India's Central Drugs Standard Control Organization (CDSCO) has implemented a mandatory digital transformation for cell and gene therapy clinical trial applications, requiring all submissions to be processed exclusively through its online SUGAM portal system. The regulatory change, announced on July 9, 2025, and effective from July 10, 2025, marks a significant shift in how clinical trial applications for cell and gene therapeutic products (CGTP) are processed in India.
Digital-Only Submission Requirements
The new mandate applies to all clinical trial applications for Phase I, II, and III studies involving cell and gene therapeutic products. Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), stated in the official notice that "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."
CDSCO will no longer accept offline submissions for CGTP clinical trial applications after the implementation date, making the regulatory submission procedure fully digital. This change streamlines the entire process and aligns with the organization's ongoing digitization efforts.
Support Resources for Stakeholders
Recognizing the need for stakeholder support during this transition, CDSCO has developed comprehensive guidance materials. The organization has made available a user manual and video tutorial for filling out online applications, which have been uploaded on the CDSCO website under the Industry section. These resources are designed to assist units that may need support in applying for clinical trials through the new digital system.
The decision to provide extensive support materials reflects industry requests for regulatory handholding whenever CDSCO switches systems from offline to online mode. This approach aims to ensure smooth adoption of the new digital submission process.
Enhanced User Experience Features
As part of its broader digitization strategy, CDSCO has recently introduced tooltips on its e-governance platform SUGAM and medical device online portals. These tooltips offer clear instructions on expected inputs for legal forms, designed to provide helpful guidance on specific requirements for each field in various application forms submitted to CDSCO for approval.
According to the DCGI, "By offering clear instructions on expected inputs, this feature aims to minimise errors and facilitates the quality of submissions." The tooltips can be accessed by hovering over the information icon or help text next to each field, encouraging stakeholders to utilize this functionality while filling applications on both portals.
Broader Digitization Initiative
This mandate for CGTP clinical trial applications represents part of CDSCO's comprehensive effort to digitize and streamline regulatory submission procedures. The organization has been systematically shifting various application forms to online mode in recent years, promoting the use of digital platforms for regulatory processes.
CDSCO has also been advancing the Online National Drugs Licensing System (ONDLS) portal, designed as a single window platform for online processing of various applications. This system handles manufacturing and sales licenses including blood banks, and other certificates like COPP, GMP, WHO-GMP, and Market Standing certificates, as well as post-approval changes.
The ONDLS system is expected to establish uniformity in document submission requirements for different types of applications and license issuance throughout India. It supports uniform administration of regulatory provisions by utilizing the latest technology tools including e-governance through online portals for state and union territory Drug Control Authorities.
The notice regarding the CGTP clinical trial application changes has been disseminated to relevant divisions within CDSCO, the CDAC Team, and the CDSCO IT cell for website uploading, with copies sent to the Joint Secretary (Drugs Regulation), Ministry of Health and Family Welfare, ensuring comprehensive implementation across all relevant stakeholders.
