The Maharashtra Food and Drug Administration has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding unit in Pune after inspections found alleged irregularities involving storage, packaging, recall procedures and distribution records.
The cancellation took effect on August 27 following regulatory scrutiny of the company’s primary warehouse at Wadki in Pune district.
Reactin Plus Packaging Triggers Action
The regulatory action followed an inspection conducted around June, during which FDA officials found that the packaging of Reactin Plus Tablets, a Schedule H prescription drug, carried an unauthorised claim describing the medicine as an “analgesic and antipyretic”.
Acting on the findings, the FDA seized stock valued at ₹11.19 lakh. The regulator said such promotional claims violated provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Following the inspection, the company was directed to withdraw the affected Reactin Plus Tablets from the market. The FDA, however, said the company did not fully comply with the recall instructions and other measures required by the regulator. The failure to adequately implement the recall became one of the issues considered while examining whether the unit was complying with drug sale and distribution requirements.
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Storage and Stock Records Under Scrutiny
A subsequent examination of the Pune unit’s sales and distribution system uncovered further alleged deficiencies. Inspectors reported discrepancies between computerised stock records and physical purchase-and-sale records. The FDA also cited inadequate pallet and rack arrangements, medicines being stored directly on the floor and deficiencies in procedures for handling expired drugs.
Following these findings, the regulator issued a show-cause notice to the licence holder. After assessing the company’s response, the authority concluded that the deficiencies identified during inspections and the directions relating to the recall had not been adequately addressed.
The FDA subsequently cancelled the drug sale licences of the C&F unit, citing what it described as serious irregularities concerning the handling and distribution of medicines.
FDA Warns of Strict Action, Cipla Contests Order
Maharashtra FDA Commissioner Tukaram Mundhe said the department would maintain a zero-tolerance approach towards violations affecting public health and drug safety, particularly those involving 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 said.
The regulator said particular attention would be paid to the advertising, sale, storage and distribution of prescription medicines as part of its enforcement efforts. Cipla Pharma & Life Sciences has contested the Pune FDA’s order cancelling the licences of the unit. The company has said the matter is currently sub judice.
The regulatory dispute follows the FDA’s findings concerning the Reactin Plus packaging, the subsequent market recall and alleged discrepancies identified at the warehouse. The cancellation remains a significant enforcement action affecting the company’s Pune C&F operations while its challenge to the order proceeds.
