Maharashtra FDA cancels Cipla facility licences in Pune over Reactin Plus irregularities

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 at Wadki in Pune, due to serious irregularities found during inspections related to the company's Reactin Plus tablets.

During the inspection in June, FDA officials found unauthorised promotional text on the packaging of Reactin Plus, a Schedule H prescription medicine. The words "analgesic and antipyretic" were found on the packaging.

The regulator seized Reactin Plus stock worth over Rs 11 lakh and ordered the firm to recall the drug from the market, citing packaging violations as per the provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945. However, the company failed to fully comply with the directions.

The FDA said such promotion of a prescription medicine could encourage people to take the drug without medical advice, increasing the risk of self-medication.

The subsequent inspection of the company’s C&F operations also found irregularities in the storage and distribution of medicines. These included discrepancies between physical and computerised stock records, gaps in purchase and sale records, and non-compliance with recall directions.

The inspection also found medicines stored directly on the floor and inadequate pallet and rack facilities. There were also shortcomings in the records and procedures for handling expired medicines.

The FDA had issued a show-cause notice to the company over the alleged violations. Its response was examined by the FDA before the licences were cancelled under the relevant provisions of the Drugs and Cosmetics Act and Drugs Rules, the statement added.

FDA Commissioner Tukaram Mundhe said the department would not show any leniency on issues concerning drug safety and public health, particularly in the advertising, sale, storage and distribution of Schedule H prescription medicines.

"Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law," he added.

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