File No.: VAC-11014(17)/4/2026-eoffice dated June 24, 2026
Applicable Act/Rule: Drugs and Cosmetics Act, 1940; New Drugs and Clinical Trials Rules, 2019
Effective Date: July 1, 2026
Directorate General of Health Services, Central Drugs Standard Control Organization (Vaccine Division) has issued a circular addressed to all stakeholders through CDSCO website, State/UT Licensing Authorities, and the CDAC Team, signed by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India).
The circular states that submission of applications for Post Approval Changes in Registration Certificate and Import Licence of Human Vaccines and Anti-sera shall be made functional in the online system of SUGAM Portal (www.cdscoonline.gov.in). All applicants seeking approval of Post Approval Changes shall apply through the SUGAM online portal in the other section checklist module of Post Approval Changes, which are already applicable for post approval changes as per CDSCO Guidance for Industry — Post Approval Changes in Biological Products: Quality, Safety and Efficacy Documents, Document No. PAC/2024 Version-1.2. Submission of applications in hard copy through CRU or by e-mail will not be accepted for processing from July 1, 2026.
Disclaimer: The information contained in this Article is intended solely for personal non-commercial use of the user who accepts full responsibility of its use. The information in the article is general in nature and should not be considered to be legal, tax, accounting, consulting or any other professional advice. We make no representation or warranty of any kind, express or implied regarding the accuracy, adequacy, reliability or completeness of any information on our page/article.
