The Central Drugs Standard Control Organization (CDSCO) has implemented a new digital system on the SUGAM Online portal for processing Post Approval Changes (PAC) related to Clinical Trials for Cell and Gene Therapeutics Products (CGTP). This move streamlines the regulatory submission process and mandates online filing for all related applications.
The new provision is now functional, and applicants seeking permission, acknowledgement, or notification of post-approval changes (Form CT-06) must submit their applications exclusively through the SUGAM Online portal (www.cdscoonline.gov.in).
End of Offline Submissions
In a decisive move to enforce digital compliance, the CDSCO announced that the offline submission of clinical trial applications of CGTP will not be accepted for processing after October 24, 2025.
The provision specifically covers Post Approval Changes pertaining to Clinical Trials (Form CT-06) for Form CT-04 applications.
Applicants must submit their application through the SUGAM Online portal according to the checklist provided in the developed modules.
A user manual and video tutorial for filing the PAC via Form CT-06 on the SUGAM portal are available on the CDSCO website.
This measure follows a previous notice dated July 9, 2025, regarding Clinical Trial Applications (Phase I, II, and III) for Cell and Gene Therapeutics Products also being processed through the SUGAM Online portal system. The Director General of Health Services is leading this regulatory shift to enhance efficiency and transparency in the oversight of these advanced therapeutic products.