India CDSCO Guidance: How to Get Export NOC for Approved & Unapproved New Drugs

The Central Drugs Standard Control Organisation (CDSCO) has published a fresh guidance document titled “Guidance Document for Issuance of No Objection Certificate (NOC) for Manufacture of Unapproved/Approved New Drugs for Export Purpose.” This update, issued on 17 July 2025, outlines the procedure, documentation, and conditions for Indian manufacturers to export drugs that may not yet be approved for the domestic market — a significant topic for pharmaceutical exporters.

The guidance is prepared in line with Rule 94 of the Drugs and Cosmetics Act, 1940, and aims to simplify and standardize the process for Indian manufacturers who:

• Have a valid license in Form 25 / Form 28 / Form 28-D (and their loan licences),

• Wish to manufacture approved or unapproved new drugs for export only.

This process applies to both:

• Unapproved APIs and formulations,

• Approved new drugs that are intended solely for foreign markets.

The Two-Step Process

The CDSCO procedure for obtaining an Export NOC is structured into two clear steps:

Step I: Online Registration & NOC Issuance

Manufacturers must first:

• Complete a one-time Integrated Registration Form (IRF) online for each product.

• Submit required documents, including:

  • Legal undertakings (Annexure I & II, digitally signed),

  • Copy of valid manufacturing licence,

  • NRA approval status or alternative evidence (like SRA approval or pharmacopeial status),

  • Reconciliation data of previous exports,

  • Details of the importing country and customers.

If all documents are in order, the CDSCO’s Zonal Office will issue the Export NOC within 7 working days, with a validity of 1 year or until the sanctioned quantity is exhausted — whichever comes first.

Step II: Release of Consignment at Port

Once an Export NOC is granted, manufacturers must:

• Use the Auto Fetch system to select the Export NOC when submitting shipment details.

• Fill reconciliation data at each consignment release.

• Upload key documents:

  • Certificate of Analysis (COA) / batch release certificate,

  • Export licence from State Licensing Authority (SLA),

  • Purchase order, export invoice, shipping bill details,

  • Original product labels showing “For export only – Not for domestic consumption.”

The port office verifies these details and, once satisfied, clears the consignment.

 National Regulatory Authority (NRA) NRA approval of the importing country is generally required, but the guidance offers alternatives:

• For unapproved APIs: pharmacopeial status in IP/USP/BP/JP/EP, or approval of formulations in SRA countries (US, EU, Japan, etc.).

• For unapproved finished formulations: SRA or importing country approval.

• For R&D or NCE batches: submission of IUPAC name, COA, and standard test procedure.

If the product has been approved by the NRA of the destination country for any firm, that approval can also be used by other applicants for the same product.

Manufacturers must submit legally binding undertakings, including:

• Commitment not to divert products for domestic use.

• Maintenance of stock registers and allowing inspections.

• Submission of export quantities via CDSCO’s online reconciliation module.

• Destruction of expired or non-utilised stock under SLA supervision.

• Assurance that labels meet Rule 94 requirements and say "For export only – Not for domestic consumption."

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