The Central Drugs Standard Control Organization (CDSCO) issued a clarification regarding labeling activities for imported drugs, in line with Rule 104A of the Drugs and Cosmetics Rules, 1945.
According to the Office Memorandum dated May 26, 2025, the CDSCO emphasized that the permission granted under Rule 104A—pertaining to labeling, overprinting, stickering, or stamping—is applicable strictly for imported drugs. This reiteration follows a previous memorandum dated January 29, 2020, and is aimed at ensuring compliance and preventing misuse of the provision.
The memorandum highlights the following key points:
- All labeling-related activities for imported drugs must be conducted under a valid manufacturing license held by the importer.
- Importers must maintain proper facilities for storage, ancillary functions, and labeling. Additionally, they are required to appoint at least one manufacturing and quality assurance (QA) personnel, approved by the State Licensing Authority (SLA).
- A Quality Control (QC) laboratory and QC personnel are not mandatory for such labeling activities.
- The labeling must adhere to existing provisions of the Drugs and Cosmetics Rules and must not obscure the original label.
- Modifications made under Rule 104A must include the license number and a note stating that the labeling activity was carried out accordingly.
For instance, if a drug is intended for Central Government Health Scheme (CGHS) supply, the label must state: “CGHS Supply – Overprinting done under Lic. No. MH/….A”.
This move is intended to reinforce regulatory oversight while allowing limited flexibility in drug labeling for imported products, ensuring both transparency and traceability in the pharmaceutical supply chain.
The CDSCO has circulated the memorandum to all stakeholders via the official website and has also notified the Ministry of Health and Family Welfare.
