The Central Drugs Standard Control Organisation (CDSCO) has announced a shift towards online applications for adding clinical trial sites and changing Principal Investigators. CDSCO is now accepting these submissions through the SUGAM portal. This notice was issued on December 26, 2024.
This online system applies to various types of clinical trials, including:
- Global Clinical Trials
- Clinical trials of New Drugs
- Subsequent New Drugs
- Investigational New Drugs
- Fixed Dose Combinations
- Bioavailability & Bioequivalence studies
Previously, these applications were handled offline. The transition to online submission is expected to expedite the process for researchers and sponsors conducting clinical trials in India.
Simplified Approval Process
The CDSCO has outlined a clear process for using the SUGAM portal for these applications:
- Applicants submit their application electronically through the SUGAM portal.
- The application must include all necessary documents as per the provided checklist.
- Additionally, approval from the relevant ethics committee is required.
Deemed Approvals
The CDSCO has implemented a “deemed approval” system for applications submitted through SUGAM.
For adding a clinical trial site, approval is considered granted if no objection is received from the CDSCO within 30 days of application submission.
Similarly, changes to the Principal Investigator are deemed approved from the date of application receipt, provided the application is complete.
