CDSCO mandates SUGAM portal for vaccine and anti-sera post-approval-change submissions from 1 July 2026
Vaccine and anti-sera applicants must submit post-approval-change applications for Registration Certificates and Import Licences via the SUGAM portal; hard-copy and email submissions are refused from 1 July 2026
Change
On 24 June 2026, the Central Drugs Standard Control Organisation (CDSCO) directed that Post Approval Changes applications for Registration Certificates and Import Licences of human vaccines and anti-sera be submitted through the SUGAM online portal, and that hard-copy submissions through the CRU or by email will not be accepted for processing from 1 July 2026.
Why it matters
Applicants seeking approval of Post Approval Changes for human vaccines and anti-sera must file through the SUGAM portal's other-section checklist module for post-approval changes, as already applicable under CDSCO Guidance Document PAC/2024 Version-1.2. From 1 July 2026, CDSCO will not process hard-copy submissions made through the CRU or submissions made by email, leaving SUGAM as the only accepted channel.
Implications
- — Regulatory affairs teams at human vaccine and anti-sera Registration Certificate and Import Licence holders must file all Post Approval Changes applications through the SUGAM portal's other-section checklist module from 1 July 2026 — applications submitted in hard copy through the CRU or by email will not be accepted for processing from that date.
- — Regulatory affairs teams must migrate any in-progress or planned post-approval-change submissions to SUGAM before 1 July 2026 — relying on the CRU or email route after the cut-off leaves the application unprocessed.
Who is affected
- — Regulatory affairs teams at human vaccine and anti-sera Registration Certificate holders
- — Regulatory affairs teams at human vaccine and anti-sera Import Licence holders
What to watch
- — 1 July 2026: CDSCO stops accepting hard-copy (CRU) and email submissions of vaccine and anti-sera post-approval-change applications; SUGAM becomes the only accepted channel.