facebook tracking

CDSCO

Clinical Trial for cell and gene therapeutic products is online


regulatory illustration
regulatory update icon
Importer & Manufacturer   |   Source: CDSCO
Published On: 09-07-2025

Enforcement Date: 10 July, 2025
Clinical Trial for cell and gene therapeutic products is online

CGPT is Now online! Application for clinical trial (Phase I/ Phase II/ Phase III) for cell and gene therapeutic products now be submitted online through SUGAM portal. After 10th July 2025 no offline application will be accepted.


As per the latest Circular issued vide File No. CELL-14011(11)/24/2025-eoffice dated 09 Jul 2025 from Cell and Gene Therapeutic Products Division of CDSCO on SUGAM Portal, applications for Clinical Trial permission are required to be submitted online.
CDSCO has made SUGAM functional for submission of Phase I/ Phase II/Phase III Clinical Trial applications pertaining to cell and gene therapeutic products. That means the applicants seeking permission to conduct clinical trial Phase I/ Phase II/ Phase III for cell and gene therapeutic products now required to apply online through SUGAM portal.
The order is effective from 10th July 2025. No application in offline mode will be accepted after the effective date.

Applicable For: Importer & Manufacturer
Reference Number: File No.: CELL-14011(11)/24/2025-eoffice Notification Link

Related Regulatory Updates

Contact us

Please feel free to talk to us if you have any questions. We endeavour to answer within 24 hours.