Importer | Source: CDSCO
Published On: 24-06-2026
Enforcement Date: 01 July, 2026
Submission of Post Approval Changes Applications of Registration Certificate and Import Licence of Human Vaccines and Anti-sera through SUGAM Portal
CDSCO has mandated that all Post‑Approval Change (PAC) applications for Registration Certificates and Import Licences of human vaccines and anti‑sera must now be submitted exclusively through the SUGAM online portal. Effective 01 July 2026, hard copy or email submissions will no longer be accepted, streamlining regulatory processes and ensuring efficient handling of PAC applications.
The Central Drugs Standard Control Organization (CDSCO) has issued a circular mandating that all Post‑Approval Change (PAC) applications related to Registration Certificates and Import Licences of human vaccines and anti‑sera must now be submitted exclusively through the SUGAM online portal.
Effective from 01 July 2026, hard copy or email submissions will no longer be accepted, ensuring a streamlined and transparent regulatory process.
Applicants are required to use the PAC checklist module available on SUGAM, in line with CDSCO’s Guidance for Industry – Post Approval Changes in Biological Products: Quality, Safety and Efficacy Documents (Document No. PAC/2024, Version 1.2).
This initiative is aimed at enhancing efficiency, reducing manual handling, and ensuring uniformity in the evaluation of PAC applications, thereby strengthening India’s regulatory framework for biological products.
Applicable For: Importer
Reference Number: F. No. VAC-11014(17)/4/2026-eoffice
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