Sugam Portal:

March 4, 2025

The Central Drugs Standard Control Organisation (CDSCO) has recently upgraded its Sugam Portal to enable online applications for clinical trial site additions and changes in principal investigators for biological products.
About Sugam Portal:
- An online platform for manufacturers to apply for drug-related licenses and approvals.
- Simplifies submissions for clinical trials, including vaccines and rDNA-based drugs.
Recent Changes in Clinical Trial Applications
- Expansion to Biological Products: As of December 2024, CDSCO allowed online applications for specific drug types. The recent update extends this facility to biological products.
- Auto-Approval Mechanism: Applications for adding clinical trial sites will be processed within 30 days, with auto-approval if no objections are raised.
- Simplified Investigator Changes: Changes in principal investigators will be approved if they meet the required criteria, streamlining the approval process.