CDSCO guideline for import drugs in bulk for non-medical uses

The Central Drugs Standard Control Organisation (CDSCO) in India outlines guidelines and procedures for obtaining permission to import drugs in bulk for non-medical uses. This process is managed through the SUGAM portal, an e-governance solution. The guidelines include circulars, annexures detailing required documents, guidance documents, and a user manual for the online system.


Key Points from the Circular

  • Streamlining the Process: CDSCO has streamlined the process for issuing Dual Use No Objection Certificates (NOCs) for drugs imported in bulk for non-medicinal use via the SUGAM portal, enhancing the ease of doing business.
  • One-Year NOCs: To reduce compliance burdens, CDSCO has initiated the issuance of 1-year NOCs, subject to specific conditions for the drugs.
  • Revised Checklist: The SUGAM checklist and related procedures have been revised, and a guidance document is attached.
  • Online Submission: Applications for Dual Use NOCs must be submitted through the SUGAM portal with fresh registration and the prescribed documents.
  • System Functionality: The modified system is now functional on the SUGAM portal.
  • Effective Date: The new online Dual Use system will be live from August 31, 2025.


Annexure Highlights

  • New Registration Start Date: The new registration process will begin on August 5, 2025.
  • Eligibility: From September 1, 2025, only users registered and approved by CDSCO as Dual Use NOC Traders/Actual Manufacturers can apply for Dual Use NOC on the new Sugam portal.
  • Required Documents:
    • Address Proof: A copy of the firm's address proof issued by a government authority, such as:
    • Certificate of Incorporation
    • Form 18
    • GST Certificate
    • INC-22
    • Importer Exporter Code (IEC) Certificate
    • BSNL/MTNL Telephone Bills
    • Undertaking Form: A scanned copy of the filled, stamped, and signed undertaking form.
    • ID Proof of Authorized Person: Valid identification as specified in Point No. 5 of the undertaking form.

Guidance Document Summary

  • Objective: Provides guidance on obtaining permission for importing drugs in bulk for non-medicinal use as per Rule 43 of the Drugs and Cosmetics Rules, 1945.
  • Scope: Covers the regulation of drugs imported for non-medicinal use in industries like pharmaceuticals, food, and animal feed.
  • Purpose: To streamline and ensure compliance in the importation process under Schedule D of the Drugs and Cosmetics Rules.
  • Procedure:
    • Online submission of application for a No Objection Certificate (NOC).
    • Registration on the SUGAM portal.
    • Application for NOC at the zonal/sub-zonal office, followed by procedures for release at the port office.
    • Applicants must register on the SUGAM Portal, selecting the user role as "Dual Use NoC."
    • Application to the concerned zonal/sub-zonal office with all necessary documents for a Dual Use NOC, valid for one year or until the sanctioned amount is exhausted.
    • Filling out Step/Phase II form, obtaining clearance from the port office, and completing the supply chain module.
  • Phase I/Step 1:
  • Registration on the Sugam portal verified by CDSCO HQ.
    • Uploading necessary documents, including undertaking forms, address proof, and ID proof. 
    • Providing details such as Corporate Identification Number (CIN), Custom House Agent (CHA) details, and Importer representative details. 
    • Dual-use NOC validity needs verification by the zonal/sub-zonal office, which may issue it within 7 working days. 
    • Required documents include the Integrated Registration Form (IRF), supporting documents, a legal undertaking on Rs. 100 stamp paper, specific usage details, permissions and justifications, quantity justification, technical literature, reconciliation data, and a declaration by the applicant.

  • Phase-II/Step 2:
    • Procedure for release of consignment at the port office after obtaining a valid Dual Use NOC.
    • Submission of documents, including a covering letter, Certificate of Analysis (CoA), bill of entry details, original label, and purchase invoice.
    • Submission of data for each import in the given online format, verified by the concerned port office.
    • Reconciliation module to be open throughout the NOC validity for repetitive releases.

  • Key Points:
    • Complete application submission required.
    • Apply for dual-use clearance at least two months before import.
    • Items must be clearly labelled with their intended use.
    • Manufacturers must submit a Licensing Authority-attested Master Formula Record.
    • Imports for purification or sterilisation are not eligible.
    • Import permission is valid for one year for actual users.
    • Step 1/Phase-I is done by CDSCO Zonal/Sub Zonal office, and Step 2/Phase-II is done by the Port Office does Step 2/Phase-II.

  • Annexure I & II: Legal undertakings to be submitted by actual users or importers/traders, including declarations about the use and handling of the imported drugs.
  • Guidelines can be found here.
Location: Mumbai, Maharashtra, India

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