Vaccine makers can add clinical trial sites through Sugam, says CDSCO

The recent notice brings applications for biological products such as vaccines and recombinant deoxyribonucleic acid (rDNA)-based drugs under the online ambit

The Central Drugs Standard Control Organisation (CDSCO) on Thursday notified that manufacturers of biological products such as vaccines and rDNA based drugs can now submit applications for the addition of clinical trial sites and changes in principal investigators (PIs) online through the Sugam Portal.

 

The Sugam Portal is an online platform that allows users to apply for licences, permissions, and approvals from the CDSCO.

 

The move comes after the apex drug regulator, in December 2024, decided to make applications for clinical trial site additions and changes of PIs available for select drug types online.

 

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

 

 

The notice brings applications for biological products such as vaccines and recombinant deoxyribonucleic acid (rDNA) based drugs under the online ambit.

 

The proposed addition or change will be deemed to be approved if no objection is raised by the CDSCO within a stipulated time frame.

 

According to the public notice, the applicant should submit the application through the Sugam Portal along with a checklist of documents and the approval of the drug regulator’s ethics committee.

 

While the proposed addition of clinical trial sites will be deemed to be approved if no objection is received from the CDSCO within 30 days of the receipt of the application, the proposed change of PI will be deemed to be approved by the CDSCO, subject to the condition that it is completed according to the checklist.

 

The CDSCO has been making efforts to digitise and streamline the regulatory submission procedure.

 

The drug regulatory body earlier switched various applications, including the submission of Periodic Safety Update Reports (PSURs) related to the marketing authorisation of new drugs, to online systems.

 

Similarly, the CDSCO’s veterinary division had also switched the submission of Form 44 for the grant of permission to import or manufacture a new drug from offline to online mode.

 

In 2023, the CDSCO also directed stakeholders to submit applications for post-approval changes (PACs) regarding marketing authorisation for antisera and human vaccines and applications for test licences for veterinary vaccines through the Sugam Portal.