The Central Drugs Standard Control Organization (“CDSCO”), under the Directorate General of Health Services, Ministry of Health and Family Welfare, has issued a clarification vide Office Memorandum dated 26.05.2025, in continuation of its earlier OM dated 24.11.2020. This clarification aims to simplify and further define the conditions applicable for overprinting, stickering, or stamping of imported drugs under Rule 104A of the Drugs and Cosmetics Rules, 1945.

Key Highlights:

1. The activity of labelling/overprinting/stickering is permitted strictly for imported drugs only, as per the existing provisions of Rule 104A
2. Such labelling activities must be carried out by the importer under a valid manufacturing license issued in their name
3. The licensed premises must include adequate facilities for storage, ancillary services, and labelling activities, and must appoint at least one manufacturing and one QA personnel to the satisfaction of the State Licensing Authority (SLA). A dedicated QC laboratory and personnel are not required for this purpose
4. Labelling activities must comply with all applicable labelling requirements under the Drugs and Cosmetics Rules and must not conceal the original label on the imported drug
5. The license number and details of the labelling activity must be clearly mentioned alongside any alterations made to the original label. Example: If the label is to include the term “CGHS Supply,” it must state — “CGHS Supply Overprinting done under Lic. No. MH…A”
6. The CDSCO reiterates that, based on the OM dated 24.11.2020, a comprehensive permission may be sought by importers for multiple products rather than applying individually for each product. This is applicable where the labelling is required for the following categories:
   1. For Hospital/Institution/Government Supply – Not to be Sold
   2. For Physician’s Sample – Not to be Sold
   3. For Managed Access Program/Clinical Trial Use Only/For Post-Trial Access Only – Not to be Sold
7. Labelling must be carried out only at licensed manufacturing premises, subject to the satisfaction of the concerned SLA.

A Copy of the Office Memorandum is linked below for your ease of reference.

Source: Central Drugs Standard Control Organization

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