CDSCO Issues Clarification on Labeling Permissions for Imported Drugs Under Rule 104A

The Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare has issued a key clarification on 26 May 2025 regarding labeling, stickering, and overprinting on imported pharmaceutical products, under Rule 104A of the Drugs and Cosmetics Rules, 1945.

This Office Memorandum is issued in continuation of CDSCO’s earlier circular dated 29 January 2020, and provides additional clarity for importers engaged in labeling modifications of imported drug consignments.

Scope of the Clarification

The permission under Rule 104A is intended strictly for drugs imported into India and where additional labeling is needed — such as for regulatory disclosures, channel-specific supply (e.g., CGHS), or local compliance requirements.

Key Conditions Outlined in the CDSCO Clarification

Applicable Only to Imports
- The labeling/overprinting/stickering activity allowed under Rule 104A is strictly limited to imported drugs.
Manufacturing License Mandatory
- The importer must possess a valid manufacturing license in their own name.
- This ensures regulatory accountability even for post-import labeling modifications.
Infrastructure Requirements
- The license holder must have:
  - Adequate storage and labeling infrastructure
  - Designated manufacturing and QA personnel
- QC laboratory and personnel are not mandatory for this activity, easing the burden on importers.
Labeling Compliance
- The new label should not obscure or conceal the original manufacturer’s label.
- All additions must comply with the Drugs and Cosmetics Rules.
- The license number and nature of overprinting must be clearly disclosed alongside.
Example Format Provided
- If overprinting is done to indicate that the drug is for CGHS supply, it should read:
  “CGHS Supply – Overprinting done under Lic. No. MH/…A”

Regulatory Intent

This clarification aims to:

Reinforce transparency and traceability in post-import labeling of pharmaceutical products.
Ensure manufacturing license oversight for quality and compliance.
Facilitate regulatory flexibility while maintaining drug safety and labeling integrity.

Implications for Importers & Distributors

Importers planning to add overprinted labels must secure the relevant manufacturing license and establish compliance-ready facilities.
All labeling modifications should be properly documented and traceable to the license holder.
This update provides regulatory certainty, especially for drugs intended for institutional supply such as CGHS, ESI, and state procurement agencies.

Conclusion

With this latest clarification, CDSCO has created a structured compliance pathway for overprinting/stickering on imported drugs. Importers must now revisit their labeling operations to ensure alignment with Rule 104A and avoid regulatory risks.

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Source: CDSCO

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