The Central Drugs Standard Control Organization (CDSCO) has announced that all applications for Post-Approval Changes in Registration Certificates and Import Licences for Human Vaccines and Anti-sera must now be submitted exclusively through the online SUGAM Portal .
This transition is part of an ongoing initiative by the Directorate General of Health Services to streamline regulatory submission procedures for biological products. Applicants are required to utilize the “other section checklist module” on the portal, ensuring all submissions align with the established CDSCO “Guidance for Industry- Post Approval Changes in Biological Products: Quality, Safety and Efficacy Documents”
To ensure a definitive shift toward digital governance, the CDSCO has stated that physical hard copies submitted through the Central Registry Unit (CRU) or digital applications sent via email will no longer be accepted for processing starting July 1, 2026. The directive, issued by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), has been circulated to all state and union territory licensing authorities, the CDAC team, and relevant industry stakeholders for immediate action.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
