The Central Drugs Standard Control Organization (CDSCO) on June 24, 2026, issued a circular regarding Submission of Post Approval Changes Applications of Registration Certificate and Import Licence of Human Vaccines and Anti-sera through SUGAM Portal.
The following has been stated:-
•CDSCO has announced that applications for Post Approval Changes in Registration Certificates and Import Licences of Human Vaccines and Anti-sera must be submitted through the SUGAM Portal.
•Applicants should use the designated Post Approval Changes module in accordance with the CDSCO guidance document on biological products.
•To streamline regulatory processes, submissions through hard copy, the Central Receipt Unit (CRU), or email will no longer be accepted from July 01, 2026.
•This move aims to ensure a fully digital and efficient application process.
[Circular No.: F. No. VAC-11014(17)/4/2026-eoffice]
