Complete Guide to Apply for CDSCO Dual Use NOC Online in India Without Rejection

Key Takeaways

• Dual Use NOC is issued under Rule 43 of the Drugs and Cosmetics Rules, 1945, for bulk drugs imported for non-medicinal use.
• The process runs on the SUGAM portal in two steps: zonal office NOC, then port office release.
• The NOC is valid for one year or until the sanctioned quantity is used, whichever is earlier.
• Name mismatches, duplicate registrations and weak undertakings are the top rejection triggers.
• Apply at least two months before your import date.

Introduction

Importing a bulk drug for non-medicinal use in India? A CDSCO Dual Use NOC is usually what stands between your consignment and the port gate.

From 1 September 2025, CDSCO moved this entire process to a new two-step system on the SUGAM portal. It is faster, but far less forgiving of errors. One mismatched address or a missing undertaking can get your application rejected.

What Is a CDSCO Dual Use NOC?

It is CDSCO’s permission to import drugs in bulk for non-medicinal use, granted under Rule 43 of the Drugs and Cosmetics Rules, 1945. Industries such as food, animal feed and pharma excipients commonly need it.

Imports meant for purification or sterilisation are not eligible under this route.

Who Can Apply?

Only users registered and approved by CDSCO as Dual Use NOC Traders or Actual Manufacturers can apply. Jurisdiction depends on the actual importer’s address or authorised branches, not the CHA’s office.

The Two-Step Process

Step 1: Registration and NOC (Zonal/Sub-Zonal Office)

1. Register on SUGAM with the “Dual Use NOC” role and complete the Integrated Registration Form (IRF).
2. CDSCO Headquarters verifies your registration.
3. Select NOC (Zone), then Dual Use NOC. You can add up to 5 products and 10 countries per product.
4. Complete the mandatory checklist and verify the OTP sent to your registered mobile.
5. CDSCO’s stated timeline for the NOC is 7 working days, though queries can extend it.

Step 2: Consignment Release (Port Office)
After Step 1 approval, apply for Dual Use NOC Step 2, choose your port office, and enter the import quantity. It must not exceed the Step 1 approval. Then update the Supply Chain Module for every release.

Documents Required

• Registration: address proof (Certificate of Incorporation, GST, IEC, etc.), signed and stamped undertaking, ID proof of the authorised person
• Step 1: signed IRF, sales contracts or agreements, a notarised undertaking on Rs. 100 stamp paper, end-use details, quantity justification with technical literature, reconciliation data of earlier imports, and a declaration that you have not applied at any other CDSCO office
• Manufacturers: Master Formula Record attested by the Licensing Authority
• Step 2: covering letter, Certificate of Analysis, bill of entry details, original label, purchase invoice

Why Applications Get Rejected

• Registering afresh when you already hold SUGAM credentials. Use the “Switch Role” option instead. Export NOC (Zone) users are the exception and need fresh registration.
• Name or address on the proof not exactly matching the undertaking and portal.
• Missing or non-notarised stamp paper undertaking.
• Step 2 quantity exceeding the Step 1 approval.
• Documents and packaging not marked “Not for Medicinal Use” or “For use as pharma aid”.
• Applying for a second Step 2 before 80% utilisation of the earlier one is reported.

Best Practices

Submit a complete application the first time. Keep books and usage records ready, as CDSCO Drug Inspectors can inspect them. Finally, file at least two months ahead of shipment.

Featured Snippet Answer

CDSCO Dual Use NOC is a permission under Rule 43 of the Drugs and Cosmetics Rules, 1945, for importing bulk drugs for non-medicinal use. Applicants register on the SUGAM portal, apply at the zonal office for a one-year Step 1 NOC, then file Step 2 at the port office to release each consignment.

FAQs

1. How long is a Dual Use NOC valid?
One year, or until the sanctioned quantity is exhausted, whichever is earlier.

2. Where do I apply?
On the SUGAM portal (cdscoonline.gov.in) under NOC (Zone), form type Dual Use NOC.

3. Can I import for sterilisation or purification under this NOC?
No. Such imports are not eligible under the dual-use provision.

4. Is a stamp paper undertaking mandatory?
Yes. It must be notarised on Rs. 100 stamp paper. Actual users follow Annexure I, while traders follow Annexure II.

5. What must be printed on labels?
“Not for Medicinal Use” or “For use as pharma aid” on containers and consignment documents.

6. Can I switch my existing SUGAM login?
Yes, through “Switch Role”. Registering again with new credentials leads to rejection.

Conclusion

A Dual Use NOC is a documentation-driven approval. Correct registration, matching details and a complete Step 1 file decide how smoothly your shipment clears.

CTA

A V International has supported importers and exporters with licensing and regulatory approvals for over 35 years. Our team can handle your SUGAM registration, undertakings, Step 1 and Step 2 filings and reconciliation. Contact A V International to get your Dual Use NOC filed right the first time.

Written By
Akash Bhangare
Having more than 10 years of experience in EPR Compliance, Legal Metrology, DGFT Regulations, and Import Export Consulting Services in India.
Associated with A V International, a company with over 35 years of expertise in Environmental Compliance, EPR Registrations, Licensing, and Regulatory Approvals.