CDSCO Launches New Online System for Dual Use NOC via Sugam Portal

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Dated: 04.08.2025

CDSCO Launches New Online System for Dual Use NOC via Sugam Portal

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, Government of India, has introduced a new online Dual Use NOC system on the SUGAM portal. This initiative aims to simplify the process of obtaining No Objection Certificates (NOCs) for importing drugs in bulk for non-medicinal use, ensuring transparency, efficiency, and ease of compliance for stakeholders. The system will go live on August 31, 2025, with registrations starting from August 5, 2025.

Key Highlights of the New Dual Use NOC System

Ease of Doing Business: The streamlined process reduces compliance burdens and introduces a one-year validity for NOCs, subject to prescribed conditions.
Online Application: Applications for Dual Use NOCs must be submitted through the SUGAM portal, ensuring a fully digital and user-friendly experience.
Two-Step Process: The system is divided into two phases:
- Step 1: Registration and application for NOC at zonal/sub-zonal offices.
- Step 2: Release of consignments at port offices.

Registration Process (Step 1) 

Documents Required for Registration 

Applicants must upload the following documents:

Address Proof: Acceptable documents include Certificate of Incorporation, GST Certificate, Importer Exporter Code (IEC), and others.
Undertaking Form: A scanned copy of the duly filled, stamped, and signed undertaking form.
ID Proof of Authorized Person: Valid ID proof as specified in the undertaking form.

Procedure

Log in to the SUGAM portal and select the “Dual Use NOC” user role.
Fill out the Integrated Registration Form (IRF) and upload the required documents.
Provide details such as Corporate Identification Number (CIN), Importer/CHA details, and authorized personnel information.
Submit the application for verification by CDSCO Headquarters.
Once verified, the zonal/sub-zonal office will issue the NOC within seven working days.

Consignment Release Process (Step 2) 

Required Documents 

At the time of consignment release, applicants must submit:

Covering Letter: Outlining the purpose, name, and quantity of drugs to be imported.
Certificate of Analysis (CoA): Document verifying the quality of the imported drugs.
Bill of Entry Details: Accurate details of the bill of entry.
Label: Original label of the product.
Invoice: Purchase invoice for the consignment.

Procedure

Apply for Step-2 NOC on the SUGAM portal after approval of Step-1.
Select the approved license number and drug name from the dropdown menu.
Enter the quantity to be imported, ensuring it does not exceed the approved quantity.
Submit the application along with the required documents for verification by the port office.

Supply Chain Module

After approval of Step-2, applicants must use the Supply Chain Module to manage repetitive consignment releases. This module allows users to:

Submit data for each import in the prescribed format.
Provide reconciliation data for previously submitted quantities.
Ensure compliance with the conditions of the NOC.

Benefits of the New System

Transparency: The online system ensures that all applications and approvals are visible to stakeholders.
Efficiency: The streamlined process reduces the time required for obtaining NOCs and releasing consignments.
Compliance: The system ensures adherence to regulatory requirements, minimizing the risk of unauthorized imports.

Conclusion

The new Dual Use NOC system on the SUGAM portal is a significant step towards modernizing drug import processes in India. By leveraging technology, CDSCO has created a transparent, efficient, and user-friendly platform that supports industry interests while ensuring regulatory compliance. Stakeholders are encouraged to familiarize themselves with the system and begin registrations from August 5, 2025, to take full advantage of this initiative.

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Source: CDSCO

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