Mandatory Online Submission of Post Approval Changes for Human Vaccines and Anti-sera via SUGAM Portal from July 2026

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Dated: 25.06.2026

Mandatory Online Submission of Post Approval Changes for Human Vaccines and Anti-sera via SUGAM Portal from July 2026

The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Government of India, has announced a significant update to the regulatory process for human vaccines and anti-sera. Effective from July 1, 2026, all applications for Post Approval Changes (PAC) in Registration Certificates and Import Licences for these products must be submitted exclusively through the SUGAM online portal.

Key Highlights of the New Submission Process

Transition to Online Submissions
- All applicants seeking approval for post approval changes in human vaccines and anti-sera are now required to use the SUGAM portal (www.cdscoonline.gov.in).
- The online system is designed to streamline and standardize the regulatory submission procedure, ensuring greater efficiency and transparency.
Scope of Changes Covered
- The new process applies to all post approval changes as outlined in the “COSCO Guidance for Industry-Post Approval Changes in Biological Products: Quality, Safety and Efficacy Documents” (Document No. PAC/2024 Version -1.2).
- Applicants must use the “other section checklist module” within the SUGAM portal for these submissions.
Discontinuation of Hard Copy and Email Submissions
- From July 1, 2026, applications submitted in hard copy (via CRU) or by email will no longer be accepted or processed.
- This move ensures that all regulatory submissions are centralized and traceable within the digital system.

Steps for Applicants

Access the SUGAM Portal
- Visit www.cdscoonline.gov.in and log in with your credentials.
Navigate to the Relevant Module
- Select the “other section checklist module” for post approval changes related to human vaccines and anti-sera.
Prepare and Upload Required Documents
- Ensure all documentation aligns with the latest COSCO guidance (PAC/2024 Version -1.2).
- Upload quality, safety, and efficacy documents as specified.
Submit the Application Online
- Complete the submission process through the portal. Track the status of your application within the system.

Benefits of the Online Submission System

Efficiency: Faster processing and reduced paperwork.
Transparency: Real-time tracking and centralized records.
Compliance: Ensures adherence to the latest regulatory guidelines.

Stakeholders Informed

All relevant stakeholders, including State and UT Licensing Authorities and the CDAC Team, have been notified of this change for necessary action and compliance.

This update marks a major step towards digital transformation in the regulation of biological products in India, promoting a more robust and transparent approval process for human vaccines and anti-sera.

In case you face any issues related to Indirect Tax-Customs, GST, Foreign Trade Policy (FTP), Arbitration matters and Central Licensing and related advisory matters in India then please feel free to get in touch with SJ EXIM Services.

We offer Legal advice and litigation support in matters related to Indirect Tax-Customs, FTP, other Indirect Tax matters & Arbitration law, all sorts of Central licensing and related matters. Come and explore the new way of doing business with us!

Source: CDSCO

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