The Central Drugs Standard Control Organization (CDSCO) has announced that all Clinical Trial Applications (Phase I, II, and III) for Cell and Gene Therapeutic Products (CGTP) must now be submitted exclusively through its online portal system, SUGAM. This notice was issued on July 9, 2025.
Effective July 10, 2025, the CDSCO will no longer accept offline submissions for CGTP clinical trial applications. This change streamlines the regulatory submission procedure, making the process fully digital.
Applicants seeking permission for CGTP clinical trials can now utilize the SUGAM Online portal system to submit their applications as per the provided checklist in the developed modules. To assist users with the transition, a comprehensive user manual and video tutorial for filling out these applications are available on the CDSCO website.
The decision, issued by Drugs Controller General (India) aims to benefit all stakeholders involved in clinical trials. The notice has been disseminated to relevant divisions within CDSCO, the CDAC Team, and the CDSCO IT cell for website uploading, with a copy for information sent to the Joint Secretary (Drugs Regulation), Ministry of Health and Family Welfare.