CDSCO brings clinical trial site addition and change of PI applications to online mode
Posted on January 2, 2025
The Central Drugs Standard Control Organisation (CDSCO) has sought the industry to start submitting the applications for clinical trial site addition and change of principal investigator through online mode, as part of streamlining the regulatory submission procedure.
The applicants should submit their applications for these purposes through the Sugam portal along with the checklist of documents and the approval of the ethics committee.
“In order to streamline the regulatory submission procedure, the submission of applications for addition of Clinical Trial Site and change of Principal Investigator are functional on online system of Sugarm portal (www.cdscoonline.gov.in) for Global Clinical Trials, Clinical trials of New Drugs, Subsequent New Drugs, Investigational New Drugs, Fixed Dose Combinations and Bioavailability & Bioequivalence studies,” said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), in a notice issued to all stakeholders.
Applicants seeking for approval of Clinical Trial Site addition and change of Principal Investigator applications may apply through the online portal, said the official.
The proposed addition of clinical trial sites is deemed to be approved if no objection is received from the CDSCO within 30 days of the receipt of the application and the proposed change of Principal Investigator is deemed to be approved by the CDSCO from the date of receipt of application subject to the condition that application is complete as per the checklist, added the drug regulator.
It may be noted that the CDSCO, as part of its efforts to digitise and streamline the regulatory submission procedure, has earlier switched various applications including the submission of Period Safety Update Reports (PSUR) related to marketing authorisation of new drugs and others to online systems. The veterinary division of the drug regulatory office has announced that it is switching submission of Form 44 for grant of permission to import or manufacture a new drug from offline to online mode.
In November, 2023, the CDSCO directed all stakeholders to submit the applications for Post Approval Changes (PACs) with regard to marketing authorisation for human vaccines and antisera through online system of Sugam Portal under Post Approval Changes, as it is stopping the offline submission process from December 1, 2023.
In the beginning of 2023, CDSCO switched the procedure for submission of form for test license for veterinary vaccines and drugs to online, stopping the facility of offline submission of applications in hard copy following this. In 2021, it has switched the applications for registration of centres for Bioavailability and bioequivalence (BA/BE) studies and application for PACs in BA/BE studies online.
The CDSCO has also launched the National Single Window System (NSWS) portal on January 1, 2024, initially offering three activities for the medical devices industry, in an effort to improve the ease of doing business to the industry
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