The Central Drugs Standard Control Organization (CDSCO) has made a major digital move. It now requires all post-approval change applications for Cell and Gene Therapy clinical trials to be filed online.
Table of Contents
The system, available on the SUGAM Online portal, is designed to streamline and speed up the submission process. Applicants must now use the portal to submit Form CT-06 for any post-approval changes.
This update officially ends offline submissions. Starting October 24, 2025, no paper-based or physical applications will be accepted for processing. The CDSCO has clearly stated that all Post Approval Change applications related to Form CT-04 must go through the online system.
A Major Push toward Digital Compliance
CDSCO’s latest decision officially ends paper-based applications. This move is part of a larger effort to bring transparency and consistency to the regulatory process.
Applicants must follow the updated checklist on the SUGAM portal before filing their applications. The shift will not only save time but also help minimize human errors and paperwork delays.
To make the transition smoother, the CDSCO has also released a user manual and a video tutorial on its website. These resources guide applicants step by step through the new submission process.
Aligning With Global Standards in Clinical Research
This decision follows a previous notice issued on July 9, 2025, which required all clinical trial applications for Cell and Gene Therapy products (Phase I, II, and III) to be filed online.
The change, driven by the Director General of Health Services, underlines India’s growing focus on digital transformation in the healthcare sector. It also signifies the government’s intent to align with global regulatory practices for managing complex and growing therapies.
With this step, India joins the ranks of nations adopting end-to-end digital systems for clinical research oversight. It promises quicker responses, better tracking, and greater responsibility in managing innovative therapeutic trials.
CDSCO’s mandate for online submissions marks a strong leap toward digital governance. The modification will improve efficiency, bring transparency, and help India modernize its regulation of cell and gene therapy research.
This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.
