Maharashtra FDA Cancels Cipla Pune Drug Sale Licences Over Regulatory Breaches

The Maharashtra Food and Drug Administration has cancelled the drug sale licences of a Cipla Pharma Life Sciences Ltd. facility in Pune, citing serious regulatory breaches involving the storage, recordkeeping, and promotional packaging of a prescription medicine. The action, effective from August 27, 2026, follows inspections that uncovered multiple irregularities at the company's Carry and Forwarding agent warehouse in Wadki.

The regulatory action was initiated after an inspection in June 2026 found that the packaging for Reactin Plus Tablets, a Schedule H prescription medicine, contained unauthorised promotional text describing the drug as an "analgesic and antipyretic." The FDA stated that such advertising of a prescription medication could encourage self-medication and pose risks to public health. Officials seized stock of the misbranded tablets valued at Rs 11.19 lakh and directed the firm to recall the product from the market.

A subsequent inspection of the facility's operations revealed further non-compliance. Inspectors found discrepancies between physical stock and computerised purchase and sales records, improper storage with medicines placed directly on the floor, and...