The Central Drugs Standard Control Organization (CDSCO) has announced the expansion of its online application process through the SUGAM portal to include applications for Clinical Trial Site Addition and change of Principal Investigator for clinical trials of biological products, specifically vaccines and rDNA products. This notice was issued on February 24, 2025.
This development follows a previous notice dated December 26, 2024, and aims to streamline the application process for clinical trial modifications.
Applicants seeking approval for Clinical Trial Site Addition and change of Principal Investigator for all clinical trials, including those involving biological products, can now submit their applications through the SUGAM portal.
Application Requirements
Applicants are required to:
- Submit their applications through the SUGAM portal.
- Include a checklist of required documents.
- Provide approval from the Ethics Committee.
Deemed Approval Process
Proposed additions of clinical trial sites are deemed approved if no objection is received from the CDSCO within 30 days of application receipt.
Additionally, proposed changes of Principal Investigator are deemed approved from the date of application receipt, provided the application is complete and adheres to the checklist requirements.
