CDSCO has activated the online submission of Post Approval Changes (PAC) for Clinical Trials (Form CT-06) related to Cell and Gene Therapeutic Products via the SUGAM portal. Effective from October 24, 2025, offline submissions will no longer be accepted. Applicants must follow the checklist and use the provided user manual and video tutorial available on the CDSCO website.
The Central Drugs Standard Control Organization (CDSCO) has announced a significant update regarding the submission of Post Approval Changes (PAC) for Clinical Trials (Form CT-06) concerning Cell and Gene Therapeutic Products. As part of its ongoing digital transformation, CDSCO now mandates that all PAC submissions be made exclusively through the SUGAM Online portal (www.cdscoonline.gov.in).
This move aims to streamline regulatory procedures and enhance transparency in clinical trial approvals. The portal is now fully functional for this purpose, and applicants can submit their requests for permission, acknowledgment, or notification by following the checklist provided in the module.
A detailed user manual and video tutorial are available on the CDSCO website to assist stakeholders. Importantly, CDSCO will no longer accept offline submissions for CGTP clinical trials after October 24, 2025. All stakeholders are advised to transition to the online system promptly to ensure compliance.