CDSCO Makes SUGAM Portal Mandatory for Imported Vaccine, Anti-sera Approval Changes from July 1
New Delhi: In a move aimed at streamlining the regulatory submission process for imported biological products, the Central Drugs Standard Control Organization (CDSCO) has directed that all applications seeking approval for Post Approval Changes (PACs) in Registration Certificates (RCs) and Import Licences of human vaccines and anti-sera must be submitted exclusively through the SUGAM online portal from July 1, 2026.
Issuing a circular dated June 24, 2026, the Vaccine Division of CDSCO stated that the online submission facility for Post Approval Change applications has now been made functional on the SUGAM Portal.
According to the circular, in order to streamline the regulatory submission procedure, the 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).
The circular states,
"All applicants seeking approval of such Post Approval Changes shall now 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."
The regulator has further clarified that submission of Post Approval Changes (PAC) applications in hard copy through the Central Receipt Unit (CRU) or by e-mail will no longer be accepted for processing from July 1, 2026.
To view the official notice, click the link below.
