Manufacturers licensed under Form 25, 28, or 28-D (including loan licences) can apply to the CDSCO Zonal Offices for a No Objection Certificate (NOC) to manufacture unapproved or approved new drugs solely for export purposes. This guidance ensures standardisation and traceability, in line with Rule 94 of the Drugs and Cosmetics Act and MoHFW guidelines.

• Applicability:
  Applies to export of unapproved or approved new drugs (excluding NDPS and banned drugs). NOCs are issued with 1-year validity or until the approved quantity is exhausted, whichever is earlier.

Step-I: Online Registration with Zonal Office

• One-time registration via the Integrated Registration Form (IRF) is required.
• Zonal offices will verify and issue Export NOC within 7 working days.
• Documents required:
  • IRF/Export NOC form
  • Legal Undertaking (Annexure I for API, Annexure II for Formulation)
  • Manufacturing Licence (Form 25/28/28-D or respective loan licence)
  • Reconciliation data of prior NOCs
  • NRA approval status or equivalent regulatory documents (for API/FF/R&D/NCE)

Step-II: Consignment Release at Port Office

• After NOC is issued, consignment release requires:
  • Selection of valid NOC (auto-fetch)
  • Online submission of reconciliation details
  • COA/Test Certificate
  • Purchase Order/Export Invoice/Shipping Bill details
  • Original label of the product
  • Export Licence issued by SLA

Key Points:

1. PO-specific NOC discontinued, except for NDPS and banned drugs.
2. NOC validity is 1 year or until sanctioned quantity is used, whichever is earlier.
3. Formulation drugs: Unexported stock can be reused within 60% residual shelf life; otherwise, it must be destroyed.
4. API drugs: Unexported stock allowed within 3 months residual shelf life; beyond that, destruction is mandatory.
5. Timeline: NOC to be issued within 7 working days (Step I: 5 days, Step II: 2 days).
6. NDPS/banned drugs: Will continue to follow quantity-specific and PO-specific NOC for each consignment.