CDSCO Mandates Online Submissions for Gene Therapy Trials
In News
What Happened
Why It Matters
Background
History & Context
What Changed
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Submission Method: BEFORE, applicants could submit physical or offline documents for CGTP clinical trials. NOW, all applications for Phase I, II, and III trials must be exclusively submitted online via the SUGAM portal.
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Post-Approval Changes: BEFORE, post-approval modifications (like Form CT-06) required physical filings which were difficult to track. NOW, dedicated digital modules on SUGAM handle all post-approval permissions, acknowledgments, and notifications.
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Transparency and Tracking: BEFORE, offline tracking of sensitive trial data often led to administrative opacity and delays. NOW, the centralized portal offers real-time tracking, along with standardized user manuals and video tutorials for mandatory digital compliance.
Prelims Angle
NCERT Connection
Practice Questions
Q1
Correct Statement(s)Consider the following statements regarding the regulation of Cell and Gene Therapeutic Products (CGTP) in India: 1. The CDSCO has mandated that all clinical trial applications for CGTP must be submitted exclusively through the online SUGAM portal. 2. Offline submissions for Phase I, II, and III CGTP trials are still permitted in exceptional cases for domestic manufacturers. Which of the statements given above is/are correct?