Maharashtra FDA Cancels Cipla's Pune Facility Drug Licences Over ‘Unauthorised Promotional Text'

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd’s carry and forwarding (C&F) facility in Wadki, Pune, following inspections that uncovered multiple regulatory violations involving the distribution and handling of medicines.

The cancellation took effect on August 27, FDA officials said on Friday, as reported by Hindustan Times.

The action followed an inspection of the company’s main warehouse in June, during which officials flagged packaging on Reactin Plus, a Schedule H prescription medicine. The FDA found the words “analgesic and antipyretic” printed on the product packaging, describing this as unauthorised promotional information.

The regulator said such labelling could encourage consumers to use a prescription medicine without consulting a doctor, potentially increasing the risk of self-medication.

The FDA subsequently seized Reactin Plus stock valued at ₹11.19 lakh and directed the company to recall the medicine from the market. The regulator cited provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 in taking the action.

A further inspection of the C&F facility found additional shortcomings related to the storage, documentation and distribution of medicines.

Among the issues identified were differences between the physical inventory and computerised stock records, inconsistencies in purchase and sales documentation, and failure to comply with the directions issued for recalling the medicine.

Inspectors also found medicines placed directly on the floor, along with inadequate pallet and rack arrangements at the facility. The FDA additionally pointed to deficiencies in the systems and records used for managing expired medicines.

The regulator issued a show-cause notice to the company over the alleged violations and subsequently examined its response.

Following that process, the FDA decided to cancel the drug sale licences of the facility under the applicable provisions of the Drugs and Cosmetics Act and Rules.

The action against the Pune facility comes after the regulator's inspections identified concerns spanning both the labelling of a prescription medicine and the procedures followed for storing, recording and distributing pharmaceutical products.