Drugs Rules 1945, Part IX labelling
Drugs Rules, 1945 (formerly Drugs and Cosmetics Rules), Part IX: labelling and packing of drugs
Summary
India's detailed labelling rules: name with the proper name more prominent than the brand, content, licence number, batch, manufacturing and expiry dates, MRP, manufacturer address, and the schedule-specific warnings and symbols.
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Key labelling requirements (4), transition and timeline notes, related documents and CSV export are available to testers.
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Relevance by packaging component
| Component | Relevance | What it concerns |
|---|---|---|
| CartonOuter packaging / folding carton | D Direct | |
| LabelImmediate container label (bottle, tube, large vial, bag) | D Direct | |
| Blister / foilBlisters, strips, sachets, lidding foil | D Direct | |
| Small unitSmall immediate packaging: ampoule, small vial, cartridge, pen | D Direct | |
| LeafletPackage leaflet / PIL, package insert, prescribing information, Medication Guide | I Indirect | |
| DeviceIntegral or co-packaged device and its instructions for use | – | |
| Shipper / caseTertiary packaging: shipping case, homogeneous case, pallet | – | |
| e-LabellingElectronic product information, QR / 2D-code linked content | – |
packart.dev summary, not a quotation of the source. Confirm requirements in the official text before regulatory use.