CDSCO Mandates Online Submission of PAC Applications for r-DNA Products via SUGAM Portal

New Delhi: The Central Drugs Standard Control Organization (CDSCO) has announced that all applications related to Post Approval Changes (PAC) for recombinant DNA (r-DNA) products must now be submitted online through the SUGAM portal, discontinuing the facility of hard-copy submissions.

In a circular issued by the Biological Division under the Directorate General of Health Services, CDSCO stated that the move aims to streamline and digitize the regulatory submission process for marketing authorization holders seeking post-approval modifications to r-DNA products.

The circular issued by the Biological Division of CDSCO stated,

"In order to streamline the regulatory submission procedure, the submission of applications for Post Approval Changes (PAC) for r-DNA products is now functional through the online system of the SUGAM portal (www.cdscoonline.gov.in ) under the module “Post Approval Changes – MA."

The circular states that all applicants seeking the above-mentioned PAC must apply through the online portal as per the checklist available in the module.

The regulator further clarified that offline submission of applications in hard copy will no longer be accepted for processing from March 5, 2026 onward. The shift is expected to improve efficiency, transparency, and faster regulatory processing for biologics and r-DNA product approvals.

The circular was issued under the authority of Rajeev Singh Raghuvanshi, Drugs Controller General (India), and has been circulated to all stakeholders, CDSCO zonal and sub-zonal offices, the CRU section at CDSCO headquarters, and the CDAC team.

Industry stakeholders and applicants dealing with biotechnology and recombinant biologics will now be required to adopt the fully digital submission mechanism for all PAC-related regulatory filings.