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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Submission of Clinical Trial Site Addition and Principal Investigator Change Applications through SUGAM Portal

24-Feb-2025 | F.No.10171/DCGI/10/2024-eoffice

Central Drugs Standard Control Organization has issued a notification regarding the submission of applications for adding Clinical Trial Sites and changing Principal Investigators through the SUGAM portal (www.cdsconline.gov.in). This applies to clinical trials of biological products like vaccines and rDNA.

By virtue of the notice, applicants seeking approval for Clinical Trial Site Addition and Principal Investigator change should now submit their applications through the SUGAM portal, along with the required checklist of documents and approval from the ethics committee. The addition of a clinical trial site will be deemed approved if there are no objections from CDSCO within 30 days of receiving the application. The change of Principal Investigator will be considered approved from the date of receipt of the application, provided the application is complete as per the checklist.

Please refer the attached documents for more information.

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