Clinical exclusivity for indigenous medicines can improve long-term affordability and access

Nikkhil Masurkar, CEO, Entod Pharmaceuticals opines that in the absence of clinical data exclusivity, competitors may obtain approvals without undertaking comparable clinical investment, discouraging companies from investing in indigenous research

Experts are increasingly highlighting the importance of providing a limited period of clinical data exclusivity for indigenously developed medicines, including repurposed drugs, to support long-term affordability, continuous innovation and improved patient access in India.

Developing new therapies requires significant investment in formulation development, toxicology studies, clinical trials, regulatory submissions and pharmacovigilance. However, patent protection alone is often insufficient, particularly for repurposed medicines, improved formulations, or novel drug delivery systems. In the absence of clinical data exclusivity, competitors may obtain approvals without undertaking comparable clinical investment, discouraging companies from investing in indigenous research.

A limited exclusivity period of around 3–4 years would allow innovators to recover part of their R&D investment and encourage continued development of therapies tailored to Indian patient needs. Contrary to earlier concerns within sections of the industry, and considering the evolving dynamics of the domestic market, clinical exclusivity is highly unlikely to compromise affordability or patient access. After expiry of such exclusivity, multiple manufacturers could enter the market, creating competition that could ultimately result in even lower prices compared to therapies introduced via the regulated market route, where initial medicine prices and cost structures are typically much higher.

 Experts also note that Indian innovators would almost certainly not overprice medicines during their exclusivity period, given the strong price sensitivity of the Indian prescription market and the relatively lower research and clinical development costs compared to medicines developed in foreign regulated markets. Competitive market dynamics and affordability expectations within India naturally act as price-disciplining mechanisms.

In fact India already has strong affordability safeguards in place through multiple policy mechanisms, including NPPA price control provisions under DPCO, Jan Aushadhi generic medicine stores, Ayushman Bharat – PMJAY, free medicine schemes in public hospitals, and National Health Mission programmes. These frameworks ensure continued access to affordable medicines for economically vulnerable populations.

Policy experts emphasise that the current NDCT Rules should be applied appropriately to ensure that clinical data exclusivity is effectively available for drugs indigenously developed in India, particularly where such therapies address unmet medical needs and are not approved in regulated markets.

A balanced policy approach supporting limited clinical exclusivity for indigenously developed medicines can help strengthen India’s transition towards an innovation-driven pharmaceutical ecosystem, improving long-term affordability, encouraging continuous research, and enhancing patient access to new therapies developed within the country.

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