CDSCO Moves Clinical Trial Applications to Online Portal

The online submission process is now available through the Sugam portal, which is designed to centralize and simplify regulatory applications.

The Central Drugs Standard Control Organization (CDSCO) has announced that the application submission process to add clinical trial sites and change principal investigators (PIs) will now be conducted online.

This shift, part of the regulator's ongoing efforts to streamline regulatory procedures, applies to various clinical trial categories, including global clinical trials, clinical trials for new drugs, bioequivalence studies, and others.

Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), confirmed the move in a notice to industry stakeholders. "To streamline the regulatory submission procedure, the submission of applications for the addition of a Clinical Trial Site and change of Principal Investigator is functional on the online system of Sugam 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 Raghuvanshi.

Application Process Simplified via Sugam Portal

The online submission process is now available through the Sugam portal, which is designed to centralize and simplify regulatory applications.

As part of the new process, applicants must submit their clinical trial site addition and change of principal investigator requests alongside the required checklist of documents and approval from the ethics committee.

Once an application is submitted, the proposed addition of a clinical trial site will be approved if CDSCO raises no objections within 30 days of receipt.

Similarly, applications for changing the principal investigator will be approved from the date of receipt, provided the application is complete according to the checklist requirements.

The move aligns with CDSCO’s broader digital transformation initiative to improve efficiency in the regulatory submission process. CDSCO has already implemented online systems for several other applications, including the submission of Period Safety Update Reports (PSURs) for new drugs and applications for test licenses for veterinary vaccines and drugs.

Continuing Efforts to Streamline Healthcare Regulations

This online submission initiative for clinical trial site additions and PI changes is one of several steps taken by CDSCO to streamline the regulatory process for the healthcare sector.

In 2023, the CDSCO also made online submissions mandatory for Post-Approval Changes (PACs) related to marketing authorisation for human vaccines and antisera. This decision followed a similar move in 2021 when the submission process for bioavailability and bioequivalence study registrations was transitioned online.

On January 1, 2024, the CDSCO launched the National Single Window System (NSWS) portal, initially focused on medical devices, to further improve the ease of doing business for the healthcare industry in India. This platform offers a single window for various regulatory approvals, ensuring quicker and more efficient processing for stakeholders in the medical device sector.