The Central Drugs Standard Control Organisation (‘CDSCO’), has issued a Guidance Document for Issuance of No Objection Certificate (“NOC”) for the manufacture of unapproved or approved new drugs for export purposes under the Drugs and Cosmetics Rules, 1945. This document outlines a structured two-step online process applicable to manufacturers holding a valid Form 25/28/28-D license (or respective loan licenses), and applies to all such drugs, excluding narcotic/psychotropic substances (“NDPS”) and banned drugs. The guidance replaces any earlier procedural ambiguity with a clearly defined registration and reconciliation-based model for obtaining and utilising Export NOCs.

Key Highlights:

1. Eligibility and Scope: Applicable to manufacturers holding a valid Form 25/28/28-D license (including loan licensees) for export of unapproved/approved new drugs from India. Not applicable to NDPS or banned drugs.
2. Two-Step Procedure for Export NOC:
   1. Step I:
      • One-time online registration via Integrated Registration Form, followed by NOC issuance within 7 working days (5 days for Step I).
      • Submission of documents such as manufacturing license, legal undertakings (Annexure I & II), reconciliation data, and approval status from the NRA (of importing country/SRA/India).
   2. Step II:
      • Clearance of export consignments at the port office by submitting export NOC, updated reconciliation details, COA, PO/Invoice/Shipping Bill, product label, and export license. Port clearance to be completed within 2 working days.
3. Validity and Shelf-life Norms:
   • Export NOCs will now carry a 1-year validity or till sanctioned quantity exhaustion, whichever is earlier.
   • Un-exported formulations may be used for a subsequent export order if they retain at least 60% of shelf life; otherwise, they must be destroyed in the presence of the State Licensing Authority (SLA).
   • For APIs, this period is limited to a 3-month residual shelf life.
4. Such NOCs are now discontinued except for NDPS and banned drugs, which still require quantity- and PO-specific NOCs.
5. Submission of falsified documents may lead to NOC cancellation and debarment for one year.

The guidance document is linked below, for your ease of reference.

Source: Central Drugs Standard Control Organisation

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