Pune: FDA Cancels Cipla C&F Drug Sale Licence, Seizes Reactin Plus Stock Worth Rs 11.19 Lakh
Pune, 29th August 2026: The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd’s carry and forwarding (C&F) agency in Wadki, Pune, and seized misbranded Reactin Plus Tablets worth Rs 11.19 lakh, the department said in an official statement on Friday.
According to the FDA, an inspection in June found irregularities in the packaging of Reactin Plus, a Schedule H prescription medicine. The packaging carried the words “Analgesic and Antipyretic” along with advertising/promotional material that was found inconsistent with provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
The FDA said such advertising could encourage consumers to purchase and use prescription medicines without consulting a doctor, potentially posing a public health risk. The company was directed to withdraw the tablets from the market but failed to fully comply with the directions, the statement said.
The inspection also found deficiencies in the storage and distribution system, discrepancies between purchase and sales records and computerised records and physical stock, and non-compliance with medicine recall instructions. Medicines were also found stored directly on the floor, with inadequate racks for proper storage.
FDA Commissioner Tukaram Mundhe said no negligence would be tolerated concerning medicine safety and public health. “In particular, medicines classified under Schedule H, which are prescription medicines, must be subject to strict compliance with all applicable legal requirements governing their advertising, sale, storage and distribution,” he said.
Cipla Pharma & Life Sciences, however, said it had contested the Pune FDA’s order and that the matter was sub judice.
“Cipla Pharma & Life Sciences (CPLS) has contested the Pune FDA’s order pertaining to the operations of a C&F warehouse operated on behalf of CPLS and the matter is currently sub judice. As the issue is under judicial consideration, it would not be appropriate to comment further on the proceedings at this stage. We would, however, like to clarify that the order does not allege any concerns relating to the safety, quality or efficacy of our products, nor does it involve or indicate any patient safety issue. Cipla has been a trusted healthcare organization for nine decades and continues to uphold the highest standards of quality, regulatory compliance and patient safety.”
