CDSCO Issues Comprehensive Export NOC Guidelines for Unapproved & Approved New Drugs

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Dated: 09.05.2025

CDSCO Issues Comprehensive Export NOC Guidelines for Unapproved & Approved New Drugs

The Central Drugs Standard Control Organisation (CDSCO) has released a comprehensive guidance document to streamline the issuance of No Objection Certificates (NOCs) for Indian manufacturers seeking to export unapproved or approved new drugs. This initiative, based on Rule 94 of the Drugs and Cosmetics Act, 1940, is crucial for exporters navigating compliance with international pharmaceutical trade protocols.

Objective of the Guidance

To define the two-step online procedure for obtaining Export NOCs for:

Unapproved Active Pharmaceutical Ingredients (APIs)
Approved New Drugs
Fixed Dose Combinations (FDCs) intended only for export

This policy excludes NDPS and banned drugs unless specified, and enforces strict reconciliation, documentation, and shelf-life protocols.

Step-I: One-Time Online Registration with CDSCO Zonal Office

Before exporting, manufacturers must complete a one-time Integrated Registration Form (IRF) and submit the following:

Export NOC / IRF Form – System-generated and digitally signed.
Legal Undertakings (Annexure-I & II) – By API/formulation manufacturers.
Valid Manufacturing License – In Form 25/28/28-D including loan licenses.
Reconciliation Data – For prior NOCs showing batch-wise export records.
NRA Approval / Supporting Docs – Proof of acceptance by importing country or reference to SRA approvals like USFDA, EMA, etc.

Timeline for NOC Issuance: Within 7 working days (5 for Step-I, 2 for Step-II)

Step-II: Consignment Release at Port Office

After securing the Export NOC, the exporter must present:

Valid NOC reference
Online reconciliation details per consignment
COA/Test Certificate
PO/Invoice/Shipping Bill details
Product labels with “For Export Only”
Export license issued by the SLA

The reconciliation module remains active throughout the 1-year NOC validity.

Key Compliance Conditions

NOC is valid for 1 year or till quantity exhaustion, whichever is earlier.
Unexported stock must be used within:
- 60% residual shelf-life for formulations
- 3 months residual shelf-life for APIs
- Else, mandatory destruction in presence of State Licensing Authority.
For NDPS/banned drugs, only PO-specific, quantity-specific NOCs are issued.

Legal Undertakings (Annexure I & II)

Undertakings must ensure:

No domestic diversion
Labeling as per Rule 94
Export-only usage
Open access for inspections
Real-time reconciliation via CDSCO’s portal

Failure to comply or submission of falsified documents leads to NOC cancellation and 1-year bar on future applications.

Conclusion

This guidance reflects CDSCO’s proactive approach in aligning with global pharmaceutical norms while maintaining stringent regulatory oversight. Indian exporters now have a clear, time-bound framework for securing NOCs, ensuring both compliance and competitiveness in global markets.

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Source: CDSCO

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