Maharashtra FDA Cancels Cipla Pune Unit's Drug Licence Over Reactin Plus Lapses

The cancellation came into effect on August 27 following inspections of the company’s main warehouse, while Cipla has contested the order, stating that the matter is currently under judicial consideration.

According to the FDA, the action followed multiple deficiencies identified during inspections of the company’s drug storage and distribution operations. During an inspection conducted around June this year, FDA officials reportedly found that the packaging of Reactin Plus Tablets carried an unauthorised claim describing the prescription medicine as an “analgesic and antipyretic”. The regulator stated that the claim had been made without the required permission and was contrary to the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. The FDA subsequently seized stock of Reactin Plus Tablets valued at approximately Rs 11.91 lakh in connection with the alleged violation.

The regulator directed the company to recall the affected Reactin Plus Tablets from the market. However, according to the FDA, the company did not fully comply with the recall-related directions and other corrective measures prescribed in the matter. A subsequent inspection of the C&F unit’s drug sale and distribution system reportedly identified further discrepancies, including differences between purchase and sale records and actual computerised stock records, along with non-compliance with directions concerning the recall of the medicines. Officials also found medicines stored directly on the floor and flagged inadequate arrangements for pallets and racks required for appropriate storage. Deficiencies were further identified in the records and procedures concerning the handling of expired medicines.

Following the findings, the Maharashtra FDA issued a show-cause notice to the licence holder and examined the company’s explanation. After considering the response, the regulator concluded that the deficiencies observed during the inspections, as well as the directions issued regarding the recall of Reactin Plus Tablets, had not been adequately complied with. The FDA subsequently cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd’s C&F unit at Wadki, Pune, with effect from August 27.

Meanwhile, Cipla has challenged the regulatory action and maintained that the matter is sub judice. In a statement, the company stated that the FDA order pertains to the operations of a C&F warehouse operated on behalf of Cipla Pharma & Life Sciences and that it would not be appropriate to comment further while the matter remains under judicial consideration. The company, however, clarified that the order does not allege any concerns regarding the safety, quality or efficacy of its products and does not involve or indicate any patient safety issue. Cipla also reiterated its commitment to maintaining high standards of quality, regulatory compliance and patient safety.

Commenting on the action, Maharashtra FDA Commissioner Tukaram Mundhe stated that the department would not show leniency in matters concerning drug safety and public health, particularly with regard to 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,” Mundhe told PTI.

India Today reports that Cipla continues to maintain that the FDA’s order does not raise concerns regarding the safety, quality or efficacy of its medicines and does not indicate any patient safety issue, while the matter remains under judicial consideration.