No More Offline Filings: CDSCO Mandates Submission of Post-Approval Changes for Cell and Gene Therapy Trial via SUGAM Portal
New Delhi: In a major regulatory development aimed at strengthening transparency and efficiency in India's clinical trial oversight, the Central Drugs Standard Control Organization (CDSCO) has announced that all post-approval changes (PACs) related to clinical trials of Cell and Gene Therapeutic Products (CGTPs) must now be submitted exclusively through the SUGAM online portal.
The announcement, issued under File No. CELL-14011(11)/24/2025-eoffice by the Cell and Gene Therapeutic Products Division of CDSCO marks a critical step in India’s transition to a fully digital regulatory framework for emerging therapeutic technologies.
According to the notice signed by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), this move follows CDSCO’s earlier circular dated July 9, 2025, which had made online submission of Phase I, II, and III clinical trial applications for CGTPs mandatory via the SUGAM portal. Building upon that initiative, the new provision now extends the digital submission system to Form CT-06, covering post-approval changes, permissions, acknowledgments, and notifications pertaining to ongoing clinical trials.
The circular clarifies that the online filing system is fully operational, and applicants can now submit their PAC applications using the dedicated modules on the SUGAM platform (www.cdscoonline.gov.in) in accordance with the prescribed checklist.
To facilitate the transition, CDSCO has also made available a user manual and video tutorial on its website i.e., https://cdscoonline.gov.in/CDSCO/Industry. to guide stakeholders through the submission process.
Importantly, the notice states, "It is hereby informed that the offline submission of clinical trial applications of CGTP will not be accepted by CDSCO for processing after 24th October, 2025."
