The Central Drugs Standard Control Organisation (CDSCO) has notified pharmaceutical companies that it will no longer accept offline submissions of clinical trial applications for Cell and Gene Therapy Products (CGTPs).

To streamline the regulatory submission process, the CDSCO has introduced a provision for filling clinical trial applications related to CGTPs through the SUGAM online portal.

 “This provision is now made functional and the applicants seeking for such permission may now submit the clinical trial applications (Phase I, II and III) through SUGAM Online portal system as per the checklist in the developed modules,” stated Drugs Controller General Dr. Rajeev Singh Raghuvanshi in an official notice.

 “It is hereby informed that the offline submission of clinical trial applications of CGTP will not be accepted by CDSCO for processing after July 10, 2025.” 

The user manual and video tutorial for submitting clinical trial applications via the SUGAM portal are also made available on the CDSCO website.

All stakeholders involved in clinical trials have been officially notified that offline submissions for CGTP-related trials will not be accepted for processing after the aforementioned date.