What information is required on pharmaceutical labels in India?

Pharmaceutical labels in India are governed by the Drugs and Cosmetics Act and Rules and other applicable provisions, with required declarations varying by product type and drug schedule. Common information can include the drug name, manufacturer and licence details, batch number, manufacturing and expiry dates, storage conditions, dosage or caution statements where applicable, and other category-specific declarations. Serialisation or track-and-trace should be included only where the applicable rule or export requirement calls for it.

The detailed wording, symbols, warnings, and packaging requirements can vary significantly between prescription medicines, OTC products, scheduled drugs, biologicals, and other categories. GMP requirements also affect packaging controls and product integrity, but the exact tamper-evidence or closure specification should not be assumed from a generic label rule. Regulatory affairs review is therefore necessary for the specific product and pack format.

For export drug formulations, India maintains DGFT track-and-trace and barcode requirements at defined packaging levels as applicable, commonly using GS1 standards. The exact current requirement can change through DGFT notifications and may differ between primary, secondary, and tertiary packaging. Brands should confirm the latest DGFT, CDSCO, and destination-market requirements before printing; this answer is general information and not a substitute for regulatory or legal advice.