The Central Drugs Standard Control Organization (CDSCO) has announced the launch of a new online Dual Use No Objection Certificate (NOC) system through its SUGAM Portal, effective August 31, 2025. The move aims to simplify compliance and speed up approvals for bulk drug imports intended for non-medicinal use.
According to the circular signed by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India, the updated process will:
-
Issue 1-year NOCs for eligible drugs, reducing repetitive documentation.
-
Use a revised SUGAM checklist and updated application procedures.
-
Require applicants to file fresh registrations via the portal with all prescribed documents.
“This modified system is now functional on the SUGAM portal at www.cdscoonline.gov.in and will go live from August 31, 2025, to support industry interests and ease of doing business,” the circular stated.
Industry Impact
The changes are expected to reduce the compliance burden on pharmaceutical importers while improving transparency in the approval process. Stakeholders have been advised to review the accompanying User Manual and Guidance Document for detailed application steps.
About Dual Use NOC
A Dual Use NOC is mandatory for bulk drug imports that can be used for both medicinal and non-medicinal purposes. The CDSCO regulates these approvals to ensure safety, traceability, and adherence to prescribed conditions.
%20In%20Drug%20Development){kind=link}