India CDSCO Launches: New Online Dual Use NOC System via SUGAM Portal

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, has released a notice a streamlined online system for issuing Dual Use "No Objection Certificates" (NOCs) through the SUGAM Portal. This initiative aims to enhance the ease of doing business and reduce compliance burdens for importers dealing with bulk drugs intended for non-medicinal use.

From 1 September 2025, only users registered and approved by CDSCO as Dual Use NOC Traders/Actual Manufacturers will be eligible to apply through the new system. The registration process for this upgraded system begins on 5 August 2025, and the online platform will go live on 31 August 2025.

A Dual Use NOC is an approval granted under Rule 43 of the Drugs and Cosmetics Rules, 1945, allowing the import of drugs in bulk for non-medicinal purposes—such as food, animal feed, cosmetics, industrial processing, or as intermediates for other drugs. These substances must be clearly labeled "Not for Medicinal Use" on all documents and packaging.

Key Features of the New System

1. One-Year Validity – NOCs will now be valid for up to one year or until the sanctioned quantity is exhausted, whichever is earlier.

2. Fully Online Processing – All applications, approvals, and supply chain records will be handled through the SUGAM portal.

3. Two-Step Process:

   • Step 1 (Zonal/Sub-Zonal Office) – Registration and NOC issuance.

   • Step 2 (Port Office) – Consignment clearance and supply chain documentation.

4. Mandatory Documentation – Includes address proof, ID proof of the authorized person, legal undertaking, technical literature, and quantity justifications.

5. Supply Chain Module – Continuous reconciliation and tracking of imports for regulatory oversight.

Procedure Overview

Step 1 – Registration & NOC Application

• Applicants must register on the SUGAM portal under the “Dual Use NOC” role.

• Submit required documents such as:

  • Government-issued address proof (e.g., Certificate of Incorporation, GST Certificate, IEC)

  • Legal undertaking on stamp paper

  • ID proof of the authorized signatory

• CDSCO verifies documents and issues the NOC within 7 working days (5 days at zonal level + 2 days at port).

Step 2 – Consignment Release at Port

• After obtaining the NOC, applicants must submit:

  • Cover letter with purpose and product details

  • Certificate of Analysis (CoA)

  • Bill of Entry and invoice

  • Original product label

• The port office verifies documents before releasing the shipment.

Compliance Highlights

• Applications should be submitted at least 2 months before planned import to avoid delays.

• NOCs are issued only to actual users, not intermediaries.

• Imports for purification or sterilization purposes are not eligible.

• All packaging and labels must prominently display “Not for Medicinal Use” or “For use as pharma aid”.

• The CDSCO will maintain a centralized record of all approvals and consignments through the SUGAM system.

For full details, including the guidance document, check the official CDSCO notice and user manual here: CDSCO – New Online Dual Use NOC Circular