CDSCO Enables Online Clinical Trial Site Addition & Investigator Change

With the intention to ease the process for regulatory submissions, the Central Drugs Standard Control Organisation (CDSCO) has informed that the manufacturers of biological products like vaccines and rDNA drugs can now apply for the addition of clinical trial sites and changes in principal investigators (PIs) through the Sugam Portal. 

The Sugam Portal is a web-enabled module where users can submit applications for licenses, permissions, and approvals to be issued by the CDSCO. 

This follows the decision that was taken by the apex drug regulator in December, 2024, to allow for applications of change of clinical trial sites and changes of PIs to be done online for certain drug categories. 

The earlier notice had included only global clinical trials, clinical trials for new drugs and subsequent new drugs, investigational new drugs, fixed-dose combinations (FDCs) and bioavailability and bioequivalence studies. 

The latest notice expands the scope to include applications for biological products which include vaccines and recombinant deoxyribonucleic acid (rDNA) drugs under the purview of online submission. 

If the CDSCO does not raise an objection within the prescribed time frames for the proposed addition or change, it shall be deemed to have been approved.

As noted in the public notice, the applying party will need to submit the application and documents approvals from the ethics committee of the drug regulator through the Sugam Portal. 

Unless the CDSCO objects to the addition of the preliminary application within 30 days, it will be accepted as legitimate. This also applies to the change in Principal Investigator, as long as it is accomplished in the manner specified in the checklist. 

The CDSCO is continuously trying to streamline and digitise the regulatory submissions processes. 

Previously, the drug regulatory staff had other submissions, in addition to the PSURs, associated with the marketing licensing of new drugs, conducted through different online systems. 

Also, the veterinary division of the CDSCO had transitioned the import or manufacturing sanction submissions of Form 44 from hard copy to soft copy. 

In 2023, the CDSCO issued instruction to stakeholders to issue post approval change applications to market authorisation for immunobiological products along with test licenses for veterinary vaccines and submit them through the Sugam Portal.