market

These factors can only be fully assessed once the final packaged product is known.

How Could PPWR Affect Your Business?

The impact will vary depending on your products and the markets you sell into. Here are the anticipated effects:

• Increased Documentation Requirements: Businesses may increasingly request technical information and supporting documentation from their packaging suppliers to assist with their own compliance assessments.
• Packaging Design Reviews: Businesses may need to review packaging specifications to ensure they align with future requirements around recyclability, minimisation and recycled content targets.
• Future Recyclability and PCR Requirements: Certain packaging categories, particularly plastic packaging, are expected to face increasing requirements around recyclability performance and minimum levels of post-consumer recycled (PCR) content from 2030 onwards.
• PFAS and Material Requirements: From 12 August 2026, initial focus areas are expected to include requirements relating to certain substances, including PFAS restrictions and heavy metal limits.

What About Pharmaceutical Packaging?

The regulation recognises the particular safety, quality and efficacy requirements associated with pharmaceutical packaging.

Specific derogations from certain recyclability and recycled-content requirements apply to immediate packaging of medicinal products. Certain outer packaging may also benefit from a derogation where it is necessary to comply with requirements intended to preserve the quality of the medicinal product.

Other pharmaceutical, secondary and transport packaging will generally remain subject to the wider PPWR requirements unless a specific derogation applies.

How Origin Can Support You

At Origin, we are actively monitoring PPWR developments and working closely with our supply chain partners to understand evolving requirements.

From 12 August 2026, we will be able to start providing supporting product information and documentation, where applicable, to help our customers with their own internal assessments and compliance activities.

This may include information relating to:

• Product specifications and intended use
• Material composition data where available
• Relevant compliance statements and supporting documentation
• Information received from our manufacturing partners

As guidance and secondary legislation continue to develop, we will continue to review our processes and communicate relevant updates to our customers.

Preparing for the Future

Although some technical details are still being finalised, businesses selling into the EU should begin considering:

• Which products are placed on the EU market
• Whether internal compliance responsibilities are clearly defined
• What information may be required from packaging suppliers
• Future packaging design and sustainability objectives

Early engagement can help reduce future disruption and ensure your packaging strategy remains aligned with upcoming regulatory requirements.

Need More Information?

As PPWR requirements continue to develop, businesses may wish to refer to official sources and seek independent advice where necessary. Useful resources may include:

• European Commission – Packaging and Packaging Waste: https://environment.ec.europa.eu/topics/waste-and-recycling/packaging-waste_en
• EUR-Lex – Regulation (EU) 2025/40: https://eur-lex.europa.eu/
• EUROPEN: https://www.europen-packaging.eu/
• European Plastics Converters (EuPC): https://www.plasticsconverters.eu/

If you have questions regarding packaging supplied by Origin and require supporting documentation relating to PPWR, please speak to your Account Manager or contact our Quality Team at origin-qa@originltd.com.

Disclaimer: This information is based on our understanding of PPWR at the time of publication and may change as further guidance and legislation are introduced. Origin will continue to monitor developments and update this information where appropriate. While we are happy to support customers with available documentation and information, responsibility for determining applicability and ensuring compliance with PPWR ultimately remains with the organisation placing the packaged product on the EU market.

The post PPWR: What the New EU Packaging Regulations Mean for Businesses Selling into Europe appeared first on Origin Pharma Packaging.

Amgen has announced plans to open a new Science and Innovation Center at Genome Valley in Hyderabad. The centre will join Amgen’s global Research and Development network, which consists of seven research laboratories, expanding the company’s research and scientific capabilities.

The new site reflects Amgen’s focus on fighting diseases by using biology and technology. By integrating scientific capabilities with data and digital innovation, the company aims to accelerate the discovery and development of medicines for patients worldwide.

“The new center in Genome Valley expands the way we integrate experimental science with data and technology across our global research capabilities and complements our strong U.S.-based Research and Development footprint,” said Jay Bradner, M.D., executive vice president of Research and Development, Artificial Intelligence and Data at Amgen. “By connecting these capabilities, we can learn faster and translate those insights into innovative medicines for patients.”

“Hyderabad has built one of the world’s strongest life sciences ecosystems, with deep capabilities in pharmaceuticals and vaccines. The next chapter is about taking that strength into discovery and innovation. Amgen’s decision to establish its Science and Innovation Center in Genome Valley reflects Hyderabad’s growing role as a global hub for high-value research, bringing together scientific talent, technology and industry at scale. Our ambition is to make Hyderabad a place where the next generation of medicines and therapies can be discovered, developed and taken to the world.” said Shri D. Sridhar Babu, Hon’ble Minister for Information Technology, Electronics & Communications, Industries & Commerce, and Legislative Affairs, Government of Telangana.

The centre is expected to be operational in 2027 and will bring together scientists and technologists across discovery chemistry, drug metabolism and pharmacokinetics and precision medicine, working with Amgen’s research sites around the world. This approach is designed to enhance how medicines are discovered and developed, improving speed, precision and efficiency.

“This new center reflects Amgen’s commitment to advancing scientific excellence, and India will be an important part of our global R&D network” said Som Chattopadhyay, senior vice president of Global Business Solutions and national executive at Amgen. “By expanding Amgen’s global research capabilities through its Hyderabad site, we are enabling deep scientific collaboration and look forward to participating in the local innovation ecosystem.”

Genome Valley offers scientific expertise and infrastructure, and the new facility will complement Amgen’s existing technology and innovation site in Hyderabad. Together, these sites will enable integration of wet-laboratory science with technology, advancing how the company develops medicines.

“Hyderabad’s strong life sciences ecosystem and deep STEM expertise enable us to apply advanced technologies at scale,” said Naveen Gullapalli, managing director, Amgen India. “Our new center at Genome Valley will help integrate biotechnology and digital innovation to serve more patients globally.”

The post Amgen to open Science and Innovation Center at Genome Valley appeared first on Express Pharma.

Sentynl Therapeutics, a US-based biopharmaceutical company and wholly owned subsidiary of Zydus Lifesciences, and Mereo BioPharma Group, a clinical-stage biopharmaceutical company focused on rare diseases, have entered into an option and licence agreement for the US commercial and global manufacturing rights to alvelestat for AATD-LD.

Alvelestat is a neutrophil elastase inhibitor being readied for Phase 3 and, if approved, would be the first oral treatment for this rare, progressive genetic lung disease affecting an estimated 50,000-80,000 individuals in the United States.

The option and licence agreement grants Sentynl the exclusive right to acquire a licence to commercialise alvelestat for AATD-LD in the United States, while Mereo will retain commercial rights in the rest of the world. The agreement also grants Sentynl global rights to manufacture alvelestat for AATD-LD and, on exercise of the option, provides funding for the alvelestat Phase 3 development programme, which could be initiated in early 2027.

“This partnership marks a pivotal moment for Sentynl’s rare disease strategy. Mereo’s alvelestat is a highly promising, differentiated candidate that meaningfully expands our portfolio and has the potential to address an area of significant unmet need,” said Dr Sharvil P. Patel, Managing Director, Zydus Lifesciences Limited. “AATD-LD has a profound impact on patients’ lives. If approved, alvelestat has the potential to be a meaningful new option that could help their quality of life.”

“We take great pride in having built a sustainable approach for developing therapies for ultra-rare conditions, and this partnership allows us to expand that strategic focus to a larger population within the rare disease community, enabling us to help more people,” said Matt Heck, Chief Executive Officer of Sentynl Therapeutics. “For patients with AATD-LD, the current standard of care is demanding, often relying on generalized therapies or frequent intravenous treatments. We see a clear opportunity to improve upon that with alvelestat. Mereo has built a strong foundation for this asset, making them an ideal partner as we collaborate during the option period to prepare for the next phase of development.”

“We are very pleased to have the opportunity to partner with Sentynl to advance alvelestat for patients with AATD-LD. We have been preparing alvelestat for a global Phase 3 study, backed by positive efficacy data from two Phase 2 studies. We believe Sentynl’s commitment to rare diseases and established commercial infrastructure make them the ideal partner for alvelestat and look forward to collaborating with them during the option period, when we plan to refine the global Phase 3 study design,” said Denise Scots-Knight, Chief Executive Officer of Mereo BioPharma.

Mereo will receive a non-refundable option fee from Sentynl and, on exercise of the option, the company would also receive up to $40 million in upfront and R&D payments until NDA filing. Under the terms, Mereo would also be eligible to receive double-digit tiered royalties on US net sales of alvelestat.

Mereo will lead the global Phase 3 study and regulatory interactions until the study is completed. During the option period, the companies will collaborate to advance manufacturing and streamline the Phase 3 study design.

The post Zydus’ Sentynl enters option and licence deal for alvelestat appeared first on Express Pharma.

You have recently stepped into a new role as COO of Shilpa Medicare – Formulations. What excites you the most, and what are you most careful about? 

Joining Shilpa Medicare at this stage of its evolution is both an exciting opportunity and a significant responsibility. What excites me most is the opportunity to contribute to an organisation that has already established strong scientific capabilities and a differentiated position in oncology and specialty pharma. The global pharma landscape is evolving rapidly, and companies that can consistently combine scientific innovation, manufacturing excellence, and regulatory credibility will emerge as long-term leaders. 

I believe there is tremendous opportunity to further strengthen operational excellence, accelerate commercialisation, improve execution speed, and build an integrated quality culture across the organisation. My focus will be on creating sustainable systems rather than short-term achievements. 

At the same time, I am very conscious that growth should never compromise quality or patient safety. The pharma industry operates on trust. Every product we manufacture ultimately reaches patients whose lives depend on our commitment to quality. Therefore, maintaining regulatory compliance, strengthening our pharma quality system, developing our people, and ensuring robust governance will remain non-negotiable priorities. 

For me, sustainable growth is achieved when scientific excellence, operational excellence, and quality excellence progress together. 

You’ve spent much of your career building scale, strengthening operations, and navigating global regulatory environments. How will that experience shape your leadership approach at Shilpa Medicare – Formulations? 

Throughout my career, I have learned that successful pharma organisations are built on systems rather than individuals. My leadership philosophy has always centered around creating processes that are scalable, predictable, compliant, and continuously improving. 

Global regulatory inspections have taught me that compliance cannot be prepared for just before an inspection—it must be embedded into daily operations. This requires cross-functional collaboration where quality, manufacturing, engineering, supply chain, R&D, regulatory affairs, and commercial teams work towards common objectives. 

My approach will emphasise three pillars: 

• Operational excellence: 

Building highly efficient, data driven manufacturing systems that improve productivity while maintaining the highest quality standards. 

• Quality culture:

Moving beyond documentation-driven compliance toward a culture where every employee understands their responsibility toward patient safety and product quality.

• People development:  

Investing in leadership development, technical competency, and empowering teams to make scientific, evidence-based decisions. Ultimately, my objective is to create an organisation where operational discipline and innovation complement each other rather than compete. 

Biosimilars are getting more competitive. Where do you see real room to differentiate today? 

The biosimilar industry has evolved significantly. Price alone is no longer a sustainable differentiator. True differentiation now lies in delivering consistent quality, regulatory confidence, supply reliability, and patient-centric solutions. 

Manufacturing excellence has become a strategic advantage. Companies that demonstrate robust process controls, strong analytical capabilities, and reliable commercial supply will gain greater confidence from regulators and healthcare providers. 

Another important differentiator is lifecycle management. Developing improved formulations, convenient delivery systems, patient support services, and digital health integration can significantly enhance value beyond the molecule itself. 

Global partnerships will also play an increasingly important role. Collaborations that combine scientific expertise, manufacturing capability, and commercial reach can accelerate market access while reducing development risks. 

Finally, digital manufacturing, artificial intelligence, advanced analytics, and continuous manufacturing technologies will become increasingly important in improving efficiency, reducing costs, and ensuring product consistency.

When you look at Shilpa Medicare – Formulations three years from now, what do you want it to be known for? What is the one big bet you think will define whether you get there or not? 

Three years from now, I would like Shilpa Medicare Formulations to be recognised globally for three attributes: uncompromising quality, execution excellence, and scientific innovation. 

I envision an organisation known for consistently delivering high-quality oncology and specialty medicines across global markets while maintaining strong regulatory credibility. The one strategic bet that will define this journey is building an integrated culture of operational excellence supported by digital transformation.

Digital technologies— including electronic quality systems, advanced manufacturing analytics, predictive maintenance, automation, and real-time process monitoring—can transform both compliance and operational performance. However, technology alone is insufficient. Success depends on developing people who understand how to leverage these tools effectively. 

Organisations that successfully combine digital capabilities with strong quality culture will be best positioned for sustainable growth. 

There’s a lot happening in science, be it new therapies or new technologies. How do you decide what is worth investing in and what is just noise? 

Every innovation should ultimately answer one question: Does it create meaningful value for patients, healthcare systems, and the organisation? 

I generally evaluate investments across five dimensions: Scientific differentiation, Unmet medical need, Regulatory feasibility, Commercial sustainability and Operational scalability. 

Not every emerging technology requires immediate adoption. Some technologies generate excitement but lack commercial maturity or practical application. 

Conversely, technologies that improve product quality, manufacturing robustness, regulatory compliance, data integrity, supply reliability, or patient outcomes deserve serious consideration. 

I also believe innovation should not be confined to drug discovery. Process innovation, manufacturing innovation, quality innovation, and digital innovation often generate equally significant competitive advantages. Balanced investment decisions require scientific rigor, business discipline, and long-term strategic thinking. 

As regulatory expectations for oncology and other niche formulations like TDS and ODG rise globally, credibility is becoming a business moat. How do you plan to build that at Shilpa Medicare – Formulations? 

Credibility cannot be built during inspections—it is built every day through disciplined execution. My approach focuses on strengthening the entire Pharmaceutical Quality System rather than isolated compliance initiatives. 

This includes: 

• Robust quality risk management 
• Strong contamination control strategies 
• Advanced data integrity practices 
• Effective deviation and CAPA systems 
• Scientific process validation 
• Comprehensive training and competency development 
• Continuous process verification 
• Transparent quality governance 

For specialised formulations such as oncology products, transdermal systems (TDS), and orally disintegrating dosage forms (ODG), manufacturing complexity demands even greater process understanding and contamination control. 

Equally important is leadership behavior. Quality should never be viewed as the responsibility of the QA department alone. Every function—from R&D to Engineering to Manufacturing—must own quality. 

When this culture becomes embedded throughout the organisation, regulatory confidence naturally follows. 

Which markets are you most focused on right now, and why? 

Our focus should remain balanced between highly regulated markets and highgrowth emerging markets. Highly regulated markets such as the US, Europe, Canada, Australia, Japan, and the UK continue to represent significant opportunities because they reward companies with strong quality systems and regulatory excellence. 

At the same time, emerging markets across Asia, Latin America, Africa, and the Middle East continue to experience increasing demand for high-quality, affordable specialty medicines.

A diversified global presence reduces business risk while creating sustainable long-term growth. Success in these markets will depend not only on obtaining approvals but also on ensuring reliable supply, maintaining regulatory compliance, understanding local healthcare needs, and building long-term partnerships. 

At a strategic level, what do you believe companies like yours should focus on: innovation, partnerships or scale? Why? 

I do not view innovation, partnerships and scale as competing priorities—they are mutually reinforcing. Innovation creates differentiated products and technologies. Partnerships accelerate development, expand market access, and bring complementary capabilities. Scale enables affordability, operational efficiency, and global competitiveness. The companies that will lead the next decade are those capable of integrating all three. 

However, if I had to identify the foundational element, I would say quality-driven innovation. Innovation without quality cannot reach patients. Scale without quality is unsustainable. Partnerships succeed only when built on trust and credibility. 

Ultimately, pharma success is built on a simple principle: delivering safe, effective, high-quality medicines to patients consistently. Everything else—innovation, partnerships, and scale— should strengthen that mission. 

lakshmipriya.nair@expressindia.com 

laxmipriyanair@gmail.com

The post Inside Shilpa Medicare’s growth strategy: Quality, digital and global ambitions appeared first on Express Pharma.

Mistake #1: Looking Only at the Total Fish Oil Content

One of the most common misconceptions is assuming that a higher amount of fish oil automatically means a higher amount of Omega-3. In reality, fish oil contains various fatty acids, and only a portion may consist of Omega-3 fatty acids such as EPA and DHA. When comparing products, consumers should look beyond the total fish oil content and review the actual Omega-3 composition declared on the label.

Mistake #2: Ignoring EPA and DHA Information

EPA (Eicosapentaenoic Acid) and DHA (Docosahexaenoic Acid) are the most recognized Omega-3 fatty acids found in fish oil. Some consumers purchase supplements without reviewing how much EPA and DHA the product actually contains. Clear labeling of EPA and DHA content provides transparency and allows consumers to better understand the composition of the supplement they are purchasing.

Mistake #3: Choosing Based on Price Alone

Price is often an important factor, but it should not be the only consideration. A lower-priced product may not necessarily offer the same level of quality management, traceability, documentation, or supplier oversight as a product supported by structured quality systems. Consumers should evaluate overall value rather than focusing exclusively on cost.

Mistake #4: Not Reading the Product Label

The label contains important information that helps consumers understand the product.

Key details include:

• Ingredients
• EPA and DHA content
• Recommended daily intake
• Storage instructions
• Batch number
• Best-before date

Reading the label carefully allows consumers to make more informed choices and compare products more effectively.

Mistake #5: Overlooking Storage Instructions

Many consumers pay attention to ingredients but overlook storage recommendations. Environmental factors such as heat, humidity, and direct sunlight can affect product quality during storage. Following the manufacturer’s storage instructions helps maintain product integrity throughout its shelf life.

Mistake #6: Ignoring Product Traceability

Traceability is an important indicator of a professionally managed product. Batch numbers and documented records allow products to be tracked throughout the supply chain. Products supported by strong traceability systems provide greater transparency and enable efficient investigation should any quality-related concerns arise.

Mistake #7: Not Considering Quality Systems

The quality of a supplement is influenced not only by its ingredients but also by the systems used to manage it.

Consumers often focus on the product itself without considering:

• Supplier qualification
• Documentation control
• Storage conditions
• Distribution practices
• Quality oversight

Companies that operate under structured quality systems are better positioned to maintain consistency and transparency throughout the product lifecycle.

Mistake #8: Overlooking Regulatory Compliance

Regulatory compliance is an important aspect of responsible product management. In Germany, food supplements must be notified to the competent authority before they are placed on the market. This process helps ensure transparency and supports regulatory oversight. Products introduced through compliant and transparent processes provide additional confidence for consumers and business partners.

The MVS Omega-3 Approach

At MVS Pharma GmbH, MVS Omega-3 is managed through a structured quality framework that emphasizes transparency, traceability, and compliance.

The product benefits from:

• Qualified suppliers
• Defined quality specifications
• Controlled documentation
• Batch traceability
• GDP-aligned storage and distribution practices
• Successful BVL notification prior to market entry

These elements help support consistency and reliability throughout the product lifecycle.

Conclusion

Choosing an Omega-3 supplement involves more than comparing prices or reading marketing claims. Factors such as EPA and DHA content, labeling transparency, traceability, storage conditions, quality systems, and regulatory compliance all contribute to product reliability.

By understanding these common mistakes, consumers can make more informed decisions and better evaluate the products available on the market. A quality-focused approach helps ensure that confidence is built not only on the product itself, but also on the systems that support it.

About MVS Supplements
Omega-3 products can differ in purity, oxidation, concentration, and molecular form. At MVS Pharma, supplements are built as systems. We apply a pharmaceutical development mindset (research, specification, verification, and stability) to ingredients where quality is measurable. We start with purified, contaminant-controlled raw materials and prioritize high- concentration actives. To make sure you get only the freshest, safest, and highest-quality fish oil with every dose, we engineered the first-ever dual protection system, ensuring oxidation control from production to the moment each capsule is consumed.

→ Discover MVS Omega-3 here.

Because quality, safety, freshness, and bioavailability aren’t just goals – they are our standard.

About MVS Pharma GmbH
MVS Pharma GmbH also develops medical products and operates as an audited GDP wholesaler. We run an internal quality management system aligned with GMP principles, employ pharmaceutical professionals, and contribute to specialist publications.

Disclaimer
This content is provided for informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment. Food supplements are not a substitute for a varied, balanced diet and a healthy lifestyle. If you have a medical condition, take medication, are pregnant or breastfeeding, or have health concerns, consult a physician or qualified healthcare professional before using supplements.

The post Common Mistakes Consumers Make When Buying Omega-3 Supplements appeared first on MVS Pharma.

Although food supplements are not classified as medicinal products, they are still subject to comprehensive regulations designed to ensure transparency, accurate labeling, and consumer safety. Understanding these requirements helps explain why Germany is considered one of Europe’s most trusted markets for food supplements.

Protecting Consumer Confidence

One of the primary objectives of German food supplement regulations is to protect consumers by ensuring that products entering the market are properly documented and transparently presented.

Regulatory requirements help ensure that:

• product information is accurate and complete;
• ingredients are clearly declared;
• labeling complies with applicable legislation; and
• responsible companies can be identified.

These measures enable consumers to make informed purchasing decisions based on reliable product information.

Compliance Before Market Entry

Before a food supplement is placed on the German market, companies must fulfil specific legal obligations. One of the most important requirements is the mandatory notification of the product to the competent authority.

This notification process provides authorities with essential product information, including:

• product name;
• composition;
• labeling;
• responsible food business operator.

Submitting this information before market entry supports regulatory transparency and enables effective market surveillance.

The Role of the BVL

In Germany, notifications for food supplements are submitted to the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) (Federal Office of Consumer Protection and Food Safety).

The BVL coordinates information relating to food supplements and supports cooperation with the competent authorities responsible for market surveillance throughout Germany. It is important to understand that product notification is not the same as product approval. The responsibility for ensuring compliance with applicable legislation remains with the company placing the product on the market.

Clear and Transparent Product Labeling

Product labels are one of the most important communication tools between manufacturers and consumers.

German legislation requires food supplement labels to provide clear information, including:

• product identity;
• ingredient list;
• nutritional information;
• recommended daily intake;
• storage instructions;
• warnings where applicable;
• responsible operator details.

Transparent labeling helps consumers understand the product and use it responsibly.

Traceability and Accountability

Germany also places strong emphasis on product traceability. Manufacturers and distributors are expected to maintain appropriate documentation that allows products to be traced throughout the supply chain.

Effective traceability supports:

• product identification;
• quality investigations;
• efficient corrective actions if required;
• consumer confidence.

These systems contribute to responsible product management and regulatory oversight.

Supporting Quality Through Structured Systems

Compliance with regulatory requirements is strengthened by robust internal quality systems. Many responsible companies implement structured processes covering:

• supplier qualification;
• documentation control;
• product specifications;
• storage and distribution;
• corrective and preventive actions;
• continuous improvement.

These quality systems help ensure that regulatory obligations are integrated into daily operations rather than treated as isolated activities.

The MVS Omega-3 Example

MVS Pharma GmbH follows a structured approach to product quality and regulatory compliance. As part of its market introduction, MVS Omega-3 (Fish Oil Capsule) successfully completed the mandatory notification process with the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) before being placed on the German market. This milestone confirms that the required product information, including composition and labeling details, was formally submitted in accordance with German and European regulatory requirements.

In addition, MVS Pharma supports the management of MVS Omega-3 through documented quality procedures, supplier qualification, batch traceability, and a Quality Management System aligned with the principles of EU Good Distribution Practice (GDP). Together, these measures reflect the company’s commitment to transparency, quality, and responsible market participation.

Why These Requirements Benefit Everyone

Germany’s regulatory framework benefits all stakeholders.

• For consumers, it provides greater confidence in product transparency and accountability.
• For distributors and retailers, it supports reliable supply chains and clearly documented products.
• For responsible manufacturers, it establishes a fair and consistent framework that promotes quality, compliance, and consumer trust.

Conclusion

Germany’s strict requirements for food supplements are designed to promote transparency, accountability, and consumer protection throughout the product lifecycle. From mandatory notification and clear labeling to traceability and quality management, these measures contribute to a trusted marketplace for both consumers and industry.

The successful notification of MVS Omega-3 with the BVL demonstrates MVS Pharma GmbH’s commitment to meeting these regulatory expectations and providing a product supported by structured quality systems and responsible product management.

About MVS Supplements
Omega-3 products can differ in purity, oxidation, concentration, and molecular form. At MVS Pharma, supplements are built as systems. We apply a pharmaceutical development mindset (research, specification, verification, and stability) to ingredients where quality is measurable. We start with purified, contaminant-controlled raw materials and prioritize high- concentration actives. To make sure you get only the freshest, safest, and highest-quality fish oil with every dose, we engineered the first-ever dual protection system, ensuring oxidation control from production to the moment each capsule is consumed.

→ Discover MVS Omega-3 here.

Because quality, safety, freshness, and bioavailability aren’t just goals – they are our standard.

About MVS Pharma GmbH
MVS Pharma GmbH also develops medical products and operates as an audited GDP wholesaler. We run an internal quality management system aligned with GMP principles, employ pharmaceutical professionals, and contribute to specialist publications.

Disclaimer
This content is provided for informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment. Food supplements are not a substitute for a varied, balanced diet and a healthy lifestyle. If you have a medical condition, take medication, are pregnant or breastfeeding, or have health concerns, consult a physician or qualified healthcare professional before using supplements.

The post Why Germany Has Strict Requirements for Food Supplements appeared first on MVS Pharma.

Traceability is a fundamental principle of modern quality management. It enables manufacturers and distributors to identify, document, and monitor a product throughout its entire lifecycle, from raw material sourcing to final delivery. In today’s increasingly regulated marketplace, traceability not only supports product quality but also strengthens transparency, accountability, and consumer confidence.

What Is Traceability?

Traceability is the ability to follow the history, movement, and location of a product throughout the supply chain.

For nutritional supplements, this means maintaining documented information that allows a product to be traced from:

• raw material sourcing;
• manufacturing and packaging;
• storage and warehousing;
• transportation and distribution; and
• final delivery to the customer.

A well-designed traceability system provides visibility at every stage of the product journey.

Why Is Traceability Important?

Traceability is much more than a documentation exercise. It plays an essential role in protecting product quality and ensuring responsible product management.

An effective traceability system helps companies to:

• identify products quickly;
• verify product history;
• investigate quality concerns efficiently;
• support corrective actions when necessary; and
• maintain confidence throughout the supply chain.

By maintaining accurate records, companies can respond more effectively whenever additional information about a product or batch is required.

How Traceability Supports Product Quality in Nutritional Supplements?

Quality begins long before a product reaches consumers. Every stage of the supply chain contributes to the final quality of a nutritional supplement.

Traceability helps ensure that:

• approved raw materials are used;
• production activities are documented;
• storage conditions are monitored;
• products are distributed through controlled processes; and
• each batch can be identified throughout its lifecycle.

These measures contribute to consistent product management and support long-term product reliability.

Traceability and Regulatory Compliance of Nutritional Supplements

European food legislation requires food business operators to maintain systems that enable products to be traced throughout the supply chain. This principle supports consumer protection and allows authorities to investigate products efficiently whenever necessary.

Maintaining complete and accurate records demonstrates that a company manages its products in a structured and transparent manner.

Although traceability requirements differ from those applied to medicinal products, the underlying objective remains the same, ensuring that products can be identified, documented, and managed responsibly.

What is The Role of Batch Numbers in Nutritional Supplements?

One of the most visible elements of traceability is the batch number printed on product packaging.

A batch number links the finished product to its manufacturing and quality records. It allows companies to identify:

• when the product was produced;
• which raw materials were used;
• applicable quality documentation;
• storage and distribution records.

For consumers, the batch number may appear to be a simple code, but it forms an essential part of a comprehensive quality management system.

Traceability Throughout Distribution

Traceability does not end after manufacturing. It continues throughout storage and distribution.

Maintaining records of product movement helps ensure that products are:

• stored under appropriate conditions;
• handled according to defined procedures;
• distributed through controlled supply chains; and
• delivered with documented accountability.

These activities contribute to product integrity from warehouse to customer.

Traceability in Nutritional Supplements: The MVS Omega-3 Approach

At MVS Pharma GmbH, traceability is integrated into the Quality Management System supporting MVS Omega-3 (Fish Oil Capsule).

The product is managed through documented procedures covering:

• qualified supplier selection;
• defined product specifications;
• batch identification;
• controlled documentation;
• GDP-aligned storage and distribution practices; and
• product records maintained throughout the supply chain.

In addition, MVS Omega-3 successfully completed the mandatory notification process with the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) before being introduced to the German market. Together with structured documentation and traceability, this reflects MVS Pharma’s commitment to transparency, regulatory compliance, and responsible product management.

Building Consumer Confidence

Consumers increasingly value transparency and accountability when selecting nutritional supplements. A strong traceability system demonstrates that a company understands the importance of quality management and has established documented processes to support product consistency throughout its lifecycle. For distributors, retailers, and consumers alike, traceability provides confidence that products are managed responsibly and that reliable information is available whenever needed.

Conclusion

Traceability is one of the cornerstones of modern quality management. It provides visibility throughout the product lifecycle, supports regulatory compliance, and strengthens confidence in nutritional supplements. At MVS Pharma GmbH, traceability is an integral part of the quality framework supporting MVS Omega-3. Through documented procedures, batch identification, controlled distribution, and transparent product management, MVS Pharma is committed to ensuring that every product is managed with consistency and accountability.

About MVS Supplements
Omega-3 products can differ in purity, oxidation, concentration, and molecular form. At MVS Pharma, supplements are built as systems. We apply a pharmaceutical development mindset (research, specification, verification, and stability) to ingredients where quality is measurable. We start with purified, contaminant-controlled raw materials and prioritize high- concentration actives. To make sure you get only the freshest, safest, and highest-quality fish oil with every dose, we engineered the first-ever dual protection system, ensuring oxidation control from production to the moment each capsule is consumed.

→ Discover MVS Omega-3 here.

Because quality, safety, freshness, and bioavailability aren’t just goals – they are our standard.

About MVS Pharma GmbH
MVS Pharma GmbH also develops medical products and operates as an audited GDP wholesaler. We run an internal quality management system aligned with GMP principles, employ pharmaceutical professionals, and contribute to specialist publications.

Disclaimer
This content is provided for informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment. Food supplements are not a substitute for a varied, balanced diet and a healthy lifestyle. If you have a medical condition, take medication, are pregnant or breastfeeding, or have health concerns, consult a physician or qualified healthcare professional before using supplements.

The post Why Traceability Matters in Nutritional Supplements? appeared first on MVS Pharma.

The clinical partnership will focus on developing combination therapies for patients with RAS-addicted cancers.

It will evaluate combinations such as BeOne’s MTA-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor, BGB-58067, and a trispecific epidermal growth factor receptor × mesenchymal epithelial transition factor × mesenchymal epithelial transition factor (EGFR × MET × MET) antibody, BG-T187.

They will be studied alongside Revolution Medicines’ RAS(ON) inhibitor assets, daraxonrasib; zoldonrasib; elironrasib; and RMC-5127.

Planned studies will explore potential targeted therapy approaches using these combinations.

In a separate component of the arrangement, Revolution Medicines has granted BeOne exclusive rights to develop and commercialise, or solely commercialise, according to territory, its four RAS(ON) inhibitors in certain Asian regions.

The agreement stipulates that Revolution Medicines will receive development and sales milestone payments, along with tiered royalties on net sales from these territories.

Revolution Medicines retains all development and commercial rights for the products outside the licensed regions, notably including Japan and South Korea.

BeOne will also be responsible for funding and conducting a global registrational Phase III trial for one of the Revolution Medicines’ RAS(ON) inhibitors, utilising its internal development resources.

Revolution Medicines will continue to pursue global registrational studies across its broader portfolio.

BeOne co-founder, chairman, and CEO John Oyler said: “We are pleased to enter this collaboration with Revolution Medicines, which gives BeOne the opportunity to evaluate combinations between assets from our oncology pipeline and four promising RAS(ON) inhibitors from Revolution Medicines.

“In parallel, the regional rights transaction allows us to use our global development superhighway capabilities and established commercial presence, with the goal of bringing more medicines to patients with difficult-to-treat cancers.”

In August 2025, BeOne’s investigational Bruton’s tyrosine kinase (BTK) degrader, BGB-16673, received priority medicines (PRIME) designation from the European Medicines Agency to treat Waldenstrom’s macroglobulinemia in individuals previously treated with a BTK inhibitor.

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Jazz Pharmaceuticals plans to fund the acquisition with a combination of cash on hand and existing financing facilities.

Actio Biosciences’ main clinical asset, ABS-1230, is a small molecule inhibitor targeting the potassium sodium-activated channel subfamily T member 1 (KCNT1) ion channel.

It is being investigated for the treatment of KCNT1+ epilepsy, a rare genetic developmental and epileptic encephalopathy.

KCNT1+ epilepsy typically presents in infancy, resulting in frequent and treatment-resistant seizures and significant developmental delays.

Few patients achieve basic milestones, and the disease can be fatal during childhood. For patients whose disease manifests later, symptoms often include disruptive night-time seizures, along with psychiatric and cognitive complications.

There are currently no therapies approved by the US Food and Drug Administration (FDA) for this condition.

ABS-1230 is currently being studied in the ongoing Phase Ib/IIa KYRON trial, which aims to serve as a registrational study in support of a future new drug application in the US.

The asset has secured FDA fast track, rare paediatric disease and orphan drug product designations, and has been accepted into the FDA’s Rare Disease Evidence Principles programme.

As part of the deal, Actio Biosciences will spin out a new private company focused on genetic rare neurological diseases, retaining certain personnel and assets except for ABS-1230. Jazz Pharmaceuticals will hold a minority equity interest in this new entity.

Jazz Pharmaceuticals president and CEO Renee Gala said: “The acquisition of ABS-1230 represents a highly strategic expansion of our rare epilepsy portfolio, building upon the global success of Epidiolex and deepening our leadership in rare and severe epilepsies.

“The emerging clinical profile of ABS-1230 is highly encouraging, and we look forward to closing the proposed transaction and collaborating with our new Actio Biosciences colleagues to address an urgent patient need.”

Financial advisor for Jazz Pharmaceuticals is Moelis & Company, with Hogan Lovells Cadwalader US serving as legal advisor. Actio Biosciences’ financial advisors are J.P. Morgan Securities and Centerview Partners, with legal counsel from Cooley.

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Access to medication and clean water is a balancing act. As the production and access to medication grow, a new set  of water-related challenges presents itself, such as antimicrobial resistance, ecotoxicity, and emerging contaminants  including residual active pharmaceutical ingredients (APIs), and endocrine disrupting chemicals (EDCs) in surface  waters, groundwater, soil, drinking water, or even within the food chain. 

For pharmaceutical companies looking to improve their environmental, social and governance (ESG) performance,  effective water management within manufacturing processes can serve as a strategic lever to translate typical  challenges into opportunities for environmental sustainability and business resilience. Here are some areas that  decision-makers can consider:  

1. Water quality and process resilience  

Water is deeply embedded in pharmaceutical manufacturing—not only as a utility, but as a critical raw material  used across production, formulation, dilution, cleaning, and rinsing processes. Depending on the application,  water demand can be substantial: in some cases, producing a single ton of active ingredient may require  hundreds of cubic metres of water across production and cleaning operations. 

This reliance creates a unique operational challenge. Because water readily dissolves, absorbs, and transports  contaminants, maintaining consistent quality standards becomes essential—not just for regulatory compliance,  but for process integrity and product safety. Most pharmacopeias therefore require pharmaceutical  manufacturers to begin with drinking water and further purify it to application-specific standards, such as  purified water or water for injection (WFI). 

For pharmaceutical manufacturers, water security has become a strategic imperative—not merely an  environmental consideration, but a fundamental pillar of operational resilience and long-term business viability.  As a result, pharmaceutical manufacturers devote significant resources to water purification, microbiological  control, and the maintenance of highly controlled water systems. In an industry where water quality directly  affects both product quality and operational continuity, pharmaceutical water control is a continuous, dynamic  process, rather than a static checkpoint.  

2. Water consumption and reuse  

Water reclamation and reuse are becoming more compelling as rising raw water and discharge tariffs narrow  the cost gap between recycled and fresh water. API manufacturing facilities that generate larger volumes of  wastewater with lower contaminant levels could recycle water for cooling towers, washing applications, and  other ancillary needs.  

Digital monitoring capabilities are also accelerating the adoption of water reuse initiatives. AI-driven predictive  maintenance flags membrane degradation and system wear before it affects performance, while online  microbial analysis gives operators real-time contamination visibility.  

Together, these tools give operators a clearer picture of water and wastewater treatment processes, enabling  informed decisions about optimising water consumption. They also support a more connected view of  operations, where water performance is considered alongside energy use and overall process efficiency. Water  reuse and recycling will increasingly become an essential pillar for the long-term viability of operations. 

3. Solvent recovery  

Spent solvents can constitute between 50-80 per cent of the waste of a chemical API plant, and up to 40 per cent of these  solvents can be regenerated through innovative volatile organic chemicals (VOC) treatment technologies.  Recovered solvents can re-enter production or be sold to third parties—converting what was a disposal cost  into a revenue stream. Technologies capable of achieving these recovery rates are well-established and  deployable at API manufacturing scale. 

Maximising these benefits often depends on how recovery processes are integrated with existing production  and waste handling systems, ensuring that efficiencies gained in one area do not introduce trade-offs in  another. 

By approaching these three areas as an integrated system rather than separate compliance tasks, manufacturers can  convert typical challenges into tangible sustainability and commercial gains. 

Looking beyond individual treatment technologies—to how water, waste, and energy systems interact across an  operation—is where that integration becomes most effective. When these capabilities are brought together,  manufacturers gain a more precise and resilient response to both operational demands and environmental pressures,  safeguarding critical resources and supporting environmental security for manufacturers and the communities they  operate in alike. 

These topics will be explored further in a masterclass series by Veolia for pharmaceutical professionals, with a focus on  building water security and operational resilience through integrated approaches to GMP design, microbial control,  validation, and wastewater management. More information and registration details are available here:  https://go.watertechnologies.com/Pharmaceutical-Masterclass-RP.html 

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Merck is expanding its Singapore laboratory to strengthen analytical and biosafety testing services for customers across the Asia Pacific region. Biosafety testing is a step in the drug development and manufacturing process, helping to ensure that biologics are safe, effective and compliant with regulatory requirements.

The expansion builds on Merck’s global testing expertise of more than 75 years and marks a milestone in providing a local contract testing services portfolio for the region’s growing biopharma industry.

“Localizing these BioReliance testing capabilities means our Asia Pacific biopharma customers can accelerate their development timelines, improve operational efficiency, and meet evolving regulatory and sustainability standards” said Paolo Carli, Head of Advanced Solutions for the Life Science business of Merck. “This investment underscores Merck’s commitment to empowering medicine makers by providing industry-leading analytical and biosafety testing services and technical expertise.”

Merck’s Singapore laboratory will become the first BioReliance facility in Asia-Pacific to offer both Cell Line Characterization services and GMP next-generation sequencing (NGS) capabilities. It will also offer molecular methods including Blazar®, a proprietary platform for rapid virus detection.

The expanded facility aims to support the industry’s move towards quality control testing of biologics and 3Rs (Replacement, Reduction, and Refinement of animal use) through molecular methods.

“Merck’s expansion of the BioReliance lab will bring world-class and next-generation testing services to biopharmaceutical companies in Singapore and the region. We look forward to continuing our partnership with Merck to strengthen Singapore’s ecosystem, build new capabilities within our local workforce, and enable the delivery of innovative therapies to patients,” said Goh Wan Yee, Senior Vice President and Head of Healthcare, Singapore Economic Development Board.

The Singapore BioReliance® lab was opened in 2018, and the expansion will bring the total lab area to over 1,000 square metres. The expansion is also a step in Merck’s broader strategy to support the region’s life science ecosystem and drive scientific progress.

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The healthcare industry reported 87 deals worth $29.5 billion in July 2026, compared with the last 12 months’ average of 85 deals worth $29.6 billion, according to GlobalData. Deal value increased by 55.2 per cent in July 2026 compared with July 2025.

Vertex Pharmaceuticals Inc agreed to acquire Crinetics Pharmaceuticals Inc, a pharmaceutical company focused on developing therapies for endocrine diseases, for $85 per share in cash, representing a total enterprise value of approximately $9.8 billion.

Eli Lilly and Company agreed to acquire AtaiBeckley Inc, a clinical-stage biopharmaceutical company developing therapeutics for mental health conditions, for up to $3.8 billion.

Apollo Global Management agreed to obtain a minority stake in Bayer’s long-acting reversible contraceptives (LARC) business for $3.4 billion. These were the three major deals reported in July 2026.

Venture capital funding decreased by 6.4 per cent in July 2026 compared with July 2025. The healthcare industry reported 83 venture capital (VC) deals worth $2.3 billion in July 2026, compared with the last 12 months’ average of 114 deals worth $3.3 billion.

Chai Discovery Inc raised $400 million in a Series C financing round to build AI models to accelerate pre-clinical drug discovery by predicting and reprogramming the interactions between molecules.

AdvanCell Isotopes Pty Ltd, a clinical-stage radiopharmaceutical company developing targeted alpha therapies for cancer, raised $315 million in a Series D financing round to advance its lead therapy ADVC001 towards registrational development.

Celea Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing treatments for people with serious respiratory diseases, raised $180 million in financing to execute its strategy of unlocking the full potential of deupirfenidone for patients. These were the three major VC deals reported in July 2026.

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India’s pharma and healthcare sectors recorded total funding of $69.8 million across 18 rounds between July 01 and July 31, 2026, according to data from Tracxn. The data covers the HealthTech, Life Sciences and Healthcare sectors in India.

Funding was 34.42 per cent lower than the previous month and 59.71 per cent lower than the same month last year. The previous month was June 01 to June 30, 2026, while the same month last year was July 01 to July 31, 2025.

Stagewise funding in July comprised 12.3 per cent from seed-stage funding, 34.4 per cent from early-stage funding and 53.4 per cent from late-stage funding.

Funding stood at $57.9 million in August 2025, $128.7 million in September, $159.7 million in October, $27.2 million in November and $162.1 million in December. In January 2026, funding stood at $222.0 million, followed by $50.5 million in February, $220.1 million in March, $291.5 million in April, $116.4 million in May, $106.5 million in June and $69.8 million in July.

Iswarya Fertility Center accounted for a $37.0 million deal in July, followed by Arp at $10.0 million, Age Care Labs at $9.0 million, Supply6 at $5.0 million, V6 Clinics at $2.0 million, Mandrake Bio at $1.9 million and FibroHeal at $1.5 million.

Unilever Ventures, Antler and Unicorn India Ventures were the most active VCs. Unilever Ventures participated in one round for Supply6, Antler participated in one round for Mandrake Bio, and Unicorn India Ventures participated in one round for Bioscan Research.

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India is widely recognised as the “Pharmacy of the World” for its large-scale production of affordable medicines. However, the country’s pharmaceutical marketing regulatory framework has not kept pace with international standards. While medicine quality and patient welfare should remain the primary objectives of healthcare, unethical marketing practices continue to influence prescribing behaviour, raising concerns about transparency, accountability, and rational use of medicines.

The current Uniform Code for Pharmaceutical Marketing Practices (UCPMP) is largely voluntary and lacks statutory backing. As a result, compliance depends mainly on industry self-regulation, with limited legal consequences for violations. In contrast, developed countries such as the United States, France, and the United Kingdom have legally enforceable systems that require public disclosure of financial relationships between pharmaceutical companies and healthcare professionals.

The absence of mandatory disclosure in India makes it difficult for patients to know whether prescribing decisions are influenced by gifts, sponsorships, or other financial incentives. Weak grievance redressal mechanisms, fragmented legal provisions, and limited regulatory oversight further reduce public confidence in the existing system.

These challenges become even more significant in rural and underserved areas, where shortages of qualified healthcare professionals and limited access to reliable medical information increase the risk of irrational prescribing and unethical promotional practices. Effective regulation should therefore not only address industry conduct but also strengthen patient protection and promote evidence-based healthcare.

Why reform is necessary?

India can substantially improve its regulatory framework through five key reforms:

• Provide statutory backing to the UCPMP by amending the Drugs and Cosmetics Act.
• Mandate public disclosure of all transfers of value from pharmaceutical companies to healthcare professionals.
• Establish an independent regulatory authority with adequate investigative and enforcement powers.
• Strengthen grievance redressal through a transparent national reporting system.
• Make patient welfare, rational prescribing, and medicine quality the central objectives of pharmaceutical marketing regulation.

These reforms would improve transparency, reduce conflicts of interest, encourage ethical marketing practices, and enhance public trust in the healthcare system. They would also align India more closely with internationally accepted standards while supporting the country’s commitment to Universal Health Coverage.

As India continues to expand its leadership in global pharmaceutical manufacturing, it must also demonstrate leadership in ethical pharmaceutical governance. A robust and transparent regulatory framework will not only safeguard patients but also strengthen the credibility and long-term sustainability of India’s pharmaceutical industry.

Ultimately, the success of pharmaceutical marketing regulation should be measured not by the volume of medicines sold, but by its contribution to patient safety, rational prescribing, and the overall quality of healthcare.

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Amneal Pharmaceuticals has completed its acquisition of Kashiv BioSciences, LLC, creating a fully integrated global biosimilars business with capabilities across research, development, manufacturing and commercialisation. The combination establishes one of the industry’s few fully integrated biosimilars platforms, the company said.

“The completion of this acquisition marks a pivotal step in Amneal’s strategy to become America’s #1 Affordable Medicines company,” said Chirag Patel, Co-Founder and Co-Chief Executive Officer. “With this acquisition, we have created an integrated biosimilars business that can launch multiple biosimilars each year and extends our growth profile into the next decade.”

“We are pleased to welcome the Kashiv team to Amneal and thank our shareholders and other stakeholders for their strong support,” said Chintu Patel, Co-Founder and Co-Chief Executive Officer. “This acquisition helps to position Amneal to capitalize on an unprecedented wave of biologic loss of exclusivity. Together, we will pursue this significant opportunity and work to expand patient access to high-quality, affordable biologic medicines.”

The acquisition combines Kashiv’s biologics research, development and manufacturing capabilities with Amneal’s commercial scale, establishing biosimilars as a major long-term growth pillar within the company’s Affordable Medicines business. The transaction provides Amneal access to the global biosimilars market with more than $300 billion in projected global biologics loss-of-exclusivity over the next decade. The combined portfolio is expected to support a consistent cadence of biosimilar launches for years to come.

The transaction builds on a relationship between Amneal and Kashiv spanning more than a decade, providing a foundation for integration. Integration planning and related activities are underway and are focused on combining the companies’ development and manufacturing capabilities and advancing the biosimilar pipeline.

Goldman Sachs & Co. LLC served as financial advisor and Richards, Layton & Finger, P.A. served as legal counsel to the Committee of Independent Directors of the Board of Directors. Simpson Thacher & Bartlett LLP served as legal counsel, among other financial and compliance advisors, to Amneal.

J.P. Morgan Securities LLC served as financial advisor, Holland & Knight LLP served as legal counsel, and Dhinal Shah Associates served as an advisor in India to Kashiv.

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Lupin has received approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet, the company announced.

The US FDA has approved Lupin’s Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet as bioequivalent to the reference listed drug (RLD) Lokelma for Oral Suspension of AstraZeneca Pharmaceuticals LP. The product is indicated for the treatment of hyperkalaemia in adults.

Sodium Zirconium Cyclosilicate for Oral Suspension (RLD Lokelma) had estimated annual sales of USD 568 million in the US, according to IQVIA MAT June 2026.

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Energenesis’ ENERGI-F703DFU is currently in Phase III clinical development in both Taiwan and the US.

The two companies have also stated their intention to discuss future licensing for manufacturing and commercialisation in Taiwan and selected ASEAN markets, should agreements and regulatory approvals be reached.

The initiative combines Energenesis’ ENERGI drug development platform and ongoing clinical programme with Taiwan Tanabe Seiyaku’s capabilities in pharmaceutical development, production, and commercial operations within Taiwan.

Energenesis Biomedical chairman and CEO Dr Han-Min Chen said: “This agreement is an important milestone as ENERGI-F703DFU progresses from late-stage clinical development toward registration and commercial readiness.

“By combining Energenesis’ development expertise with Taiwan Tanabe’s pharmaceutical capabilities, we aim to establish an efficient pathway for a potential Taiwan NDA and prepare for broader access in Asia.

“We remain focused on completing the Phase III programme and generating the evidence required to bring a new treatment option to patients with diabetic foot ulcers.”

The partnership is expected to enhance efficiency in preparing for the registration process in Taiwan, aim to mitigate commercialisation risk, and provide a basis for expanded regional market access.

For Energenesis, working with Taiwan Tanabe is anticipated to supply established local experience in manufacturing, regulatory affairs, and commercial access.

Energenesis Biomedical expects to complete enrolment for the Phase III study in 2027, after which it will progress to data analysis. If the trial reaches its specified endpoints, preparation of a Taiwan NDA would be prioritised.

ENERGI-F703DFU is a topical small-molecule gel that is intended to promote healing of DFUs by modulating cellular energy pathways.

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Vanflyta received approval in the country in June 2026 for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, as well as for maintenance monotherapy following consolidation chemotherapy.

The indication covers treatment of adult patients with newly diagnosed FLT3-ITD-positive acute myeloid leukaemia (AML) as determined by an appropriate validated diagnostic test. Approval was based on data from the QuANTUM-First trial.

Innovent Biologics executive director and chief commercial officer Vivian Zhang said: “Innovent has continued to expand its product footprint in this field, building a diversified portfolio and strong market presence, including TYVYT (sintilimab injection), Halpryza (rituximab injection), olverembatinib, Fucaso (Equecabtagene Autoleucel Injection), Jaypirca (pirtobrutinib), and the addition of Vanflyta will further enhance our synergistic offerings.”

“Vanflyta will be the 20th product in Innovent’s commercialised product portfolio. Through collaborative efforts, we aim to bring forward innovative medicines to benefit patients with cancer and further strengthen our leadership in oncology.”

Daiichi Sankyo China president Michio Hayashi said: “The partnership with Innovent Biologics reflects our commitment to delivering innovation to patients in China.

“By combining our research and development capabilities with Innovent’s commercial capabilities in China, we believe this collaboration can accelerate access to Vanflyta for patients with newly diagnosed FLT3-ITD-positive AML and ultimately help improve outcomes in this high-risk patient population.”

Last month, Innovent Biologics agreed an exclusive licence deal worth up to $1.1bn with Spero Therapeutics, granting Spero the rights to develop, research, manufacture and commercialise IBI355, also known as SP001, outside Greater China.

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Biodeal Pharmaceuticals announced a growth investment of ₹385 crore from RMB Capitalworks, a joint venture between Rand Merchant Bank and Capitalworks Group. The investment will support the company’s next phase of expansion across specialty pharmaceuticals, manufacturing capabilities, and regulated markets.

Biodeal has built more than two decades of leadership in nasal drug delivery, supported by integrated pharma development and manufacturing capabilities. The investment will support Biodeal’s next phase of expansion, strengthening its positions across Asian markets while accelerating growth across CIS, LATAM, Africa and Europe.

“This investment represents much more than capital – it is a strong endorsement of the platform we have built over the past two decades. At Biodeal, we have consistently focused on creating differentiated capabilities in specialty pharmaceuticals, anchored by leadership in nasal drug delivery and a relentless focus on quality and manufacturing excellence. This milestone reflects the strength of what we’ve built and the scale of what lies ahead. We are delighted to welcome RMB Capitalworks as a long-term strategic partner – we chose to partner with them because of the value they bring beyond capital, and their operational expertise, governance philosophy and growth mindset align closely with our vision as we build a globally competitive specialty pharmaceutical company and advance on our path towards a planned public listing,” said Anurag Kumar, CMD, Biodeal Pharmaceuticals.

“We love founders passionate about building enduring businesses, and we saw that exact fire in Anurag. We work closely with founders to co-create solutions that unlock personal value and provide the long-term financial stability needed to execute ambitious growth plans. Healthcare is a core focus for us, and Biodeal fits our thesis of a differentiated player primed for rapid growth. We are proud to act as true partners, working alongside the Biodeal team to strengthen governance, accelerate expansion, and build a leading pharmaceutical powerhouse,” said Anshuman Malur, Managing Partner, RMB Capitalworks.

A company release informed, “Biodeal has delivered consistent profitable growth over the past five years, with FY26 revenue estimated to grow 60%+ year-on-year and EBITDA margins expanding further. The company is entering its next phase of growth with a clear ambition; to strengthen its position as a globally trusted specialty pharma partner while advancing confidently on its path towards a planned public listing.”

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Zydus Lifesciences (including its subsidiaries and affiliates), an innovation-driven global lifesciences company, launched REVAHALE (Revefenacin), India’s first once-daily nebulised Long-Acting Muscarinic Antagonist (LAMA) indicated for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD).

REVAHALE is the first and only LAMA available in India that combines once-daily dosing with nebulised administration, offering a new treatment option for COPD patients who require nebulised therapy. Designed to provide sustained 24-hour bronchodilation with a single daily dose, REVAHALE addresses important challenges associated with inhaler-dependent therapies, particularly among elderly patients and those with severe respiratory impairment.

COPD remains a significant public health challenge in India and is a leading cause of morbidity and mortality. While inhaled bronchodilator therapies have transformed disease management, many patients continue to experience difficulties using handheld inhalers, cognitive limitations, severe breathlessness, or an inability to generate sufficient inspiratory effort for effective drug delivery.

REVAHALE has been developed to address these unmet needs through a convenient nebulised delivery platform that reduces dependence on inhalation technique and inspiratory flow. The therapy is compatible with standard jet nebulisers, providing flexibility and ease of use for patients and caregivers.

Revefenacin is designed to deliver sustained bronchodilation over 24 hours through once-daily administration. Clinical studies have demonstrated significant and sustained improvements in lung function in patients with moderate to very severe COPD, while maintaining a favourable safety profile. Its lung-selective design is intended to maximise bronchodilatory effects in the airways while minimising systemic exposure.

By combining once-daily administration, compatibility with standard jet nebulisers and sustained 24-hour bronchodilation, REVAHALE offers a differentiated maintenance treatment option in COPD care.

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It aims to accelerate the discovery and validation of new small molecule drug candidates across several disease targets.

By combining Evotec’s screening capabilities, AI-enabled discovery platform and compound libraries with Odyssey’s expertise in autoimmune and inflammatory disease biology, the companies seek to identify validated hit series and advance encouraging therapeutic programmes.

Evotec chief scientific officer Dr Cord Dohrmann said: “Drug discovery increasingly depends on the ability to integrate deep disease biology with advanced experimental and computational approaches to drug discovery.

“This collaboration with Odyssey illustrates well Evotec’s strategy in applying integrated discovery platform technologies to complex disease areas where new approaches are urgently needed.

“Together, we aim to generate differentiated and validated starting points for Odyssey to develop into new therapies for autoimmune and inflammatory diseases.”

This partnership intends to leverage complementary scientific strengths to boost early-stage research and produce new medicines.

Evotec may receive milestone payments based on the delivery of validated hit series successful for targeted diseases, though financial specifics of the agreement remain undisclosed.

Evotec’s expertise covers biologics, small molecules, cell therapies and associated modalities, supported by Molecular Patient Databases, PanOmics and iPSC-based disease modelling platforms.

In a separate development, Niagen Bioscience selected Evotec to support the advancement of NB4168, a small molecule designed for oral pharmaceutical development.

This work will be conducted in collaboration with Niagen Bioscience’s wholly owned subsidiary, NAD Pharmaceuticals, which is focused on developing accelerated ageing and rare genetic disease therapies.

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Ono will work alongside Mediar to utilise its fibrosis-focused discovery platform, expertise in myofibroblast development, and knowledge of fibrosis pathways.

This partnership gives Ono the exclusive option to license worldwide rights to develop and commercialise these therapeutic programmes. The company will also provide an upfront payment to Mediar and support research and development costs.

Ono Pharmaceutical discovery and research corporate officer / executive vice-president Seishi Katsumata said: “Fibro-inflammatory diseases remain areas of significant unmet medical need, and we believe biologics innovation is essential to provide meaningful therapeutic advances.

“Mediar has established deep scientific expertise in fibrosis and antibody discovery. By combining Mediar’s capabilities with Ono’s experience in immunology and inflammation research area, we aim to create novel antibody therapeutics that may offer new treatment options for patients.”

In addition to this collaboration, Mediar will continue progressing its portfolio targeting fibrotic disorders. This includes MTX-474, an EphrinB2-targeting antibody currently in Phase II development for systemic sclerosis.

Additionally, MTX-463, an anti-WISP1 antibody, is being developed in partnership with Eli Lilly and Company for idiopathic pulmonary fibrosis. MTX-439, an anti-SMOC2 antibody, is in Phase I trials for chronic kidney disease-mediated fibrosis.

MTX-474 functions by neutralising the EphrinB2 signalling pathway, which contributes to fibrosis onset and progression.

Similarly, MTX-463 targets the WNT1-inducible signalling pathway protein-1 (WISP1), a crucial factor in fibrosis development. MTX-439 aims to inhibit the activity of SMOC2, a protein linked to the pathogenesis of kidney fibrosis.

Mediar Therapeutics CEO Rahul Ballal said: “This strategic collaboration with Ono is an important milestone for Mediar and reflects the growing recognition that directly targeting the myofibroblast can unlock new therapeutic possibilities in fibrotic diseases.”

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PayU and Marg ERP have announced a strategic partnership to power Marg Pay, Marg ERP’s integrated payments solution for digital payment collection and reconciliation for pharma distributors and MSME retailers.

The partnership integrates PayU’s payment infrastructure into Marg ERP’s workflow, creating a connected environment for ordering, payments and reconciliation.

According to the companies, manual payment reconciliation has remained a challenge for pharma distributors and MSME retailers due to the time and errors involved, as well as exposure to cash pilferage. For pharma distribution, the companies said these challenges can translate into working capital risk, revenue loss and customer churn.

Marg Pay, integrated with PayU’s payment solution, will enable invoicing, collection and reconciliation through digital payment workflows.

MSME retailers will be able to generate Dynamic QR codes against individual invoices, enabling digital payments to be automatically reconciled within Marg ERP. Distributors will be able to generate payment links against individual invoices, with payments reconciled bill-by-bill and posted directly into the ERP. The companies said this will support faster collections, same-day settlements and operational efficiency.

“Digital payments are integral to how businesses operate, yet collections and reconciliation remain fragmented and laborious. Together with Marg ERP, we aim to simplify financial administration and bring more predictability to the cash flow of Indian pharma distributors and retailers. This deepens Marg ERP’s role in digitising the pharma sector while expanding PayU’s positioning as an embedded finance aggregator.”, said Vineet Sethi, Chief Growth and Marketing Officer, PayU.

“Digital payments are no longer just about collecting money, they are about creating smarter financial cash flows for all trades. Through our partnership with PayU, we are strengthening the Marg Pay ecosystem to help distributors, retailers and MSMEs accept payments securely. Not only payment, Marg Pay also facilitates the reconciliation for retailers and distributors accounts automatically. We enable businesses to operate with greater efficiency and confidence”. – Thakur Anup Singh, CMD, Marg ERP Ltd.

The partnership will also extend to Marg’s eRetail application, which supports B2B ordering, payments and reconciliation.

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Few global leaders have kept the world of trade on its toes quite like the United States President Donald Trump. His latest announcement of a phased tariff regime on pharmaceutical imports into the US once again has sent ripples across the Indian pharma industry, triggering discussions on exports, competitiveness and the future of one of India’s largest overseas markets. As explored in this month’s cover story, the development is yet another reminder that in today’s world, trade policy can alter industry sentiment almost overnight 

This feature, however, begins where that conversation leaves off. If tariffs represent one side of the trade equation, Free Trade Agreements (FTAs) represent the other. Every Free Trade Agreement is, in essence, a wager. A wager that easier market access today will deliver economic gains years later. New Delhi has been placing that bet with increasing conviction. Since 2021, India has concluded nine FTAs across 38 countries, signalling a shift in its trade strategy. For pharma, one of the country’s largest export sectors, the expectation is clear. The outcome, however, is far less certain. 

Indian pharma built its global standing long before the current FTA momentum gathered pace. That raises an important question. Can preferential trade agreements fundamentally alter the industry’s competitive position, or do they merely provide an advantage that still has to be earned through quality systems, regulatory credibility, innovation and manufacturing excellence? 

More than a tariff story 

Much of the public discourse around FTAs tends to revolve around tariff concessions. Yet, for pharma, tariffs have rarely been the defining factor in determining export success. In many developed markets, pharma products already attract relatively low or zero import duties under existing WTO commitments. The latest generation of FTAs therefore offers value in a different way: by making trade more predictable, reducing operational friction and creating an environment that encourages long-term commercial relationships. 

For businesses making in vestments that often take years to translate into commercial returns, predictability carries considerable weight. Vivek Valsaraj, CFO, Piramal Pharma, believes the significance of FTAs extends well beyond their impact on duties. “India’s expanding FTA network should be viewed as more than a trade facilitation mechanism. At their core, FTAs bring together interdependent economies, create greater predictability in commercial relationships and provide businesses with the confidence to make long-term investments.” 

That perspective is echoed by Neeraj Bansal, Partner and Head, India Global, KPMG in India, who argues that the real commercial gains increasingly lie in easing the movement of business rather than merely lowering import costs. According to him, agreements such as the India–UAE CEPA, India–Australia ECTA and the India–UK CETA are designed to strengthen regulatory cooperation, improve customs efficiency and enhance policy certainty, making it easier for companies to operate across borders. As India’s pharma exports crossed USD 31 billion in FY26, reducing such business friction is becoming increasingly important as companies expand across regulated and high growth markets. 

For an industry whose global reputation was built on manufacturing scale, cost competitiveness and quality rather than preferential trade access, this distinction is significant. As Dr Vellaian Karuppiah, COO, Shilpa Medicare, points out, “India’s export strength was built on manufacturing scale, cost competitiveness, quality systems and one of the largest bases of regulator-approved facilities outside the US — not on tariff preferences.” In his view, the significance of the latest agreements lies less in tariff reductions and more in the regulatory cooperation, customs facilitation and greater predictability that accompany them, enabling companies to move from opportunistic, priceled exports towards deeper, long-term supply relationships.

Do FTAs really create a competitive advantage? 

Paradoxically, the biggest value proposition of modern FTAs may have very little to do with tariffs. For the pharma industry, preferential market access has never been the sole determinant of export success. Instead, the debate is increasingly shifting towards what happens beyond the tariff schedule — regulatory cooperation, customs facilitation, institutional cooperation and the ability to reduce the non-tariff frictions that often determine how quickly and efficiently medicines reach global markets. 

It is this distinction that many industry leaders believe is often overlooked. As Bansal highlights, “FTAs should be viewed as enablers rather than standalone growth drivers.” He argues that market access today is increasingly shaped by ease of doing business rather than import duties alone, with provisions that improve regulatory cooperation, customs efficiency and business certainty often delivering greater commercial value than tariff concessions themselves.

The same sentiment resonates from the manufacturing floor. Dr Karuppiah, believes “Tariff concessions are essentially a one-time reset; the durable advantage sits with the other three,” referring to regulatory compliance, manufacturing excellence and supply-chain resilience. While lower tariffs may create an initial commercial advantage, sustaining that advantage depends on consistently meeting stringent quality standards, navigating regulatory inspections and ensuring uninterrupted supply. 

The commercial implications extend beyond exports to investment decisions themselves. Valsaraj notes, “Tariff benefits are certainly helpful, but in our view, they are only one part of a much larger equation.” In an environment marked by geopolitical shifts and supply-chain realignments, he believes the certainty created by FTAs encourages businesses to make long-term manufacturing investments and forge deeper commercial partnerships. 

That perspective extends to the research-based pharma industry as well. According to Anil Matai, Director General, OPPI, investment decisions are influenced as much by confidence in intellectual property protection, regulatory stability and the ability to commercialise innovation as they are by market access itself. In that sense, FTAs are becoming less about lowering barriers to trade and more about signalling a stable, predictable environment for long-term investment. 

Taken together, the message is clear. FTAs may widen the doorway to international markets, but walking through it still demands capabilities that no trade agreement can confer. For Indian pharma, competitiveness will continue to be earned through quality, regulatory credibility, innovation and execution rather than tariff concessions alone. 

Beyond volume, towards value 

If the last three decades established India as the world’s pharmacy, the next may well determine what kind of pharmacy it becomes. The industry’s global leadership has largely been built on affordable generics, vaccines and cost-efficient manufacturing. Increasingly, however, export growth is expected to come from products where scientific capability, technical complexity and regulatory expertise command a premium over manufacturing scale alone. 

For integrated manufacturers and CDMOs, this shift presents a significant opportunity. Valsaraj, believes “the greatest opportunities are likely to arise in high-value segments where integrated players capable of supporting the full product lifecycle—from development through commercial manufacturing— can differentiate themselves through technical capabilities, quality excellence and execution reliability, rather than cost alone.” He points to growing global demand for sterile injectables, complex formulations, antibody-drug conjugates (ADCs), peptide technologies and integrated CDMO services, particularly across North America, Europe, the UK and Japan. 

Dr Karuppiah, sees a similar shift unfolding within pharma manufacturing. “In plain generics, price competition is intense and a tariff concession is quickly competed away. In complex formulations, injectables, biologics, biosimilars and other specialty segments, the barriers to entry — regulatory, technical and logistical — are far higher, so reduced friction and regulatory cooperation disproportionately help companies that already have depth in these areas.” In other words, FTAs may not fundamentally change the economics of conventional generics, but they could improve market access for companies already positioned in differentiated, higher value segments. 

The opportunity, however, extends beyond expanding exports. It also presents a chance for India to deepen its role within global pharma value chains. According to Matai, “The next opportunity lies in moving up the value chain—from being recognised primarily for scale and affordability to becoming a global centre for innovation-led manufacturing.” He believes this transition will depend on strengthening capabilities in biologics, advanced therapies, specialty medicines, novel drug delivery systems and other technology intensive areas, supported by continued investments in research infrastructure, scientific talent and advanced manufacturing. 

Yet, higher-value exports demand higher-value capabilities. As pharma supply chains become increasingly specialised, manufacturers will need to strengthen automation, digital manufacturing, integrated development capabilities and supplychain resilience. Dr Karuppiah emphasises the importance of backward integration, API and key starting material diversification, digitised and traceable manufacturing, scalable capacity and stronger ESG credentials. Similarly, Valsaraj believes competitive advantage will increasingly depend on advanced manufacturing technologies, integrated development and manufacturing solutions, innovation led capabilities and the ability to serve as reliable long-term partners rather than simply efficient manufacturers. 

On the other hand, Bansal, argues that the companies most likely to benefit from FTAs will be those that view them as part of a broader growth strategy rather than a standalone trade advantage. He believes firms investing in innovation, complex generics, biosimilars and specialty medicines, while combining strong regulatory track records with reliable manufacturing operations and diversified supply chains, will be better positioned to convert preferential market access into sustained business growth. 

Collectively, the experts suggest that the next phase of India’s pharma exports will not be defined by greater volumes alone. Rather, it will depend on whether Indian companies can leverage expanding market access to build deeper capabilities, strengthen innovation and move decisively towards higher-value manufacturing.

What still needs fixing? 

While FTAs can create favourable conditions for trade, they cannot, on their own, transform India’s pharma export trajectory. Their success will ultimately depend on how effectively they are complemented by domestic reforms that strengthen the industry’s competitiveness, resilience and innovation ecosystem. 

A recurring theme across industry voices is the need to reduce structural vulnerabilities within the supply chain. Dr Karuppiah, believes that reducing dependence on imported APIs and key starting materials remains critical to strengthening supply security. In his view, market access created through FTAs will generate lasting value only if it is supported by continued investment in innovation, quality infrastructure and regulatory credibility at home. 

Adding to it, Matai emphasises that intellectual property protection and stronger incentives for R&D, clinical development, advanced manufacturing and talent development will be essential to support long-term investment. 

Among this discussion, Bansal, offers a note of caution. While FTAs undoubtedly create new opportunities, they also expose Indian companies to stronger global competition and increasingly demanding regulatory expectations around quality, sustainability, data integrity and supply-chain traceability. Companies that assume lower trade barriers will automatically translate into higher exports risk overlooking the execution required to compete in these markets. Instead, he believes the greatest gains will accrue to businesses that combine market access with innovation, operational excellence and a deep understanding of evolving customer and regulatory requirements. 

In brief

Ultimately, trade agreements, much like tariffs, are ultimately instruments of policy. Their significance lies not merely in what they promise on paper, but in how effectively industry translates those promises into commercial outcomes. As global supply chains continue to evolve and geopolitical considerations increasingly shape pharma trade, India’s expanding FTA network offers an important opportunity. Whether that opportunity becomes a lasting competitive advantage, however, will depend less on the agreements themselves and more on the capabilities, innovation and regulatory credibility that Indian pharma brings to the table. 

neha.aathavale@expressindia.com

nehaaathavale75@gmail.com

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The Central Drugs Standard Control Organisation (CDSCO) will organise quarterly stakeholder meetings under the chairmanship of the Drugs Controller General of India (DCGI) to discuss regulatory developments, implementation issues and procedures.

According to an office order issued by CDSCO on 6 August 2026, the initiative aims to strengthen stakeholder engagement, enhance transparency, improve regulatory compliance and facilitate the dissemination of regulatory developments and stakeholder expectations on regulatory updates.

The first meeting is scheduled for 24 August 2026 from 2:30 pm to 5:00 pm at the second floor of CDSCO headquarters at FDA Bhawan, New Delhi.

According to CDSCO, the meetings will provide a platform for interaction between the regulator and stakeholders, including discussions on regulatory updates, implementation issues, regulatory procedures and feedback from industry and other stakeholders.

CDSCO has asked 12 industry associations to nominate not more than two representatives, comprising the president or chairman and secretary or general secretary, or a senior representative, to participate in the meeting with the DCGI. The associations include the Indian Drug Manufacturers’ Association (IDMA), Organisation of Pharmaceutical Producers of India (OPPI), Bulk Drug Manufacturers Association (India) [BDMA(I)], Federation of Pharma Entrepreneurs (FOPE), Indian Pharmaceutical Alliance (IPA), Federation of Indian Chambers of Commerce and Industry (FICCI), Confederation of Indian Industry (CII), Indian Vaccine Manufacturers Association (IVMA), Himachal Drug Manufacturers Association (HDMA), Laghu Udyog Bharati (LUB), Indian Federation of Animal Health Companies (INFAH) and Veterinary Vaccine India Manufacturers Association (VVIMA).

The nominated representatives’ names, designations, email IDs and contact numbers, along with brief discussion points not exceeding one page, are to be submitted to CDSCO by 12 August 2026. CDSCO stated that invitations will be issued in the names of the nominated representatives and only those representatives will be permitted to attend the meeting. Subject experts from the respective associations may attend with prior permission.

Reacting to the development, Harish Jain, President, Federation of Pharma Entrepreneurs (FOPE), states: 

“ FOPE welcomes the CDSCO’s initiative to institutionalise Quarterly Stakeholder Meetings under the chairmanship of the Drugs Controller General of India. This is a significant step towards making regulatory engagement more structured, transparent and responsive.

For the pharma industry, particularly MSMEs, timely clarification on regulatory requirements and a predictable implementation framework are extremely important. A regular institutionalised dialogue will help identify practical challenges at the ground level, reduce avoidable ambiguity and facilitate smoother compliance.

FOPE looks forward to using this platform constructively to present the concerns and suggestions of pharma entrepreneurs and to work closely with CDSCO in strengthening India’s regulatory ecosystem. We believe that effective regulation and ease of doing business must go hand in hand, with patient safety and quality remaining paramount.

We appreciate the DCGI for creating this forum for continuous stakeholder engagement and look forward to making these quarterly interactions meaningful and outcome-oriented.”

Anil Matai, Director General, OPPI:

“ OPPI warmly welcomes CDSCO’s initiative to institutionalize Quarterly Stakeholder Meetings under the chairmanship of the Drugs Controller General (India). Structured, recurring engagement of this kind strengthens the trust and transparency that must underpin India’s regulatory ecosystem. As the pharmaceutical industry continues to invest in research-driven and innovative therapies to meet evolving patient needs, a predictable and collaborative regulatory dialogue is essential — it allows industry to align emerging science with regulatory expectations early, rather than navigating them in isolation. We look forward to constructive discussions with CDSCO and believe this platform can meaningfully accelerate the translation of innovation into accessible healthcare solutions for patients across India.” 

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By Lindsey Coulter

Healthcare compliance has never been more complex. As care expands beyond traditional hospitals into ambulatory surgery centers, outpatient clinics, rehabilitation facilities and other non-acute settings, facility leaders must maintain safe, efficient operations while navigating evolving regulations, staffing shortages, aging infrastructure and growing patient expectations. 

For many organizations, compliance is still viewed primarily as preparing for inspections. However, effective compliance goes far beyond meeting regulatory requirements. A proactive approach strengthens operational resilience, minimizes disruptions, supports workforce accountability and, most importantly, creates safer environments for patients, caregivers and visitors. When building systems perform reliably and teams prioritize compliance every day, organizations are better equipped to prevent issues before they become costly problems. 

Facilities engineering teams are at the center of that effort, ensuring critical systems — from HVAC and emergency power to water safety and building access — support safe, uninterrupted patient care. Technology is also transforming compliance by automating inspections, streamlining documentation and providing greater visibility into operational risks, helping organizations improve both regulatory readiness and day-to-day performance. 

Experts at ABM, a leading facility management and maintenance services corporation, help clients by offering practical strategies for strengthening compliance programs, improving infection prevention, leveraging technology to identify risks and building partnerships that support long-term operational success.   

Engineering Manager Brian Maiden of ABM blends hands-on technical leadership with a strong background in facilities operations, team management, building maintenance and regulatory compliance. With well over a decade of experience in the industry leading large teams, Maiden is an expert at managing complex building systems and driving operational excellence and efficiency, while maintaining high levels of client satisfaction.  

“Our ultimate goal is to preserve patient health,” Maiden said. “Compliance is part of keeping facilities performing at their best so patients are safe and comfortable.” 

Healthcare Construction + Operations News spoke with Maiden, about why compliance should be viewed as an ongoing operational discipline rather than a regulatory obligation, the hidden facility systems that have the greatest impact on patient safety, and the practical steps healthcare organizations can take to build stronger, more resilient compliance programs. 

HCO: Building systems often operate behind the scenes until something goes wrong. What role do engineering, and facility maintenance teams play in supporting compliance every day? 

Maiden: Building automation systems and remote access to these systems play a critical role in maintaining regulatory compliance. Engineering isn’t just maintaining buildings; it’s maintaining the conditions that make safe patient care possible. When building systems perform reliably, compliance becomes a natural outcome of good operational discipline. We aim to protect patient health and safety and operational continuity by proactively managing and documenting complex building systems. We keep systems running at their best so the providers can perform their best. 

HCO: What are some of the most common compliance gaps you’ve encountered in non-acute healthcare environments?  

Maiden: Uncontrolled access to clinical areas, such as propped doors, unlocked staff areas and unrestricted vendor access. 

HCO: How does compliance affect the patient’s experience, even when patients may never notice the work facilities teams are doing?  

Maiden: Compliance ensures that the patient’s experience is safe, sterile and, ultimately, seamless. Making sure things like air filtration are accurate, adhering to strict water temperatures and reliable emergency power to help prevent crisis and instill trust.  

HCO: Audit readiness is becoming increasingly important. What separates organizations that are always prepared from those scrambling before an inspection?  

Maiden: We at ABM do not treat audits as an abrupt event; rather, we incorporate them into everyday processes and daily physical operations. 

HCO: Technology has transformed facilities management. How are digital tools helping organizations improve compliance and documentation?  

Maiden: We leverage computerized maintenance management systems to digitalize and automate checklists in real time, such as audit trails and facility management systems like IMPAK. 

HCO: If you could offer one piece of advice to facilities directors looking to strengthen compliance over the next year, what would it be?  

Maiden: To transition from reactive to proactive checklist and approach; learning from past mistakes by implementing centralized and standardized compliance dashboards. 

To help healthcare leaders navigate these challenges, Healthcare Construction + Operations News is partnering with ABM for the free webinar, “Beyond the Hospital: Facility Compliance Challenges in Non-Acute Healthcare,” on Sept. 1 at 9 a.m. PST. Subscribe today and watch the HCO News website for details.

The post Strengthening Compliance Beyond the Hospital: ABM Shares Strategies for Safer Healthcare Facilities appeared first on HCO News.

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On July 21, 2026, US President Donald Trump announced a three-phase tariff regime on generic medicines entering the US, with zero duty until August 2028, a 100 per cent tariff for the following year, and a 200 per cent tariff from 2029 onwards. The announcement sparked immediate concern across India’s pharma industry. Markets reacted swiftly, with stocks such as Dr Reddy’s and Cipla coming under pressure. SBI Research estimated that, with nearly 40 per cent of India’s pharma exports headed to the US, steep tariffs could dent sector earnings in FY26. Dr Reddy’s CEO Erez Israeli reminded investors that shifting generic manufacturing to the US was “a four-to-seven-year industrial undertaking,” not a quick fix. A day later, India’s External Affairs Minister S Jaishankar met US Secretary of State Marco Rubio in Manila as both countries worked towards an interim trade agreement. 

But tariffs are only the trigger. Indian pharma is now operating in a world where geopolitics, trade policy, regulation and supply chain resilience are becoming as important as manufacturing capabilities. The question is no longer whether India can produce medicines at scale. It is whether it can remain competitive in an increasingly volatile global landscape. 

This question formed the backdrop to two recent discussions organised by Express Pharma: the inaugural edition of its virtual thought leadership series, Pharma Frontlines, and a panel discussion on Geopolitics, Trade and Trust at the Chandigarh Pharma Summit. Bringing together industry association leaders, manufacturing heads, supply chain experts, quality professionals and regulatory specialists, the discussions explored how Indian pharma is responding to a rapidly changing global environment. While each conversation approached the issue from a different perspective, both pointed to the same conclusion: the industry’s future will depend not just on what it manufactures, but on how well it manages uncertainty. 

A trade weapon India has faced before 

Pharma and geopolitics have always gone hand in hand, but India has often managed to transform challenges into opportunities. There are several cases in point. 

In 2001, Cipla’s Yusuf Hamied changed the conversation around access to medicines. He offered a triple-antiretroviral cocktail to Médecins Sans Frontières for $350 per patient a year, compared to an originator price of more than $10,000. The move challenged the global patent system and helped shape the WTO’s Doha Declaration. More importantly, it established India as a trusted supplier of affordable medicines.

India reinforced that trust during the COVID-19 pandemic through the Vaccine Maitri initiative, launched in January 2021, supplying vaccine doses to 94 countries and two UN agencies. The initiative strengthened India’s reputation as a reliable manufacturing partner for the world.

Today’s challenge, however, is very different. In 2001 and again in 2021, India’s manufacturing strength helped expand access to medicines. Now, that same strength is being tested as countries seek to bring manufacturing closer to home. 

Trade policies are shifting, regulations are becoming more complex, and supply chains are increasingly vulnerable to geopolitical shocks. 

India can still manufacture at scale. But the next phase of growth will depend on how well the industry adapts to this new reality. 

Leadership in an era of uncertainty 

Tariffs dominate the headlines, but industry leaders believe they are only one part of a much larger shift. The bigger question is not whether Indian pharma can absorb higher duties, but how it prepares for a world where trade rules, regulations and geopolitical priorities are constantly evolving.

For Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance (IPA), understanding the India-US pharma relationship is the starting point. 

India exports over $12 billion worth of medicines to the US, accounting for nearly one-third of its pharma exports. Indian companies also supply almost half of the generic medicines used by American patients. This dependence, Jain says, is often overlooked. “There is a tremendous reliance on the generic drugs, because they ensure accessibility, affordability, and they have played a very important role to improve healthcare outcomes in the US.” 

In other words, the relationship is not one-sided. While India depends on the US as its largest export market, the US healthcare system also depends heavily on Indian manufacturers to keep medicines affordable and accessible.

Jain also pointed out that Indian companies have not waited for policy changes to strengthen their US presence. Companies such as Sun Pharma, Zydus and Lupin already operate more than 40 manufacturing facilities across 12 US states, reflecting a long-term commitment to the market rather than a short-term response to tariffs. 

Dr TS Parmar, Secretary General, Indian Drug Manufacturers Association (IDMA), widened the discussion beyond bilateral trade. Healthcare, he argues, cannot be viewed through the lens of one country alone. It is, as he describes it, “a composite partnership.” While governments may seek to bring manufacturing back home, globally integrated pharma supply chains cannot be rebuilt overnight. 

For both Jain and Parmar, tariffs are only one part of the challenge. The more significant concern lies in the growing complexity of doing business across multiple regulatory jurisdictions. 

Jain believes non-tariff barriers are likely to become a greater obstacle than tariffs themselves. Indian manufacturing sites continue to undergo separate inspections by regulators in the US, Europe, the UK and Africa, even though many of the requirements overlap. Greater regulatory convergence, he argues, would reduce duplication, lower costs and improve the efficiency of global supply chains. He says, “If there is a regulatory convergence, it would become very, very important.” 

The discussion points to a broader shift in the industry’s priorities. Competitiveness is no longer determined solely by manufacturing efficiency or cost. It increasingly depends on a company’s ability to navigate a complex web of regulations, trade policies and international partnerships. For today’s pharma leaders, managing uncertainty is becoming as important as managing operations.

When geopolitics reaches the factory floor 

Geopolitical events are now influencing day-to-day operations in ways that would have been difficult to imagine a few years ago. 

Saurabh Sharma, GM-Supply Chain, Sentiss Pharma, describes the shift and says what was once a purely operational function has been pulled into the centre of business strategy. 

He shares how the recent US-Iran conflict disrupted pharma logistics almost overnight. Air cargo operations through Dubai were affected for nearly two weeks, delaying temperature-controlled pharma shipments. He informs that their shipments were stuck for almost two weeks because the flights were not allowed and even a one-degree temperature excursion recorded by data loggers triggered a compliance investigation. 

The experience fundamentally changed the way his company evaluates suppliers. He states, “Choosing the partner is also now becoming very critical.” 

For Sharma, procurement is no longer about securing the lowest price. Companies are evaluating suppliers on the total cost of ownership. As he explains, “It comprises of many things like quality, cost, of course, one factor, then delivery is another factor. Then the compliance is what is the business continuity? What is the financial strength of the supplier?” Thus, compliance history, delivery reliability, financial stability and operational capability have become key metrics. 

His experience reflects a wider transformation across the industry. Supply chains are no longer just sourcing and logistics functions. They have become vital for business continuity, regulatory compliance and an organisation’s ability to respond to disruption. In an era of geopolitical uncertainty, resilience has become as valuable as efficiency. 

The business of being ready 

The growing uncertainty in global trade is forcing pharma companies to make decisions faster than ever before. What once unfolded over months now demands action within days, often based on incomplete information and with significant financial implications.

Vishnu Mirge, AVP – Site Head, Sun Pharmaceutical Industries, offers a glimpse into how quickly companies now have to respond. Following the US announcement of a 100 per cent tariff on branded formulations, his team took the unusual decision to double production over three months by securing six months’ worth of input-material inventory instead of the usual three. 

This was far more than an operational adjustment. It required rapid financial approvals, close supplier coordination and the confidence to invest ahead of demand. 

For Mirge, the experience reinforced a simple lesson. “If you are agile enough to respond to that demand positively, then that is the success mantra.” 

His example highlights that competitive advantage is no longer determined solely by manufacturing capacity or cost efficiency. Increasingly, it depends on how quickly organisations can assess risks, align cross-functional teams and respond to changing market conditions. 

But responding quickly is only one part of the equation. As supply chains grow more complex and regulatory expectations continue to rise, companies are also rethinking how they approach quality and compliance.

It is in this context that Dr Sanjit Singh Lamba, Managing Partner, Trillyum Consulting, challenges the industry’s traditional approach to vendor qualification. He states, “We don’t need just a vendor qualification. We need something called continuous vendor verification (CVV). This is something I am driving more and more in companies, that they don’t treat vendor qualification as a paper exercise and then remain quiet for two to three years.” 

His argument reflects a wider industry reality. Nearly 20 per cent of cold-chain pharma material is wasted every year, while first-timepass rates remain at around 80 per cent, Lamba pointed out. As biologics account for a growing share of the industry’s pipeline, these inefficiencies will become even more critical to address. 

Addressing these challenges will require more than stronger processes alone. Technology has an increasingly important role to play but as an enabler rather than a substitute for robust quality systems. 

Taken together, these perspectives reveal how leadership priorities are evolving. Companies are no longer preparing only for the next regulatory inspection or market opportunity. They are building organisations that can anticipate disruption, respond with speed and embed quality across every stage of manufacturing and supply chain operations. 

Reducing dependence, building resilience 

While companies are strengthening agility and quality systems, another strategic priority continues to dominate boardroom discussions, i.e. reducing dependence on China.

Progress is visible, but industry leaders agree that self-reliance remains a longterm journey rather than an immediate destination. Achieving it will require more than identifying alternate suppliers; it demands a systematic approach to qualification, risk management and long-term partnerships.

Ravi Bharadwaj, Corporate Quality Head, Ind Swift Laboratories, believes diversifying away from China is achievable, but only with discipline. He opines that successful diversification requires good planning and change management, with supplier qualification backed by comprehensive audits that evaluate suppliers’ capabilities and compliance levels. He cautions that supplier qualification cannot be treated as a one-time exercise, as a supplier that has successfully completed process validation and stability studies may later receive an FDA warning letter, forcing companies to start the qualification process all over again. 

Moreover, supplier qualification is only one part of the challenge. The industry’s continued reliance on China for critical raw materials remains a structural vulnerability with far-reaching implications for cost and supply continuity.

Dr Saurabh Pandey, Cluster Lead-API ManufacturingToansa-Punjab, Sun Pharmaceutical Industries, points to the scale of the challenge and informs, “Currently, we have around 65 per cent to 70 per cent of the APIs getting imported from China based on the cost pricing. With the recent geopolitical changes, we have seen a 40 per cent increase in the pricing of drugs like paracetamol and azithromycin”. He notes the price shocks this dependence has already produced and cautions that prolonged reliance on a single source “will certainly set up a monopoly in the market, and any amount of instability in China will lead to disruptions, not only in the supplies, but to an increase in the pricing.” 

Trust becomes the new currency 

Yet resilience is not built through supply chain diversification alone. In an increasingly regulated global market, trust is as an equally key differentiator. 

If cost and scale defined Indian pharma’s last decade, trust may define its next one, and that trust is often built or broken in the quality function.

As a result, the role of quality leaders are also being reshaped. Yogesh Sharma, Head-Quality & Compliance, Sun Pharmaceutical Industries, describes how the job itself has been redefined. Five years ago, quality was reactive, teams scrambled only when an inspection was announced, pulling together data to prove there was nothing non-compliant. He explains that today, quality leaders are now measured not only on compliance but also on their ability to act as business partners. Their KPIs reflect their contribution to business deliveries and organisational commitments because the cost of a lapse is no longer just a regulatory problem; it is a commercial one. 

The shift is being reinforced by a regulatory landscape that is evolving just as rapidly. Dr Dr Pardeep Agnihotri, Sr GM – Corporate Regulatory Affairs, CEPH Lifesciences notes that global regulators have raised the bar considerably over the same period, pushing manufacturers toward “a sciencebased, risk-based, and datacentric approach.” He explains that companies are expected to adopt the ALCOA principles, strengthen data integrity and digitalisation, implement comprehensive contamination control strategies (CCS), and ensure facilities remain inspection-ready at all times rather than preparing only for scheduled audits. 

While these expectations have become more demanding, they have also highlighted where India’s strengths and its challenges, lie. Agnihotri argues that India has built genuine strength in costcompetitive manufacturing, API exports, regulatory dossier preparation and CDMO services. At the same time, he points out that gaps remain in data integrity and compliance with evolving regulations. He underscores that quality excellence is an ongoing process, not a one-time milestone. 

The road to 2030 

As the discussion turned from today’s challenges to tomorrow’s priorities, Prafulla Padhy, Head – Supply Chain Management, Fresenius Kabi Oncology, laid out a vision for where Indian pharma needs to go. He said the industry must move from volume-led manufacturing to innovation, supported by stronger intellectual property protection. He also highlighted the need to strengthen supply chain resilience through indigenous API and KSM manufacturing, improve end-to-end visibility across the supply chain, build quality and compliance so India is recognised as a trusted and reliable partner, adopt more sustainable practices, and make medicines more accessible by reaching tier II and tier III cities as well as rural areas. 

“It’s time for India to move forward in its innovation journey,” he said, “and that’s possible only if we fortify each link in this pharma value chain.” 

His vision brought together many of the themes that had emerged throughout the discussion. Whether it was building resilient supply chains, strengthening quality systems, embracing innovation or expanding access, the underlying message was clear. The pharma value chain is only as strong as its weakest link. 

That is perhaps the defining challenge and opportunity for Indian pharma today. As global trade dynamics shift, the industry’s ability to anticipate change will matter more than ever. 

Thus, success by 2030 will not be determined by how companies respond to disruption, but by how well they prepare for it.  

lakshmipriya.nair@expressindia.com

lakshmipriyanair@gmail.com

The post Power, politics and pharma appeared first on Express Pharma.

This technology is intended to convert biologics typically given via intravenous infusion into more convenient subcutaneous formulations.

Under the agreement, Alteogen is set to receive an upfront payment and could earn additional amounts through development, regulatory, and sales milestone payments.

The company will also receive royalties on net sales for any product commercialised using this technology.

Alteogen CEO Tae-Yon Chun said: “We are pleased to enter into this licence agreement with a global leader with a long-standing commitment to advancing innovative therapies for patients with serious unmet medical needs.

“We will continue to accelerate the growth of our platform technology through strategic global partnerships.”

ALT-B4, which is provided to the counterparty under the licence, allows biologics normally given intravenously to be converted into subcutaneous formulations.

The technology achieves this by temporarily breaking down hyaluronan in the extracellular matrix, which facilitates faster and more efficient absorption and dispersion of drugs administered together with ALT-B4.

Alteogen operates in the development and commercialisation of biologics, such as antibody-drug conjugates, biobetters, and biosimilars.

Its pipeline includes clinical-stage long-acting therapeutic proteins and next-generation antibody-drug conjugates that use its proprietary NexP-fusion and NexMab platform technologies.

Developed since Alteogen’s founding in 2008, its Hybrozyme technology enables subcutaneous delivery of medicines that are typically administered intravenously.

In March 2025, AstraZeneca entered an exclusive licence agreement with bio-platform company Alteogen, involving the latter’s hyaluronidase utilising Hybrozyme platform technology, ALT-B4, to develop subcutaneous formulations of several oncology assets.

The post Alteogen signs $365m Hybrozyme licensing deal with pharma company appeared first on Pharmaceutical Business review.

The new arrangement will extend the use of Schrödinger’s technologies, including Bunsen and the AI-driven synthesis planning platform RetroSynth, throughout BMS’s scientific teams.

The collaboration aims to enable the pharmaceutical company’s researchers to explore chemical space more extensively, prioritise molecular candidates with additional confidence, and support decision-making in the early stages of drug discovery.

Bunsen is an agentic AI co-scientist tailored to perform complex molecular discovery workflows by executing Schrödinger’s computational methods, conducting planning and interpretation tasks, and integrating with other research technologies.

Schrödinger platform chief scientific officer Robert Abel said: “BMS is a long-standing customer and collaborator, and they have been an industry leader in integrating computation into drug discovery.

“We are thrilled they are deploying Bunsen at a large scale. Adopting Bunsen and our computational platform at scale will empower a broader group of scientists to embrace a predict-first computational approach.”

BMS computational sciences vice-president Stephen Johnson said: “Over the past several years, AI has become a key enabler for our scientists, allowing them to scale their creativity and scientific expertise across our research organisation.

“Bunsen is another capability we are adding to that toolkit, one that allows our scientists to think differently about how physics-based tools can be used to navigate molecular design space and accelerate the discovery of innovative medicines for patients.”

Schrödinger reports that its software platform combines AI with physics-based simulation to support hypothesis evaluation and synthetic feasibility in molecular research.

Included in the expanded agreement, RetroSynth is described as enabling high-throughput evaluation of chemical synthesis pathways.

The company’s computational solutions are licensed by customers in the global pharmaceutical, biotechnology, industrial, and academic sectors.

Last month, BMS further established itself on the growing list of big pharma partners who are forging tight collaborations with big tech, as it deepens its collaborations with Nvidia to deploy an AI-enabled supercomputer that it claims is the “most powerful single-owned Nvidia infrastructure in life sciences”.

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Gland Pharma and Neuland Laboratories have announced a long-term strategic contract development and manufacturing organisation (CDMO) partnership to manufacture sterile active pharmaceutical ingredients (APIs) for microparticle depot products.

Under the partnership, Gland Pharma will establish a sterile manufacturing suite for APIs related to microparticle depot products. According to the companies, the collaboration combines Neuland’s complex API development and manufacturing capabilities, including expertise in complex chemistry, process development and custom manufacturing, with Gland Pharma’s sterile manufacturing capabilities and regulatory compliance to serve demand for sterile APIs used in microparticle depot products and other sterile APIs.

The companies stated that the collaboration expands their existing relationship by creating a manufacturing platform that aligns their capabilities under a long-term partnership. As part of the collaboration, Gland Pharma will expand its sterile manufacturing infrastructure by adding a dedicated suite at its JNPC facility in Visakhapatnam to support Neuland’s demand for sterile APIs.

According to the companies, the facility will be constructed and operated in compliance with cGMP, USFDA and European Union standards and will be supported by Gland Pharma’s aseptic manufacturing capabilities. Together, the companies will offer a CDMO solution covering development, scale-up, regulatory support and commercial manufacturing of sterile APIs.

The companies stated that the manufacturing suite will add approximately 1,400 kg of annual capacity, providing manufacturing flexibility across multiple sterile products while supporting future growth.

According to the companies, the partnership is expected to strengthen global supply by combining Neuland’s development and regulatory capabilities with Gland Pharma’s manufacturing infrastructure.

Commenting on the development, Srinivas Sadu, Executive Chairman, Gland Pharma, said, “We are pleased to further strengthen our collaboration with Neuland through this strategic partnership. This investment expands our capabilities in sterile API manufacturing and supports increasing customer demand. By leveraging the complementary strengths of both organizations, we will provide a robust and scalable CDMO solution backed by world-class quality, compliance and manufacturing excellence. We believe this partnership creates a strong foundation for sustainable growth and long-term value creation for our customers and both organizations.”

Saharsh Davuluri, CEO & MD, Neuland Laboratories, said, “Demand for sterile APIs continues to grow as pharmaceutical companies advance increasingly complex injectable therapies. Through this partnership with Gland Pharma, we are combining Neuland’s expertise in complex APIs with Gland’s proven sterile manufacturing capabilities to create a differentiated platform for global customers. Together, we are strengthening our ability to deliver the quality, reliability, and supply assurance that innovators and generic companies expect from their CDMO partners.”

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The Indian Pharmacopoeia Commission (IPC), Ministry of Health & Family Welfare, Government of India, participated in the 10th Anniversary Meeting of the South-East Asia Regulatory Network (SEARN) held in Kathmandu, Nepal, on 4–5 August 2026.

The meeting brought together representatives of National Regulatory Authorities (NRAs), pharmacopoeias and international organisations from across the South-East Asia Region to mark a decade of regional collaboration and discuss measures to strengthen regulatory systems for ensuring the quality, safety and efficacy of medical products.

SEARN is a collaborative platform established by the World Health Organization (WHO) South-East Asia Regional Office (SEARO) to strengthen regulatory systems across Member States. Since its inception in 2016, the network has facilitated cooperation among National Regulatory Authorities through knowledge sharing, regulatory convergence, capacity building and reliance mechanisms. It operates through thematic working groups focusing on quality assurance, pharmacovigilance, clinical trials oversight, regulatory preparedness and medical device regulation to improve access to safe, effective and quality-assured medical products across the region.

The IPC delegation comprised Dr. V. Kalaiselvan, Secretary-cum-Scientific Director; Dr. Jai Prakash, Senior Principal Scientific Officer; Dr. Robin Kumar, Senior Principal Scientific Officer; and Mr. Arvind Kumar Sharma, Scientific Officer.

During the meeting, IPC highlighted India’s commitment to strengthening the drug regulatory system and promoting access to quality-assured medicines through internationally harmonised standards. The delegation presented IPC’s initiatives in the development and publication of the Indian Pharmacopoeia, the establishment of Indian Pharmacopoeia Reference Substances (IPRS) and Impurity Reference Standards (IMPRS), pharmacovigilance and materiovigilance activities under the Pharmacovigilance Programme of India (PvPI) and Materiovigilance Programme of India (MvPI), capacity-building programmes, and collaborative efforts with national and international stakeholders.

During the meeting, IPC was recognised as the WHO-SEARN Regional Centre of Excellence in Pharmacovigilance and the Technical Centre in Quality. According to IPC, the recognition acknowledges its contributions to strengthening pharmacovigilance systems, advancing pharmaceutical quality standards and supporting regulatory capacity building across the WHO South-East Asia Region. IPC stated that the designation reinforces its role in pharmacopoeial science and standards and supports collaboration, knowledge sharing and harmonisation among Member States.

The meeting also provided a platform for the exchange of scientific knowledge, regulatory experiences and discussions on pharmaceutical regulation, including quality assurance, safety, regulatory reliance, digital transformation and regional cooperation. IPC reaffirmed its commitment to supporting collaborative initiatives aimed at strengthening regulatory systems and improving public health outcomes across the South-East Asia Region.

According to IPC, its participation in the 10th Anniversary Meeting of SEARN, along with its designation as the Regional Centre of Excellence in Pharmacovigilance and Technical Centre in Quality, marks another step in India’s contribution to regional regulatory cooperation. The commission stated that it will continue supporting WHO-SEARN initiatives, regulatory systems and the availability of safe, effective and quality-assured medical products across the South-East Asia Region.

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This fragmentation can lead to underutilisation of valuable biomedical data.

Under the agreement, Chugai scientists will use Biomni Lab to consolidate AI-driven capabilities and diverse biomedical resources in a single digital workspace.

This integration aims to enable researchers to interact with proprietary data within Chugai’s secure environment, generating new hypotheses and supporting decision-making throughout the drug discovery process.

The platform is expected to be applied across several areas of Chugai’s research, such as single-cell analysis, disease biology, human genetics and target evaluation.

Chugai biological technology department head Sohei Oyama said: “We are excited about the opportunity to work with Phylo and explore the capabilities of Biomni Lab in our research environment.

“As scientific data continues to grow in scale and complexity, scientists need tools designed for the unique challenges of drug discovery research and capable of connecting insights across diverse sources of knowledge.

“We believe Biomni Lab can help our scientists explore scientific questions more effectively and accelerate our drug discovery to create innovative medicines for patients.”

Phylo co-founder and CEO Kexin Huang said: “Our vision is to help biopharma become AI-native, and Biomni Lab is built to make that transition practical for discovery teams today. Chugai’s longstanding track record of R&D innovation makes it an ideal setting to demonstrate how agentic AI can accelerate breakthrough discovery.”

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Asymchem Group will contribute 1.05bn yuan while Hillhouse Qirui will invest 177m yuan.

Following the transaction, Asymchem Group’s shareholding in AsymBio is set to rise to 83.4965%.

Hillhouse Qirui’s investment is described as reflecting long-term confidence in both AsymBio and the wider biologics CDMO sector.

The financing round also brings together other unnamed investors and is said to align with Asymchem Group’s strategic approach of providing “one-stop, end-to-end CDMO” services.

The additional capital comes as AsymBio expands its research and development capabilities, good manufacturing practice (GMP) manufacturing lines, and high-containment facilities.

The company states that the new funding will be directed towards supporting the scaling of client programmes and increasing operational efficiency.

Financial results released by AsymBio indicate that the company generated 470m yuan in revenue during 2025, with revenue for the first quarter of 2026 exceeding 140m yuan.

AsymBio operates as a subsidiary of Asymchem Group and focuses on biopharmaceutical CDMO services, ranging from early-stage and process development to toxicology, clinical, and large-scale commercial manufacturing.

The group points to its experience in the production of antibody-drug conjugates (ADCs) and ongoing expansion into novel drug conjugates (NDCs) and various protein-based therapeutics.

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When an Rx product gets approval to move into the OTC market, it’s often seen as a major achievement. And rightly so. Years of scientific work, regulatory effort and planning go into reaching that stage.

But from what I’ve seen over the years, that’s only the beginning.

Some brands make the transition and go on to become household names. Others struggle to build momentum, even though they have strong science behind them.

The difference usually isn’t the product itself.

It’s what the company does after the switch.

The real challenge is no longer regulatory. It’s commercial!

Why good products still struggle

Many organisations approach an Rx-to-OTC switch using the same thinking they use for prescription brands. That works only up to a point. 

Once a product reaches consumers, the rules change.

Consumers don’t buy a product because they’ve read a clinical paper. They buy it because they understand what it does, they can find it easily and they trust it enough to choose it over other options.

This is where many promising brands lose momentum.

The product may be good. But if it isn’t easy to find, easy to understand or supported in the right places, consumers simply move on.

Four things successful brands usually get right

Over the years, I’ve noticed that brands which make a successful transition from Rx to OTC tend to focus on four areas.

1. They speak the consumer’s language

Healthcare professionals and consumers look at products differently.

Doctors want evidence.

Consumers want clarity.

They want to know what the product does, why it matters and whether they can trust it.

Simple communication often has a bigger impact than complicated scientific messaging.

2. They make the product easy to find

Distribution is no longer just about reaching as many outlets as possible.

It’s about being available where consumers actually shop.

That includes neighbourhood pharmacies, modern trade, e-commerce and increasingly quick commerce.

If consumers can’t find the product when they need it, someone else’s brand usually wins.

3. They build a business, not just a launch

Many companies put enormous effort into launch planning.

Far fewer keep improving after launch.

The brands that continue to grow are the ones that keep refining pricing, pack sizes, channel strategy, retail execution and consumer engagement.

Launching the product is only the first milestone.

Building the business takes much longer.

4. They bring everyone together

An OTC business cannot be built by one function alone. Marketing, sales, medical, trade, supply chain and digital teams all have a role to play.

When these teams work towards the same objective, execution becomes faster and the consumer experience becomes stronger.

The market has changed

India’s self-care market is growing steadily. Consumers are becoming more aware of their health, looking for reliable information online and taking a more active role in managing everyday health conditions. At the same time, digital commerce and quick commerce are changing how people discover and buy OTC products. Companies now need to think beyond traditional pharmacy distribution if they want to stay relevant.

This is why an Rx-to-OTC strategy today looks very different from what it did even a few years ago. Success is no longer decided by one launch event.

It is built through hundreds of small commercial decisions made every day.

Three questions every leadership team should ask

Before approving the next Rx-to-OTC opportunity, I believe every leadership team should pause and ask three simple questions.

• Are we launching an OTC product, or are we building an OTC brand?

• Does our distribution strategy reflect how consumers shop today?

• Are all our commercial teams working towards the same outcome, or are they still operating in silos?

These questions don’t require complex answers. But they often reveal whether the organisation is truly ready for the journey ahead.

A final thought

An Rx-to-OTC switch creates an opportunity but doesn’t guarantee success.

The brands that grow are rarely those with only the strongest science. They are the ones that understand consumers better, make their products easier to access and keep improving long after the launch is over.

In the years ahead, I believe the biggest advantage won’t come from making more Rx-to-OTC switches but will come from building organisations that know how to turn those switches into brands people trust and choose again and again.

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On July 21, US President Trump unleashed uncertainty on the tariff front once again. Generics exported to the US will have zero tariff until August 1, 2028, after which tariffs are proposed to increase to 100 per cent from August 2028 and 200 per cent from August 2029. However the two year interim period makes it seem like a negotiation tool. 

As Bharat Celly, Equity Research Analyst at Equirus Securities points out, the proposal runs counter to the intent of the Hatch-Waxman framework, which was designed to reduce drug prices through greater generic competition. Imposing 100–200 per cent tariffs on imported generics could instead raise the cost of low-priced medicines and, in shortage-prone categories, increase the risk of supply disruptions rather than drive reshoring. 

Param Desai, Research analyst – PL Capital points out that President Trump’s term ends in January 2029, while the major tariff impact begins from August 2028, so the eventual implementation remains uncertain if there is a change in administration. 

An Ind-Ra analysis believes that the evolving tariff environment could accelerate consolidation across the generic pharma industry, strengthening the market position of larger and better-capitalised companies. As operating challenges increase, small generic companies may find it difficult to remain competitive due to weaker balance sheets, lower pricing flexibility, and limited ability to undertake significant greenfield investments in the US, particularly where investment paybacks remain unattractive. 

The Ind-Ra report posits that tariff-driven disruptions could create opportunities for partnerships, acquisitions, and strategic investments. Distressed generic assets may become attractive acquisition targets, while Indian pharma companies could increasingly collaborate with US contract manufacturing organisations to establish domestic manufacturing capabilities in a capital efficient manner and meet local sourcing requirements where necessary. 

India has already diversified beyond the US market, through numerous free trade agreements (FTAs). India’s FTA network now includes 15 agreements covering 27 countries, and counting. Though we still haven’t been able to make a trade deal with the US, which is the world’s biggest pharma market, 6Wresearch’s recently released India Export Attractiveness Tracker 2026 makes the point that India’s next export wave will not be won on tariff advantage alone — most of the frictionless doors (Japan, Egypt, Mexico) are already open, and most of the mature markets (US, China, UAE) are now regulatory contests rather than tariff contests. 

For instance, the report points out that the US applies 213 regulatory measures whereas China applies 148 measures on medicines. Both large pharma export markets thus come with a dense regulatory architecture. 

The playbook is therefore twofold: scale fast in the zero-tariff corridors while capacity is uncontested, and invest early in regulatory and standards compliance in the high-value, high-friction markets — because that is where the next $30.1 billion in untapped potential will actually be won.

According to 6Wresearch’s report, built on UN Comtrade data, generic medicines are the fourth anchor of India’s highest-value future export potential by 2031. Smartphones, polished diamonds, and refined petroleum, lead the list. 

Pharma exports currently make up $39.45 billion, of which medicines make up 44.7 per cent. By 2031, the report projects that medicines alone carry export potential of $23.30 billion, led by the US ($8.67 billion), Switzerland ($3.15 billion), China ($1.81 billion), Japan ($1.45 billion) and Canada ($758.62 million). Human vaccines have an export potential of $209 billion. Within the exports to the US, medicines lead with 9.6 per cent share followed by smartphones (8.8 per cent). 

The pharma sector could scale this to $66.81 billion, with the US alone accounting for $20.13 billion — nearly a third of the total — followed by China ($ 8.79B), Switzerland ($ 5.68B), Japan ($4.23B) and Brazil ($3.36B). 

But the July 21 tariff announcement put this at risk. As the cover story in the August 2026 Express Pharma edition analyses, in a world shaped by geopolitics, economic nationalism and heightened scrutiny on quality and resilience, India’s next phase of growth will depend on trust, innovation and strategic agility. (See story, Power, politics and pharma). 

India will have to work on deepening and expanding current FTAs to increase our export competitiveness. A key part of these measures is mutual recognition of standards and regulatory cooperation. The US tariffs could well be a blessing in disguise if we can look beyond the US and achieve these wins. 

VIVEKA ROYCHOWDHURY, Editor 

viveka.r@expressindia.com 

viveka.roy3@gmail.com 

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Chakravarthi AVPS, Chairman and Managing Director, Ecobliss India Private Limited, has received the CMO Asia Business Leadership & Excellence Award in the category of Asia Business Leader of the Year – Indian Pharma for his contribution to advancing India’s pharmaceutical sector and patient-focused healthcare.

The award was presented at a ceremony held at the Pan Pacific Singapore on Tuesday evening. The annual recognition honours individuals contributing to industry development across the Asia-Pacific region.

Chakravarthi shared the recognition with Dr. Anne Phey, Founder & CEO, The School of Leadership; Rohit Gandhi, Group CEO, APAR Technologies Singapore; Munas van Boonstra, APAC Managing Director, TLC Worldwide; Charu Sethi, OpenRouter; and Dr. Tarita Shankar, Chairperson and President Designate, Indira University.

According to the formal citation, the award recognises Chakravarthi’s leadership in promoting Indian pharmaceutical capabilities on global platforms, patient-focused healthcare solutions, pharmaceutical packaging and international collaborations that support trust in Indian healthcare.

For more than 25 years, Chakravarthi has represented India at global healthcare, packaging and pharmaceutical conferences, highlighting the country’s focus on quality, innovation and affordable medicines. Under his leadership, Ecobliss India has expanded its presence in medication adherence packaging and patient-focused packaging designs aimed at reducing prescription errors and supporting patient outcomes.

Reflecting on the recognition, Chakravarthi dedicated the award to the Indian pharmaceutical community, stating that India’s role has expanded beyond manufacturing to becoming a global healthcare partner. He said that healthcare creates impact when treatment adherence is simplified and noted that packaging supports patient safety and health outcomes. He also emphasised that partnerships between governments, academia and industry remain important for advancing medical progress across countries.

Chakravarthi continues to engage with regulatory and industry organisations, including FOPE, FABA, Pharmexcil, IPA, CII, FTCCI, INBA, LSSSDC, WPO and IIP. Through these organisations, he continues to promote international collaborations and India’s manufacturing capabilities.

According to the company, the recognition comes as the Indian pharmaceutical sector continues to expand its global presence and strengthen its position in healthcare and patient solutions.

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1. Pharmaceutical primary packaging is undergoing significant transformation globally. What trends are shaping the future of primary packaging materials?

The pharmaceutical industry is experiencing a period of rapid change. Manufacturers today are expected to ensure the highest levels of patient safety while also improving manufacturing efficiency, meeting increasingly stringent regulatory requirements, and supporting sustainability goals.

As a result, pharmaceutical primary packaging materials are no longer viewed simply as components. They are becoming strategic enablers of product quality, operational excellence, regulatory compliance, and environmental responsibility. We see growing interest from pharmaceutical companies in solutions that can help them future-proof their operations while maintaining the highest quality standards.

2. In its recent communication, SCHOTT highlighted FIOLAX® Pro as the future standard for Type I pharmaceutical glass tubing within its portfolio. What led SCHOTT to take this direction?

At SCHOTT, continuous innovation has always been part of our commitment to the pharmaceutical industry. As market requirements evolve, we continuously review and strengthen our portfolio to meet future pharmaceutical glass packaging needs.

FIOLAX® Pro glass tubing is developed to address three fundamental industry requirements – drug safety, manufacturing efficiency, and product carbon footprint reduction with its optional product line FIOLAX® Pro OCF. 

The aim is to provide pharmaceutical companies with a future-ready glass solution that helps address both current and emerging expectations across the value chain.

3. What makes FIOLAX® Pro different from conventional FIOLAX® clear?

FIOLAX® Pro combines advancements in material composition, manufacturing technology, and quality transparency.

From a safety perspective, it offers a future-proof glass composition with the absence of any heavy metals and supports easy compliance with ICH Q3D requirements. It is designed to deliver minimal drug-container interactions through superior extractables and leachables performance, constant glass composition, and consistently high hydrolytic resistance.

From an operational standpoint, it supports smooth machinability during converting and fill-finish processes through high cosmetic quality and precise dimensional accuracy. Moreover, the transformation temperature of FIOLAX® pro is quite identical to FIOLAX® clear minimising disruption and simplifying adoption.

Every product delivery is supported by a digital quality data package enabled by SCHOTT’s perfeXion® process, providing an unprecedented level of quality transparency. 

4. Sustainability is becoming increasingly important for pharmaceutical manufacturers. How does FIOLAX® Pro address this?

Sustainability is now a strategic priority for many pharmaceutical companies, and this extends to primary packaging materials and supply chains. In fact, nearly top 20 pharma companies have set strategic SBTi climate targets to reduce their carbon footprint drastically in the upcoming years.

SCHOTT support these ambitions, with the optional FIOLAX® Pro OCF product line, which will be available first quarter of 2027 with an approx. 50 per cent lower product carbon footprint*. This is enabled by a new electric melting tank technology, powered by 100 per cent of electricity in the production process covered by renewable energy Guarantees of Origin; natural gas is now only used in the separate refining unit and working tank part for technical reasons any longer.

We believe innovations like these can help pharmaceutical companies advance their sustainability commitments without compromising quality or performance.

*Calculation of greenhouse gas emissions from cradle-to-gate per kilogram of saleable glass tubing compared to the market average for borosilicate glass tubing [average value according to ecoinvent 3.10; glass tube production, borosilicate // DE. The value currently calculated is based on empirical values and simulation data]. Relevant information about the FIOLAX® Pro OCF product line and the electrical tank can be found in the implementation plan.

5. Some pharmaceutical companies are asking how FIOLAX® Pro fits within SCHOTT’s broader FIOLAX® portfolio. Can you clarify?

Certainly. We understand that the right material makes all the difference in pharmaceutical packaging. As industry requirements rise, SCHOTT remains dedicated to advancing innovation and maintaining quality leadership, ensuring we are prepared to meet both current and future needs. Because patient safety starts with us. 

The journey of FIOLAX® Pro clearly demonstrates SCHOTT’s steadfast commitment. The introduction of FIOLAX® Pro does not alter SCHOTT’s commitment to supply reliably. Rather, it further develops our current portfolio and paves the way for the future of SCHOTT’s Type I glass portfolio.

6. There is considerable discussion around FIOLAX® Pro in the market. Should pharmaceutical companies view this as a signal that they need to immediately transition away from packaging made out of FIOLAX® clear?

Not at all. The introduction of FIOLAX® Pro should be viewed as the next evolution step of SCHOTT’s portfolio and our continued commitment to innovation in pharmaceutical primary packaging.

FIOLAX® Pro is developed to address emerging industry priorities around drug safety, operational efficiency, quality transparency, and sustainability. 

At the same time, FIOLAX® clear remains an established and trusted product used by pharmaceutical manufacturers around the world. 

FIOLAX® Pro will be established as the new standard Type I clear glass for all pharmaceutical applications, gradually succeeding FIOLAX® clear in the long term. But we understand that the pharmaceutical industry operates within long product lifecycles, extensive qualification requirements, and is a highly regulated. Therefore, this evolution will be managed with utmost care and in close partnership with converters and pharmaceutical companies, ensuring sufficient time for qualification, regulatory alignment, and adaptation. Please be assured that this transition is designed to unfold over an extended, decade-scale period, ensuring a seamless and well-supported process that prioritises pharma community requirements and the highest industry standards.

During this time pharmaceutical companies can continue to rely on FIOLAX® clear with confidence. FIOLAX® clear will be available for years to come, and any transition to FIOLAX® Pro would naturally follow global adoption patterns and will occur gradually over an extended period.

Our message to the market is simple – pharmaceutical companies should choose the solution that best fits their business, regulatory requirements, and sustainability objectives. For those interested in the benefits offered by FIOLAX® Pro, SCHOTT is ready to support them with comprehensive material in our Technical Dossier now. For companies continuing with FIOLAX® clear, SCHOTT remains fully committed to ensuring reliable supply and long-term partnership.

7. How should pharmaceutical companies approach FIOLAX® Pro today?

Like I already mentioned, FIOLAX® Pro should be viewed as an attractive option for companies that are looking to enhance safety, efficiency, or sustainability within their primary packaging strategy all given by a future-proof glass.

Every pharmaceutical company has unique technical, regulatory, and commercial requirements. Therefore, decisions regarding qualification and adoption should be driven by individual business needs and long-term plans.

Our role is to provide pharmaceutical companies with choices on the right basic glass material, technical support by knowledge sharing, and all information necessary to make the best decision for their product needs. We encourage pharmaceutical companies to use the coming years to evaluate FIOLAX® Pro and to define individual qualification and implementation roadmaps. SCHOTT tubing will be happy to extend its support to the pharmaceutical companies, at all times.

8. What assurance would you like to give pharmaceutical manufacturers in India or what would be the key take aways from this discussion?

India is one of the fastest growing pharmaceutical markets globally, and we see increasing interest from Indian pharmaceutical manufacturers in advanced patient care solution such as biosimilars like GLPs, ADCs, etc across pharmaceutical container formats.

As companies evaluate how to meet rising expectations around product quality, operational performance, regulatory compliance, and sustainability, FIOLAX® Pro pharmaceutical glass offers a compelling path forward. 

I would say that the market should see FIOLAX® Pro as an opportunity. It is a future-oriented solution for companies seeking additional benefits in areas such as safety, efficiency and product carbon footprint reduction. 

Our commitment is to provide all partners along the pharma value chain with reliable supply, clear communication and access to the best technologies available, today and in the future.

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Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Indocyanine Green for Injection, USP, 25 mg/vial, a sterile lyophilised powder for reconstitution.

The company stated that Indocyanine Green for Injection is the generic equivalent of the reference listed drug (RLD), IC-Green by Diagnostic Green LLC. The USFDA has designated the application as a Competitive Generic Therapy (CGT). According to the company, eligibility for the 180-day exclusivity available to certain competitive generic therapies is determined by the USFDA and, where applicable, the period begins from the date of first commercial marketing.

According to Zydus, Indocyanine Green for Injection is an optical imaging agent indicated for fluorescence imaging of vessels, blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro and reconstructive surgeries, including general minimally invasive surgical procedures. It is also indicated for fluorescence imaging of extrahepatic biliary ducts, fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer, and ophthalmic angiography. The product is indicated for use in adults and, for certain indications, in paediatric patients aged one month and older.

The product will be manufactured at the group’s USFDA-approved injectable manufacturing facility at Jarod, near Vadodara, Gujarat, and will be marketed in the United States by Zydus Pharmaceuticals (USA).

Commenting on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences, said, “Indocyanine green sits at the intersection of medicine and imaging science, requiring precise control of chromophore purity, photostability and lyophilisation. Developing and securing approval for such a complex product with our partner reflects the capabilities we have built and our shared commitment to high standards. It also advances our goal of making essential medicines and diagnostics more accessible, while strengthening our presence in the functional dye and imaging agent segment, where we continue to invest.”

According to the company, the approval adds to its portfolio of injectable and imaging products and reflects a development model combining internal formulation and analytical capabilities with an external partner selected for the programme. Zydus added that it continues to invest in the functional dye and imaging agent segment.

The product will be supplied as a kit containing single-patient-use vials of Indocyanine Green for Injection, 25 mg, as a sterile lyophilised green powder for reconstitution, together with single-dose vials of Sterile Water for Injection, 10 ml.

According to IQVIA MAT June 2026 data cited by the company, the reference product recorded annual sales of approximately USD 125.8 million in the United States, reflecting growth of 61.0 per cent, with volumes of 0.64 million units, reflecting growth of 27.1 per cent.

The company stated that it now has 445 approvals and has filed 513 ANDAs with the USFDA as of 30 June 2026.

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Howden Insurance Brokers India has developed a Cancer Care Group Policy for employee health protection in India. AstraZeneca India has integrated the policy into its employee well-being programme to provide health benefits that extend beyond conventional insurance coverage.

According to Howden India, its market assessment found that dedicated group cancer insurance solutions remain largely unavailable, with insurers citing concerns around incidence risk, pricing uncertainty and limited actuarial data.

The company stated that while the burden of cancer has been recognised, developing an insurance model has remained a challenge because of the condition’s treatment costs and duration. Through collaboration with select insurers, Howden India developed a cancer care group policy that can serve as a model for employer-sponsored, disease-specific insurance solutions in India.

According to the company, the policy has been designed to make cancer protection more accessible. It stated that as cancer treatment often extends beyond standard hospitalisation timelines, the policy provides dedicated coverage for prolonged treatment pathways, including emerging therapies and oral medications.

The policy offers sum insured options ranging from ₹15 lakh to ₹30 lakh, with family coverage including parents. It also covers all existing cancer-related claims without a waiting period and includes extended pre- and post-hospitalisation benefits, along with integration with existing Mediclaim policies.

Commenting on the development, Amit Agarwal, MD & CEO, Howden India, said, “Innovation in insurance is not about creating more products; it is about solving problems that matter. By developing a dedicated cancer care solution, we have shown that complex health risks can be addressed through collaboration, creativity and a willingness to challenge traditional approaches to employee benefits.”

Praveen Rao Akkinepally, Country President & Managing Director, AstraZeneca India, said, “At AstraZeneca, we are driven by a purpose to transform care, and improving access to life-saving therapies is fundamental to realising that. Health insurance is a critical enabler of equitable healthcare access, particularly in addressing the growing burden of serious illnesses, including cancer. As we continue to advocate for inclusive healthcare in India, we believe meaningful change must begin at home. We are proud to introduce AstraZeneca Cancer Care Cover for our employees and their dependents and hope this starts a broader conversation about redefining employee well-being in today’s context and inspires an innovative and progressive approach to healthcare access across the country.”

According to Howden India, the Cancer Care Group Policy reflects the company’s focus on developing need-based insurance solutions for corporate clients. The company stated that it will continue working with insurers and employers to expand access to disease-specific coverage models that address healthcare priorities across the Indian workforce.

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Fermenta Biotech has announced the listing of its equity shares on the National Stock Exchange of India (NSE).

Effective 4 August 2026, the company’s 2,94,30,987 equity shares, with a face value of ₹5 each, have been listed and admitted to dealings on the NSE under the symbol FERMENTA and ISIN INE225B01021. The company’s equity shares will continue to remain listed on the BSE under Scrip Code 506414.

The listing was marked with a bell-ringing ceremony at the NSE’s Exchange Plaza office in Mumbai’s Bandra Kurla Complex. Representatives from the NSE, Fermenta’s Board, senior leadership team and other stakeholders attended the event.

According to the company, the listing comes during its 75th year. Founded in 1951 and listed on the BSE since 1977, Fermenta has expanded from its pharmaceutical and biotechnology operations to manufacturing Vitamin D3 API, nutritional ingredients, green chemistry products, APIs and customised food premixes. The company serves customers in more than 60 countries.

Fermenta stated that the NSE listing reflects its growth, expanding customer base and investor interest. According to the company, the listing provides access to shareholders and market participants across both Indian stock exchanges, supporting broader participation, visibility and price discovery.

Commenting on the development, Prashant Nagre, Managing Director, Fermenta Biotech, said;“Fermenta’s listing on the NSE represents a significant milestone in a landmark year for the Company, as we commemorate 75 years of Fermenta and nearly five decades as a publicly listed enterprise, alongside important recognitions in food safety and workplace culture. It reflects a journey shaped by resilience and a path forward defined by innovation, scale and focus. We will continue to enhance our capabilities across nutrition, food fortification, green chemistry and specialised solutions.

The NSE listing further strengthens our capital-market presence and reaffirms our commitment to transparency, responsible governance and consistent engagement with shareholders. We extend our sincere appreciation to our promoters, Board, shareholders, employees, customers, partners and all other stakeholders for their continued confidence in Fermenta.”

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Under the agreement, Curium US will purchase all outstanding shares of Lantheus for $102.50 per share upon closing.

Lantheus’ shareholders are also set to receive non-transferable contingent value rights (CVRs) that could provide up to an additional $12.00 per share if certain commercial milestones for the company’s product portfolio are met by 2030. This brings the potential total consideration per share to $114.50.

The offer represents a 38% premium to Lantheus’ 60-day volume-weighted average price, a 29% premium to its 30-day average. It is also 21% above the company’s closing price as of 21 May 2026, the last day before media reports emerged about the potential sale.

The proposed transaction has received unanimous approval from Lantheus’ Board of Directors.

Lantheus executive chair and CEO Mary Anne Heino said: “We believe this transaction is the ultimate validation of what the Lantheus team has built over seven decades of innovation in radiopharmaceuticals.

“Combining strategically with Curium brings together two pioneers with complementary strengths and a shared passion for nuclear medicine. Together, we can broaden and accelerate patient access to life-changing diagnostics and therapeutics and fully realise the differentiated outcomes and value radiopharmaceuticals can deliver.”

If approved and finalised, the new combined entity would operate across oncology, neurology, and cardiology in more than 70 countries. It will integrate Curium’s theranostics capabilities and global manufacturing operations with Lantheus’ US-based radiodiagnostics business.

Curium CEO Renaud Dehareng said: “Lantheus is the ideal partner to accelerate what we have been building at Curium. We have executed a strategy to build an innovative, theragnostic platform by expanding our global manufacturing footprint, advancing our radioligand therapy pipeline across key regions, and positioning Curium to drive the next generation of theragnostic innovation.

“Lantheus’ complementary business accelerates our strategy with a robust US commercial infrastructure, a complementary F18-isotope based prostate diagnostics franchise and marks our entry in the US market for diagnostic solutions targeting Neurology and Echocardiography.

“Together, we will provide meaningful theragnostic options to patients from SPECT and PET diagnostics to targeted radioligand therapy across the globe. This combination unlocks an opportunity that neither company could achieve alone, as it positions us to reach significantly more patients and clinicians globally.”

The transaction will be financed through a mix of debt and equity, with no financial conditions attached. The companies expect the merger to close in the first half of 2027, subject to regulatory and Lantheus’ shareholder approvals.

Until then, Lantheus will continue to operate as an independent, publicly listed company.

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Olomorasib (LY3537982) is an investigational inhibitor targeting the KRAS G12C protein and belongs to a class of next-generation therapies under study for various solid tumours.

This marks the second breakthrough therapy designation the experimental drug has received from the US regulator.

In September 2025, the FDA designated olomorasib in combination with Keytruda (pembrolizumab) for the first-line treatment of metastatic or locally advanced non-small cell lung cancer (NSCLC) in patients testing positive for KRAS G12C mutations and a PD-L1 expression of 50% or higher.

Both designations require molecular confirmation through FDA-recognised testing methods.

Breakthrough therapy status is granted to drug candidates that show initial clinical evidence of significant benefits over existing therapies in the treatment of serious conditions.

The FDA’s latest decision for olomorasib was based on preliminary findings from the open-label, multicentre, Phase I/II LOXO-RAS-20001 trial.

This study is assessing safety, tolerability, and early signs of efficacy in people with KRAS G12C-mutant advanced solid tumours, including advanced pancreatic cancers previously exposed to systemic treatment.

Lilly executive vice-president and oncology president Jacob Van Naarden  said: “Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumours harbour a KRAS G12C mutation face limited options once their disease progresses. This breakthrough therapy designation reflects the early potential we’re seeing with olomorasib in this setting and the critical need for new treatment options.

“With now two breakthrough therapy designations across pancreatic and lung cancers, olomorasib continues to demonstrate broad potential clinical evidence across KRAS G12C-driven tumours and reflects our commitment to bringing meaningful new treatment options to patients living with these cancers.”

LOXO-RAS-20001 includes both a Phase Ia dose escalation stage for monotherapy and a Phase Ib expansion phase looking at olomorasib alone and in combination with other treatments.

According to Lilly, KRAS mutations account for the majority of RAS-associated cancers in humans and appear in 90% of pancreatic cancers, with the G12C subtype estimated in 1% to 2% of patients with this disease.

Recently, Lilly expanded its partnership with Resilience by investing in Ohio-based pharmaceutical manufacturing to boost US production of critical medicines.

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According to the Cancer Association of South Africa (CANSA), one in four South Africans will be diagnosed with cancer during their lifetime. While awareness campaigns have helped people recognise the warning signs of breast, prostate and lung cancer, hundreds of rare cancers continue to go largely unnoticed because their symptoms resemble illnesses that people experience without a second thought.

Addressing an unmet need in oncology care, Dr. Reddy’s Laboratories South Africa has announced the registration of a PD-1 inhibitor for the treatment of recurrent or metastatic nasopharyngeal carcinoma (RM-NPC), a form of head and neck cancer. The registration aims to expand access to cancer treatments for patients living with the disease.

Unlike chemotherapy, which works by killing rapidly dividing cancer cells and can also affect healthy fast-growing cells such as those in the bone marrow, digestive tract and hair follicles, immunotherapy helps the body’s immune system recognise and fight cancer. It is a form of biological therapy that harnesses the immune system rather than directly attacking cancer cells. According to the company, immunotherapy has changed the treatment landscape for several cancers and has expanded treatment options for patients with certain advanced or difficult-to-treat cancers.

The World Health Organisation estimates that there are more than 500 rare cancers, many of which receive little public attention. Among them is nasopharyngeal carcinoma (NPC), a form of head and neck cancer in South Africa.

According to the 2024 South African Journal of Oncology, which references GLOBOCAN 2020 data from the International Agency for Research on Cancer (IARC), the disease has a five-year prevalence of 0.88 cases per 100,000 people in South Africa. NPC is frequently diagnosed at an advanced stage, creating challenges for treatment and long-term disease management.

Despite advances in cancer treatment over the past decade, innovation for recurrent or metastatic nasopharyngeal carcinoma has remained limited, highlighting an unmet need for new therapies.

“Every cancer patient deserves access to innovative treatment options, regardless of how rare their diagnosis may be,” says Dr. Rashem Mothilal, General Manager, Dr. Reddy’s Laboratories South Africa. “The registration of this immunotherapy represents an important step forward for patients living with recurrent or metastatic nasopharyngeal carcinoma and reflects our commitment to expanding access to advanced oncology treatments in South Africa.”

Nasopharyngeal carcinoma develops in the tissue behind the nose and above the back of the throat. Early symptoms include persistent nasal congestion, hearing loss, recurrent ear infections and swollen lymph nodes in the neck. These symptoms can be mistaken for other conditions, delaying diagnosis until the disease has reached an advanced stage.

According to the company, the registration forms part of Dr. Reddy’s broader mission to expand access to cancer therapies and improve outcomes for patients with complex and underserved diseases. It stated that, as cancer care continues to evolve through immunotherapy and precision medicine, access to these innovations remains important in addressing treatment gaps.

Dr. Reddy’s Laboratories stated that persistent nasal congestion, repeated ear infections, unexplained hearing loss, frequent nosebleeds or swelling in the neck should not be ignored if they continue, worsen or keep returning. While these symptoms are often caused by common conditions, the company encouraged anyone experiencing persistent or unexplained symptoms to consult a healthcare professional. It added that early diagnosis remains one of the most important factors in improving treatment options and outcomes for patients living with nasopharyngeal carcinoma.

The company stated that access to new treatment options can offer patients living with recurrent or metastatic nasopharyngeal carcinoma improved treatment options and outcomes. It added that expanding access to therapies and promoting awareness of rare cancers can help ensure that patients are not overlooked because of the rarity of their diagnosis.

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Under the agreement, IMPACT Therapeutics will receive an upfront payment, near-term regulatory milestone payments, and additional commercial milestones tied to meeting specified sales targets.

The company is also entitled to tiered royalties up to the mid-twenties percent on product net sales.

The deal expands senaparib’s potential availability to all 27 European Union member states, Australia, Iceland, Liechtenstein, New Zealand, Norway, Switzerland, the UK, and a range of territories in the Middle East and North Africa.

The companies anticipate that this partnership will accelerate the availability of senaparib following regulatory approvals.

Senaparib is a poly(ADP-ribose) polymerase 1 and 2 (PARP1/2) inhibitor developed by IMPACT Therapeutics.

The company previously received approval from the National Medical Products Administration of China in January 2025 for the use of senaparib as a first-line maintenance therapy in adult patients with advanced forms of ovarian, fallopian tube, or primary peritoneal cancer.

The product was also added to China’s National Reimbursement Drug List in December 2025.

In Europe, a marketing authorisation application for senaparib as a first-line maintenance therapy in adult patients with advanced ovarian cancer was accepted by the European Medicines Agency in August 2025, and a decision is expected in the second half of 2026.

Pharmanovia brings established expertise and infrastructure to the collaboration, which IMPACT Therapeutics states will assist in making the treatment more widely accessible across the covered regions.

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The funding will be used to advance its ATLAS clinical trial, which is assessing its lead candidate [Ac-225]RTX-2358, a fibroblast activation protein (FAP)-targeted radiotherapeutic, for patients with advanced sarcomas.

Further resources will also be directed towards moving a next-generation radioligand therapy candidate into clinical studies.

Ratio Therapeutics plans to expand its discovery pipeline to additional cancer targets and apply its technology to new tumour types that are not currently being addressed.

The company will also use the investment to scale its proprietary radiopharmaceutical technology and manufacturing capabilities to meet both pipeline and anticipated commercial demand.

Ratio Therapeutics CEO Dr Jack Hoppin said: “This financing reflects the confidence our investors and strategic partners have in the progress we have made to date and the opportunities that lie ahead.

“As we march the ATLAS trial forward and prepare for our fifth IND [investigational new drug] filing, these proceeds are instrumental across the development and ultimately the supply of our targeted and PK-optimised radiopharmaceuticals.”

The company’s development portfolio includes [Ac-225]RTX-2358 in the ATLAS Phase I/II trial and next-generation programmes targeting gastrin-releasing peptide receptor (GRPR), as well as additional mono- and bispecific radioligand therapies and imaging agents.

The pipeline assets are based on Ratio’s Trillium pharmacokinetic tuning technology and Macropa chelator platform.

Ratio Therapeutics has also established external validation of its approach through partnership programmes, such as its collaboration with Novartis in somatostatin receptor type 2 (SSTR2) radioligand therapy.

On the manufacturing side, Ratio Therapeutics utilises a hybrid model, combining a vertically integrated site in Utah with outsourcing to external partners and diversified isotope supply.

This approach is designed to provide flexible clinical and potential commercial supply as the company expands its radiopharmaceutical pipeline.

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Eisai, a research and development-based pharmaceutical company headquartered in Japan, has announced the launch of LEQEMBI (lecanemab) in India for the treatment of early Alzheimer’s disease, following marketing authorisation from the Central Drugs Standard Control Organization (CDSCO).

In India, LEQEMBI is indicated for patients with Mild Cognitive Impairment (MCI) and mild dementia due to early Alzheimer’s disease. The company stated that it marks the introduction of a disease-modifying therapy (DMT) in the country’s Alzheimer’s disease treatment landscape.

The launch comes amid a growing dementia burden in India, driven by an ageing population, late diagnosis and limited awareness.

According to estimates cited in the AIIMS–USC LASI study, the estimated dementia prevalence in India among adults aged 60 years and above was 7.4 per cent in 2023. About 8.8 million Indians over the age of 60 are living with dementia. The number is projected to nearly double by 2036, highlighting a significant unmet need.

LEQEMBI has received approvals in several developed markets, including the United States, Japan and countries across Europe, as well as select developing countries. The company also stated that there is emerging real-world experience indicating the potential value of LEQEMBI in slowing disease progression and improving patient outcomes.

LEQEMBI (lecanemab) is a humanised monoclonal antibody that selectively targets aggregated amyloid-beta, enabling its clearance while reducing further deposition. It is approved for use in early-stage Alzheimer’s disease, including Mild Cognitive Impairment (MCI) and mild dementia.

According to the company, LEQEMBI works through a dual mechanism targeting both the removal of existing amyloid-beta plaques and the prevention of new plaque formation, a pathological hallmark of Alzheimer’s disease.

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Mumbai-based Encube Ethicals has filed its Draft Red Herring Prospectus (DRHP) with the Securities and Exchange Board of India (SEBI) for its Initial Public Offering (IPO).

The IPO, with a face value of Re 1 per equity share, comprises an offer for sale of Rs 3,000 crore by promoter Mehul Madhusudan Shah and investor selling shareholder Frontier Investment Holdings Pte. Ltd.

The issue is being made through the book-building process in accordance with the SEBI (Issue of Capital and Disclosure Requirements) Regulations. Under the issue structure, not more than 50 per cent of the offer is reserved for Qualified Institutional Buyers (QIBs), not less than 15 per cent for Non-Institutional Investors (NIIs), and not less than 35 per cent for Retail Individual Investors (RIIs).

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The Union Health Ministry has extended the QR code and barcode mandate to four additional categories of life-saving drugs, building on the existing framework covering the top 300 pharma brands. What does the expanded mandate mean for pharmaceutical manufacturers and healthcare providers?

It simply means more medicines will now carry product identifiers in the form of QR codes, and gradually the entire healthcare system will be covered. For manufacturers, this is about preparing their packaging and data systems to meet the requirement, while for healthcare providers, it gives a simple way to check if a medicine is genuine before it reaches patients. Overall, it is another step toward safer and more transparent supply chains. Verification will now happen at every level – from pharmacies to warehouses to hospitals, making the supply chain safer and more transparent overall.

Will this expanded mandate eliminate counterfeit medicines, even though QR codes have been digitally copied in the past?

It is a wrong notion that QR codes alone can stop counterfeiting. QR codes or 2D barcodes are meant for capturing and linking the product with its data. Their role is to connect the physical pack with digital information. When linked to a proper traceability system, they help track the flow of medicines and make it easier to spot irregularities. The mandate builds this foundation, but the real strength comes from how well the codes are implemented and connected to reliable data.

How much will such mandates add to the average spend of pharma companies on such security features?

Costs vary widely and there is no single average. The main change is printing 2D codes and adding variable data like batch details and expiry, so the incremental cost is small if serialisation systems already exist. Firms that already export to regulated markets will not need to experience extra expenditure. Smaller manufacturers and first-time adopters will have to bear the initial costs for equipment, software and training etc. Over time, better traceability brings savings from fewer recalls, fewer reprints and smoother operations. 

How can GS1 standards enable end-to-end drug traceability, from manufacturing and distribution to dispensing?

GS1 standards give every product, shipment and location a unique ID. A product ID on the pack, a shipment ID on the box and a location ID at each facility let everyone record the same facts in the same way. When these IDs are printed as scannable codes and linked to a data record, every movement becomes an accessible and verifiable event. For instance, a medicine can be followed from the production line to the distributor, to the pharmacy and finally dispensed to the patient. Any mismatch or unexpected stop can be monitored. In short, unique IDs plus an end-to-end traceability system create a clear and trusted trail across the whole supply chain.

Beyond regulatory compliance, what are the other benefits that pharma companies can gain from traceability data?

Traceability pays back in many ways. Recalls become faster and far more precise, so only affected packs could be pulled back. Inventory becomes visible across the supply chain, reducing expiry losses and stock outs. Companies can spot any diversion and safeguard their brand. Operations run smoother and more efficiently. And when healthcare providers and patients can verify a medicine instantly, trust grows.

Can you give examples of how global GS1 standards have supported traceability across healthcare supply chains?

GS1 standards have been instrumental in strengthening healthcare supply chain traceability worldwide. In the European Union, GS1 DataMatrix barcodes are mandated under the ‘Falsified Medicines Directive’ to verify medicines at the point of dispensing. Nigeria uses GS1 serialisation to combat counterfeit drugs through ‘NAFDAC’. In France, hospitals apply GS1 identifiers to track medical devices and medicines, ensuring compliance and patient safety. Similarly, the UK NHS “Scan4Safety” programme leverages GS1 barcodes to reduce errors and improve inventory management. 

Importantly, GS1 2D barcodes are now recommended or mandated in healthcare regulations across more than 70 countries, showing how trusted product identity and interoperability are enabling safer healthcare and more resilient supply chains globally. 

Will digital product identification become the backbone of India’s future pharma compliance ecosystem?

Yes. Digital IDs give every medicine a digital, scannable identity that works in both physical and digital systems. With a national drug registry and electronic health records coming online, these IDs will let regulators, distributors and pharmacists read the same trusted data at every step. That makes inspections easier and dispensing safer. In short, a unique digital identity is not just a compliance tool; it rather becomes the foundation that links manufacturing, distribution and patient care in a single, reliable system.  

How can India’s policy makers make these mandates more enforceable and effective?

The need is to focus on making the data usable, not just mandatory. The healthcare ecosystem requires a unique identification system backed by global standards for trusted product records and for every scan to show accurate information. 

Additionally, it is vital to ensure all participants use the system for warehousing, distribution, point of sale and recalls. Promotion of common standards and registry connectivity should also fall in place so data is interoperable across the chain. We must also support MSMEs with technical help, affordable solutions and capacity building programs. 

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Power, Politics And Pharma

Click to download: August 2026 Digital Magazine

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While existing RNA therapies have shown progress in liver and muscle targeting, other tissues remain difficult to reach.

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With this initiative, the total number of jobs generated by Resilience across its Ohio sites will exceed 1,400.

Preparation for the site expansion has commenced, and complete operations are projected to begin in early 2027.

The expanded collaboration builds upon a strategic partnership between the two firms first formed in 2023.

This initiative is in response to growing patient demand for injectable treatments for diabetes and obesity in the US.

Resilience president and CEO William Marth said: “We are proud of what we have built together with Lilly and this new expansion as we scale production of complex medicines in Ohio.

“Our investment reflects our long-term commitment to building one of the largest and most advanced sterile injectable and device assembly and packaging operations in the US, and demonstrates how trusted partnerships, operational excellence, and disciplined execution can strengthen America’s medicine supply.”

Lilly executive vice-president and manufacturing operations president Edgardo Hernandez said: “As demand for our medicines continues to increase, scaling complex manufacturing programmes requires proven technical capability, an uncompromising commitment to quality, and the ability to deliver consistently over time.”

The partnership has so far resulted in the production of more than 150 million doses of medicines for US patients in vial and pre-filled syringe formats.

Resilience operates two facilities in the region, employing nearly 1,000 staff across various functions.

The location in Blue Ash, Ohio, was recently established as Resilience’s global headquarters. The company’s partnerships with REDI Cincinnati, JobsOhio, and Ohio Life Sciences have also supported workforce development efforts in the Cincinnati area.

Prior to this, Eli Lilly and Company entered an agreement with Innovent Biologics for the commercialisation of Verzenios (abemaciclib) in mainland China.

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The Society of Clinical Research and Medical Professionals (SCRMP) will host SCRMP Nexus 2026 – Hyderabad Edition on 8 August 2026 at Novotel Hyderabad Airport, bringing together senior leaders from the pharmaceutical, CRO, biotechnology, healthcare and technology sectors to discuss the future of clinical research, pharmacovigilance, regulatory science, medical affairs and AI-driven healthcare.

The conference is expected to welcome 30+ speakers, 22+ sponsors, 21+ exhibitors, representatives from 75+ organizations and over 130+ delegates, making it one of India’s leading life sciences networking events.

The scientific programme will feature keynote presentations and panel discussions led by experts from organisations including Government of Telangana Life Sciences, Dr. Reddy’s Laboratories, Bristol Myers Squibb, Sanofi, USP India, Wockhardt, Cipla, AstraZeneca, Novartis, Novo Nordisk, Sandoz, Sun Pharmaceutical Industries, Pfizer, Syneos Health, Accenture, PharmaLex and several other leading organisations.

Notable speakers include Sarvesh Singh, Dr. Anu Kumar Saini, Dr. Retesh Kumar Bhumbak, Dr. Girish Kapur, Dr. Anitha Kumari, Zoher Jiwani, Dr. Rajeev M. Patil, Dr. Prasad Deshmukh, Dr. Kiran Kandula, Joydeep Sengupta, Gargi Chatterjee, Dr. Neeraj Mehta, Narendra Annamaneni, Dipankar Dey, along with many other industry experts.

SCRMP extends its sincere appreciation to its Board Members and Organizing Committee—Jayapaul Bonthu, Dr. Bitumani Borah, Ankit Jain, Firoz Momin, Arvind Chauhan, Aparna Kiran Gandham, and Rahul Joshi for their outstanding leadership and invaluable contributions in curating a high-impact scientific programme for SCRMP Nexus 2026 Hyderabad.

The conference is supported by Pharmacoevidence, Navatio Pharma, ALWIS Solutions, Techsol Life Sciences, MetatronicMind Technologies, THRANA, Advity Research, KnowledgeWorks, Nested Knowledge, AccuScript Consultancy, VictoLabs AI, CRQA, CliniMinds, Premise Bio, PV Analytica, Datafoundry AI, eTrialTrack, Sarjen Systems, Croissance Clinical Research, BioAgile Therapeutics and Inductive Quotient. SCRMP also thanks the Journal of Patient Safety & Epidemiology (JPSE) as the Official Journal Partner and Express Pharma, BioSpectrum and Pharma Now as Official Media Partners.

Dr. Umama Yezdani, Hon. Founder, SCRMP, said: “SCRMP Nexus was established to create a collaborative platform where industry, academia and healthcare professionals can exchange ideas, build partnerships and accelerate innovation. We look forward to welcoming the life sciences community to Hyderabad for a day of learning, networking and meaningful collaboration.”

Mohammad Gayoor Khan, Co-Founder & General Secretary, SCRMP, added: “SCRMP Nexus reflects our commitment to strengthening collaboration across the pharmaceutical and healthcare ecosystem. We thank our speakers, sponsors, exhibitors, partners and delegates for supporting this vision and look forward to an engaging conference that inspires innovation and professional excellence.”

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India is building a future-ready drug regulatory framework to accelerate healthcare innovation while maintaining the highest standards of patient safety, quality, and efficacy, Union Minister for Health and Family Welfare J P Nadda said in his virtual address at the inaugural Global Drug Regulatory Conclave (GDRC) 2026. 

Reinforcing this vision, Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi announced at the event that the Central Drugs Standard Control Organisation (CDSCO) will roll out the first phase of an end-to-end digital drug regulatory platform within the next 18 months, marking a significant step in modernising India’s pharmaceutical regulatory ecosystem.

Addressing regulators, policymakers, industry leaders, and delegates from across the globe, Nadda said India’s pharmaceutical industry is evolving from a global supplier of affordable generic medicines to a global center of pharmaceutical innovation. As healthcare advances towards biologics, biosimilars, gene therapies, precision medicine, AI-assisted drug development, and digital therapeutics, he said India’s regulatory framework must evolve in parallel to facilitate innovation while upholding uncompromising standards of safety, quality, and efficacy.

Highlighting the Government’s ongoing regulatory reforms, Nadda said CDSCO is undergoing a comprehensive transformation driven by transparency, scientific rigour, efficiency, accountability, and digital governance. He added that digital regulatory platforms, risk-based oversight, strengthened inspection systems, and enhanced surveillance are creating a modern regulatory ecosystem that inspires greater global confidence. Calling for deeper international collaboration, he urged regulators to strengthen information sharing, regulatory science partnerships, collaborative inspections, and the convergence of scientific standards to improve global access to safe, effective, and affordable medicines.

In his opening remarks at the event, Dr Rajeev Singh Raghuvanshi outlined CDSCO’s roadmap for regulatory transformation centered on digitalisation, innovation, quality assurance, and global regulatory convergence. He said the upcoming common digital regulatory platform will integrate the entire pharmaceutical regulatory value chain from research and clinical development to manufacturing, approvals, distribution, and post-market surveillance—bringing together central and state regulators, manufacturers, and other stakeholders into a single digital ecosystem.

Dr Raghuvanshi said more than 99 percent of CDSCO’s regulatory processes have already been digitised, significantly improving transparency and approval timelines. Building on this, CDSCO is piloting Artificial Intelligence across regulatory processes to create a faster, more agile, and data-driven regulatory system. He also announced that GMP and Certificate of Pharmaceutical Product (COPP) certificates will soon carry QR-code-based digital authentication, enabling overseas regulators to instantly verify their authenticity while reducing verification timelines.

Highlighting initiatives to strengthen quality and innovation, Dr Raghuvanshi said CDSCO has streamlined its export regulatory framework through a fully digitized export No Objection Certificate (NOC) system, introduced globally aligned regulatory reliance mechanisms, and accelerated approval pathways to enable faster patient access to innovative therapies. Around 25–30 percent of clinical trials are currently being considered for waiver for eligible innovative products. He further highlighted MedTech Mitra, which has already supported more than 800 startups in navigating regulatory pathways, and noted that similar facilitation mechanisms are planned for biologics and other emerging technologies.

Further, speaking at the event, Mohit Yadav, IFS, Joint Secretary, Department of Commerce, EP (Pharma), said, “For pharmaceuticals, regulation is the true border. Faster, transparent, and predictable pathways can improve patient access without lowering standards. India must build on the trust it has earned through quality manufacturing by deepening regulatory cooperation, reliance, and responsible use of digital and AI-enabled tools.”

Namit Joshi, Chairman, Pharmexcil, said, “India has earned its position as the pharmacy of the world, and the next step is to become a stronger regulatory partner. As global expectations on quality and compliance continue to evolve, GDRC will bring regulators and industry together to promote harmonised standards, clearer regulatory pathways, and faster access to quality, affordable medicines. It will also help translate policy into consistent compliance across the industry, strengthening confidence in Indian pharmaceuticals across global markets.”

The Global Drug Regulatory Conclave 2026, organized by the Central Drugs Standard Control Organization (CDSCO) in association with Pharmexcil, brought together global drug regulatory authorities, policymakers, researchers, industry leaders, and international organizations to deliberate on the future of pharmaceutical regulation. The conclave focused on strengthening regulatory cooperation, advancing digital transformation, promoting regulatory science, encouraging innovation, and building resilient global healthcare supply chains that ensure timely access to safe, effective, and affordable medicines.

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Global pharma major Lupin announced that following approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application, the company launched Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vial in the United States.

Lupin’s Sugammadex Injection is the bioequivalent to Bridion Injection of Merck, Sharp & Dohme LLC (Merck) and is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery.

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Amgen announced the launch of the first Amgen Scholars Program in India at the International Institute of Information Technology Hyderabad (IIIT Hyderabad), bringing the globally respected undergraduate summer research program to India for the first time.

Supported through a two-year commitment from Amgen through summer 2027, the program reflects the company’s long-standing commitment to advancing science education and inspiring future innovators. The inaugural cohort comprises 10 undergraduate scholars, including students from India, Vietnam, Qatar, and Dubai, creating opportunities for scientific collaboration and exchange across Asia. The students represent universities across Asia and are pursuing undergraduate programs in science, engineering, and related disciplines, reflecting the program’s regional diversity and academic excellence.

As part of the intensive two-month residential research experience, students will explore artificial intelligence and machine learning applications in fundamental sciences, drug design and discovery, healthcare, cheminformatics, genomics and related areas alongside faculty mentors at IIIT Hyderabad. They will also have an opportunity to participate in seminars, networking events and a regional Amgen Scholars Symposium to be held in Tokyo in August 2026. At the conclusion of the program, each scholar presents their research through a scientific poster presentation. The scholars were selected through a rigorous evaluation by an expert committee at IIIT Hyderabad based on academic excellence, research aptitude, motivation for doctoral studies, and demonstrated interest in applying AI and machine learning to drug discovery.

“Scientific breakthroughs begin with curious minds and meaningful opportunities to learn,” said Naveen Gullapalli, Managing Director, Amgen India. “We are proud to bring the Amgen Scholars Program to India. We hope to inspire talented students to pursue research careers while helping build the interdisciplinary skills needed to strengthen India’s scientific ecosystem.”

“We are delighted to serve as the host institution for the first Amgen Scholars Program in India,” said Deva Priyakumar, professor & dean (R&D), IIIT Hyderabad. “The program aligns well with our research-led approach to education and provides undergraduate students with an exceptional opportunity to contribute to cutting-edge research in AI for healthcare and drug discovery while learning from leading faculty.”

“AI is transforming every stage of biotech research, from understanding disease biology to discovering new medicines,” said Sandeep Shukla, professor & director, IIIT Hyderabad. “This program gives students an opportunity to work on real scientific problems while developing the interdisciplinary research skills needed to address tomorrow’s complex healthcare challenges.”

Designed to inspire the scientists of tomorrow, the Amgen Scholars Program is a long-standing, signature initiative of the Amgen Foundation, providing undergraduates the opportunity to engage in a compelling summer, scientific research experience at some of the world’s leading institutions. This program builds on successful programming in the United States, with over 4,000 US students having benefited from the program. Twenty-six leading institutions across the world currently host the summer research program. More than 6,000 students from over 1,000 colleges and universities have participated to date. Financial support for students is a critical component of the program, which seeks to ensure that eligible students, regardless of their financial status, can participate.  The Amgen Scholars Program seeks to expand research, learning and networking opportunities for students committed to pursuing advanced degrees in STEM. Thousands of program alumni have gone on to complete graduate education and build careers across academia, biotechnology and healthcare in more than 40 countries. www.amgenscholars.com. 

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Arboreal Bioinnovations, India’s first specialty food and nutraceutical ingredients technology company, today announced the successful close of its ₹230 crore Series A funding round. EAAA, the alternatives arm of Edelweiss and Omnivore co-led the funding round, with continued backing from existing investor Rainmatter by Zerodha.

The transaction represents one of the largest Series A fundraises in India’s specialty food ingredients sector. Arboreal will deploy the capital to expand its manufacturing capacity, strengthen its research and development capabilities, and accelerate the commercialization of its next generation of functional ingredients.

Arboreal has built a differentiated “contextual innovation” model focused on developing ingredient solutions for the specific nutritional, functional, sensory and commercial requirements of Indian consumers and brands. This approach has enabled hundreds of emerging and challenger brands to launch category-defining products and scale rapidly across the food, beverage and nutraceutical markets.

The company’s integrated ingredient technology platform brings together ingredient engineering, process research and development, formulation science and precision manufacturing. Arboreal has developed and commercialized proprietary ingredients across next-generation proteins, cocoa-based ingredients, natural zero-calorie sweeteners and functional fibres, with several additional ingredient platforms currently under development.

Having more than doubled its growth year-on-year, Arboreal’s portfolio of “better-for-you” ingredients and its “ingredient-first innovation” model have supported more than 300 product launches across over 1,100 consumer brands and nutraceutical manufacturers during the past 18 months.

Swati Pandey, Co-Founder and CEO, Arboreal Bioinnovations, said, “This fundraise is a strong validation of the direction we are taking as a company. It gives us the fuel to accelerate our mission of building clean, science-led solutions that address some of the world’s most pressing nutritional and food challenges, with innovation originating in India and reaching consumers globally.

Manish Chauhan, Co-Founder and COO, Arboreal Bioinnovations, said, “This fundraise marks an important milestone in Arboreal’s journey from building IP led ingredient technologies to enabling big shifts across categories through ingredient first innovation. The confidence shown by EAAA, Omnivore and Rainmatter validates both the strength of our platform and the opportunity ahead of us. It gives us the ability to invest more deeply in science, manufacturing, talent and long-term innovation, while building a platform capable of creating differentiated ingredients for some of the world’s most important food and nutraceutical brands. We are excited to build Arboreal into a globally respected ingredient technology company from India.

Ashish Agarwal, Managing Director, Private Equity, EAAA Alternatives, added, ” The investment in Arboreal reflects the core philosophy of our Fund’s strategy – backing businesses with the potential to emerge as category leaders. As the first investment from our Discovery Fund II, we are particularly excited at the long term growth prospects of Arboreal’s next-generation yeast protein products We look forward to working with Swati and Manish as they continue to build category leadership in R&D-led nutraceutical ingredients.”

Jinesh Shah, Managing Partner at Omnivore, said, “The shift toward clean-label and functional foods requires engineered ingredients that deliver clear health benefits without sacrificing taste or margins. Arboreal fills a critical market gap with locally developed formulations. From sweetener alternatives to novel yeast proteins and collagens, Arboreal’s R&D stack positions them to power the next wave of health and wellness brands.”

Dinesh Pai, Head of investments at Rainmatter, said, “We all lament that India does not allocate capital for enough R&D. Aside from all the things everyone else shared in their reasoning for the investment, we truly wanted to back Swati and Manish in building a world class R&D team working on food ingredients from India. We believe that they are the right team, with exceptional grit to chase down this problem. Rainmatter exists to back these audacious bets, and this is one of them.

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By Lindsey Coulter

SMRT Architects & Engineers recently announced Principal Rebecca Casey, AIA, as Director of its Health & Wellness Practice, expanding the firm’s focus beyond traditional clinical spaces to address the rapidly growing demand for holistic, community-wide health and well-being in the built environment. 

Casey brings more than 20 years of dedicated healthcare architecture experience spanning complex acute care, ambulatory care, behavioral health facilities and specialized environments for aging across the Northeast. A champion of rigorous, human-centered approaches grounded in clinical processes, Casey analyzes how spatial design directly impacts patient outcomes, staff retention and community wellness. 

Now leading a multidisciplinary team of architects, engineers, and planners, Casey will focus on emerging market needs, particularly the integration of behavioral health services and the rising demand for wellness-focused community and institutional spaces. 

“This practice has remarkable depth, built on decades of deep client partnerships and a shared belief that design has the power to heal,” said Casey. “As we look ahead, our challenge and opportunity is to expand how we define health in the built environment. I am honored to lead this incredibly talented team as we continue to design spaces that support caregivers, comfort families, and promote healthier communities.”    

HCO: SMRT has renamed the practice “Health & Wellness” rather than simply “Healthcare.” What does that change in terminology signal about where the industry is headed, and how should healthcare organizations be thinking differently about future capital investments? 

Casey: I’m a strong proponent of population health, of getting further upstream in care. Over the past 10-15 years, the broad adoption of the Social Determinants of Health (SDOH) framework has deepened our understanding of how much contributes to wellbeing, beyond the absence of medical conditions. One of SMRT’s core values is that we design with purpose.  For us, that means applying a values-based, evidence-supported design process across the full continuum of care, not only for patients, but also for the providers, staff, and families who share that space. 

HCO: You have said that design should support caregivers, comfort families, and promote healthier communities. How do you translate those goals into specific architectural decisions during the planning and design process? 

Casey: There’s a strong, growing body of research on how the built environment affects the health of everyone in it, not just patients. Evidence-based design is central to translating that research into practice, and I start from an upstream mindset. WELL is my go-to framework: I’m a WELL AP and WELL Faculty, and I recommend it both as a catalog of evidence organized by impact area and as a set of design criteria for measurable outcomes. A few parameters have become standard on nearly every project: 

• Daylight (with glare control), or when that’s not possible — simulated daylight informed by circadian rhythm supporting levels and colors 

• Biophilic design: access to nature and nature-mimicry or artwork.  Design for joy. 

• Choice: accommodating a range of sensitivities so people can self-manage comfort 

• Indoor air quality and thermal comfort, addressed through HVAC systems — particularly in healthcare — but also material selections, and operational planning 

HCO: Behavioral health integration is becoming a priority across nearly every healthcare setting. What design strategies are proving most effective for embedding behavioral health services into general hospitals, outpatient facilities, and community-based environments? 

Casey: This is a three-part answer to a three-part question!  

• Flexibility: Outpatient behavioral health integration is still evolving. Building space for social workers and behavioral health staff into primary care and other clinic pods is now standard, but that space needs to flex as care models continue to change.  

• De-escalation: On several Emergency Department (ED) expansions and renovations, we’ve expanded space for de-escalation. Applying what we know about behavioral health and neurodivergent needs, buffered space set apart from the ED core, even something as simple as an alcove, can change outcomes when space is limited.  

• Community-based care: Getting care into the community is proving effective in many places. The UVMH Barron Center Mental Health Urgent Care in Burlington, where we partnered, is one example: the space and its open-door model were so effective that the hospital’s emergency room (ER) saw a near-immediate drop in visits. 

HCO: Healthcare organizations continue to struggle with workforce shortages and staff burnout. What role can facility design play in improving caregiver well-being, recruitment and long-term retention?

Casey: My colleague Jeana Stewart, NCIDQ, LEED AP, WELL AP, who leads our Workplace sector, is also a WELL AP and closely tracks trends in work environments. Healthcare has an opportunity to learn from how corporate workplace culture has evolved. People need spaces that support the kind of work they do, but they also need a sense of place, an environment that makes the healthy choice the easy choice. Break rooms matter, but there are other ways to build in that sense of care. On a recent post-occupancy visit with a client in upstate New York, staff feedback reinforced that people want to come to work somewhere that feels light and welcoming and supports their work and connection to each other.  

HCO: Your background emphasizes research-based, human-centered design. Can you share examples of research or post-occupancy findings that have changed the way you approach healthcare projects today?

Casey: One example that comes up across nearly every project, particularly in behavioral health, is the choice of whether to put glass between staff and patients at registration and nursing stations. I first came across this in a study years ago, and I’ve seen it repeated across settings, from inpatient behavioral health to outpatient primary care. Sound privacy matters, but so does access to staff, and the evidence shows physical barriers can increase agitation. Given how much violence healthcare workers face today, that needs to be a risk assessment made project by project. Where we can design for human dignity without barriers, we help set a tone of trust.      

HCO: How do you see wellness standards and evidence-based design influencing healthcare architecture? Are owners placing greater emphasis on measurable outcomes related to occupant health and well-being? 

Casey: I do see that happening, finally. There’s a long-standing critique, and an ongoing effort to change that healthcare in the US is built around disease, sickness and injury rather than health support: intervention rather than prevention. The shift toward population health has been slow because the payment system doesn’t incentivize wellbeing or address the non-medical determinants of health. But the evidence base for those determinants has made it easier to build the case for the built environment’s impact on health and wellbeing. I’d still like to see healthcare go further upstream: first, do no harm, starting the moment someone walks through the door. Wayfinding is one example: it shouldn’t be a source of frustration for anyone. 

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This combined company intends to apply for a listing on the Nasdaq Capital Market under the “CALD” ticker symbol.

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The recommendation is based on data from the Phase III VESALIUS-Cardiovascular (VESALIUS-CV) trial, which involved more than 12,000 patients.

The trial evaluated the effect of adding evolocumab to standard lipid-lowering therapy in adults at high risk but with no previous heart attack or stroke.

It found that Repatha significantly reduced the risk of major adverse cardiovascular events.

Results showed a 25% relative reduction for a composite of coronary heart disease death, myocardial infarction or ischaemic stroke, and a 19% decline in a broader composite endpoint that also included arterial revascularisations.

A 36% reduction in the risk of myocardial infarction was also reported.

Amgen chief medical officer Paul Burton said: “There remains a significant unmet need in Europe, where many patients at high cardiovascular risk are unable to achieve recommended LDL-C levels despite available lipid-lowering therapies.

“The CHMP’s positive opinion reflects the strength of Repatha’s clinical evidence and brings us one step closer to making Repatha available to more patients who may benefit from it.”

In 2015, Repatha was initially approved in the EU for certain adults and paediatric patients with primary hypercholesterolaemia or mixed dyslipidaemia, as well as for reducing cardiovascular risk in adults with established ASCVD.

A final decision from the European Commission (EC) is expected in the coming months.

Burton added: “Repatha is the only PCSK9 inhibitor proven in a Phase III clinical trial to reduce the risk of a first major cardiovascular event. If approved by the EC, this expanded indication has the potential to redefine cardiovascular care for appropriate patients in Europe.”

Earlier this year, Amgen secured approval from the EC for Uplizna (inebilizumab) as an add-on treatment to standard therapy for adults with generalised myasthenia gravis who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.

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The two-day conference brought together leading oncologists, clinicians, public health experts, researchers, policymakers, artificial intelligence specialists and implementation partners to advance India’s roadmap towards oral cancer elimination.

Biocon Foundation, the Corporate Social Responsibility (CSR) arm of the Biocon Group, in association with the Indian Institute of Science (IISc) and Translational AI for Networked Universal Health Care (TANUH), commemorated World Head & Neck Cancer Day by hosting the 7th edition of the Oral Cancer Task Force (OCTF) Annual Conference on July 27–28, 2026, at the BITS Pilani, Goa Campus.

The two-day conference brought together leading oncologists, clinicians, public health experts, researchers, policymakers, artificial intelligence specialists and implementation partners to advance India’s roadmap towards oral cancer elimination. This year’s theme, ‘Integrating AI, Research, and Advocacy towards Oral Cancer Elimination,’ underscored the role of artificial intelligence, implementation research and multi-stakeholder collaboration in strengthening oral cancer prevention, early detection and access to timely care.

Kiran Mazumdar-Shaw, Founder & Managing Trustee, Biocon Foundation, and Convenor, OCTF, said, “India has a unique opportunity to redefine the global approach to oral cancer by harnessing the power of artificial intelligence, scientific innovation, and strong public health systems. Through the Oral Cancer Task Force, we are bringing together expertise across sectors to develop scalable, technology-enabled solutions that can drive early detection, improve access to timely treatment, and ultimately save lives. The goal is to ensure that these innovations reach far and wide, making quality cancer care more equitable and accessible.”

Oral Cancer Task Force Members, “Oral cancers are responsible for a humongous amount of mortality and morbidity in India.  Eliminating this scourge necessitates a comprehensive, pragmatic approach that integrates health and technology through tobacco control and cessation, AI-enabled screening and early detection, timely referral pathways, down staging of disease, and quality care across the continuum of care. It is heartening to know that AI-enabled oral cancer screening at the district level has been implemented. This initiative marks a significant step towards AI-assisted approach to improve oral cancer outcomes.”

Established in 2018 by Biocon Foundation, the Oral Cancer Task Force (OCTF) is an independent multidisciplinary platform bringing together clinicians, researchers, public health experts, policymakers and technology partners to reduce the burden of oral cancer through research, innovation, evidence generation, advocacy and policy engagement. Over the years, OCTF has contributed to the development of consensus guidelines for Oral Potentially Malignant Disorders (OPMDs) and Head & Neck Cancers, while advancing technology-enabled screening approaches across India.

Advancing AI-enabled screening at scale

A key highlight of the conference was the progress made under the Centre of Excellence for Artificial Intelligence (AI-CoE), a first-of-its-kind multicentric initiative involving 28 consortium partners with IISc serving as the nodal institution.

The initiative has developed an AI-assisted, mobile phone-based white-light imaging solution that stratifies oral lesions into high- and low-risk categories, enabling early identification of oral cancer. The technology powers Aarogya Aarohan, an AI-enabled mobile application currently deployed across Public Health Centres in Goa. Designed for use by frontline healthcare workers, the application can operate on low-cost smartphones, function offline in low-connectivity settings and support referral workflows across different levels of the healthcare system, making point-of-care screening more accessible and scalable.

Since 2014, Biocon Foundation has screened more than 100,000 individuals across multiple states through a community-based oral cancer screening programme. The Foundation contributed over 30,000 annotated oral lesion images that enabled the development of Aarogya Aarohan in collaboration with IISc and TANUH. The deployment of the application has contributed to a ten-fold increase in screening capacity over the past 18 months while helping identify community-specific intervention strategies.

Driving an integrated strategy for oral cancer elimination

The conference reaffirmed OCTF’s commitment to advancing oral cancer elimination through three strategic priorities:

• Tobacco cessation through education, awareness and school health programmes
• Screening and early detection
• Timely diagnosis and initiation of treatment

Supported by collaborations across public health, clinical research, artificial intelligence and policy, these efforts aim to build a scalable, evidence-based framework for oral cancer control in India.

The conference featured keynote addresses, expert talks, panel discussions, stakeholder consultations and strategic planning sessions covering AI-assisted screening, integration of AI into clinical workflows, digital innovations for community-based screening, tobacco cessation and improving timely access to treatment. Drawing inspiration from global efforts towards cervical cancer elimination, the deliberations will inform the development of a robust and scalable oral cancer elimination strategy that can be adapted across geographies and health systems.

Consensus guidelines updated

The conference also unveiled the 2026 update to the Indian Clinical Practice Consensus Guidelines for Head & Neck Cancer, developed under the aegis of OCTF. Presented by Dr Kumar Prabhash, the updated guidelines reflect the latest clinical evidence and continue OCTF’s efforts to standardise evidence-based management of head and neck cancers across India. The initiative is coordinated by Dr Neera Gupta, Vice President – Clinical Development & Medical Affairs, Immuneel Therapeutics, and the updated guidelines will continue to be published in the Journal of Cancer Research and Statistics and Treatment.

The conference brought together experts from Tata Memorial Hospital, IISc, the Government of Goa, Biocon Foundation and leading academic, clinical and public health institutions from India and abroad. Keynote speakers and panellists included Dr Srinath Reddy, Dr Shekhar Salkar, Dr Guruprasad Naik, Dr Upendra Bhojani, Dr Sumirtha Gandhi, representatives from the Department of Health Services, Government of Goa, Prof Paturu Kondaiah, Dr Anupama Shetty, Dr Manisha Khorate, Dr Anupama Borkar, Prof Kunal Korgaonkar, Dr Praveen Birur and several other national and international experts.

The conference concluded with a renewed commitment from clinicians, researchers, policymakers and technology partners to accelerate the adoption of AI-enabled, evidence-based approaches for oral cancer prevention, early detection and treatment, strengthening India’s journey towards eliminating oral cancer as a major public health challenge.

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Aesthetic medicine is no longer a boutique corner of healthcare. The International Society of Aesthetic Plastic Surgery counted close to 38 million surgical and non-surgical aesthetic procedures worldwide, a rise of 42.5 per cent over four years. That is a volume curve most therapeutic specialities would envy. It is also a stress test. When a discipline scales this quickly, the question that decides its future is not how many procedures it can deliver but how safely, consistently and accountably it can deliver them. Growth has arrived. Governance must now catch up.

The pattern will be familiar to anyone who has watched other sectors industrialise. Demand outruns regulation, capital outruns capability, and operators of wildly uneven quality fill the gap. Injectables administered in salons. Energy devices run without medical oversight. Every such shortcut erodes the one asset on which the entire category depends, which is public trust. How the speciality responds to that erosion will determine whether aesthetic medicine matures into a credible branch of clinical practice or stalls as a consumer fad with a safety problem attached.

The trust deficit that follows fast growth

Trust is the real currency here. A patient choosing a filler, a peel or a laser protocol cannot independently audit the pharmacology or the physics involved. They are buying judgement, and judgement is precisely what clinical governance exists to institutionalise. Governance in this context means defined lines of medical accountability, documented protocols for patient selection and informed consent, adverse event reporting that actually gets reported, regular audit cycles, and credentialing that separates a trained dermatologist or plastic surgeon from an enthusiastic technician with a device. None of this work is glamorous. All of this is what separates medicine from retail.

Doctor-led protocols are at the centre of that architecture. A protocol written and owned by a qualified physician does three things a marketing-led playbook never will. It screens out patients who should not be treated, arguably the most underrated safety intervention in aesthetics. It standardises technique so that outcomes are reproducible across practitioners and locations rather than dependent on one gifted pair of hands. And it closes the feedback loop, because physicians who own protocols also own complications, and ownership is what drives iteration and improvement. Evidence-based practice, in other words, is not a slogan but an operating system. Nowhere are the stakes of getting that operating system right higher than in the markets growing fastest, and India now sits squarely in that category.

India’s opportunity arrives with an obligation attached

The national context sharpens the argument considerably. Government data released through the Press Information Bureau places India’s medical value travel market at roughly USD 8.7 billion in 2025, projected to reach USD 16.2 billion by 2030, and records 507,244 international patients arriving specifically for medical treatment in 2025. Aesthetic, dermatological and wellness services form a growing slice of that inflow, alongside the far larger domestic market being created by rising incomes, urbanisation and the normalisation of aesthetic care among both women and men.

India’s pitch to the world rests on a simple proposition, globally benchmarked clinical standards delivered at a competitive cost. That proposition collapses the moment standards become negotiable. Accreditation frameworks such as NABH, rigorous physician credentialing and transparent outcome reporting are not bureaucratic overhead in this reading. They function as the export licence for an entire sector and as the domestic patient’s first line of defence. What the state signals through policy, capital has begun to price.

What investors are actually underwriting

The investor lens makes the same point in blunter language. Organised aesthetic dermatology in India is consolidating, with clinic chains raising institutional capital and pursuing multi-city expansion, often through partner-led and franchise-style models. Anyone who has sat through diligence on a healthcare asset knows where the sharp questions land. Who owns the medical protocols? What is the verified complication rate? Does quality survive when the founding dermatologist is in one city while the twentieth clinic opens in another? Clinical governance is the answer to every one of those questions, which is why it has quietly shifted from compliance cost to valuation driver.

A chain that can demonstrate physician-owned protocols, structured training pathways, technology-enabled record-keeping and audited outcomes is effectively buying itself a lower cost of capital and a durable licence to scale. A chain that cannot demonstrate these protocols is one viral complication away from reputational impairment that no marketing budget can repair. Outcome-based care, long the language of hospital medicine, is becoming the language of aesthetic medicine’s terms. sheets as well. And the same logic that reassures an investment committee is, in the end, what protects the individual sitting in the consultation chair.

Because that is where the argument terminates, with the patient. Aesthetic medicine is unusual in that its consumers are largely healthy people accepting clinical risk in pursuit of quality-of-life gain. That inverts the normal risk calculus of medicine and raises, rather than lowers, the ethical bar. The most credible emerging model treats the patient as a whole system rather than a procedure site. Skin, hair, nutrition, hormonal balance and lifestyle are assessed together. Artificial intelligence and imaging support the physician’s judgement without ever replacing it. Success is measured in outcomes sustained over years, not transactions completed per day. Practices built this way have grasped something the wider category is still learning: that genuine transformation is never only about appearance but about confidence, wellbeing and care that understands the person behind the presenting concern.

The direction of travel is clear. Regulators are moving, investors are discriminating, and patients are becoming far more sophisticated buyers of medical judgement. The clinics and chains that dominate the next decade will be those that treated clinical governance as a founding principle rather than a retrofit and doctor-led protocols as the product itself rather than the fine print. In aesthetic medicine, as everywhere else in healthcare, the physician-led model is not a constraint on growth. It is the only version of growth worth financing.

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RPG Life Sciences announced the execution of a Business Transfer Agreement for the transfer of the Company’s Active Pharmaceutical Ingredients (API) business to RPG Active Pharma Limited (“RPG Active Pharma” or “RPGAP”), a wholly owned subsidiary of RPG Life Sciences, as a going concern on a slump sale basis.

The proposed transfer is part of RPG Life Sciences’ strategy to create a focused API business with dedicated capital, sharper management attention and greater strategic flexibility, while the Company also continues to build its formulations business.

This business has been created at a time when the global pharmaceutical supply chains are undergoing structural realignment and India is increasingly emerging as a preferred destination for reliable, high-quality API manufacturing.

The Company has entered into an investment agreement to forge a strategic partnership with Inv Ascent, a healthcare-focused private equity investor, through an investment in RPG Active Pharma. The partnership brings together RPG Life Sciences’ pharmaceutical experience, manufacturing capabilities and execution track record with lnvAscent’s 20-years’ experience of investing in and scaling pharma businesses. Accordingly, funds managed by lnvAscent will make an initial investment of an
amount upto Rs. 243 er. in RPG Active Pharma.

The agreement envisages investments by the Company and lnvAscent upto Rs. 700 er. in RPGAP in tranches. The investment is expected to provide RPG Active Pharma with the capital and strategic support required to strengthen manufacturing infrastructure, expand the product portfolio, enhance process development capabilities and pursue organic and inorganic growth opportunities.

In addition, the RPG Active Pharma has also executed a Share Purchase Agreement for acquisition of 100% equity share capital of Actis Generics Private Limited – an API manufacturing company based in Visakha patnam. The proposed acquisition is expected to expand RPG Active Pharma’s manufacturing base, broaden its operating platform and support its strategic growth objectives.

The investment by India Life Sciences Fund – a life sciences focused fund – and the proposed acquisition of Actis Generics are intended to establish RPG Active Pharma as a focused API manufacturer for the next phase of RPG Life Sciences’ API growth. RPG AP will focus on augmenting its manufacturing capabilities, expanding its API portfolio and serving customers across domestic and international markets with a strong emphasis on quality, reliability and long-term partnerships. The transactions are subject to customary regulatory approvals and pre-closing conditions.

Commenting on the development, Ashok Nair, Managing Director, RPG Life Sciences, said: “Building a meaningful and scalable presence in AP/s has been a strategic priority for RPG Life Sciences. RPG Active Pharma gives us a focused business to pursue this opportunity with greater speed, discipline and scale. We are pleased to partner with lnvAscent, whose pharma investing experience and long-term partnership approach complements our vision for the business. The proposed acquisition of Actis Generics further strengthens this business and supports our ambition to build a high-quality AP/ business with expanded manufacturing capabilities, a broader product portfolio and the ability to create sustainable value for all stakeholders.”

Commenting on the partnership, Dr Jeevak Gupta, Managing Director, lnvascent, said: “We are excited to partner with RPG Life Sciences in building RPG Active Pharma into a differentiated AP/ business. RPG Life Sciences has established pharmaceutical capabilities, a strong operating foundation and a clear ambition to scale its AP/ business. We believe RPG AP is well positioned to benefit from the long-term growth opportunity in high-quality AP/ manufacturing, and we look forward to supporting the business through capital, strategic guidance and our healthcare sector experience.”

Khaitan & Co. acted as the legal counsel and structuring advisor to RPG group for the investment transaction. o3 Capital acted as an exclusive financial advisor, Quillan Partners acted as legal counsel and Deloitte undertook financial due diligence on the acquisition of Actis by RPG Active Pharma.

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MRG Group, a diversified business conglomerate, has announced its strategic collaboration with Arica Pharmaceutical, reinforcing its commitment to supporting India’s rapidly growing healthcare sector while fostering innovation, quality, and community well-being.

The partnership brings together MRG Group’s vision for diversified growth and Arica Pharmaceutical’s expertise in delivering quality healthcare solutions. Established in 2023, Arica Pharmaceutical has built its presence in the pharmaceutical industry with a focus on anti-diabetic, neurosciences, and cardiovascular therapies and is now gearing up to expand into multiple therapeutic categories as part of its long-term growth strategy.

The collaboration is expected to create opportunities for innovation, business expansion, and initiatives aimed at improving healthcare accessibility while strengthening the pharmaceutical ecosystem in India.

Speaking on the occasion, Rajjath Goel, Managing Director, MRG Group, said, “At MRG Group, we believe meaningful growth is driven by partnerships that create lasting value for society. Our collaboration with Arica Pharmaceutical reflects our commitment to supporting sectors that have a direct impact on people’s lives. We look forward to working together to drive innovation, encourage responsible growth, and contribute towards building a healthier future for India.”

The leadership of Arica Pharmaceutical expressed confidence that the collaboration with MRG Group will further strengthen the company’s expansion plans and accelerate its vision of becoming a trusted healthcare partner through quality products, innovation, and patient-centric solutions.

The partnership reflects the shared vision of both organizations to promote healthier lifestyles, strengthen communities, and contribute to India’s evolving healthcare landscape.

As India’s pharmaceutical sector continues to witness robust growth, the collaboration between MRG Group and Arica Pharmaceutical is expected to lay the foundation for future strategic initiatives focused on healthcare innovation, expansion, and sustainable value creation.

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Pfizer and BioNTech SE announced that the European Commission (EC) has granted marketing authorization for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the Emergency Task Force (ETF) of the European Medicines Agency (EMA) to update COVID-19 vaccines to target the XFG variant of the JN.1 lineage for the 2026-2027 season. The ETF stated that “the evidence suggests that targeting XFG would provide the best protection against COVID-19.”

The marketing authorization is valid in all 27 European Union (“EU”) Member States, as well as Iceland, Liechtenstein and Norway. Pfizer and BioNTech have already initiated manufacturing of the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness in anticipation of the respiratory disease season, when the demand for COVID-19 vaccination is expected to increase. EU Member States as well as Norway, will be supplied either via the EC contract or according to individual country government policies.

The EC approval follows the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation from July 23, 2026 based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical and real-world data supporting the safety and efficacy of the Pfizer and BioNTech COVID-19 vaccine as well as manufacturing/quality and non-clinical data showing that the monovalent XFG-adapted COVID-19 vaccine generated strong immune responses against currently circulating SARS-CoV-2 lineages, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1 and other contemporary lineages.2

The companies have also submitted data for the updated COVID-19 vaccine to regulatory authorities around the world. The companies are continuing to monitor the evolving epidemiology of COVID-19 in preparation to meet global public health needs.

The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for the Pfizer-BioNTech COVID-19 vaccine and its adapted vaccines in the United States, the EU, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in other countries.

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Sun Pharmaceutical Industries announced that it has received approval from the Brazilian Health Regulatory Agency, ANVISA to manufacture and market semaglutide injection in Brazil for the treatment of adults with inadequately controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

Sun Pharma plans to launch the product in the next few days in partnership with Hypera Pharma, a leading pharmaceutical company in Brazil. It will be available as a pre‑filled, multi‑dose injectable pen in two strengths (2 mg/1.5 mL and 4 mg/3 mL) allowing flexible, once‑weekly dosing.

“The approval of semaglutide in Brazil expands access to an evidence-based treatment option for people living with inadequately controlled type 2 diabetes. It reflects the strength of our development and manufacturing capabilities and our commitment to delivering high-quality medicines across global markets,” said Aalok Shanghvi, Chief Operating Officer, Sun Pharma.

Digvijay Singh, Regional Head, Brazil & LATAM, said, “This approval marks an important step in strengthening our diabetes portfolio in Brazil. We look forward to working closely with our partner to make this treatment option available to patients and support better diabetes care across the country.”

The semaglutide injectable market in Brazil is approximately USD 413 million (IQVIA, MAT June 2026).

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CureMeAbroad, a medical tourism discovery and concierge platform operated by Luxora Health Care Experiences, has signed Memoranda of Understanding (MoUs) with Asia Cosmetics in Thailand and Dr. Brenda’s Clinic in Mexico to expand its network of international healthcare providers.

According to the company, the partnerships are intended to facilitate access to cosmetic and aesthetic treatments for patients from the United States, the United Kingdom, Germany, Australia and GCC countries. The collaborations also establish a framework for patient referrals, care coordination, quality standards and post-treatment support.

Commenting on the development, Aditya Oza, CEO and Co-Founder, CureMeAbroad, said, “Patients travelling abroad for cosmetic procedures are making one of the biggest healthcare decisions of their lives, yet many still rely on social media or unverified online recommendations. Our partnerships with Asia Cosmetics and Dr. Brenda’s Clinic give patients access to trusted providers backed by structured care coordination, while enabling our partners to receive a consistent pipeline of well-informed international patients. This is how medical tourism should operate with accountability on both sides.”

Thailand has long been a destination for medical tourism, supported by internationally trained specialists and comparatively lower treatment costs. Mexico has also emerged as a destination for patients, particularly from the United States, seeking cosmetic procedures such as liposuction, rhinoplasty and body contouring due to its proximity and cost advantages.

Dr Jeab, Head, Asia Cosmetics, Thailand, said, “Thailand has become one of the world’s preferred destinations for cosmetic and aesthetic treatments because patients value both quality and trust. Through our partnership with CureMeAbroad, we look forward to welcoming more international patients with a seamless treatment experience backed by transparent communication, personalized care, and internationally accepted clinical standards. Together, we aim to make cross-border healthcare more accessible and reassuring for patients worldwide.”

Under the agreements, CureMeAbroad will coordinate patient services including teleconsultations, treatment planning, travel arrangements, hospital coordination and post-treatment follow-up.

Mikhail Bohra, Co-Founder and CMO, CureMeAbroad, said, “Cosmetic and aesthetic procedures continue to be among the highest enquiry categories on our platform, particularly from patients in the US and Auz. People today are looking for trusted providers as much as affordable treatment. These partnerships allow us to offer verified options in two of the world’s most sought-after cosmetic tourism destinations.”

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ChrysCapital, one of the biggest private equity firms investing in India, acquired a controlling 70.68% stake in Novartis India Limited (NIL). The transaction marks a defining moment for ChrysCapital and for the Indian pharmaceutical sector bringing one of India’s longstanding pharmaceutical businesses under dedicated private equity ownership, with the ambition to build a leading branded-generics platform for the Indian market.

NIL has a legacy spanning several decades and a portfolio of brands that are trusted both by healthcare professionals and patients. NIL operates across key therapeutic areas including pain management, calcium supplementation, gynecology, neurosciences, and transplant immunology through brands such as Voveran, Calcium Sandoz, Tegrital etc. Built on a strong foundation of scientific excellence, physician trust, and nationwide reach, NIL has played a meaningful role in improving healthcare outcomes for millions of patients across the country.

The acquisition marks ChrysCapital’s first majority-controlled investment in the Indian pharmaceutical sector and reflects the firm’s strong conviction in the long-term growth potential of India’s branded pharmaceuticals market. Building on a proven healthcare investment track record, ChrysCapital aims to leverage its sector expertise and extensive network to support the next phase of growth for NIL and strengthen its position as a leading pharmaceutical business. NIL will adopt a new name and corporate identity to celebrate the company’s separation from its previous owners and the beginning of a new era.

To support the company’s next phase of growth, NIL has appointed Dr. Vikas Gupta as the CEO and Managing Director. Further, Ramesh Ramadurai, Suchita Sharma and Shashank Sinha have joined as Independent Directors on the Board of NIL.

“A strong management team is central to any successful organization, and NIL is fortunate to have Dr. Vikas Gupta at the helm – someone who brings both the experience and the vision this business needs. Combined with NIL’s legacy brands and market standing, ChrysCapital believes the foundation for long-term value creation is firmly in place.” – Kshitij Sheth, Managing Director, ChrysCapital Advisors.

Dr. Vikas Gupta, Chief Executive Officer and Managing Director, NIL, said: “NIL has earned its place in Indian healthcare over many decades. Today we begin a new and exciting chapter in NIL’s history. We carry forward decades of scientific rigour and physician trust – from that strong foundation and with ChrysCapital’s backing we have the resources and focus to grow our portfolio with purpose, reach more patients, and build on what this organization has always stood for.”

For this transaction, Kotak acted as the exclusive financial advisor to Novartis AG. Freshfields, AZB & Partners advised Novartis AG as legal counsels and Ernst & Young advised Novartis AG on the financial and tax diligence. Shardul Amarchand Mangaldas & Co acted as the legal counsel and Alvarez & Marsal, Dhruva Advisors and Price Waterhouse & Co. were the financial and tax advisors for ChrysCapital.

The post ChrysCapital completes acquisition of an Indian subsidiary of a global pharma company appeared first on Express Pharma.

This antisense oligonucleotide has been developed to suppress WISPER, a heart stress-specific lncRNA that is overexpressed in hypertrophic cardiomyopathy, including nHCM.

By targeting this lncRNA in cardiac myofibroblasts, the therapy is intended to facilitate the precise reprogramming of these fibrotic and pathological cell states.

HAYA Therapeutics CEO and co-founder Samir Ounzain said: “HAYA was founded on the belief that the regulatory genome offers a new way to address the underlying biology of disease. This regulatory designation recognises the potential of HTX-001 to offer a differentiated therapeutic approach for patients with nHCM.”

HAYA Therapeutics chief medical officer Jordan Shin said: “Patients with non-obstructive HCM are seeking treatments that go beyond management of symptoms. This designation reflects the urgency of delivering better therapeutic options.

“With our Phase I clinical trial already underway, fast track designation allows us to work more closely with the FDA as we advance HTX-001, our investigational precision RNA-guided therapy designed to reprogramme disease-driving cardiac fibroblasts—the sentinel effector cells that act to drive fibrosis and remodelling in the myocardium.”

The designation seeks to expedite the development and review of drugs intended for serious conditions where there is an unmet medical need.

It may result in more frequent interactions with the FDA and eligibility for various expedited review processes.

HTX-001 has not received approval from the FDA, European Medicines Agency (EMA), or any other regulatory authority. Its safety and potential to provide clinical benefit are yet to be determined.

In May 2025, Haya Therapeutics procured $65m in Series A funding to expedite the clinical development of HTX-001 for treating heart failure.

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The licensed assets focus on targeting key molecular drivers implicated in a range of cancers. The portfolio includes multiple programmes covering different targets and biological pathways.

CORE Biomedicine plans to use these assets to support its precision medicine strategy and aims to develop therapies for a broader set of cancer patients.

The company uses a lineage-based approach intended to identify and target oncology drivers beyond genomics, seeking to enable the discovery of therapies for wider patient populations.

CORE Biomedicine co-founder and business development head Dr Douglas McMillin said: “CORE was created to advance an exceptional portfolio of oncology programmes grounded in deep cancer biology, precision medicine and lineage therapeutics.

“We believe these programmes have tremendous potential to address significant unmet medical needs across multiple cancers, and we are committed to advancing them efficiently toward the clinic and ultimately to patients.”

In a separate development, CORE Biomedicine completed a $21m Series A funding round co-led by Elikon Venture and UTokyo Innovation Platform, with involvement from CD Capital, InnoPinnacle Fund, Mitsubishi UFJ Capital, Root Venture Partners, Suzhou Capital Group, Vision Incubate, and YuanBio Venture Capital.

These funds are intended to support the advancement of the company’s lead programmes from discovery to early clinical development.

Additionally, the company’s wholly owned subsidiary, CORE Biomedicine Japan, received a grant through the Strengthening Program for Pharmaceutical Startup Ecosystem, a scheme run by the Japan Agency for Medical Research and Development (AMED).

This initiative is aimed at accelerating research and development activities and fostering collaborations within Japan’s biopharmaceutical sector.

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We keep telling ourselves the same story: India is the pharmacy of the world, and now it is graduating to specialty. I have sat through enough industry panels to know the script by heart — small molecules to complex generics, biologics, peptides, modified release. Say it enough times and it starts to sound like a plan. It isn’t, yet. It is an ambition standing on a foundation we haven’t finished building.

Let me start with what’s real. Everything on that list — complex generics, biologics, peptides, large molecules, delayed and modified release systems — sounds like a formulation upgrade. It isn’t. A modified-release tablet isn’t a regular tablet with a coating; ensuring a consistent release profile batch after batch, across the full shelf life, across varying humidity and storage conditions in Lagos versus Ludhiana, is a different discipline entirely. A peptide isn’t a small molecule with a longer name — you’re managing aggregation, oxidation, and an impurity profile that can shift with a single degree of temperature variance during lyophilisation. Biologics carry a manufacturing memory: change the cell line, the media, even the mixing speed, and you have effectively made a new molecule.

None of this happens on the first batch. It happens on the fifteenth, the twentieth pilot batch, each one interrogated for stability, impurity and bioequivalence before it is allowed anywhere near a tech transfer document. That is the honest cost of the transition we are all talking about at conferences — and it is a cost very few companies are actually underwriting.

Here is where I will be direct, and probably unpopular: the biggest opportunity in front of Indian pharma right now isn’t being wasted because of talent, or ambition, or even capital. It is being wasted because we are trying to build a specialty and complex-generics business on top of a raw material supply chain we don’t control.

We love talking about the coming patent cliff — and it is real. Somewhere between $200 billion and $400 billion of branded biologic and complex-molecule revenue loses exclusivity globally between 2025 and 2030. By some estimates, close to 90% of the biologics coming off patent in this wave don’t yet have a biosimilar in active development. That is not a crowded market. That is a door standing open. And yet, when I look at how much of that opportunity Indian companies are actually positioned to walk through with our own upstream chemistry — our own key starting materials, our own fermentation and peptide-synthesis capability — the honest answer is: not nearly enough.

We still import roughly two-thirds of our API and KSM requirement from China, and for several fermentation-based and antibiotic categories, that dependence runs past 90 per cent. For the complex molecules we are now chasing — peptides, biologics, hormone-based APIs — the upstream chemistry is even thinner domestically. So we have built a formidable formulation and fill-finish engine, and we are bolting it onto a supply chain we don’t own. That is not self-reliance. That is assembly with better branding.

I don’t say this to be cynical about where we are headed — I say it because I think the industry is more comfortable talking about the destination than the plumbing. PLI outlays, bulk drug parks coming up in Gujarat and Himachal Pradesh, the renewed push on fermentation and flow chemistry from our research institutions — these are real, and they matter. But the pace of KSM and API self-sufficiency has to move at the same speed as our specialty ambitions, or we will spend the next decade being extremely good at finishing molecules we cannot fully make.

The second shift nobody wants to dwell on: while we are moving from generics to specialty, the compliance bar under our feet is rising just as fast. CDSCO and DCGI aren’t asking the same questions they asked five years ago. Data integrity isn’t a documentation exercise anymore — it is continuous, electronic, and traceable in real time across every step from raw material receipt to batch release. Companies that treated quality systems as an audit-season activity are going to find that model doesn’t survive contact with a complex molecule pipeline. You cannot paper-trail your way through a peptide impurity investigation after the fact. The instrumentation, the logging, the electronic batch records have to be built into the process from day one, not retrofitted before an inspection.

That is actually the good news buried in this. Higher compliance standards are a moat, not a burden — but only for companies willing to invest in them before they are forced to. The ones who wait for a regulatory observation to modernise their data systems will find themselves permanently a step behind competitors who built for scrutiny from the start.

So where does that leave us? I think India’s complex-molecule story is genuinely ours to win — the manufacturing discipline, the regulatory experience, the sheer volume of GMP-approved capacity we have built over three decades gives us a real head start. But winning it means we stop celebrating formulation wins as if they were full value-chain wins. It means treating upstream chemistry — KSMs, fermentation, peptide synthesis — as core strategic infrastructure, not a sourcing line item to optimise on price. And it means building compliance and data integrity into our operating DNA before the next inspection cycle forces the issue.

The patent cliff isn’t going to wait for us to fix our supply chain. Companies elsewhere — some in China, some in the West — are already moving on the same opportunity with a shorter list of dependencies. If India wants to convert this generics-to-specialty transition into real, durable value, rather than another chapter of “we make it cheaper, someone else makes it possible,” the work has to start upstream. That is not a comfortable message for an industry that likes talking about its formulation strength. But I would rather say it now than read it in someone else’s cover story five years from now.

The post Bridging generics and specialty: A roadmap to complex molecule innovation appeared first on Express Pharma.

Dermatology has always occupied an unusual position in medicine — visible enough to attract cultural attention, complex enough to demand serious clinical rigour, and broad enough to sit at the intersection of disease management, aesthetics, and now, something considerably larger. The convergence happening today between dermatology, wellness, and longevity medicine reflects a measurable shift in how patients understand their own bodies and what they expect from healthcare, and the numbers behind that shift are significant.

The global wellness economy reached a record $6.8 trillion in 2024, growing at 7.9 per cent from the previous year. Within that figure, the public health, prevention, and personalised medicine segment reached $240 billion, expanding at 8.8 per cent annually. At the same time, the anti-ageing market, valued at $79.5 billion in 2024, is projected to exceed $168 billion by 2035.

Contrary to popular belief, these are not siloed markets. In fact, they are overlapping expressions of the same consumer reorientation away from reactive treatment and toward the proactive management of biological ageing.

Skin as a biological signal, not a cosmetic concern

The skin is the body’s largest organ and one of its most visible biological readouts. Chronic pigmentation, impaired barrier function, and persistent inflammation are not merely cosmetic inconveniences. They are surface expressions of systemic processes — oxidative stress, hormonal dysregulation, nutritional deficiency, chronic inflammation — that are simultaneously affecting every other organ system. Research confirms that epigenetic ageing and biological skin age are directly influenced by lifestyle behaviours and targeted interventions, meaning what is visible on the skin reflects biological processes that determine longevity outcomes well beyond appearance. A dermatologist reading these signals correctly is not practising aesthetics. They are practising preventive medicine.

Longevity is earned, not administered

The most important point longevity medicine is making is that no clinical intervention substitutes for the foundational work of lifestyle. Nutrition, resistance training, regular exercise, adequate sleep, stress management, and the deliberate optimisation of daily habits are the primary drivers of healthy ageing. These are not adjuncts to medical treatment. They are the treatment, and everything else is supplementary.

Simply put, don’t just look strong, be strong. The goal is not the appearance of health or youth, but the preservation of genuine physical capacity, metabolic resilience, and cognitive function into the eighth and ninth decades of life. Muscle mass maintained through resistance training in one’s 40s and 50s is among the strongest predictors of functional independence in one’s 80s. Cardiovascular fitness built through regular aerobic exercise directly influences the inflammatory load the body carries as it ages. These are not wellness trends. They are biological investments with compounding returns.

Where dermatology and longevity medicine meet

The convergence of dermatology with this broader longevity framework is happening because the two share the same underlying biology. Oxidative stress, chronic low-grade inflammation, hormonal decline, and mitochondrial dysfunction are simultaneously drivers of skin ageing and systemic ageing. Interventions that address these processes — whether through targeted nutrition, photoprotection, regenerative therapies, or lifestyle modification — work on both simultaneously.

India’s anti-ageing products market, valued at $1.97 billion in 2024 and projected to reach $4.84 billion by 2033 at a CAGR of 10.7 per cent as per industry estimates, reflects a consumer base beginning to understand this connection. The fastest-growing segment is not the patient seeking correction — it is the younger urban consumer seeking prevention, increasingly aware that the biological processes underlying ageing begin in the mid-20s, well before they become visible.

The clinician’s evolving role

For healthcare providers, this convergence demands a broader frame of reference. The clinician who understands skin health as a component of systemic longevity, who asks what the skin reveals about the patient’s metabolic and inflammatory state, and who integrates lifestyle counselling into their clinical conversation, is practising the kind of preventive medicine the next decade of healthcare will increasingly require. The skin is where that conversation often begins. Healthspan is where it ends.

The post The convergence of dermatology, wellness, and longevity medicine appeared first on Express Pharma.

The agreement aims to address an estimated 75% of ReNU syndrome cases.

This syndrome was recognised as a distinct genetic disorder in 2024, following research led by Dr Nicola Whiffin at the University of Oxford’s Big Data Institute and Dr Ernest Turro from the Icahn School of Medicine at Mount Sinai.

The condition affects cognitive, language, and adaptive behavioural development.

BioMarin chief scientific officer Dr Kevin Eggan said: “For many families, a ReNU diagnosis can finally provide answers, but currently there are no approved medicines that address the underlying cause of the disease.

“By combining BioMarin’s expertise in genetic medicines with n-Lorem’s pioneering antisense capabilities, we aim to bring the first treatment option for people living with ReNU syndrome.”

As part of the early-stage collaboration, BioMarin and n-Lorem will carry out preclinical trials, with joint decisions on selection of the lead candidate for future clinical studies.

BioMarin will head the development of the medicine intended for broader use in the ReNU syndrome community.

n-Lorem founder, chairman and CEO Dr Stanley Crooke said: “Our commitment is to develop ASO medicines and, when we recognise the opportunity to support even more individuals, identify a partner that can advance our medicines to be commercially approved.”

Preparatory patient enrolment for individualised clinical trials of the ASO candidate is underway.

In April 2026, BioMarin completed its acquisition of Amicus Therapeutics for $14.50 per share in an all-cash deal for a total equity value of nearly $4.8bn.

The post BioMarin and n-Lorem partner on early research for ReNU syndrome therapy appeared first on Pharmaceutical Business review.

The main asset involved is FB102, Forte Biosciences’ first-in-class anti-CD122 antibody, which will be added to argenx’s immunology portfolio. FB102 was evaluated in Phase Ib studies for vitiligo and celiac disease.

These studies were a key factor in deciding to proceed from a strategic investment to acquisition by argenx.

Forte Biosciences expects to release Phase II data for FB102 in the second half of this year.

argenx CEO Karen Massey said: “The acquisition of Forte Biosciences builds on the strength of that foundation and advances our ambition to be the leading immunology innovator of the future.

“The addition of FB102 to our portfolio aligns perfectly with the argenx playbook: compelling biology, strong clinical validation and broad potential to address patient need.

“I am grateful to the Forte Biosciences team for their outstanding work. Together, we look forward to unlocking the full potential of FB102 and accelerating its impact for patients.”

Under the agreement, argenx will begin a cash tender offer, via a wholly owned subsidiary, for acquiring all of the outstanding Forte Biosciences’ common stock shares at $77 per share price.

This represents a premium of around 86% to Forte Biosciences’ volume-weighted average price since announcing positive Phase Ib trial data for vitiligo on 9 July.

The offer will be funded entirely from argenx’s cash on hand and is not subject to financing conditions.

Completion requires the tender of a majority of outstanding Forte Biosciences shares and the expiration of applicable regulatory waiting periods.

The transaction will see FB102 added to argenx’s existing antibody-based programmes, including adimanebart, ARGX-121, efgartigimod, empasiprubart, and several early-stage molecules.

Goldman Sachs International is acting as exclusive financial adviser and Freshfields as legal adviser to argenx. Guggenheim Securities is the exclusive financial adviser to Forte Biosciences, and Wilson Sonsini Goodrich & Rosati is serving as legal counsel.

In July 2024, China’s National Medical Products Administration (NMPA) approved Zai Lab and argenx’s efgartigimod alfa subcutaneous injection (efgartigimod SC), 1,000mg (5.6ml)/vial for the treatment of generalised myasthenia gravis (gMG).

The post argenx signs agreement to buy Forte Biosciences for $2.2bn appeared first on Pharmaceutical Business review.

Cipla and its wholly owned subsidiary Cipla USA announced that it has received US Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in all three strengths—100/50 mcg, 250/50 mcg, and 500/50 mcg. 

The product is a therapeutically equivalent version of Advair Diskus, a widely prescribed combination therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). According to IQVIA, the US market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million. 

This approval represents Cipla’s first dry powder inhaler (DPI) approval from its US-based manufacturing network, marking a significant milestone in the company’s continued expansion of complex respiratory capabilities in the United States. 

Commenting on the approval, Achin Gupta, Managing Director & Global CEO, Cipla, said: “At Cipla, we’re passionate about respiratory care given our longstanding expertise. This approval reinforces our commitment to expanding access to complex therapies in the US and highlights our strength in developing and scaling sophisticated inhalation products through integrated capabilities.” 

Backed by Cipla’s vertically integrated inhalation platform, the product reflects the company’s commitment to strengthening U.S. manufacturing capabilities for complex respiratory treatments. 

Marc Falkin, Chief Executive Officer, Cipla North America, added: “This approval marks our first dry powder inhaler from our New York facility and reflects our targeted investments in building differentiated inhalation manufacturing capabilities in the US. It strengthens our ability to provide reliable, high-quality supply in an important and competitive category”.

The post Cipla receives US FDA approval for Generic Advair Diskus appeared first on Express Pharma.

Speaker in this video:
Dr Sanjit Singh Lamba, Managing Partner, Trillyum Consulting

Topic: Impact of AI in enhancing quality and compliance

Key Takeaways:
[1] AI is not a replacement for pharma’s quality systems. It is a layer of intelligence that unlocks step-change performance.

[2] The future of compliance is predictive, not reactive. AI can identify patterns, flag deviations early, and even recommend CAPAs before issues escalate.

[3] AI is no longer a “nice-to-have.” As regulatory expectations grow and data volumes explode, intelligent systems are becoming essential for quality and compliance.

The post Dr Sanjit Singh Lamba, Managing Partner, Trillyum Consulting appeared first on Express Pharma.

Speaker in this video:
Prof. Krishan Gopal, NIPER – Mohali

Topic: Next generation of pharma leaders: Academia’s role in bridging the talent gap

Key Takeaways:
[1] Don’t just hire talent—help create it. Stronger industry-academia partnerships will be key to keeping India’s biopharma growth on track.

[2] Biopharma is a national priority. The government’s Biopharma SHAKTI Mission is backing new NIPERs, upgraded campuses and expanded training to build India’s future workforce.

[3] India’s biggest biopharma challenge isn’t demand. It’s talent. As the industry grows, the need for skilled, industry-ready professionals is becoming more urgent than ever.

The post Prof. Krishan Gopal, NIPER – Mohali appeared first on Express Pharma.

Panellists Speaker in this video:
○ Ms Lakshmipriya Nair, Assistant Editor, Express Pharma (Moderator)
○ Mr Ravi Bhardwaj, Corporate Quality Head, Ind Swift Laboratories
○ Mr Vishnu Mirge, AVP – Site Head, Sun Pharmaceutical Industries
○ Dr Pardeep Agnihotri, Sr GM – Corporate Regulatory Affairs, CEPH Lifesciences
○ Mr Yogesh Sharma, Head-Quality & Compliance, Sun Pharmaceutical Industries
○ Mr Saurabh Sharma, GM-Supply Chain, Sentiss Pharma
○ Dr Saurabh Pandey, Cluster Lead-API Manufacturing-Toansa-Punjab, Sun Pharmaceutical Industries
○ Mr Prafulla Padhy, Head – Supply Chain Management, Fresenius Kabi Oncology

Key Highlights:
[1] Supply chain, manufacturing, and quality have become strategic business functions, driving resilience and sustainable growth.

[2] Geopolitical uncertainties and supply disruptions are reshaping pharma strategies, with greater focus on risk management and business continuity.

[3] Quality and compliance have moved to the boardroom, emphasising data integrity, inspection readiness, and a strong quality culture.

[4] AI, digitalisation, and Industry 4.0 are enabling predictive, data-driven decision-making across manufacturing and quality operations.

[5] Reducing dependence on China for APIs requires stronger domestic manufacturing, supplier diversification, and policy support.

[6] Innovation, ESG, and workforce capability will be key drivers of the industry’s next phase of growth.

[7] India’s future pharma leadership will depend on balancing affordability, compliance, resilience, and innovation.

The post Panel Discussion: Geopolitics, trade and trust The forces reshaping India Pharma Inc appeared first on Express Pharma.

Speaker in this video:
Mr Priadarshan Singh, Sales Manager, ROMACO Group

Topic: Pharma processing and packaging: From powder to patient

Key Takeaways:
[1] Romaco is looking beyond individual machines to complete solutions, offering integrated technologies that support the entire pharma manufacturing and packaging process.

[2] Efficiency is at the heart of its innovation. Faster changeovers, easier cleaning, lower product loss and energy-saving technologies are helping manufacturers improve productivity without compromising quality.

[3] The company is strengthening its presence in India, with an Experience Centre in Hyderabad that allows customers to test, optimise and develop solutions closer to home.

The post Mr Priadarshan Singh, Sales Manager, ROMACO Group appeared first on Express Pharma.

Panellists Speaker in this video:
○ Mr Rajesh Kumar Chopra, Founder & CEO, RAJBIOTEC (Moderator)
○ Dr Sukhjeet Singh, CSO, Acme Formulations
○ Mr Anmol Aggarwal, Lead, R&D Strategy, Venus Remedies
○ Dr Pankaj Bhatt, AVP – Technical Operations, Piramal Consumer Healthcare
○ Mr Bhupendra Pratap Singh Chauhan, Head CQA (Formulation), Morepen Laboratories
○ Mr Bhapinder Singh Grover, Founder & CEO, BSG Pharmaconsult
○ Mr Gursharanjit Singh, GM-Operations, Gracure Pharmaceuticals

Key Highlights:
[1] India must transition from a generics leader to an innovation-driven pharmaceutical powerhouse.

[2] Stronger R&D infrastructure, funding, and policy support are essential to drive innovation.

[3] Collaboration between industry, academia, regulators, and global partners is key to successful drug development.

[4] AI, digitalisation, and smart manufacturing will improve quality, productivity, and regulatory compliance.

[5] Mid-sized companies need timely funding and strategic partnerships to commercialise innovative products.

[6] India should expand beyond generics into biosimilars, biologics, peptides, and novel therapies to increase export value.

[7] Developing specialised talent, strong IP strategies, and globally recognised brands will strengthen India’s global pharmaceutical leadership.

The post Panel Discussion: From generic success to innovation leadership What’s next for Indian Pharma appeared first on Express Pharma.

Speaker in this video:
Mr Abhinav Vikash, Head Engineering, Sun Pharmaceutical Industries

Topic: The talent challenge: Building pharma leaders for the next decade

Key Takeaways:
[1] Great leaders aren’t born. They’re developed through continuous learning, exposure and experience.

[2] The best leaders understand more than just their own function. Cross-functional exposure builds stronger decision-makers.

[3] Mentorship matters. Technical skills may get you promoted, but emotional intelligence helps you lead.

The post Mr Abhinav Vikash, Head Engineering, Sun Pharmaceutical Industries appeared first on Express Pharma.

Speaker in this video:
Mr Shivaji Chakraborty, Head – Packaging Development, Fresenius Kabi Oncology

Topic: Indian pharma in a geopolitical crossfire: Preparing to navigate the challenges

Key Takeaways:
[1] Geopolitical tensions are driving up costs and disrupting supply chains, making resilience a key priority for Indian pharma.

[2] Diversified sourcing, domestic manufacturing, flexible logistics, and intelligent packaging are essential to strengthen operational resilience.

[3] Digital traceability, sustainability, and supportive government initiatives will be critical to maintaining India’s global pharma competitiveness.

The post Mr Shivaji Chakraborty, Head – Packaging Development, Fresenius Kabi Oncology appeared first on Express Pharma.

Panellists Speaker in this video:
○ Dr Govind S Pandey, CEO & MD, Gamp Technologies (Moderator)
○ Mr Jawaid Imam, Sr VP – Works, Aristo Pharmaceuticals
○ Mr Narender Pal Singh, VP & Site Head, Panacea Biotec
○ Mr Abhay Inamdar, VP – Engineering & Projects, Immacule Lifesciences
○ Dr Pirthi Pal Singh, VP and Head – R&D, Tirupati Group
○ Mr Narotam Kumar Juneja, Technical Advisor, Uniserum Lifesciences
○ Mr Ravinder Pal Singh, Lead – CMO Quality (North & East India Region), Sun Pharma
○ Ms Suman Sharma, DGM-Quality, Indchemie Health Specialities

Key Highlights:
[1] North India has the potential to become a global pharma hub by focusing on capability, innovation, and quality.

[2] Digitalisation, automation, and AI will be key to improving compliance, efficiency, and manufacturing excellence.

[3] Talent development and retention are essential, supported by stronger industry-academia collaboration.

[4] Collaboration across Punjab, Haryana, Himachal Pradesh, and Chandigarh can create an integrated and globally competitive pharma ecosystem.

[5] Advanced manufacturing and R&D capabilities will be critical for driving innovation and producing complex generics and biologics.

[6] Industry-friendly government policies, infrastructure, and faster approvals will be crucial to attract investment and accelerate growth.

[7] A strong focus on quality, compliance, and sustainability will be vital for North India’s long-term global competitiveness.

The post Panel Discussion: India Pharma 2030 Can North India become the next global manufacturing powerhouse appeared first on Express Pharma.

This article maps where drug product is lost across sterile fill-finish, and how to recover it.

What is Product Loss in Fill-Finish?

Product loss in fill-finish is the portion of a drug product batch that does not become an acceptable finished unit. Loss can occur when product remains in vessels, filters, tubing, pumps, and filling equipment; when units are consumed for testing; or when filled containers are rejected during inspection.

Some product loss is unavoidable. Sterile filters retain a certain amount of liquid, analytical testing requires finished units, and each container may need to be filled above its labeled volume to ensure the required deliverable volume. Other losses can be reduced through process and equipment design. Oversized filters, excessive tubing, destructive weight checks, poor vessel drainage, inconsistent filling, and avoidable cosmetic rejects can all increase product loss in fill-finish.

These losses matter most when batch volume is limited or the drug product is expensive, difficult to manufacture, or intended for a small patient population. For high-value biologics, oligonucleotides, orphan drugs, and gene therapies, recovering even a few additional milliliters can produce more finished units, protect clinical supply, and reduce the need for additional drug substance manufacturing.

The sources of product loss vary across the fill-finish process:

Understanding where these losses occur allows sponsors and fill-finish manufacturers to focus engineering efforts on the steps that have the greatest effect on overall batch yield.

Where product loss occurs in: Formulation and Compounding

Vessel and surface hold-up

Drug product wets every surface it touches:

• The compounding vessel
• The impeller or mixer
• Dip tubes
• The transfer set feeding the filter

The residual liquid retained on those surfaces when the vessel drains is hold-up volume, and it does not scale with batch size, but with wetted surface area. That distinction becomes critical at small volumes. A 200 L batch may lose a fraction of a percent to vessel hold-up, but a 2 L batch of an oligonucleotide or viral vector, processed in comparable hardware, can lose several percent to the same surfaces.

How to reduce hold-up during formulation

Select the appropriate vessel geometry. How a vessel drains determines how much of that film you recover. Conical or dished bottoms with the outlet at the true low point drain cleanly, but flat-bottomed or side-drained vessels leave a heel. Glass and stainless vessels that must be siphoned or pumped from the top strand more product than single-use bags that drain by gravity from the bottom.

Where drug product is lost in: Sterile Filtration

Sterile filtration is usually the single largest source of unrecoverable loss during the manufacturing process.

Filter hold-up

Filter hold-up is often one of the largest contributors to product loss in fill-finish because product remains inside the membrane, housing, and tubing after filtration. Proper filter sizing helps reduce this loss.

How to reduce filter hold-up

Right-size the filter. Matching the most effective filtration area to the batch volume and the product’s fouling behavior (the accumulation of particles or substances on the filter) will reduce hold-up significantly. A Vmax or Pmax study should be conducted to identify the best-fit membrane type and size for a given drug product lot.

Flow-path hold-up

Filtration pumps bulk solution from a source vessel through tubing, across two filters, and into a receiving vessel or surge bag. Product is retained on every wetted surface along that path, with most of it retained in the filter housings and downstream tubing.

How to reduce flow-path hold-up during filtration

Blow down the filtration line. A low-pressure gas purge after filtration pushes product through the assembly more completely. The greatest recovery here typically comes from clearing the tubing between the two filters.

Where drug product is lost in: Sterile Filling

Sterile filling also loses product during setup, filling, and end-of-fill activities.

Line priming

Before the first container is filled, the fill line assembly must be purged of air and brought to a stable, repeatable fill weight. Drug product is pumped through the assembly to displace air ahead of the fill—a step called priming. To confirm the line is free of air and bubbles, some manufacturers require a set prime volume from each fill needle, typically 5–10 mL per needle. That volume is discarded, and it scales with the number of needles on the line.

How to reduce line priming loss

Rescue dosing. On fill lines with rescue-dosing capability, line priming losses can be eliminated. The system weighs each dispensed container and directs the line to top up any that fall short, bringing them into the acceptable fill-weight range rather than rejecting them.

Weight checks

Weight checks run before, during, and at the end of the fill to keep fill volumes in range. Each needle must pass consecutive checks before the fill starts, confirming stable, repeatable weights. During the run, a bracketing weight checks catch any drift, and a final check on the last container bookends the lot.

How to reduce loss from weight checks

Non-destructive weight checks. Some manufacturers, including Argonaut, offer 100% non-destructive weight checks on their filling lines that eliminate product loss from weight checks. With this capability, comes the potential to top up low-filled units to bring them into range (i.e. rescue dosing), which is also a capability at Argonaut.

End-of-batch losses

Filling is often stopped when air reaches the pump, because entrained air destroys fill-weight accuracy. Whatever product remains downstream — in the manifold, tubing, and needles — is typically dispensed to waste.

How to reduce end-of-batch losses

Rescue dosing. On fill lines with rescue-dosing capability, end-of-batch losses can be almost entirely recovered. Rescue dosing non-destructively weighs each dispensed container and tops up any that fall below specification, bringing them into the acceptable fill-volume range. Because every container is verified to contain the correct volume the batch can continue to run, even as pump accuracy is lost.

Overfill

Overfill is deliberate loss. To guarantee the labeled deliverable volume after withdrawal (per USP requirements for injections), every unit is filled slightly above label claim.

How to reduce overfill

Accurate fill pumps. The size of that overfill is set by fill-weight variability: a filler with a tight fill-weight distribution (expressed as coefficient of variation, or CV) can safely target a smaller overfill than a variable one. Across a large batch, trimming the overfill target can increase yield.

Where drug product is lost in: Sampling and Analytical Testing

Finished-unit consumption affects final batch yield, and sterile filling manufacturers should optimize testing where possible to reduce sampling requirements.

In-process samples

Bioburden (pre- and post-filtration), appearance, and fill-weight checks all draw product. Non-destructive in-process weight checks — weighing containers before and after filling rather than emptying sacrificial units — remove one recurring sampling loss entirely.

Release testing

Sterility, endotoxin, potency, particulate, and identity testing each consume finished units. Because these quantities are largely fixed by method and USP guidelines, they weigh far more heavily on a 500-unit orphan batch than on a 50,000-unit commercial one.

Stability studies

Every timepoint, at every storage condition, across the full shelf-life program pulls units, and for a first-in-class biologic the protocol can be extensive. 

How to reduce sampling

Non-destructive testing. Using non-destructive test methods will reduce sampling requirements, as it will allow one unit to undergo multiple analytical tests. The greatest impact will be through using a non-destructive container closure integrity test (CCIT), which FDA guidance permits in place of sterility testing during stability studies. This dramatically reduces the number of required units to be sampled for stability.

Cosmetic rejects. Every product lot undergoes 100% visual inspection after fill-finish. Some units are rejected for cosmetic defects, such as scratches or scuffs. Because these units are pulled from the lot regardless, they’re well suited for destructive quality testing: the cosmetic flaw won’t influence lab results and using them improves overall batch yield.

Planning. Strategic resource utilization can reduce the number of units required for analytical testing, especially for stability programs. Planning minimal-but-sufficient pull schedules and using small-volume, low-sample-count analytical methods directly protects inventory.

Designing a Fill-Finish Process That Minimizes Product Loss

Product loss in fill-finish is resolved by cumulative design choices. There are several technologies and capabilities that will consistently improve drug product yield:

• Isolator-based filling improves sterility assurance and reduces particulate rates which in-turn reduces reject rates and improves batch yield.
• Non-destructive weight checks, especially 100% and real-time checks will ensure fill volumes remain in range without consuming product.
• Rescue dosing will reduce loss by bringing low-filled units into range and allow the fill line assembly to be emptied completely at the end of the fill.
• High-precision pumps reduce overfill, allowing sponsors to get more units out of the same batch volume.
• Minimal to no glass-to-glass contact fill line designs will reduce the incidence of cosmetic rejects and protect batch yield.

There are also many strategies that help improve yield, regardless of facility or equipment:

• Identifying areas of loss. Estimating the volume of loss a manufacturer expects to have at each step will help identify where to engineer out product loss before filling begins.
• Match equipment to batch scale. Identifying the best-fit filters, reducing tubing lengths and sizes, optimizing the vessel to improve drainage, or using fewer fill heads are just some of the ways that equipment can be scaled to the batch size to reduce product loss.
• Use high-quality components to reduce cosmetic reject rates.
• Build in recovery via validated blow-down steps to turn filter and line hold-up from loss into product.
• Reduce sampling burden by design. Non-destructive weight checks, small-volume assays, and lean stability plans preserve finished units.
• Tighten fill accuracy via using smaller ID tubing to reduce fill-weight variability and overfill.

The most effective time to engineer out product loss in fill-finish is before the first vial is filled, which makes your choice of fill-finish partner one of the highest-leverage yield decisions you’ll make.

How Argonaut Reduces Product Loss in Fill-Finish

At Argonaut Manufacturing Services, we know every milliliter matters. Our fill-finish operations are built around this principle. Every detail from facility layout and equipment selection to filtration, filling, and container handling is designed to maximize yield without compromising quality or scalability.

Our capabilities include:

• Isolator-based filling for high sterility assurance and lower particulate-driven rejects
• Minimal-to-no glass-to-glass contact to reduce cosmetic rejects that erode yield
• 100% non-destructive weight checks with rescue dosing – every filled container is verified, and low-filled units are brought into range
• High-precision fill pumps that hold a tight fill-weight distribution, allowing smaller overfill targets
• Single-head filling available on all lines to minimize line loss for small batches
• Systems engineered to reduce and recover hold-up during filtration and filling
• Low visual inspection reject rates as a result of controlled, consistent manufacturing operations
• Minimal line-loss – we can reduce total line loss to as little as 25 mL on each of our filling lines

Argonaut has experience filling drug product lots as small as 200 mL, and in one 500-vial fill we achieved 99% of theoretical batch yield.

Download the Every Milliliter Matters whitepaper for the full case study.

Evaluating Fill-Finish Partners

If you are a sponsor qualifying a fill-finish partner, ask questions that probe the whole manufacturing process:

• Do you model hold-up and mass balance before selecting equipment?
• How do you design fill programs to improve yield?
• What recovery steps do you run after filtration and at end of filling?
• Do you offer non-destructive in-process weight checks and rescue dosing? If not, how do you reduce product loss from these checks?

For high-value biologics, orphan drugs, gene therapies, and oligonucleotides — products where the batch may be the entire supply and every milliliter carries outsized value — improving yield should be a major focus of your fill-finish partner. 

For a complete picture of where losses accumulate and how to reduce them before filling, download Every Milliliter Matters.

FAQs

1. What causes product loss in fill-finish?

Product loss is caused by many factors: 

• Adsorption and adhesion to product-contact materials (e.g. compounding vessels, mixing surfaces, tubing, etc.)
• Hold-up in sterile filters and transfer tubing
• Line priming and end-of-batch losses during filling
• Destructive weight checks
• Visual inspection rejects
• Deliberate overfill
• Finished units consumed by in-process, release, stability, and retained sampling

2. How much product loss is typical in fill-finish?

It varies widely with batch size and process design, but larger commercial batches may lose only a few percent, while small high-value batches can lose double digits, largely because hold-up and sampling losses are fixed by surface area and test methods, not by batch volume, so they weigh more heavily on small runs.

For an example comparing total product loss between a baseline batch against an optimized process, see Drug Product Loss: Understanding Yield

3. What is filter hold-up, and how do you reduce it?

Filter hold-up is product trapped in the membrane, housing, and tubing after filtration. Because hold-up is roughly proportional to membrane area, right-sizing the filter to the batch (via a Vmax or Pmax study) and adding a validated gas blow-down recovery step are the two most effective ways to reduce it.

4. How does overfill contribute to product loss in fill-finish?

Overfill is the extra volume added to each vial to guarantee the labeled deliverable volume after withdrawal. The required overfill is driven by fill-weight variability, so a filling line with tighter fill accuracy (lower CV) can safely target a smaller overfill, giving less product away on every unit.

5. How does batch size affect product loss in fill-finish?

Smaller batches often lose a larger percentage of their yield during sterile filling. Hold-up volume scales with wetted surface area and sampling scales with fixed test requirements so the same hardware and testing burden consumes a much larger share of a 2 L batch than of a 200 L one.

• UCI Health — Irvine Rehabilitation Hospital is scheduled to begin welcoming patients at the end of July.
• The four-story, 70,000-square-foot facility includes 52 private rooms and specialized services for brain and spinal cord injuries.
• Therapy spaces include a large rehabilitation gym, simulated home environments, a mock kitchen, a simulated car and an outdoor mobility courtyard.
• The hospital is a joint venture between UCI Health and Lifepoint Rehabilitation and will also support clinical research

IRVINE, Calif. — UCI Health has marked the approaching opening of its new 52-bed inpatient rehabilitation hospital in Irvine, Calif., with a ribbon-cutting event attended by more than 150 employees and community members.

The 70,000-square-foot UCI Health — Irvine Rehabilitation Hospital is expected to open by the end of July. Located less than two miles from UCI Health — Irvine, the freestanding facility is designed to extend the health system’s continuum of care for patients recovering from stroke, traumatic injury, complex surgery and other serious conditions.

The four-story hospital is a joint venture between UCI Health and Lifepoint Rehabilitation. It includes a specialized brain and spinal cord injury unit, an independent living suite and technology intended to help patients practice daily activities before returning home.

“Access to specialized care for patients recovering from stroke, traumatic injury, complex surgery and more in this hospital strengthens the continuum of care across all of the UCI Health system, providing a seamless transition from acute care to rehabilitation, and then to home.” said UCI Health President and CEO Chad T. Lefteris, according to an article from UCI Health.

Each of the hospital’s 52 private rooms includes a bathroom, shower and sitting area for family members and visitors. The facility also has small-group recreation spaces, a large dining area with outdoor seating and a dedicated brain injury unit with space for rehabilitation therapies.

A rehabilitation gym occupies much of the fourth floor and includes a simulated car and mock kitchen. An outdoor courtyard on the same floor features walking paths with different surfaces, a garden and a small putting green, giving patients opportunities to practice mobility in varied environments.

“It was about two and a half years ago that many of us were here. It was a patch of dirt and we had shovels in our hands to celebrate the groundbreaking,” said Dr. Jay Han, Medical Director of the UCI Health rehabilitation program, in a statement from UCI Health. “And here we are, standing beside a brand-new, four-story, state-of-the-art rehabilitation building right here in Irvine, California. It’s just amazing. I’m very proud of everyone today.”

UCI Health also plans to use the hospital as a setting for clinical research. Physicians and other healthcare professionals will study emerging rehabilitation technologies and therapies, while eligible patients with conditions including stroke, traumatic brain injury, spinal cord injury, severe burns, polytrauma and amputations may have opportunities to participate in research.

The new hospital will be part of UCI Health, Orange County’s only academic health system.

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However, the company notes that experimental validation, which involves steps such as expression, binding characterisation, and developability testing, is typically fragmented.

These processes often involve several providers and can take three to four weeks, creating delays in the design-build-test-learn cycle.

RushData was developed to address these workflow bottlenecks.

Central to the new service is Biointron’s one-day transient Chinese Hamster Ovary (CHO) expression system, which the company reports can reduce the time from sequence submission to experimental data delivery to a matter of days.

The platform incorporates antibody expression, binding analysis, and early developability profiling within one standardised workflow.

Data generated is structured for compatibility with AI and ML pipelines, facilitating model training and validation.

Supporting more than 3,000 molecules per batch in parallel, RushData uses CHO cells for producing data.

Biointron states that this approach delivers data that is predictive of performance and relevant to further development due to CHO’s suitability for human-like post-translational modifications and protein folding.

Available service options range from basic rapid screening packages to standard binding characterisation and premium packages with early developability assessments.

Analytical methods incorporated into selected services include differential scanning fluorimetry for thermal stability, AC-SINS for self-interaction, and polyspecificity reagent binding.

Biointron provides contract research services in antibody discovery, expression, and optimisation to the biopharma sector worldwide.

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The approval introduces a new choice for individuals seeking relief from persistent pain.

Tylenol with Naproxen combines acetaminophen, known for its fast-acting effect, with naproxen sodium, a non-steroidal anti-inflammatory drug, which is intended to offer longer-lasting results.

The combined formulation begins working in under 30 minutes and delivers pain relief for up to 12 hours.

Kenvue cited results from eight clinical studies that evaluated the performance of Tylenol with Naproxen against products containing either acetaminophen or naproxen sodium alone.

The company noted that data showed improved pain relief with the fixed-dose combination compared to the individual ingredients.

The company referenced findings from the Kenvue Pain Consumer Survey conducted in March 2026, which involved 6,240 respondents.

In that survey, approximately 75% of people living with persistent pain reported dissatisfaction with current pain relief methods.

Kenvue chief medical officer Dr Rajesh Mishra said: “This milestone reflects the long-standing leadership of Tylenol in translating rigorous clinical science into accessible, over-the-counter solutions.

“Persistent pain often leaves people trapped in a cycle of trial and error, navigating between choosing short-term relief or more complex treatment options.

“Tylenol with Naproxen simplifies that choice, offering fast onset, 12-hour duration, and the safety profile of two well-established non-opioid ingredients in one fixed-dose.”

FDA approval of Tylenol with Naproxen grants Kenvue a three-year period of exclusivity for the new OTC formulation.

Tylenol with Naproxen is expected to be available soon at major retailers across the US.

The post Kenvue’s Tylenol with Naproxen gains FDA approval appeared first on Pharmaceutical Business review.

Why the regulation matters

This recent move to limit the sale of some cough syrups over-the-counter (OTC) is an essential measure to enhance the safety of medicines in India. Traditionally, cough medicines have been considered to be regular household remedies, but with the growing risk of misuse, self-medication and health implications, regulators have made tighter controls on the medicines. This decision has also raised the broader issue: should more medicines be only available with a doctor’s prescription?

The Indian government has been using the easy availability of medicines as a means to allow people to take care of minor ailments quickly and conveniently. But the fact that it’s readily available may lead to overuse, as people will sometimes self-diagnose and self-medicate without proper medical supervision.

The risks of unsupervised use

Not all cough syrups are simple remedies. Some of them may contain codeine and other substances that may give rise to addiction, drowsiness or misuse if not taken under supervision. The recreational abuse, especially among young people, has raised the issue of more effective regulation.

Cough syrups aren’t the only problem. People still buy and buy on the internet medicines with no prescription, like antibiotics, painkillers, steroids and sleep medicines. These practices can help reduce symptoms for a while, but can lead to permanent health issues. Overuse of painkillers may have adverse effects on the liver, kidneys, and digestive system and when used without supervision, they can mask symptoms and prevent a proper diagnosis of underlying diseases.

A public health perspective

Among the most compelling reasons to keep some drugs behind the prescription counter is safeguarding public health. Proper use of antibiotics has been a factor in the increasing problem of antimicrobial resistance worldwide, for example. Using antibiotics unnecessarily or incorrectly can cause the bacteria to become resistant so that antibiotics are ineffective against them in future infections.

This is prescription-based access, ensuring medicines are only used when clinically appropriate, and encouraging appropriate diagnosis. It also facilitates health care workers to monitor treatment, screen for side effects and prevent possible drug interactions.

Balancing safety and accessibility

Although the regulations can enhance safety, they must be applied wisely. India still has issues with accessing healthcare, particularly in the rural parts of the country and in areas with limited access to medical professionals. Increased number of medicines to become prescription only may lead to delays in treatment for some patients if access to medicines is not also improved.

Hence, any increase in prescription demands should be matched by enhanced healthcare structures, increased access to telemedicine and increases in access to competent medical practitioners. Patient safety always comes first and is inextricably linked with accessibility.

Strengthening the role of pharmacists

Pharmacists are often the first healthcare professionals consulted by patients. As Medication Regulations change so does their role. Pharmacists can provide these services if they are trained and supported to do so, and educate patients, alert them to possible risks, and ensure that they seek medical advice if needed.

An improved pharmacist-counselling could aid in minimizing medication misuse, while maintaining that people could still obtain timely and reliable healthcare guidance.

The way forward

The conversation should not be about limiting access to medicines but about responsible access to medicines. This new regulation on cough syrups is indicative of the trend to focus on patient safety, evidence-based treatment and rational drug use. Policymakers should keep assessing medicines with a high risk of misuse and continue to allow healthcare services to be available for those who require them.

Finally, the prescription wall should be used as a form of protection, not as an obstruction. Over all, India has the potential to build a safer drug ecosystem by rolling out sensible regulations, doing public education , widening the reach of health care, and reinforcing pharmacy practice, which will help keep patients safe and also support wider health improvements.

The post End of OTC cough syrups: Should more medicines move behind the prescription wall? appeared first on Express Pharma.

Immuneel Therapeutics Private Limited and the BRIC Translational Health Science and Technology Institute (THSTI) have officially entered into a  Memorandum of Understanding (MoU), to establish a collaboration to qualify, establish, and manage  a cutting-edge facility for the Current Good Manufacturing Practice (cGMP)-compliant manufacturing  of CAR-T cell therapies and Lentiviral Vectors (LVVs).  

Strategic collaboration to operationalize clinical pipelines 

The partnership synergizes THSTI’s newly established small-footprint cleanroom facility with  Immuneel’s validated, commercial-grade cell therapy ecosystem and industrial operational expertise.  The primary goal of this collaboration is to operationalize the facility, obtain necessary regulatory  approvals from the Central Drugs Standard Control Organization (CDSCO), and successfully translate  academic and industrial research pipelines into clinical realities.  

The facility’s functional footprint operates with distinct allocations:  

• Lentiviral Vector (LVV) Suite: running on a campaign mode to manufacture vector lots for Immuneel  programs and generate clinical-grade vectors for academic and industry pipelines.  •CAR-T Manufacturing Suite: using time-block campaigns dedicated to pilot batches, closed  processes, and semi-integrated processes.  
• Quality Control (QC) Lab: maintaining continuous utility for analytics under unified standard  operating procedures.  

A milestone in industry-academia collaboration 

The partnership synergizes THSTI’s newly established cleanroom facility with Immuneel’s validated  commercial-grade cell therapy ecosystem. By uniting academic research capabilities with industrial  operational expertise, the collaboration seeks to accelerate the translation of early-phase clinical  pipelines into viable treatments for patients.  

“Industry and academia collaborations are the need of the hour to bring out the best of India’s  scientific and translational capabilities. This partnership represents a vital step in operationalizing  clinical pipelines, and it begins as one of the many such collaborations needed in India to ensure we  can compete and lead on a global scale.” said Dr Lakshmikanth Gandikota, Chief Scientific Officer,  Immuneel Therapeutics.  

Advancing India’s global competitiveness 

Through this agreement, both parties will work toward obtaining necessary regulatory approvals from  the Central Drugs Standard Control Organization (CDSCO). The joint effort aims to create a shared  capacity manufacturing ecosystem that fosters innovation while enhancing India’s self-reliance in  advanced therapeutics. 

“True innovation thrives when academic research leverages industrial rigour. This strategic alliance  with Immuneel enables THSTI to operationalize clinical pipelines efficiently, ensuring that promising  laboratory-developed constructs are rapidly translated into clinical realities for patients in India and  beyond.” said, Prof. G Karthikeyan, Executive Director, THSTI. 

“This collaboration bridges the critical gap between scientific discovery and clinical delivery. By  partnering with an industry leader to manage our facility operations, we can efficiently navigate  regulatory pathways and ensure our investigator-initiated academic studies have reliable access to  clinical-grade materials.” added Dr Amit Awasthi, Senior Professor, THSTI. 

The post Immuneel Therapeutics and THSTI announce strategic partnership to  advance CAR-T cell therapy and Lentiviral Vector manufacturing  appeared first on Express Pharma.

The Optima AUC instrument enables precise quantification of peptide species, providing valuable insight into sample purity. This capability supports applications such as: • Lot-release testing • Stability studies • Batch-to-batch comparisons.

Why downloads this whitepaper?

Analytical Development Head/Scientist – This case study provides a detailed workflow on Analytical Ultracentrifugation use case to solve one of the hardest problems in peptide therapeutics characterizing self-association, multimerization and aggregation analysis in it’s native state.

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The Application Note highlight the versatility and utility of AUC for the characterization of LNP formulations. AUC can precisely determine the size distribution of LNP formulations in agreement with AF4-MALS and TEM. In addition, it can identify and quantify the presence of free cargo and empty LNPs in solution and can be used to determine the number of mRNA copies per LNP. Overall, AUC is a quantitative, first-principle method that is non-destructive, provides a comprehensive and reliable approach to the characterization of LNPs, and has become an indispensable tool in LNP research.

Why downloads this whitepaper?

The Formulation Scientist, Analytical Development Head/Scientist – This Application Note addresses the single biggest regulatory and analytical bottleneck in genetic medicine: accurately characterizing highly complex, heterogeneous lipid nanoparticles (LNPs).

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The AUC is a valuable tool to analyze rAAV vectors notwithstanding the composition and length of the transgene or the viral serotype. AUC as a matrix-free in-solution, high resolution method allows the rAAV vectors payload characterization in a near-native environment, contrast to every chromatographic technique uses a matrix, which particles have to pass through. Thus, not only can particles interact with the matrix, but also dilution effects might dissolve aggregated AAV particles and finally might falsify the true picture of a virus batch.

Why downloads this whitepaper?

The Analytical Head/Scientist or QC Head/Scientist – This Application Note provides empirical, peer-reviewed proof that standard chromatographic methods are leaving them blind to critical impurities in their viral batches.  Also it cites research showing that AUC is highly sensitive to the specific genetics of their unique construct, regardless of the viral serotype and ability to detect and quantify empty and full particles along with partials.

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Analytical ultracentrifugation remains a versatile and valuable technique for understanding the fundamental properties of macromolecules in solution. The continuous advancements in AUC technology demonstrate its indispensable role in various fields of research. The most recent AUC instrument, the Optima AUC, introduced improvements such as enhanced wavelength accuracy, allowing more confidence in your measurements. This is especially useful when measuring low-concentration proteins in the 215-230 nm range, where the OD change is steep between wavelengths. Faster scanning capabilities enable the collection of dense raw datasets, which can help improve RSMDs and be useful when collecting information on fast sedimenting analytes. Multiwavelength capabilities, which allow for protein and DNA overlapping signals to be deconvoluted into separate profiles based on their spectral differences, provide direct access to the molar stoichiometry of interacting complexes and improve the characterization of viral vector loading states.

Why downloads this whitepaper?

The whitepaper highlights four recent, high-impact peer-reviewed applications leveraging Analytical Ultracentrifugation and New Optima AUC Analytical UltraCentrifuge advanced features for monoclonal antibodies (mAbs) & aggregate quantification, study membrane proteins, protein-nucleic acid Interactions and viral vectors (AAV Loading States & Contaminants).

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The GARDP Foundation (known as GARDP) and Dr Reddy’s Laboratories announced that the Thai Food and Drug Administration (FDA) has approved NUZOLVENCE (zoliflodacin), a first-in-class oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea. The approval follows a priority review submission led by Dr. Reddy’s Laboratories, with support from GARDP.

NUZOLVENCE is indicated for the treatment of uncomplicated urogenital gonorrhoea due to Neisseria gonorrhoeae in adults and paediatric patients 12 years of age and older, weighing at least 35 kg. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Zoliflodacin was developed as part of a public-private research and development (R&D) partnership with Innoviva Specialty Therapeutics, a subsidiary of Innoviva. Innoviva Specialty Therapeutics is the marketing authorization holder in the United States. Zoliflodacin was submitted for priority review in Thailand in November 2025, a process led by the global pharmaceutical company, Dr. Reddy’s Laboratories, with support from GARDP.

The Thai FDA approval comes just six months after the drug was initially approved by the United States Food and Drug Administration (US FDA), making Thailand the second country to approve the new chemical entity (NCE). This sets a new benchmark for how quickly innovative treatments can reach low-and middle-income countries (LMICs) beyond initial high-income market approvals and marks a major milestone in efforts to expand rapid access to new antibiotics globally. 

The approval is particularly significant given the growing threat of antimicrobial resistance (AMR), which is making gonorrhoea increasingly difficult to treat with existing antibiotics. The Thai FDA has granted approval for NUZOLVENCE, reflecting Thailand’s strong commitment to AMR as a national public health priority. With more than 82 million new gonorrhoea infections occurring globally each year, zoliflodacin offers much-needed hope for patients with this sexually transmitted infection (STI). 

“As a global pharmaceutical company, Dr. Reddy’s purpose is to make innovative and affordable medicines accessible to patients worldwide,” said Deepak Sapra, Chief Executive Officer, API and
Services, Dr Reddy’s. “The approval of zoliflodacin by the Thai FDA is a significant step forward in ensuring timely access to an innovative treatment for gonorrhoea, including infections caused by multidrug-resistant strains. It underscores a new paradigm for global health access – where patients in LMICs can benefit from breakthrough medicines within months of their first approval rather than waiting years. This milestone reflects the power of collaboration in advancing equitable and sustainable access to critical new therapies.”

The zoliflodacin approval follows a pivotal phase 3 clinical trial that was sponsored and led by GARDP and which met its primary objective when compared against the current global standard of care. The findings of this trial were published on 11 December 2025 in The Lancet. Supporting these clinical findings, in previous in vitro studies, zoliflodacin has also been shown to be active against all multidrug-resistant strains of N. gonorrhoeae tested, with no cross-resistance with other antibiotics. 

“This approval marks a turning point not only for the treatment of gonorrhoea, but for how new antibiotics can be made available to people globally,” said Peter Beyer, Deputy Executive Director of GARDP. “This is proof that our novel antibiotic R&D model works and demonstrates the important role that product development partnerships like GARDP play in ensuring that antibiotics with high public health value are able to progress even when the market remains unattractive. GARDP is now committed to supporting its partners in working towards making zoliflodacin available to patients in Thailand.”

The approval reflects the coordinated efforts of GARDP, Dr. Reddy’s Laboratories and its subsidiary, Aurigene Pharmaceutical Services Limited (APSL), in advancing zoliflodacin. APSL played an important role in supporting the product’s development, while Dr. Reddy’s led the regulatory submission strategy and engagement with the Thai FDA. Building on this approval, GARDP, Dr. Reddy’s and APSL will continue to work closely with healthcare stakeholders in Thailand to support commercialization, ensure reliable supply, and facilitate broad patient access to this important new treatment.

GARDP has the right to register and commercialize zoliflodacin in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries. Entasis Therapeutics, Inc., the original license holder and an affiliate of Innoviva Specialty Therapeutics, retains the commercial rights for NUZOLVENCE in the major markets, such as North America and the European Union. In addition to Thailand, GARDP is taking steps to obtain market authorization in South Africa. These countries were selected not only because they are important partners for GARDP, but also because they played a key role in the phase 3 trial.

GARDP’s work on zoliflodacin has been funded with support from the governments of Germany (BMFTR and BMG), UK (GAMRIF, part of DHSC, and DFID, which is now part of FCDO), the European Commission through its Health Emergency Preparedness and Response Authority (DG HERA), Japan (MHLW), the Netherlands (Ministries of VWS and BZ), Switzerland (FOPH), The Grand Duchy of Luxembourg, as well as the Canton of Geneva, South African Medical Research Council (SAMRC), and the Leo Model Foundation. This builds on initial work by AstraZeneca, who first identified the NCE that was to become zoliflodacin and on a critical phase 2 clinical trial sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID).

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Galderma, the pure-play dermatology category leader, has announced the launch of Sculptra in India, introducing the first proven regenerative biostimulator. Backed by more than 25 years of clinical evidence globally, Sculptra represents a new generation of injectable aesthetics that works with the body’s natural collagen production to gradually restore facial volume, improve skin quality and deliver natural-looking, long-lasting results when administered by a qualified healthcare professional.

The launch marks an important milestone in India’s rapidly evolving aesthetics landscape, where growing awareness around skin health, minimally invasive options and personalised solutions are redefining consumer expectations. Patients and healthcare professionals alike are looking to move  beyond temporary correction towards regenerative solutions that work in harmony with the body’s own biological processes.

Raghavendra Sadashiva, Managing Director, Galderma India & South Asia said, “At Galderma, our focus has always been on bringing science-led innovations that respond to the evolving needs of healthcare professionals and patients alike. The introduction of Sculptra marks an exciting milestone for India’s aesthetics landscape as regenerative dermatology continues to gain momentum globally In addition to addressing the visible signs of ageing, Sculptra works with the body’s natural collagen production to support gradual, natural-looking improvements in skin quality and facial structure15-24. We are proud to bring this globally trusted innovation to India and further strengthen our commitment to advancing dermatological science in the country.”

In addition to restoring volume Sculptra also helps address collagen loss associated with the natural ageing process. As collagen production naturally decreases over time, the skin begins to lose its structural support, resulting in reduced firmness, volume loss and the appearance of wrinkles 29-30 Through its unique PLLA-SCA formulation, Sculptra stimulates the body’s own collagen production, helping gradually restore the skin’s underlying structure while maintaining natural facial expressions and individuality.

Ravi Mittal, Business Unit Head, Aesthetics, Galderma India said, “The aesthetics landscape in India is evolving rapidly, with both healthcare professionals and patients seeking solutions that deliver natural-looking, long-lasting outcomes while addressing the deep-rooted causes of facial ageing. We are noticing a significant shift from correction towards regeneration, where collagen stimulation and skin quality are becoming central to skincare decisions. The introduction of Sculptra marks an important step in bringing regenerative aesthetics to India, offering clinicians an innovative, science-backed option that works with the body’s natural processes to gradually restore facial volume and improve overall skin quality.

Globally, aesthetic medicine is witnessing a significant shift from correction to regeneration. Rather than seeking immediate or dramatic transformation, today’s consumers are increasingly looking for skin solutions that enhance skin quality, preserve natural features and deliver subtle, progressive results. This evolution has brought renewed focus on collagen, the skin’s structural foundation, and regenerative approaches that help restore what naturally diminishes with age.|

Supported by more than 25 years of clinical evidence and extensive real-world experience, Sculptra has established itself as a trusted regenerative biostimulator among healthcare professionals across more than 40 countries and regions. Its unique mechanism of action helps stimulate collagen production across the skin’s structural framework, resulting in gradual improvements in facial volume, firmness and overall skin quality, with results that can last for more than two years.

The introduction of Sculptra further strengthens Galderma India’s Injectable Aesthetics portfolio and reflects the company’s continued commitment to bringing globally recognised innovations to Indian healthcare professionals. As the leader in pure-play dermatology, Galderma continues to advance science-backed solutions across Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology, empowering healthcare professionals with innovative options while helping address the evolving needs of patients.

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Piramal Alternatives announced the successful conclusion of the investment made by its fund, Piramal Structured Credit Opportunities Fund, in Biodeal Pharmaceuticals, achieving an internal rate of return (IRR) of over 20% following the full redemption of its ₹110 crore investment. The successful exit marks the culmination of a value-creating partnership during which Biodeal delivered significant operational and financial progress, strengthening its manufacturing capabilities, governance framework, operational discipline, and laying a strong foundation for its next phase of growth.

The Fund had invested ₹110 crore in Biodeal in 2024 as part of its strategy of backing high-growth healthcare and pharmaceutical businesses with strong fundamentals and scalable business models. The investment has now been redeemed in full, delivering an internal rate of return (IRR) of over 20% for the Fund and reflecting the value created during the partnership.

During the investment period, Biodeal delivered strong revenue growth, growing 45% year-on-year in FY25 and a further 60% in FY26, while also achieving a significant improvement in its EBITDA margin, reflecting stronger operational efficiencies alongside business expansion. 

Beyond financial performance, the partnership strengthened Biodeal’s institutional foundation — expanding manufacturing capabilities, enhancing governance frameworks and building the operational discipline needed to scale sustainably. Today, Biodeal serves customers across multiple global markets, with a continued focus on quality, compliance and innovation, and remains committed to strengthening its position as a trusted pharmaceutical partner for both domestic and international markets

Kalpesh Kikani, Managing Director & CEO, Piramal Alternatives, said, “Our investment in Biodeal was anchored in a simple thesis: back a differentiated pharmaceutical platform with a leadership position in nasal formulation and a strong promoter capable of scaling the business profitably. Over the course of our investment, Biodeal delivered exceptional performance, with revenues and EBITDA growing significantly while expanding the product portfolio and strengthening its position across domestic and export markets. The successful exit at returns ahead of our underwritten expectations validates the company’s growth potential and its ability to create value for all stakeholders. We are proud to have supported Biodeal during an important phase of its journey and wish the company continued success in its next stage of growth.”

Anurag Kumar, Chairman & Managing Director, Biodeal Pharmaceuticals, said, ” Our partnership with Piramal Alternatives has been transformational. Beyond providing growth capital, they encouraged us to strengthen governance, invest ahead of demand, enhance operational discipline and build a stronger foundation for sustainable growth. The progress we have achieved over the past two years, from strong revenue growth to improving profitability, is a reflection of the talent and dedication of the entire Biodeal team, whose hard work and commitment have been the true driving force behind this journey. We thank Piramal Alternatives for being a valuable partner in this journey and look forward to building on this momentum as we enter the next phase of Biodeal’s growth.” 

The successful completion of the partnership marks an important milestone in Biodeal’s journey as the company continues to strengthen its capabilities, expand its global footprint, and build a future-ready pharmaceutical business.

As it enters its next chapter, Biodeal remains focused on strengthening its pharmaceutical formulation development and key operations through continued investments in manufacturing excellence, capabilities and innovation, while building long-term value for customers, partners and stakeholders.

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Madhya Pradesh is steadily emerging as a pharma manufacturing hub. How do you assess the current growth trajectory of the state’s pharma MSME sector? 

Madhya Pradesh has witnessed significant growth in pharma manufacturing over the last decade, particularly in and around Indore-Pithampur, which has emerged as the state’s strongest pharma ecosystem. The state offers a strategic central location, comparatively lower operating costs, availability of industrial land, and a supportive manufacturing environment. 

The pharma cluster around Indore-Pithampur today houses a large number of formulation, API, herbal, nutraceutical, and contract manufacturing units, ranging from MSMEs to globally regulated facilities. The presence of major companies alongside hundreds of MSME units has created a strong industrial ecosystem, generating employment and supporting ancillary industries. 

From an MSME perspective, there is increasing investment in quality systems, export readiness, and product diversification. The sector is moving from being primarily a domestic supplier to becoming an important contributor to regulated and semi-regulated international markets. 

How important is the Pithampur pharma cluster in positioning Madhya Pradesh as a preferred manufacturing destination? 

Pithampur is undoubtedly the backbone of Madhya Pradesh’s pharma manufacturing sector. It has developed into one of India’s important pharma production centres, with the presence of domestic and multinational companies manufacturing for both Indian and international markets. 

The cluster provides economies of scale, availability of skilled manpower, logistics advantages, supplier networks, packaging support, engineering services, and regulatory expertise. It has also enhanced investor confidence in Madhya Pradesh as a reliable manufacturing destination. 

The upcoming infrastructure developments, including improved connectivity and industrial corridors, are expected to further strengthen Pithampur’s position in the coming years. 

What are the biggest challenges currently faced by small and medium drug manufacturers in Madhya Pradesh? 

The biggest challenge remains cost competitiveness. MSME manufacturers are facing rising costs of raw materials, packaging materials, utilities, logistics, and skilled manpower. Working capital pressure has also increased due to delayed payments from institutional buyers and government procurement agencies. 

Another challenge is maintaining profitability while complying with increasingly stringent regulatory requirements. Smaller manufacturers often operate with limited financial resources, making investments in technology upgrades, automation, validation, and documentation systems difficult. 

Availability of trained technical manpower, particularly in quality assurance, regulatory affairs, and validation functions, is also becoming a concern for many MSME units. 

What kind of policy support or incentives are most urgently needed to strengthen the pharma manufacturing ecosystem in the state? 

The sector would benefit significantly from dedicated support for Schedule M compliance, technology modernisation, and infrastructure upgrades. Interest subsidies, capital investment subsidies, and low-cost financing mechanisms can help MSMEs transition smoothly to higher quality standards. 

The government should also strengthen common facilities such as advanced testing laboratories, stability chambers, training centres, and regulatory support cells that can be shared by smaller manufacturers. 

Faster reimbursement of industrial incentives, prompt payment mechanisms in government procurement, and export promotion initiatives would further improve the competitiveness of MSME pharma companies. 

The revised Schedule M guidelines are expected to significantly impact manufacturing practices. How prepared are MSME pharma companies in Madhya Pradesh to comply with the new requirements? 

The industry understands the importance of revised Schedule M because it will strengthen product quality, patient safety, and global acceptance of Indian medicines. Many medium sized companies have already initiated infrastructure improvements, documentation upgrades, training programmes, and quality system enhancements.

However, preparedness varies significantly across the MSME segment. While some units have made substantial progress, smaller companies are still assessing the investments required for full compliance. The intent to comply is strong, but implementation timelines and financial capability remain important factors. 

What are the major concerns of smaller manufacturers regarding Schedule M implementation, especially in terms of infrastructure upgrades and compliance costs? 

The primary concern is the substantial capital expenditure required for facility modifications, HVAC systems, water systems, equipment qualification, computerised documentation, and validation activities. 

For many MSMEs, these investments can run into several crores of rupees. In addition to infrastructure costs, there are recurring expenses related to training, documentation, audits, consultants, and quality management systems. Most small manufacturers are not opposed to quality improvements; their concern is ensuring that compliance requirements are implemented in a practical manner with adequate transition time and financial support. 

Are MSME pharma companies in MP increasingly exploring opportunities in exports, nutraceuticals, and contract manufacturing? 

Yes, this trend is clearly visible. MSME companies are actively exploring export opportunities in Africa, Asia, Latin America, and other emerging markets. Many companies are also diversifying into nutraceuticals, wellness products, herbal formulations, and food supplements due to growing consumer demand. 

Contract manufacturing and third-party manufacturing have become important growth drivers. Brand owners increasingly prefer asset-light models, creating opportunities for quality-focused manufacturing companies. This shift is helping MSMEs improve capacity utilisation and expand their business beyond traditional markets. 

Looking ahead, what is your vision for the growth of Madhya Pradesh’s pharma MSME sector over the next five to ten years? 

Madhya Pradesh has emerged as one of the most attractive destinations for pharma manufacturing in India. The State Government’s industrial and MSME policies offer a strong combination of capital incentives, infrastructure support, and ease of doing business. 

Under the latest industrial promotion and MSME policies, pharma and medical device manufacturing units are eligible for substantial capital assistance on investments in land development, buildings, plant and machinery, along with interest subsidies on term loans. In several cases, incentives can range from approximately 40 per cent to over 50 per cent of eligible investments, particularly for priority sectors and MSME units. The state also provides support for laboratory infrastructure, quality certifications, and export oriented initiatives. 

Apart from financial incentives, Madhya Pradesh offers competitively priced industrial land, excellent road connectivity through national corridors, reliable power availability, and abundant water resources, which are critical for pharma manufacturing operations. The development of industrial ecosystems such as Pithampur, Indore, and Mandideep has further strengthened the state’s attractiveness for investors. Recent government initiatives to expand industrial land banks and improve logistics infrastructure are expected to accelerate industrial growth even further. 

As a result, Madhya Pradesh is witnessing growing investment interest from leading pharma companies as well as small and medium-sized manufacturers across the country. The combination of investor-friendly policies, strategic location, lower operating costs, and strong infrastructure is positioning the state as a preferred destination for pharma manufacturing and healthcare-related industries. 

I believe Madhya Pradesh has the potential to become one of India’s leading pharma manufacturing states over the next decade. The combination of strong industrial infrastructure, strategic location, expanding pharma clusters, and supportive policies creates a strong foundation for growth. 

My vision is to see Madhya Pradesh emerge as a centre for quality pharma manufacturing, exports, nutraceutical production, and contract development and manufacturing services. With continued government support, successful implementation of quality standards, and investment in innovation and skill development, the state’s pharma MSME sector can significantly increase its contribution to employment, exports, and healthcare manufacturing.

Pithampur hosts manufacturing facilities of leading companies such as Cipla, Lupin, Glenmark, Torrent, Alkem, Aurobindo and others, making it one of Central India’s most important pharma manufacturing hubs. 

swati.rana@expressindia.com
swatirana.express@gmail.com 

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Hollaender

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Continuing its tradition of recognising excellence, the FDD Leadership Awards 2026, held alongside the FDD Conclave 2026, celebrated scientists, innovators and organisations driving advances in formulation research and development (FR&D). 

The evening opened with a welcome address by Viveka Roychowdhury, Editor, Express Pharma, Express Healthcare and Express Nutra, who spoke about the vision behind the awards and the need to celebrate the people shaping the future of pharmaceutical FR&D.

The event also comprised a very interesting fireside chat, ‘The New Playbook: What will define winning FR&D teams in 2030?’, with jury members Suresh Pareek, Angel and Growth Investor (Pharma); Dr Sumedha Nadkar, Pharmaceutical Strategy and Technology Consultant; and Dr Manish Grover, Director, Healthcare Technologies, Mangrove Creations. The discussion explored the evolving FR&D landscape, emerging innovation priorities and the leadership needed to drive the next phase of pharmaceutical development. 

Following the session, the jury members present at the conclave were felicitated for their contribution to the evaluation process. Roychowdhury also acknowledged the efforts of the entire jury in identifying this year’s winners. 

The awards were then presented by the jury members and Roychowdhury, joined by Manish Jain, MD, Cilicant, and Vijay Doshi, MD, Pioma Chemicals, representing the presenting and co-presenting partners. 

The honours were presented across four categories. 

Rising Stars: The next generation of FR&D innovators 

This category recognised emerging professionals making an early impact in pharma formulation research and development. 

• Dr Ankit Anand Kharia 
• Mr Anirudha Kute 
• Mr Arjunarao Panchada 
• Ms Chitra Varma 
• Dr Kashyap Nagariya 
• Dr Mukesh Kumar 
• Dr Nandkishore Yadav 
• Mr Pankaj Soni 
• Mr Prabhat Shrivastava 
• Dr Rajiv Khurana 
• Dr Shailesh Vishwanath Biradar 

Leaders: Driving excellence through scientific leadership 

This is a category that honored professionals whose vision and sustained contributions continue to strengthen pharma FR&D. 

• Dr Alagumurugan Alagarswamy 
• Dr Ravindra Agarwal 
• Mr Sandipan Roy 
• Mr Shrenik Kole 
• Dr Syed Shah Moinuddin Hussaini 
• Dr Tathagata Dutta 

Entrepreneurs: Turning research into real-world impact 

This Editor’s Choice category recognised scientist-entrepreneurs who have successfully translated research into impactful businesses. 

• Jayanta Kumar Mandal, CEO & MD, APDM Pharmaceuticals 
• Vijayendra Kumar Redasani, CEO & MD, DelNova Healthcare 

Special Citation: Recognising breakthrough innovation 

A Special Citation was presented to Team Wockhardt for the development of Zaynich, recognising the team’s breakthrough contribution to antibiotic innovation and the fight against antimicrobial resistance. 

The ceremony was followed by a networking dinner and cocktails. Bringing together researchers, industry leaders and innovators, the FDD Leadership Awards 2026 once again underscored the importance of celebrating excellence and fostering innovation across India’s pharma FR&D ecosystem. 

lakshmipriya.nair@expressindia.com
laxmipriyanair@gmail.com 

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Online shopping has trained us to value one thing above all others: visibility. Yet what empowers a consumer comparing prices becomes a liability when the same screen displays prescription drugs with ratings and discounts inviting us to treat medicine as a commodity, substitute a prescribed brand for a cheaper alternative or abandon a drug course because the refill seems expensive. The question worth asking is whether this visibility serves us equally well when the product in the cart is medicine or whether it turns a prescription into a shopping list inviting edits that can cost lives. 

India’s e-pharmacy industry has witnessed a phenomenal growth from around $0.5 billion in 2019 to about $3.71 billion in 2025, with predictions of growing to $14.08 billion by 2034. Over-the-counter medicines currently make up about 56 per cent of sales of online pharmacies in India. E-pharmacy platforms as well as quick commerce applications providing ten minutes delivery have made medicine purchase hasslefree. This growth nevertheless has taken place in the absence of regulation; the draft of e-pharmacy regulations of 2018 is yet to be finalised after seven years and the Drugs and Cosmetics Act, 1940, dates back to pre-internet era and remains inadequate by far to meet the challenges brought forth by e-commerce in medicine. 

The regulatory deficit 

The Drugs and Cosmetics Act of 1940, together with the Drugs Rules of 1945 and the Pharmacy Act of 1948, forms the legal basis for regulating the sale of drugs in India. This legislative regime is predicated on the existence of a physical store and a licensed pharmacist. However, a legislation enacted in 1940 evidently does not envisage a sale taking place via a digital application. 

The newer statues too fail to bridge the gap. The Information Technology Act of 2000 enables the platform to take shelter under the cover of being an intermediary; the Consumer Protection Act of 2019 addresses the transactions but not the clinical risks it entails; the Telemedicine Practice Guidelines of 2020 binds the doctor prescribing the drug but not the platform dispensing it and the Digital Personal Data Protection Act of 2023 does not designate health data as a category requiring any special protection. The draft rules containing provisions relating to registration, inspection, advertisement prohibition, grievance redressal and monitoring have still not seen the light of the day. 

Judicial intervention has tried to address the risk but has not been able to make any real dent. In December 2018, for instance, the Delhi High Court placed an interim ban on the sale of medicines online, stating that it was impermissible under the Drugs and Cosmetics Act, 1940 and the Pharmacy Act, 1948. In November 2023, the court gave the government “one last chance to formulate a policy in eight weeks”, stressing that “more than five years have lapsed and the Union of India has had sufficient time to frame a policy”. However, as of now none has been formulated yet.

The antibiotic time bomb 

Nowhere is the danger of this regulatory paralysis more acute than with antibiotics. The portal through which users can search symptoms and treatments renders the need for prescription a formality. As per the cross-sectional survey conducted in 2024 among 50 Indian e-pharmacies, it has been observed that antibiotics from all three WHO AWaRe categories including “Watch” and “Reserve” antibiotics, which have relatively more resistance potential, are available for online sales. None of the portals fully complied with the safety criteria. Whereas 82 per cent of the portals demand prescription, none of the websites mentions the registration number of the pharmacist on duty and none of them has any mechanism to restrict the excessive ordering of antibiotics. The study concluded that increased access to high-risk antibiotics may translate into antibiotic misuse. 

All India Organization of Chemists and Druggists has consistently expressed its concern that illegal online pharmacies are dispensing antibiotics without authorised prescriptions misusing even the telemedicine guidelines and issuing frivolous prescriptions. The Drugs Controller General of India also has flagged unchecked antibiotic sales as a major contributor to rising drug resistance. 

According to 2021 figures, antibiotic resistance is thought to have been responsible for about 267,000 deaths in India alone with another 940,000 deaths indirectly related to it. Projected estimates indicate that about 1.2 million people will die annually from AMR by 2030 unless concerted action is taken with alacrity. Worldwide, it is predicted that there will be 39 million AMR-related deaths from 2025 through 2050. This highlights the pervasive extent of the issue. 

The data privacy gap 

In addition to the aforementioned concerns, there is another major problem with data privacy that e-pharmacies bring along. Each prescription, health history and diagnostic report uploaded constitutes a wealth of private health information. However, health information is not regarded as “sensitive personal data” in the Digital Personal Data Protection Act of 2023. 

A prescription contains information about chronic ailments, mental disorders and other sensitive aspects of a patient’s health status. Without being licensed according to the Drugs and Cosmetics Act, online portals do not have any obligation to safeguard patients’ confidentiality. While the epharmacy rules in 2018 included provisions regarding data privacy, these were never enforced. Patient information provided to epharmacies is thus left in a legal limbo, without proper safeguards and protections. 

In fact, when something is going wrong, a counterfeit drug, an adverse reaction or a prescription fulfilled without verification, the issue of liability remains unsettled. The epharmacies have tried to defend their stance that they do not need any license as they simply deliver drugs like food delivery applications. This argument deliberately misconstrues the nature of pharmaceutical transaction because the platform which controls the price, manages the interface and processes the payments cannot be considered only as a passive intermediary. In fact, in February 2023, more than 20 online pharmacies received show cause notice from the Drug Controller General of India (DGCI) as they were operating without any license. However, no punitive action was taken. As a result, the industry continues in legal uncertainty, with marketplaces disclaiming responsibility for the transactions they design. 

Charting a safe path forward 

The fix is not very complex but is certainly long overdue. What India needs is an epharmacy act that plugs several important regulatory gaps. To start with, there should be mandatory registration at the Central Licensing Authority level using a dedicated website for a specified period of time with proper verification of compliance. The draft rules proposed Form 18AA in this regard and this must be carried out immediately. Moreover, the portal must prominently display registration details, the firm’s constitution and the registered pharmacist’s name. 

In addition, the Act must proovide for a reliable electronic prescription system through the Ayushman Bharat Digital Mission as opposed to accepting scanned copies of handwritten prescriptions. There should be a centralised prescription database so that the same prescription cannot be used on multiple platforms. Patient and practitioner verification must be done by registered pharmacists before dispensing any medication. 

Moreover, the Digital Personal Data Protection Bill has to be modified in so as to classify health-related data including prescriptions, past medical history and diagnostic information under a specially protected category. Data localisation should be ensured in such a manner that all the data is stored only in India, with the platforms being subjected to greater data protection obligations than generic intermediaries. The liability conundrum must also be settled definitively. E-pharmacy platforms cannot escape liability as an intermediary while regulating the transaction. There should be a clear delineation of liability and its sharing between the platform, pharmacist, prescriber and manufacturer. The platforms need to be considered as active players in the pharma value chain. 

Additional safeguards must include an absolute bar on online sale of narcotics, psychotropic substances and Schedule X drugs. It is also crucial to clearly prohibit advertising of prescription medicines since this kind of advertising results incentivizes self-medication among patients. Every e-pharmacy must employ a registered pharmacist available round the-clock for verifying prescriptions and answering customer questions. There should also be regular inspections of the premises in addition to risk-based transaction audits. Finally, the framework must provide for a robust grievance redressal system, a dedicated monitoring body and complete supply-chain traceability from manufacturer to patient, guarding against counterfeit medicines. 

The way forward 

It needs to be acknowledged that the advent of E-pharmacies in India is no passing trend. It is a radical change whose time has come. These e-commerce platforms have the potential to bring muchneeded relief to many Indians, from the bed-ridden elderly, the chronically ill to those in the rural parts of the country who have trouble finding well-stocked physical pharmacies. They can also democratise access, make prices transparent and provide convenience that is simply unachievable through brick-and-mortar outlets. Moreover, the pandemic has accelerated this process and has expanded the market and there is no turning back now. 

\Yet paradoxically, the features that make e-pharmacies convenient also make them dangerous if the regulatory architecture fails to keep up. The interface that makes it possible for a rural patient to order his life-saving medicines can also make it possible for a teenager to order antibiotics without a doctor’s prescription. The same platform that makes it easy to compare prices can also allow a substitute product to be ordered in lieu of the one prescribed by a doctor. The solution should not thus be to turn away from digital healthcare but to create safeguards proportionate to the size of the challenge. Epharmacies need to be brought under the ambit of law, not to curb innovation but to ensure that innovation doesn’t come at the expense of the safety of patients. An epharmacy legislation with compulsory registration, secure electronic prescriptions, data protection, defined liabilities and oversight is not a deterrent to growth but a prerequisite for sustainable growth. 

E-pharmacies are here to stay. But the question is whether India will legislate to ensure that the benefits are delivered without risks. The role of the legislature and the regulator is not to impede progress but to guide it. The need is to have an online pharmacy ecosystem that delivers both convenience and safety, because a prescription should never turn into a shopping list 

The post India’s online pharmacy boom and the perils of unregulated medicine  appeared first on Express Pharma.

India’s pharmaceutical industry has gained an international reputation due to its large-scale production, advanced scientific knowledge, and competitive pricing. The sector supplies various highly regulated markets worldwide with generics, APIs, biologic, vaccines, and specialized formulations, which play a crucial role in supporting the country’s export economy. However, focusing solely on the quality of products is no longer enough. In today’s competitive landscape, exporters must deal with a complex global trade environment that requires regulatory flexibility, accurate documentation, and transparent supply chains to stand out from their competitors. Artificial intelligence is now being recognized as the key tool to help businesses navigate through these challenges.

A more demanding trade world 

The trade environment is becoming more challenging. Different markets such as the United States, European Union, United Kingdom, Middle East, Africa, and Southeast Asia have their unique requirements for labeling, serialization, quality certifications, and pharmacovigilance responsibilities. Moreover, the unpredictability of global supply chains, including shipping interruptions, export restrictions, reliance on raw materials, and sudden regulatory changes, adds to the operational complexities rapidly.

Failing to meet these requirements can have serious consequences. For instance, a missing document, an incorrect HS code, an expired permit, or a discrepancy in paperwork can lead to shipment holds, fines, and harm to reputation. In an industry where the quality of products directly impacts patients, these risks are tangible and not merely theoretical.

The question has shifted from whether exporters need technology to whether their technology is intelligent enough to anticipate problems before they escalate.

From compliance burden to regulatory intelligence

Export documentation in the pharmaceutical industry is known for being complex within the realm of global trade. This includes a variety of paperwork such as invoices, certificates, quality records, customs forms, and logistics paperwork, which have traditionally been managed using manual lists and fragmented systems. The use of AI technology is changing this situation by streamlining processes. Advanced systems can analyze product-market pairs, identify the necessary documentation for each specific destination, and keep track of any regulatory changes in real time. This allows teams to be notified of any missing documents well before a Shipment’s departure, enabling them to proactively address compliance issues. It’s important to Note that AI doesn’t replace the need for regulatory experts in the pharmaceutical field. Human judgement remains a critical aspect in this industry. However, AI can reduce repetitive tasks, identify potential risks early on, and empower skilled professionals to concentrate on strategic decision-making and handling exceptional cases.

Supply chain visibility that goes deeper

The global health crisis revealed a stark reality: having a robust manufacturing sector is insufficient if there is a lack of transparency in the supply chain. In the realm of pharmaceutical exports, having meaningful transparency involves more than just monitoring the whereabouts of shipments. It necessitates finding solutions to more challenging inquiries such as the origin of raw materials, the approval status of suppliers for the target market, the alignment of batch records with export paperwork, and the ability of the company to demonstrate the integrity of its supply chain to regulators or overseas buyers.

Artificial intelligence integrates information from procurement, manufacturing, quality control, storage, and transportation to create a unified, up-to-date overview. It predicts the potential consequences of delays in shipments, identifies suppliers with repeated quality issues, and promptly locates affected products when a country revises its import regulations. In an industry where delays can hinder patient access, this intelligence provides a direct competitive edge.

Documentation accuracy at scale

Pharma export documentation demands exactness. Product names, batch numbers, invoice values, licence references and country-specific declarations must align precisely across every document. A single inconsistency between an invoice and a certificate of analysis can stall customs clearance. AI extracts data from source systems, validates it against regulatory rules and detects inconsistencies before submission. Machine learning identifies recurring error patterns and recommends corrections. For exporters managing high volumes across multiple markets, the result is faster processing, fewer errors and stronger audit readiness.

Competing on trust

The next frontier of competitiveness will be defined by trust the ability to demonstrate compliance, respond swiftly to regulator queries, trace materials end to end and maintain transparency across markets simultaneously. India already holds the foundational strengths: manufacturing depth, scientific talent and established global market access. Layering AI-driven trade and compliance infrastructure onto these strengths positions Indian exporters to move further up the value chain  from reliable suppliers to indispensable, digitally mature partners.

AI will not eliminate pharmaceutical export complexity. It will make that complexity manageable converting reactive firefighting into proactive intelligence, and fragmented data into strategic clarity. For a sector that has already earned the title of pharmacy to the world, that shift may prove decisive.

The post How AI is redefining India’s pharmaceutical export edge appeared first on Express Pharma.

The pharma industry is entering an era where scientific innovation must move faster, scale smarter and remain affordable. Against this backdrop, Express Pharma’s FDD Con clave 2026 brought together formulation scientists, R&D leaders, technology providers and industry experts to discuss the evolving landscape of formulation development and drug delivery. Hosted by Ex press Pharma, presented by Cilicant and powered by Pioma Chemicals, the conclave served as a platform for conversations on leadership, innovation, advanced drug delivery systems, manufacturing excellence and the future of pharmaceutical research. 

The event commenced with a welcome address from Express Pharma, followed by the traditional lamp-lighting ceremony attended by Viveka Roychowdhury, Editor, Ex press Pharma; Manish Jain, MD, Cilicant; Vijay Doshi, MD, Pioma Chemicals; AVPS Chakravarthi, Chairman, FOPE Andhra Pradesh and Telangana; Dr Vellaian Karuppiah, COO, Shilpa Medicare; Dr Pavan Bhat, MD and CEO, Inventia Health care; Dr Praveen Khullar, ED, VerGo Pharma, Sreehari Babu P, CEO, HyCON Labs; and Jayanta Kumar Mandal, CEO and MD, APDM Pharmaceuticals. The ceremony symbolised the industry’s collective commitment to innovation, scientific excellence and better healthcare outcomes. 

Leadership lens: The business of FR&D amid global shifts 

The opening session, “The Business of FR&D: Global Shifts, New Pressures”, set the tone for the day. Moderated by Viveka Roychowdhury, the discussion featured Dr Praveen Khullar, Executive Director, VerGo Pharma Re search Laboratories; Sreehari Babu P, CEO, HyCON Labs; and Jayanta Kumar Mandal, CEO and Managing Director, APDM Pharmaceuticals. 

The panel examined how formulation research and development is being reshaped by rising development costs, increasing regulatory scrutiny, global competition and the need to shorten development timelines. The speakers emphasised that FR&D can no longer function as a standalone scientific activity. Instead, it must align closely with business objectives, market requirements and evolving patient needs. 

The discussion highlighted the growing importance of agility, cross-functional collaboration and strategic decision-making in ensuring that R&D investments translate into commercial success. 

From lab to market: Scaling formulation science 

A key panel discussion of the conclave focused on the journey from laboratory innovation to commercial manufacturing. 

Moderated by Dr Raviku mar N, President – Formula tions R&D, MSN Laboratories, the panel included Dr Pavan Bhat, MD and CEO, In ventia Healthcare; Dr Vellaian Karuppiah, COO, Shilpa Medicare; Dr Pankaj Mandpe, EVP-R&D, Micro Labs; Dr Madhusudhan Bommagani, President, FR&D, Cadila Pharmaceuticals; Dr Vasan thakumar Ramu, Head – R&D (Peptides and Complex Generics), Alembic Pharma ceuticals; Dr Saurabh Gupta, VP and Delivery Manager Integrated Product Development, Dr Reddy’s Laboratories; and Dr Ratnakar P Mehendre, Director, Shuban Pharmaceuticals. 

The discussion explored the challenges involved in translating promising scientific concepts into commercially viable products. Panel lists stressed the importance of integrating formulation development, process under standing, regulatory planning and manufacturing readiness early in the development cycle. 

The speakers also highlighted the growing role of complex generics, peptide based therapies and platform technologies in shaping future development strategies. A recurring theme was the need to reduce technology transfer risks and ensure scalability from the earliest stages of product development. 

Tackling nitrosamine risks 

Nitrosamine mitigation emerged as a major theme throughout the conclave. In an insightful presentation, Dr Vivek Jha, Head R&D, Cilicant, and Dhairy Sharma, Manager – Business Development (Healthcare Di vision), Cilicant, discussed the role of their Frexil technology in minimising nitrosamine risks. 

The session focused on practical approaches to mitigating nitrosamine formation and contamination, highlighting the need for proactive risk assessment, packaging innovations and collaborative strategies across the pharmaceutical value chain. 

Complementing this discussion, Dr Prafulla S Chaud 38 EXPRESS PHARMA hari, VP – Technical, Nitika Pharmaceutical Specialities, delivered a presentation on controlling nitrosamine impurities through low-nitrile excipients. 

He explained how excipient selection can significantly influence nitrosamine risk management and shared insights into material design strategies that can help manufacturers meet evolving regulatory expectations. 

Excipients as innovation enablers 

Excipients are increasingly playing a strategic role in formulation development, and this theme was explored through multiple technical sessions. 

Jaynil Doshi, Director Techno Commercial, Pioma Chemicals, presented “Hydro cel: Multi-functional Cellulose Technologies for Modern Formulators”. He highlighted how multifunctional cellulose technologies can simplify formulation development while enhancing product performance and process efficiency. The session demonstrated how advanced excipients are moving beyond traditional functionality to become key enablers of innovation across dosage forms. 

Similarly, Krutik Prajapati, Manager (Techno Commer cial), Vikram Thermo (India), discussed drug release modulation through DRUGCOAT RSPO/RLPO technologies. His presentation illustrated how advanced coating systems can provide greater control over drug release profiles while improving therapeutic outcomes and patient compliance. 

Building future-ready research infrastructure 

As India seeks to strengthen its position in global pharmaceutical innovation, research infrastructure is becoming increasingly important. 

Addressing this topic, Dr Jayant Karajgi, CEO, FTF Pharma, spoke about building world-class FR&D laboratories in India. 

He outlined the infrastructure, talent and technology investments required to create globally competitive research environments. The session underscored that innovation ecosystems require more than scientific expertise; they also depend on advanced facilities, digital capabilities and collaborative networks. 

Process optimisation and manufacturing excellence 

The link between formulation science and manufacturing outcomes was another major focus area. 

Manoj Bansal, Business Development Head – India and South Asia, Thermo Fisher Scientific, discussed advancements in hot melt extrusion technology, highlighting instrumentation considerations and methodological approaches needed for successful implementation. 

He explained how hot melt extrusion is becoming an increasingly valuable platform technology for improving solubility, bioavailability and product differentiation. 

Dr Jitendra Amrutkar, Head – Process Technology and Support, APT Shirwal, ACG Engineering, expanded the conversation through his presentation on connecting formulation science, process understanding and manufacturing outcomes.

His session emphasised that successful process optimisation requires an integrated understanding of product design, process parameters and manufacturing performance. He highlighted how data-driven process understanding can improve consistency, quality and scalability. 

Further strengthening the manufacturing focus, Vinod Vilas Kenekar, Subject Matter Expert – Process Technology, ROMACO India, explored the integration of fluidised bed granulation and tablet coating technologies. 

His presentation demonstrated how combining advanced granulation and coating platforms can enhance efficiency, product quality and operational flexibility.

Advanced drug delivery takes centre stage 

Innovation in drug delivery remains one of the most exciting areas of pharma development. 

A panel discussion on “Advanced drug delivery: From oral to injectables and beyond” brought together leading experts from across the industry. 

Moderated by Dr Manikan dan R, Sr VP, Granules India, the panel featured Dr Rakesh Bhasin, Head – Generic Formulations R&D, Biocon Pharma; Girish Achliya, CSO, Novapharm Healthcare; Dr Ganeshchandra Sonavane, CSO, Umedica Laboratories; Debjani Singh, VP – Formula tion and Development, Zydus Lifesciences; Dr Sandhya Shenoy, VP – Formulation R&D, MSN Laboratories; Dr Abhay Joshi, VP – Formula tion Development, Dr Reddy’s Laboratories; Dr Dinesh Shinde, AVP and Head – Formulation Development and Tech Transfer, Wockhardt; and Preeti Raut, Technical Consultant, Cipla. 

The panel explored innovations across oral delivery systems, injectables and emerging modalities. Discussions centred on improving bioavailability, enhancing patient convenience and developing next-generation delivery platforms capable of addressing increasingly complex therapeutic challenges. 

The speakers noted that future drug delivery innovation will require a combination of formulation expertise, device integration and patient-centric design. 

Affordable innovation as a strategic imperative 

A deep-dive discussion titled “Affordable Innovation: The New FR&D Mandate” addressed one of the industry’s most pressing challenges. Moderated by Dr Sukhjeet Singh, CSO, Acme Formulations, the session featured Dr Ravindra Agarwal, Senior Vice President, Mankind Pharma, and Dr Syed Moinuddin, Head – Global R&D, Wockhardt. 

The speakers discussed how pharma companies can balance scientific ambition with affordability and accessibility. They argued that innovation should not be measured solely by scientific breakthroughs but also by its ability to improve patient access and healthcare outcomes. 

The discussion highlighted the growing need for cost efficient development models, smarter resource allocation and scalable innovation strategies. 

Peptide delivery and emerging modalities 

Peptide therapeutics continue to attract significant attention across the pharmaceutical industry. 

Addressing this opportunity, Dr Suruchi Vishwasrao, Senior Scientist – R&D, Merck Life Sciences, presented on overcoming the challenges associated with oral peptide delivery. 

She outlined the scientific barriers that have traditionally limited oral peptide administration and discussed emerging technologies designed to improve stability, absorption and bioavailability. 

The session highlighted the considerable potential of peptide-based therapies and the innovations required to unlock broader patient access. 

Leadership lessons for the next generation 

Beyond technology and science, the conclave also focused on leadership development. 

In a session titled “The Mentorship Exchange: What FR&D leaders must learn and unlearn”, Dr Vijayendraku mar Redasani, CEO and MD, DelNova Healthcare, moderated a discussion featuring Vinod Arora, Principal Advi sor, IGMPI, and Dr Ashok Omray, Pharma Consultant. 

The speakers reflected on evolving leadership expectations within pharmaceutical organisations. They discussed the importance of adaptability, continuous learning and challenging traditional assumptions in an industry undergoing rapid transformation. 

The conversation reinforced that leadership remains a critical driver of innovation, talent development and organisational success. 

Navigating the R&D reset The concluding panel discussion addressed the changing realities facing pharma R&D organisations. 

Moderated by Dr Pirthi Pal Singh, President and Group R&D Head, Tirupati Group, the panel featured Shrenik Kole, VP and Head – Sterile Product Development, Micro Labs; Dr Sachin Mundade, VP– R&D, Micro Labs; Dr Kr ishna Murthy Bhavanasi, VP R&D, Lotus Pharmaceutical; Yogesh Joshi, Associate Director and Head (Formulation Development) and Head Clinical Manufacturing, Pira mal Pharma Solutions; Dr Arindam Halder, GM, Sun Pharmaceutical Industries; and Sandipan Roy, GM, Hetero. 

The discussion examined how organisations are responding to regulatory changes, market volatility and increasing scientific complexity. Panellists emphasised the need for flexible development models, stronger risk management frameworks and greater collaboration across functions. 

Biologics: India’s next scientific frontier 

The final session of the con clave focused on one of the most promising opportunities in healthcare. 

Moderated by Dr Vaibhav Dubey, AVP, Kashiv Bio Sciences, the fireside chat featured Dr Jaby Jacob, Senior President – R&D, BSV (A Mankind Group Company), and Dr Rakesh Kumar Sinha, Senior Vice President, Biological E. 

The discussion explored India’s growing capabilities in biologics, biosimilars and advanced biological therapies. 

The speakers highlighted the investments, talent and infrastructure required for India to emerge as a global biologics powerhouse. 

They noted that while significant progress has been made, continued investment in scientific capabilities, manufacturing infrastructure and regulatory readiness will be essential to unlock the full potential of the biologics sector. 

Looking ahead 

Across every session, a common message emerged: the future of pharmaceutical innovation will be defined by collaboration, scientific excellence and the ability to translate complex research into accessible healthcare solutions. 

From nitrosamine mitigation and advanced excipients to peptide delivery, biologics and affordable innovation, FDD Conclave 2026 showcased the breadth of innovation shaping pharmaceutical development today.

More importantly, it highlighted the evolving role of FR&D as a strategic function that must balance science, business, manufacturing and patient needs. As the industry continues to navigate new challenges and opportunities, the insights shared at the conclave provided a valuable roadmap for the next chapter of pharma innovation.  

lakshmipriya.nair@expressindia.com
laxmipriyanair@gmail.com 

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The designation aims to facilitate the development and accelerate the FDA review process for medicines that target serious conditions and fulfil unmet medical needs.

Lundbeck stated that this regulatory milestone advances its development portfolio relating to sleep-wake disorders.

Narcolepsy is described as a chronic neurological condition that affects the brain’s regulation of sleep and wakefulness.

Individuals with narcolepsy often deal with symptoms such as excessive daytime sleepiness, frequent sleep attacks, fragmented sleep during the night, sleep paralysis, and hallucinations.

Orexin-producing neurons in the lateral hypothalamus of the brain, play a central role in arousal, wakefulness, and rapid-eye-movement (REM) sleep regulation.

Orexin signals through two receptors: orexin 1 and orexin 2.

The OX2R is particularly linked to promoting wakefulness and regulating sleep-wake cycles, making it a relevant target in narcolepsy and similar disorders marked by excessive daytime sleepiness.

Discovered by Lundbeck, Lu AH69593 is designed to activate the OX2R with the aim of enhancing wake-promoting signalling. The compound is not approved for marketing anywhere and its safety and efficacy have not yet been established.

Lundbeck R&D executive vice-president Johan Luthman said: “Fast track designation is an important milestone for Lu AH69593 and for our ambition to translate compelling orexin biology into a new treatment approach for narcolepsy and other sleep-wake disorders.

“This programme is a good example of Lundbeck’s transformation of the R&D pipeline into breakthrough neurology, neuroendocrine and rare indication programmes, with potential for regulatory designations facilitating development.”

The company will continue working with the FDA as the clinical development continues.

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This expansion will increase the company’s production capacity for its cancer medicines and is expected to create around 120 new full-time jobs.

The development involves the construction of a three-storey building covering approximately 145,000ft², adjacent to BeOne’s existing Hopewell site.

Once completed, this will bring the total campus size to an estimated 545,000ft².

The new facility is scheduled to be fully operational in 2029 and will house drug product manufacturing and packaging operations, along with quality control laboratories and office space.

Some of the new capacity will be reserved for future growth and strategic partnerships.

With this addition, BeOne Medicines aims to combine its existing biologics manufacturing with new capabilities for small molecule drug products under one roof.

The expanded facility will also support the company’s haematology portfolio and larger pipeline of oncology assets, which includes more than 35 clinical and commercial-stage products.

Opened in July 2024 after an initial $800m outlay, the Princeton West Innovation Campus serves as BeOne Medicines’ flagship US manufacturing and clinical research centre.

The 42-acre site includes more than one million square feet of space that could be developed for further manufacturing needs. The Hopewell campus also supports clinical and commercial production for BeOne Medicines’ solid tumour therapies.

BeOne is conducting 93 clinical studies across 45 states and one territory at 1,100 locations, with support from over 650 investigators.

In August 2025, BeOne Medicines’ investigational Bruton’s tyrosine kinase (BTK) degrader, BGB-16673, received priority medicines (PRIME) designation from the European Medicines Agency to treat Waldenstrom’s macroglobulinemia in individuals previously treated with a BTK inhibitor.

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Riding on policy reforms that earned it the top rank among large states in NITI Aayog’s Investment Friendliness Index 2026 for Regulatory Ease and Institutional Environment, Chhattisgarh has received pharmaceutical investment proposals worth ₹992.53 crore over the past 18 months under its Industrial Development Policy 2024–30, with four projects worth ₹216 crore already under implementation, signalling that investor interest is translating into on-ground manufacturing activity.

The four projects, being developed by 9M India, Shankara Latex Industries, Avila Pharmaceuticals and Vitalis Health Services, are at various stages of implementation. Facilities by 9M India and Shankara Latex Industries are under construction and are expected to become operational soon, while projects by Avila Pharmaceuticals and Vitalis Health Services are also advancing rapidly. For pharmaceutical manufacturing, where investment decisions are cautious and project cycles can be long, this early movement is significant as it reflects progress from investment intent to execution.

“Chhattisgarh is consciously diversifying its industrial landscape, and pharmaceuticals are among the new-age sectors we are ready to host at scale. The momentum we’re seeing in Nava Raipur, reflected in the investment proposals and projects under implementation, reinforces the confidence investors are placing in Chhattisgarh’s readiness for advanced manufacturing and validates our sustained focus on ease of doing business,” Chief Minister Vishnu Deo Sai said.

Under the Industrial Development Policy 2024–30, pharmaceuticals have been identified as a thrust sector. The policy offers capital assistance linked to investment size, reimbursement of net SGST for up to 12 years, exemptions on electricity duty and stamp duty, and additional benefits for pioneer investors. The objective is to strengthen project viability, support early investors and encourage long-term manufacturing investments in the state.

The investment ecosystem has been further strengthened with the recent enactment of the Chhattisgarh Ease of Doing Business Act, 2026, making the state the first in the country to introduce a risk-based regulatory framework aimed at simplifying approvals, reducing compliance burden and enabling faster project implementation.

The state’s flagship Pharma Park at Nava Raipur is emerging as a key driver of this growth. Spread across nearly 142 acres, the park has been developed with plug-and-play infrastructure, common utilities and logistics connectivity to support pharmaceutical manufacturing. Within just over a year of opening plot allotments, the park has witnessed encouraging investor response, with seven plots already allotted, reflecting steady progress in the development of Nava Raipur’s pharmaceutical manufacturing ecosystem.

The state’s pharmaceutical ecosystem is supported by premier institutions such as AIIMS Raipur, IIT Bhilai, IIM Raipur and NIT Raipur, providing access to skilled talent, research and innovation. Backed by an installed power generation capacity of over 26,000 MW, improving road, rail and air connectivity, and proximity to key markets in central India, Chhattisgarh is building a modern pharmaceutical manufacturing ecosystem on focused policy support and scalable infrastructure rather than retrofitting legacy industrial clusters. With investment proposals steadily translating into projects under implementation and the dedicated Pharma Park attracting investor interest, the state is strengthening its position as an emerging destination for pharmaceutical manufacturing.

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Akums Drugs and Pharmaceuticals (“Akums” or “the Company”), India’s largest Contract Development and Manufacturing Organisations (CDMOs), announced that its wholly-owned subsidiary, Pure and Cure Healthcare, has received Board approval to acquire the manufacturing business of Oriflame India. The Board approval was granted at a meeting held on 23rd July, 2026.

The transaction covers two manufacturing facilities — one at Roorkee, Uttarakhand, and the other at Noida, Uttar Pradesh along with a leased warehouse situated at Noida, Uttar Pradesh— for a consideration of INR 56 Crore. The acquisition is being made purely on a cash consideration basis and is expected to be completed by 31st August, 2026, subject to customary closing conditions.

The facilities being acquired bring a wide range of manufacturing capabilities across skincare, wellness, hair care and color cosmetics. In skincare, capabilities include creams, lotions, scrubs, face wash and serums; in hair care, shampoos and conditioners; and in color cosmetics, lipsticks, foundations, primers, mascara and eyeliners. Both plants are well designed, equipped with several European-make machines across processing, filling and labelling, and offer capacities ranging from small to large batch sizes. The plants are also Halal certified, supporting global exports.  The transaction is limited to the manufacturing business of Oriflame India. All marketing, sales and trademark rights associated with Oriflame products in India are excluded from the transaction and will remain under the ownership and management of Oriflame India.

The move positions Akums to capture a larger share of India’s rapidly expanding cosmetics and personal care industry. The India cosmetics market, estimated at USD 20 billion, is projected to nearly double to in the next decade. This is driven by rising consumer demand for premium products, focus on self-care, rapid expansion of e-commerce and omnichannel retail as well as increasing influence of social media and beauty influencers.

With this acquisition, Akums will expand its existing footprint in skincare cosmetics and wellness products manufacturing while marking its foray into color cosmetics manufacturing. Cosmetics is a focus segment for Akums, which today caters multiple cosmetic clients through its existing cosmetic manufacturing facility that operates at high utilization rates. The addition of the new sites will significantly expand Akums’ presence in the cosmetics CDMO space.

Speaking on the development, Sanjeev Jain, Managing Director, Akums Drugs and Pharmaceuticals said: “This acquisition is a significant step in Akums’ strategy to diversify beyond pharmaceuticals into high-growth adjacent categories. Cosmetics, and color cosmetics in particular, represent one of the fastest-growing consumption stories in India today. Acquiring these two well-established manufacturing facilities gives us immediate, high-quality capacity and capability, and strengthens our ability to serve both Indian and global brands.”

Sandeep Jain, Managing Director, Akums Drugs and Pharmaceuticals, added: “Manufacturing facilities at Roorkee and Noida bring proven expertise and infrastructure that align closely with our quality and scale ambitions. This is a natural extension of our CDMO capabilities into cosmetics, and we see meaningful synergies with our existing operations. Our focus remains on building world-class manufacturing capacity that can cater to the growing demand for skincare and color cosmetics, both domestically and for export markets.”

Anna Malmhake, CEO and President, Oriflame said: “This agreement represents an important strategic step for Oriflame in India. By partnering with Akums, a highly respected manufacturing company with strong capabilities and a proven track record, we are securing a long-term manufacturing partnership that will continue to support the high-quality products our Beauty Entrepreneurs and customers expect.

“India remains an important growth market for Oriflame, where we have successfully operated for more than 30 years. We look forward to working closely with Akums while continuing to focus on growing our social selling business across the country.”

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Sun Pharmaceutical Industries announced that the stockholders of Organon have approved the proposals in connection with the previously announced merger transaction under which Organon is expected to become a wholly owned subsidiary of Sun Pharmaceutical Holdings USA, an indirect wholly owned subsidiary of Sun Pharma.

The shareholder approval marks an important milestone towards completion of the proposed transaction.

The acquisition remains subject to the satisfaction of the remaining customary closing conditions, including applicable regulatory approvals. For additional information regarding the proposed transaction, please refer to Sun Pharma’s announcement dated April 27, 2026.

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AFTX-201 is an investigational gene therapy delivered through a single intravenous infusion.

The therapy uses a functional BAG3 transgene and is based on the company’s proprietary capsid, which is engineered for targeted delivery to the heart at lower doses than some traditional gene therapies.

The investigational therapy is currently being studied in the Phase I/II UPBEAT clinical trial in the US and Canada.

The trial is recruiting participants aged 18 to 55 years who are diagnosed with BAG3 DCM and have difficulties with daily physical activities due to heart failure.

Affinia Therapeutics chief medical officer Hideo Makimura said: “Receiving orphan drug designation, in addition to the recent fast track designation, from the FDA marks a significant achievement for the AFTX-201 programme and we thank the FDA for their decision.

“AFTX-201 is designed to address the underlying root cause of BAG3 DCM. The UPBEAT clinical trial is actively recruiting at multiple institutions, and we look forward to continue progressing the AFTX-201 clinical programme so that we can bring this potentially transformative treatment to people living with BAG3 DCM.”

Caused by genetic changes that limit BAG3 protein production in heart muscle cells, BAG3-associated DCM is estimated to account for 2.3%-3.6% of DCM cases globally, based on published literature.

The FDA’s orphan drug designation is intended to support the development of treatments for rare diseases in the US.

It may offer development and commercial incentives such as tax credits, exemption from user fees, and potential market exclusivity if the therapy receives approval.

In October 2025, Affinia Therapeutics raised $40m in a Series C funding round, led by New Enterprise Associates.

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Key parameters for development will include oral potency, bioavailability, selectivity, and drug-like qualities.

ELEO will provide experimental resources such as biological knowledge, target validation, PCSK9 expression suppression models, and screening platforms, to test and further refine the molecules produced via computational methods.

This partnership aims to expedite the discovery process, improve candidate selection, and support the progression of the most promising compounds into preclinical development.

The announcement pointed to industry forecasts projecting the global PCSK9 inhibitor market could grow from an estimated $4.4bn in 2025 to more than $23bn by 2035.

Through their combined approach, Evogene and ELEO intend to identify and advance differentiated oral small molecules that could offer alternatives in this expanding market.

Evogene president and CEO Ofer Haviv said: “This collaboration with ELEO represents a compelling opportunity to apply Evogene’s advanced AI-driven computational capabilities to one of the most significant therapeutic areas in cardiovascular medicine.

“ELEO brings important biological expertise and a promising approach to targeting the PCSK9 pathway, while our ChemPass AI platform is uniquely positioned to design and optimise challenging small-molecule candidates.

“Together, we aim to advance differentiated, next-generation therapeutic candidates with significant potential value for future strategic partners and the global healthcare market.”

The companies indicated they may also explore broader strategic opportunities, including clinical development pathways and licensing collaborations with worldwide pharmaceutical partners seeking new solutions in the cardiovascular disease field.

Prior to this, Evogene and Tel Aviv University’s Blavatnik Center for Drug Discovery announced a collaboration that aims to expedite the development of small-molecule drug discovery originating from Israeli academic research.

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Hikal, a leading partner to global pharmaceutical, crop protection and specialty chemical companies, has announced the successful commissioning of its enhanced current Good Manufacturing Practice (cGMP)-compliant pilot plant facility at its Pune Research & Technology (R&T) campus.

The expansion strengthens Hikal’s integrated capabilities across process development, scale-up, technology transfer and clinical-stage manufacturing at its Innovation Campus at Pune, enabling the company to partner more effectively with global pharmaceutical customers from early development through commercial manufacturing readiness.

The upgraded pilot plant supports process development, technology transfer and clinical-stage manufacturing while adhering to global quality and regulatory expectations. By creating a stronger bridge between laboratory-scale research and commercial-scale production, the facility is designed to help customers accelerate development timelines, improve process robustness and generate high-quality material for regulated development programmes. It also enables the manufacture and supply of preclinical and clinical-phase development materials from the same R&T campus, allowing scientists and engineers to closely monitor processes, enhance cross-functional collaboration and reduce technology-transfer timelines to support timely project delivery for its innovator customers

The new pilot facility is designed to support flexible, cGMP-compliant scale-up across a wide range of chemistries. Its infrastructure includes reactors ranging from 20 litres to 2,000 litres, with stainless steel and glass-lined materials of construction as well as distillation and filtration through advanced equipment, including Hastelloy Agitated Nutsche Filter Dryers (ANFD) The facility also offers broad process capabilities, including cryogenic reactions, hydrogenation capabilities and high-temperature reactions and high-vacuum distillation capabilities. etc.

Commenting on the development, Sameer Hiremath, Vice Chairman and Managing Director of Hikal, said: “The commissioning of our cGMP pilot plant is an important step in strengthening Hikal’s pharmaceutical development and scale-up platform. It enhances our ability to support customers as they move from laboratory development to larger-scale, clinical development programmes, while staying anchored in quality, safety and compliance.”

The expansion reflects Hikal’s continued investment in research, development and manufacturing infrastructure to meet the evolving needs of global pharmaceutical customers while maintaining high standards of quality, safety and compliance.

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Pharmaceutical warehousing has evolved significantly from a backend storage function to a critical component of regulated supply chain operations. As pharma supply chains become more complex and compliance expectations intensify across global markets, warehousing is now expected to support not only inventory management, but also product integrity, traceability, audit readiness, and risk mitigation throughout the distribution lifecycle. 

This shift is being driven by increasingly stringent regulatory frameworks, greater scrutiny from global procurement markets, and rising expectations around visibility and quality assurance. In this environment, the warehouse is no longer evaluated solely on storage capacity or operational throughput. It is assessed on its ability to maintain compliant conditions, ensure process consistency, and provide end-to-end traceability across every product movement within the supply chain. 

The compliance burden has shifted downstream 

India’s pharma sector supplies nearly 20 per cent of the world’s generic medicines by volume. That scale comes with regulatory obligations that extend well beyond the manufacturing floor. Good Distribution Practice (GDP) guidelines from the WHO, procurement requirements from regulated markets in the US, EU and Australia, and CDSCO’s evolving domestic framework have collectively raised expectations for how pharma products must be stored, handled and moved. 

What this means in practice is that the warehouse is no longer simply assessed on throughput or space utilisation. It is assessed on its ability to demonstrate documented adherence, audit readiness, and unbroken traceability across every product movement. The burden of compliance, once concentrated upstream, has migrated decisively into distribution and storage. 

Process standardisation is not optional 

The most consistent failure mode in pharma warehousing is not infrastructure-it is process variability. Facilities that invest in controlled temperature zones, zoned storage for product segregation, and rigorous pest management often fall short when standard operating procedures are inconsistently applied or when staff rotation leads to knowledge gaps. 

GDP-aligned warehousing requires that every touchpoint i.e. goods receipt, quality inspection, storage allocation, pick and pack, cold chain handover follows a documented, auditable procedure. These are not aspirational standards. They are enforceable requirements against which logistics providers are evaluated both by regulatory bodies and by pharma clients conducting their own supply chain assessments. 

What distinguishes a genuinely compliance-ready facility is institutional discipline teams that understand the rationale behind the protocols, not merely the sequence. A process executed because it is understood is far more reliable than one executed because it is mandated. 

Traceability: The infrastructure behind accountability 

End-to-end traceability has moved from a best practice to a regulatory baseline. Export markets now require batchlevel tracking, serialisation compliance, and full chain-of custody documentation as conditions of market access. Domestically, the expectation is accelerating. A consignment that cannot be traced-precisely, across every leg of its journey is a consignment that creates liability. 

This means every inbound receipt, every storage movement, every dispatch must generate a verifiable digital record: batch numbers, expiry dates, temperature logs, vehicle and driver credentials, consignment handover confirmations. When a quality concern arises and in a sector of this scale, it will — the ability to execute a precise, time-bound recall depends entirely on whether this infrastructure existed before the issue occurred 

Building traceability requires more than technology investment. It requires process architecture ensuring that digital documentation is embedded in daily operations rather than layered on top of them. Audit readiness is not a project. It is a standing operating posture. 

Building traceability requires more than technology investment. It requires process architecture ensuring that digital documentation is embedded in daily operations rather than layered on top of them. Audit readiness is not a project. It is a standing operating posture.

Visibility across a fragmented network 

India’s pharma distribution challenge is, in part, a geography problem. Managing compliant movement from manufacturing hubs to distribution centres, and from distribution centres to hospital pharmacies, rural stockists, and export consolidation points requires coordination across a network that is structurally fragmented-multiple carriers, multiple handover points, uneven infrastructure. 

Technology infrastructure in the form of Transportation Management Systems and supply chain control towers has become the governance layer that makes compliant distribution at scale achievable. These platforms do more than optimise routes or reduce freight costs. In a regulated context, they monitor shipment parameters in real time, flag deviations before they become violations, and give logistics managers the visibility to intervene with confidence rather than react after the fact. 

For pharma companies managing multimodal movements-air for time-sensitive biologics, rail and road for bulk generics, sea for export volumes, this integrated visibility is not a convenience. It is the mechanism through which compliance is maintained across modes and across stakeholders who do not share systems. 

The coordination gap that compounds risk 

One underappreciated dimension of pharma supply chain compliance is stakeholder alignment. A pharma supply chain involves manufacturers, contract logistics providers, third-party carriers, customs agents, regulatory bodies, and end-distribution channels, each with their own systems, timelines, and information asymmetries. 

Gaps in coordination between these parties compound compliance risk. A carrier that does not receive temperature excursion alerts in time. A customs clearance delay that leaves a cold chain shipment in a sub-standard environment. A handover that is not documented because two parties assumed the other was responsible. These are not edge cases, they are recurring failure modes in a fragmented logistics ecosystem. 

 Integrated logistics models that bring planning, execution, and visibility under a coordinated framework reduce these gaps. When a single logistics partner manages multimodal movement with end-to-end accountability rather than multiple vendors each accountable for their own segment-the structural causes of coordination failure are significantly reduced. 

From storage to supply chain hub 

The pharma warehouse of the next decade will not resemble its predecessor in function or expectation. It will be a node in an interconnected network-a facility that receives, validates, stores, tracks, processes, and dispatches with the same rigour applied at the manufacturing stage. 

re, designed from inception around GDP requirements rather than retrofitted to meet them, will become the benchmark. Facilities that integrate ambient and cold chain zones, digital monitoring, controlled ancillary processes such as kitting and repacking, and seamless connectivity with transportation partners will be positioned to serve pharma clients who can no longer afford compliance ambiguity in their distribution networks. 

The shift is already underway. Pharma manufacturers are deepening their scrutiny of logistics partners not just on cost and capacity, but on demonstrated compliance capability. The providers who have invested in process integrity, traceability architecture, and technology-enabled visibility will earn that scrutiny. The rest will find themselves increasingly difficult to justify in an environment where the cost of a compliance failure is measured not in penalties, but in patient safety. 

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Every industry eventually reaches a point where yesterday’s biggest strength is no longer tomorrow’s biggest differentiator. For India’s pharma industry, that moment seems to have arrived. India’s manufacturing prowess has taken the country to the global stage. The next chapter, however, may rest less on what India can manufacture and more on what the world believes it can help create. 

If recent conversations across the industry are any indication, it has already begun to take shape. The aspiration is no longer limited to manufacturing the world’s medicines, but to becoming a destination for innovation itself. 

That ambition is also reflected in the EY Parthenon–Organisation of Pharmaceutical Producers of India (OPPI) report, Fueling innovation, advancing equity: The power of partnerships and digital-first strategies driving Indian pharma’s global dominance. Where it states that India’s pharma industry is entering precisely this next phase: One that calls for a transition from a cost-driven model to one anchored in innovation and value creation. 

However, it also makes an important distinction. Innovation partnerships are rarely won on manufacturing scale, cost or capacity alone. Drawing on insights from industry CXOs, the report notes that attracting early-stage research and co-development programmes will increasingly depend on regulatory agility, intellectual property protection, sustained R&D investment and talent development. 

It captures this shift in a single line: ‘Partnerships follow predictability.’ In other words, the question is no longer simply whether India can innovate, but whether its ecosystem offers the certainty global innovators seek before placing their next big bet. 

That naturally leads to the next question. Has India already begun building the kind of ecosystem that inspires that confidence? 

After the ‘Pharmacy of the World’

India’s appeal today stems from more than its manufacturing credentials. Over the past decade, the country has strengthened the building blocks that global innovators look for. Investments in R&D infrastructure, scientific talent, specialised technology platforms and integrated development capabilities have gradually expanded India’s role from an execution partner to a development partner. As global pharma companies increasingly look for collaborators who can contribute across the product lifecycle rather than simply manufacture at the end of it, India’s proposition has evolved accordingly. 

Validating this shift, Yogesh Joshi, Associate Director and Head – Formulation Development (CDMO vertical)/Head Clinical manufacturing, Piramal Pharma Solutions says, “Over the past decade, India has undergone a significant transformation—from being a cost-driven manufacturing hub to emerging as a credible and strategic partner for innovation and co-development in the global pharma landscape.” He also highlights that Indian CDMOs have moved well beyond traditional generics manufacturing and are now supporting early-stage development, new chemical entities (NCEs), complex formulations and lifecycle management, signalling a broader shift from execution-focused services to innovation-led collaboration. 

Joshi further attributes this evolution to sustained investments in R&D, advanced technology platforms and integrated CDMO capabilities spanning pre-formulation, development, clinical manufacturing and commercial supply. 

Dr Sandhya Shenoy, VP – Formulation R&D, MSN Laboratories, believes this transition has also been driven by stronger scientific capabilities. “Global pharma companies are increasingly seeking agile, scientifically capable partners who can contribute meaningfully throughout the development journey. India’s unique combination of scientific expertise, operational agility, speed, and scale has positioned it as a preferred destination for co-development and innovation-led partnerships rather than purely transactional outsourcing relationships.” 

Echoing a similar view, Dr Syed Shah Moinuddin Hussaini, Head, Global Pharma R&D, Wockhardt, adds, “India has developed strong R&D capabilities over the last two decades while serving regulated markets across the world. Today, many Indian companies have experienced scientists, modern R&D infrastructure, and expertise in complex product development. As a result, global companies are increasingly seeing India not just as a manufacturing destination but also as a capable development and innovation partner.” 

The global checklist 

Yet, becoming an attractive innovation destination is only half the equation. Innovation partnerships are rarely won on a single strength. Instead, global pharma companies evaluate potential partners against a checklist of capabilities. Scientific expertise, regulatory maturity, quality systems, intellectual property protection, execution excellence and talent all carry weight. The question is not whether a country excels in one area, but whether it inspires enough confidence across all of them to become a long-term innovation partner. 

According to Joshi, that evaluation begins with a partner’s ability to solve complex scientific problems while delivering consistently at a global standard. He states organisations look for expertise in complex products and advanced drug delivery systems, supported by robust quality systems, data integrity and a proven regulatory track record across pathways such as IND, NDA, ANDA and 505(b)(2). Beyond scientific capability, he highlights integrated end-to-end CDMO services, seamless technology transfer, reliable supply chains, project management and execution excellence as factors that increasingly influence partnership decisions. 

Shenoy on the other hand believes scientific capability alone is only one part of the equation. “Organisations seek partners with strong capabilities in formulation science, process understanding, and advanced technology platforms. Equally important is an innovation-oriented mindset— the ability to solve complex technical challenges, generate scientific insights, and contribute to critical development decisions.” She further points out that robust intellectual property management, governance frameworks, execution excellence and proactive regulatory compliance are equally critical to building long-term confidence. 

Summing up the industry’s priorities, Dr Moinuddin Hussaini says, “The most important factors are scientific talent, quality of R&D infrastructure, regulatory environment, IP protection, and the ability to consistently deliver high-quality outcomes. Cost remains important, but today companies are looking for capable partners who can contribute scientifically and accelerate development timelines.” 

Taken together, these perspectives suggest that attracting innovation partnerships is no longer about competing on cost or manufacturing scale alone. Increasingly, it is about demonstrating that every box on global pharma’s checklist can be ticked, consistently and predictably. 

Mind the gap 

If India’s scientific capabilities have strengthened and global interest is growing, what still prevents it from capturing a larger share of innovation-led partnerships? The experts suggest the answer lies less in capability itself and more in the ecosystem surrounding it. 

One challenge, they point out, is perception. Despite significant progress in research and development, India is still widely associated with generics and cost-efficient manufacturing. Dr Shenoy believes this perception no longer reflects reality. According to her, India’s scientific capabilities often exceed global perceptions because many organisations invest far more in programme delivery than in showcasing their scientific achievements through publications, patents, conference presentations and thought leadership. 

At the same time, Joshi believes deeper structural gaps remain. While India has made significant strides, he notes that fewer companies are engaged in early research, new drug development and advanced technologies than their global counterparts. He also points to limited capabilities in areas such as biologics, gene therapies and complex drug device combinations, alongside the need for greater consistency in quality, regulatory readiness and specialised scientific expertise. Joshi adds that stronger collaboration between academia, startups and industry, coupled with better research infrastructure, will be essential if India is to move beyond its image as a manufacturing destination and establish itself as an innovation leader. 

For Dr Moinuddin Hussaini, the ecosystem itself holds the key. “They are extremely important. Companies invest where they have confidence in the regulatory framework and intellectual property protection. Equally important is the availability of skilled scientific talent, which ultimately drives innovation and long-term growth.” He believes stronger collaboration between academia, research institutes, startups and industry could have the single biggest impact on India’s ability to become a preferred global innovation partner. 

Ultimately, India’s next challenge may not be proving that it can innovate. It is ensuring that its policies, institutions and collaborations evolve at the same pace as its scientific ambitions. Because if partnerships follow predictability, predictability is built long before the partnership begins. 

The final mile 

If there is one thread running through the industry’s vision for the future, it is that capability alone will not secure India’s place in the next phase of pharma innovation. Sustaining that momentum will require an ecosystem that evolves as quickly as the science itself. 

The EY Parthenon– OPPI report outlines three priorities to accelerate this transition. The first is regulatory agility, including aligning Indian GMP standards with global benchmarks, creating a dedicated regulatory pathway for CRDMOs and strengthening Regulatory Data Protection (RDP) to encourage early-stage research and co-development. The second is greater investment in innovation through public-private funding, higher industry spending on R&D and stronger collaboration between academia, startups and pharmaceutical companies. Finally, the report calls for a renewed focus on talent, urging academia and industry to work together to build capabilities in areas such as artificial intelligence, bioinformatics and regulatory science while linking research more closely to commercial outcomes. 

Dr Shenoy believes Indian R&D teams must also deepen their scientific capabilities to remain competitive. According to her, future programmes will increasingly demand mechanistic understanding, digital and data-driven development, and closer collaboration between formulation scientists, engineers, data scientists, regulatory specialists and clinical teams. She adds that building a stronger culture of scientific curiosity, publications, patents and global thought leadership will be equally important in positioning India as an innovation led ecosystem. 

The direction, therefore, is becoming increasingly clear. India’s manufacturing success created the foundation. Its scientific capabilities have strengthened the proposition. The next phase will depend on how effectively industry, academia and policymakers can work together to build an ecosystem that global innovators do not just recognise, but repeatedly choose. 

neha.aathavale@expressindia.com
nehaaathavale75@gmail.com 

The post The innovation litmus test  appeared first on Express Pharma.

What are the broad global consumer health trends driving the global biopharma sector this decade? 

We believe that global consumer health is moving towards a continuum of care in chronic disease pools. The continuum is increasingly being shaped by the lifestyle, pollution, and aging population as the key drivers. These pools are concentrated mainly across metabolic health, antiageing, skin and cosmetics, women’s health, gut health, sleep, immunity and preventive care. The scale is already material. We estimate the global wellness opportunity in Over-The-Counter (OTC) drugs at about $200 billion while dietary supplements another ~$210 billion.

The clinical backdrop is also supportive to this trend: we acknowledge that clinically it is estimated that globally every one in six adults is obese, and about one in eight has diabetes.

For Indian biopharma, we believe the key strategic pivot is that consumer health is becoming more science-led, with better opportunities in Rx-adjacent products where efficacy, trust and medical credibility matter. To simply put, it is pivoting from FMCG play to more a science/value play.

How are biopharma companies in India converting these trends into new revenue strategies? 

Our report on India healthcare highlights that Indian biopharma is increasingly building higher-value franchises across chronic therapies, derma, nutrition, women’s health, metabolic adjacencies, complex dosage forms, biologics, sterile manufacturing and CDMO. We believe India’s domestic pharma market at about $25- 27 billion will nearly double to about $60 billion over the next decade and chronic therapies form the largest part of this growth story in our view.

India also supplies roughly 20 per cent of global generic medicines by volume. The revenue strategy is gradually shifting from adding more SKUs to owning patient conditions through HCP education, differentiated delivery, point of care diagnostic, adherence support, and regulatory simplification in new product/therapy launches.

How much impact will geopolitical disruptions like various US tariffs (e.g. USTR Section 301, Section 232) various conflicts etc. have on the long term profitability of India’s pharma companies? 

We believe that geopolitics should be treated mainly as a margin, supply-chain and working-capital risk. In our view, global demand for prescription drugs, particularly in chronic therapies as well as in the OTC segment is relatively resilient, and India remains structurally important to global generics supply. The current pressure points in our view are reliable procurement channels, compliance to highest quality standards for these global supplier bases, and higher logistic costs.

We estimate that India’s pharma exports are around $30-31 billion, with regulated markets contributing roughly half of these exports. On the import front for the sector, we estimate that the API, bulk drug and intermediate imports are about $4.5- 5 billion in the last financial year with China continuing to dominate at nearly 74 per cent of this import basket. In our view, the recent geopolitical pressures from regional conflicts stretches this import burden while delaying realisation of exports in the short term. In the medium to long term we believe that the redrawn supply chains will increasingly put Indian biopharma in the global sweetspot and thus improve sector profitability. Furthermore, we estimate that the global sales prices realised (ASP) for majority drugs are nearly bottoming with early signs of reversal, and this in our view will boost industry margins and volumes materially.

In summary, we believe that in the short term the overhang on US tariffs, Section 232 or equivalent probes in regulated markets, China-linked supply disruptions and conflict-led freight volatility will pressurise margins. Longer term, we estimate Indian biopharma to be an integral part of redrawn supply chains in the global healthcare spend.

Specifically, what are the niche areas where India’s biopharma players are positioning themselves to transition from a volume to value, generics to innovation model?

We believe Indian biopharma is pivoting from quantity driven to quality led innovation. Our report suggests that the strongest value migration for Indian biopharma is in niche asset areas that require process and engineering depth and global market presence rather than pure patent expiries. We believe these include peptides, complex injectables, 505(B)(2) NDAs, orphan drugs, bio-betters and supplementary biologics, highpotency APIs, drug-device combinations. We also believe this is moving (from) a typical CDMO space towards Pharma as a Service (Paas). Our report suggests that this volume-value transition will potentially unlock additional $120-125 billion in revenues over the next decade and will be global in its reach.

We believe that the global regulatory and policy backdrop supports this shift. Biosimilars are also becoming mainstream, with the global market around $30–33 billion in 2024 and more than 75 biosimilars approved by the US FDA by late 2025. Similarly, 505(B)(2) and new drug development guidelines (are) increasingly conducive for the industry, and Indian policy makers (are) unlocking sectoral measures such as Bioshakti, PLI and PRIP schemes.

Will the GLP-1 opportunity turn out to be lower than initial forecasts, as the increasing competition reduces profit margins? How are the leading players planning to retain consumers/patients, given the CDSCO’s close watch on promotional vs educational content?

Our view on India’s overall GLP-1 market is modest and borderline neutral. We expect the India market to peak at about $2–2.5 billion with a high competitive intensity, despite the global excitement around the category. We acknowledge that the Indian population has a large addressable patient pool, with estimated ~100mn people living with diabetes and around 136mn with prediabetes. However, we believe that the monetisation and actually serviced market in India is limited due to affordability, India’s socio-cultural patterns on food habits and lifestyle, limited reimbursement and social perception.

Our research suggests that barring higher income strata and certain metropolitan markets, obesity is still not widely viewed as a disease in India, so awareness education will (be) required to precede treatment. Against the backdrop of regulatory watch on promotional versus educational content, patient retention will depend on compliant HCP-led initiation, nutrition counselling, titration support, side-effect management, refill reliability and affordability, rather than aggressive consumer-led promotion. 

viveka.r@expressindia.com
viveka.roy3@gmail.com 

The post Why India’s biopharma value shift could unlock an additional $125-bn opportunity  appeared first on Express Pharma.

US President Donald Trump has proposed a phased tariff framework for imported generic pharmaceuticals, under which generic drugs would continue to enter the US duty-free until August 1, 2028, before attracting a proposed 100 per cent tariff from August 2028 and 200 per cent from August 2029. The proposal, aimed at encouraging pharmaceutical companies to establish manufacturing facilities in the US, has triggered mixed reactions across India’s pharmaceutical industry. While stakeholders believe the announcement is unlikely to have any immediate operational impact, many see it as a signal for the industry to accelerate market diversification, strengthen domestic capabilities, and closely watch the progress of India-US trade negotiations.

Namit Joshi, Chairman, Pharmexcil

“Today’s announcement provides welcome clarity and aligns well with the strategy we’ve already been pursuing. The zero-tariff window through 2028 gives the industry a meaningful runway, and we see this as time we can use productively — to keep strengthening our position across multiple markets rather than relying on any single one.

We’ve been diversifying for a while now — in the Apr–May FY27 period compared to Apr–May FY26, Europe is up 21%* and now accounts for over 20% of our total pharma exports, while Latin America (LAC) remains consistent, growing 23.96% over the same two-month period and now representing nearly 8% of our exports — and that strategy continues regardless of today’s news. Generics remain a segment where India brings deep expertise and scale, supplying a large share of the world’s affordable medicines, and we expect that strength to continue.*

On the India-US trade talks: we see today’s announcement as an opportunity to build even more clarity into the FTA conversations ahead. Pharma has always been an important chapter in those discussions, and a defined tariff timeline gives both sides a clear framework to work within as they shape a strong, durable agreement — including any specific provisions for generics.”

Nikkhil Masurkar, CEO, Entod Pharmaceuticals

“While the finer details of the proposed US tariff framework on generic drugs are still unclear, I think it sends a very important message to the Indian pharmaceutical industry. We have become too dependent on one market. The United States has been an outstanding partner for Indian pharma and will continue to be an important market for us, but recent geopolitical developments show that no market can ever be taken for granted.

This should be a wake-up call for the industry. We need to start thinking beyond the US and build a more balanced global strategy. In my view, Indian pharma has become a little too US-centric over the last two decades. It’s time for us to become more India-centric in the way we think about global growth.

The biggest opportunities over the next decade will not come only from the developed world. They will come from the Global South — Asia, Africa, Latin America and the Middle East, where billions of people still need access to high-quality, affordable healthcare. India is uniquely placed to lead these markets, not just because of our manufacturing capabilities, but because we understand the healthcare challenges of developing nations better than anyone else.

Instead of constantly reacting to policy changes in one country, we should be investing more aggressively in innovation, intellectual property, domestic manufacturing and stronger partnerships across emerging markets. Diversification is no longer just about reducing business risk; it is about building India’s long-term leadership in global healthcare.

The US will remain an important market, but it should no longer define the future of Indian pharma. Our ambition should be far greater, and that is to make India the healthcare leader of the Global South and the partner of choice for emerging economies. That is where the next chapter of Indian pharma will be written. If this geopolitical uncertainty encourages our industry to diversify faster, build deeper relationships across emerging markets and lead with innovation rather than dependence, it may ultimately prove to be a turning point for Indian pharma.”

Bharat Celly, Equity Research Analyst, Equirus Securities

“The proposed extension of US tariffs to generic pharmaceuticals represents a significant policy development. While imports remain duty-free for two years from 1 August 2026, tariffs are proposed to rise to 100% from August 2028 and 200% from August 2029, with the stated objective of encouraging companies to establish manufacturing facilities in the US.

However, relocating manufacturing is not a two-year exercise. Transferring an approved product to a US facility requires site transfer filings, process validation, stability data, and FDA approval for each ANDA. For Indian generic manufacturers with large approved portfolios, the cost and timeline of re-registering products significantly exceed the proposed transition period, while the economics of many products do not support such a move.

The proposal also runs counter to the intent of the Hatch-Waxman framework, which was designed to reduce drug prices through greater generic competition. Imposing 100–200% tariffs on imported generics could instead raise the cost of low-priced medicines and, in shortage-prone categories, increase the risk of supply disruptions rather than drive reshoring.

At this stage, we view the proposal primarily as a negotiating tool, given that implementation is deferred until August 2028, beyond the next US election cycle. Accordingly, we do not expect any near-term earnings impact, although the announcement could weigh on investor sentiment and valuation multiples.”

Param Desai, Research Analyst, PL Capital

“The announcement was largely unexpected, and there is still considerable ambiguity around how these tariffs will actually be implemented. Generic drugs entering the US will continue to attract a 0% tariff until August 1, 2028, after which tariffs are proposed to increase to 100% from August 2028 and 200% from August 2029.

Several generic pharma companies already have manufacturing facilities in the US, which could partially mitigate the impact. However, a two-year window appears too short to relocate the entire generic pharmaceutical value chain to the US.

Trump’s term ends in January 2029, while the major tariff impact begins from August 2028, so the eventual implementation remains uncertain if there is a change in administration. We could see a knee-jerk negative reaction in pharma stocks today, particularly among large-cap generic players, until there is greater clarity on the policy.”

The post Trump’s proposed generic drug tariffs trigger caution, industry sees limited near-term impact  appeared first on Express Pharma.

By Mike Fitzsimmons

Healthcare construction is expected to continue to grow in 2026 with some of the same industry factors experienced last year impacting projects, including shifts in care delivery, rising demand for outpatient facilities and the need for more flexible, efficient buildings. Projects continue to become more complex with an increase in specialized clinics and large-scale hospital expansions, leading to owners and contractors having increased pressure to deliver faster while managing tighter budgets and evolving requirements.  

The result is trends such as prefabrication, distributed care models, and sustainability goals that are reshaping how facilities are designed and built. At the same time, healthcare environments must meet strict standards for infection control, resilience, and future adaptability, adding layers of cost and coordination. This requires more strategic planning from the outset.  

Amid these complexities, maintaining diligent control over capital outlays, especially for construction equipment, has become increasingly critical. It’s why financing decisions play a central role in determining not just project feasibility, but overall financial stability. Whether through traditional lending or alternative models like leasing, organizations that take a proactive, informed approach to equipment acquisition are better positioned to manage cash flow, reduce risk and keep projects on track from groundbreaking through completion. 

Regardless of all of the external factors, businesses have to move forward. How can construction firms gain control over them for their healthcare facility projects? 

Advanced Planning Pays Off 

In ever-changing economic conditions, gaining control over construction costs starts with understanding how financing decisions affect cash flow, especially when acquiring construction equipment for healthcare building projects. Securing funding is not instantaneous; it’s a structured, multi-step process that requires preparation, documentation and the right lending partner. At the center of every decision is a simple question: can the borrower repay the debt? For healthcare construction projects, where timelines are tight and capital needs are high, that scrutiny can directly impact project momentum. 

To answer that question, lenders require a clear and comprehensive financial picture. Being prepared with the right documentation can significantly accelerate the process. Typically, lenders will request: 

• Balance sheets
• Profit and loss statements, cash flow analysis
• Tax returns (2–3 years)
• Additional agreements, such as leases or contracts tied to the project

From there, underwriting goes deeper into both financial strength and operational credibility. For equipment leasing, many lenders can finance up to 100% of the equipment cost, including associated soft costs like delivery, installation and training. This means a substantial upfront contribution by the borrower is usually not required. Instead, lenders may request initial payments, such as the first and last month’s lease payment or nominal documentation fees. 

While the leased equipment itself often serves as collateral, numbers alone don’t tell the full story. Lenders also evaluate qualitative factors that influence repayment, including: 

• Creditworthiness of ownership and leadership 
• Experience managing similar construction or healthcare projects 
• Level of day-to-day involvement from principals 
• Strength and clarity of the business plan, including project timelines and financial projections 

For healthcare construction, where complexity and compliance are high, gaps in any of these areas can slow approvals or limit financing options. 

How Leasing Can Provide Clarity 

Understandably, companies may be hesitant to tie up significant amounts of capital with the purchase of construction or medical equipment for healthcare building projects. As a result, many are turning to leasing rather than buying. Leasing provides a predictable impact on cash flow, without the need for a large, up-front outlay of cash. 

With leasing, companies pay only for the equipment they need, when they need it. Payments typically do not begin while the equipment is still in transit; they start upon delivery and installation, when the equipment can be put to productive use. Leasing allows a company to safeguard its capital while increasing the predictability of its cash flow. 

Looking Ahead 

Even with a crystal ball, it would be hard to accurately predict the full impact of shifting economic conditions on prices, labor, and borrowing costs, especially as healthcare construction continues to grow. With demand rising for outpatient facilities, faster build timelines driven by prefabrication, and increased investment in resilient, future-ready infrastructure, projects are becoming more complex and capital-intensive. In this environment, healthcare companies and construction firms can take greater control of their capital and cash flow by making strategic decisions about how they acquire equipment. Aligning financing with project timelines and operational needs can help reduce risk, preserve liquidity, and keep projects moving forward. 

Mike Fitzsimmons serves as Vice President of Sales – Construction and Material Handling at Summit Funding Group. With over 30 years of experience in the equipment finance industry, Mike has held leadership roles across sales, marketing, and operations.

The post Healthcare Construction Growth: Managing Costs Amid Uncertainty  appeared first on HCO News.

The post Healthcare Construction Growth: Managing Costs Amid Uncertainty  appeared first on HCO News.

Speaker in this video:
+ Mr Vinod Vilas Kenekar, Subject Matter Expert- Process Technology, ROMACO India (ROMACO Group)

Topic: From granulation to coating: Synergizing ROMACO innojet fluidized bed and tecpharm tablet coating technologies

Key Highlights:
[1] Aerodynamics is the root cause of scale-up failure. Conventional fluidised bed equipment’s 90° plenum design creates uneven heat and mass distribution, the core problem ROMACO’s Innojet technology is engineered to eliminate.

[2] SEPAJET® makes continuous powder recovery process-safe No pulsation, no temperature or RH swings, no condensation. Filtration no longer disrupts the coating or granulation process.

[3] Energy Recovery System (ERS) turns energy waste into a quantified sustainability metric 75% recovery in hotmelt coating, 70% in pellet coating, 50% in granulation and tablet coating, with zero cross-contamination risk via no-contact airflow.

The post Mr Vinod Vilas Kenekar, Subject Matter Expert – Process Technology, ROMACO India (ROMACO Group) appeared first on Express Pharma.

Panellists in this video:
• Dr Vijayendrakumar Redasani, CEO & MD, DelNova Healthcare (Moderator)
• Mr Vinod Arora, Principal Advisor, IGMPI
• Dr Ashok Omray, Pharma Consultant

Key Highlights:
[1] Own failures as much as successes. Every setback carries insights that drive the next breakthrough.

[2] Document relentlessly. Experiments fade, but captured knowledge becomes a foundation for future innovation.

[3] Keep learning, adapting, and evolving. Science, technology, and regulations are constantly changing, and so must we.

[4] Stay curious and open-minded. Innovation often emerges when we explore new dimensions and challenge conventional thinking.

[5] Build bridges, not boundaries. Success depends on how effectively teams connect, communicate, and collaborate.

The post The Mentorship Exchange: What FR&D leaders must learn & unlearn appeared first on Express Pharma.

Speaker in this video:
+ Dr Suruchi Vishwasrao, Sr Scientist, R&D, Merck Life Sciences

Topic: Peptide delivery, reimagined: Addressing hurdles and unlocking potential in oral administration

Key Highlights:
[1] Oral delivery is the next frontier for GLP-1 therapies. The industry is moving beyond injectables toward patient-friendly oral formulations.

[2] Peptides face multiple barriers in the GI tract. Acidic pH, digestive enzymes, and poor intestinal permeability make oral GLP-1 delivery a tough formulation challenge.

[3] Mesoporous silica offers a promising delivery platform. It can protect GLP-1 analogues in the stomach, release them in the intestine, and improve bioavailability through targeted delivery. 

The post Dr Suruchi Vishwasrao, Sr Scientist, R&D, Merck Life Sciences appeared first on Express Pharma.

Panellists in this video:
• Dr Pirthi Pal Singh, President & Group R&D Head, Tirupati Group (Moderator)
• Mr Shrenik Kole, VP and Head- Sterile Product Development, Micro Labs
• Dr Sachin Mundade, VP – R&D, Micro Labs
• Dr Krishna Murthy Bhavanasi, VP – R&D, Lotus Pharmaceutical
• Mr Yogesh Joshi, Associate Director & Head (Formulation Development)/Head – Clinical Manufacturing,
Piramal Pharma Solutions
• Dr Arindam Halder, GM, Sun Pharmaceutical Industries
• Mr Sandipan Roy, GM, Hetero

Key Highlights:
[1] Early-stage excipient compatibility, stability, and process studies are crucial for designing robust formulations and reducing development risks.

[2] AI, machine learning, and digital tools can accelerate formulation optimisation, improve decision-making, and shorten development timelines.

[3] Integrating regulatory intelligence from the beginning helps navigate global compliance requirements and speeds up product development.

[4] Innovation in complex formulations requires close collaboration between R&D, regulatory, clinical, IP, and technology teams rather than working in silos.

[5] Drug repurposing and long-acting delivery systems present significant opportunities to create differentiated, high-value products.

[6] Building pharmacology, toxicology, and clinical expertise alongside formulation capabilities is essential to minimise costly late-stage failures.

[7] Strategic partnerships with academia, CDMOs, and specialised service providers are increasingly important to access capabilities, manage complexity, and improve development efficiency.

The post Panel Discussion: The R&D reset: Navigating volatility, regulation and rising complexity appeared first on Express Pharma.

Panellists in this video:
• Dr Vaibhav Dubey, AVP, Kashiv BioSciences (Moderator)
• Dr Jaby Jacob, Sr President, R&D, BSV (A Mankind Group Company)
• Dr Rakesh Kumar Sinha, Sr VP, Biological E

Key Highlights:
[1] Biologics is witnessing rapid growth, with increasing investments, technology advancement and knowledge creation driving the sector forward.

[2] Biologics success requires patience and sustained investment, as development timelines are significantly longer than traditional small molecules.

[3] Technology-led process innovation is critical to improve yields, reduce costs and make advanced therapies more affordable.

[4] The next wave of innovation lies in emerging modalities such as cell therapies, gene therapies, siRNA, and mRNA-based treatments.

[5] Strategic partnerships and in-licensing models help de-risk investments while accelerating capability building in biologics.

The post Fireside Chat: Biologics rising: India’s next scientific frontier appeared first on Express Pharma.

Panellists in this video:
• Mr Suresh Pareek, Angel and Growth Investor (Pharma) (Moderator)
• Dr Sumedha Nadkar, Pharmaceutical Strategy and Technology Consultant
• Dr Manish Grover, Director, Healthcare Technologies, Mangrove Creations

Key Highlights:
[1] Innovation is accelerating through AI, advanced drug delivery, and emerging biopharma players, making bold investment in R&D more critical than ever.

[2] A formulation succeeds only when it reaches the patient; patient impact remains the true measure of innovation.

[3] In a world of rapid change, technical expertise alone is not enough. Critical thinking, interpretation, and continuous learning are becoming essential skills.

[4] AI can accelerate discovery and decision-making, but human judgment, scientific understanding, and cross-cultural collaboration remain irreplaceable.

[5] The scientists who stand out will be those who can simplify complexity, communicate beyond scientific jargon, and connect their work to the larger business and patient impact.

[6] Innovation needs a bridge between science and business. Sustainable growth comes from balancing scientific excellence with commercial value and profitability.

The post The New Playbook: What will define winning FR&D teams in 2030? appeared first on Express Pharma.

Award Winners:

Award Category: Rising Stars
Dr Ankit Anand Kharia
Mr Anirudha Kute
Mr Arjunarao Panchada
Ms Chitra Varma
Dr Kashyap Nagariya
Dr Mukesh Kumar
Dr Nandkishore Yadav
Mr Pankaj Soni
Mr Prabhat Shrivastava
Dr Rajiv Khurana
Dr Shailesh Vishwanath Biradar

Award Category: Leaders
Dr Alagumurugan Alagarswamy
Dr Ravindra Agarwal
Mr Sandipan Roy
Mr Shrenik Kole
Dr Syed Shah Moinuddin Hussaini
Dr Tathagata Dutta

Award Category: Entrepreneurs
Mr Jayanta Kumar Mandal
Mr Vijayendra Kumar Redasani

Special Citation: Breakthrough Innovation
Team Wockhardt