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) unit in Pune, citing serious regulatory lapses involving the storage, packaging and recall of Reactin Plus Tablets. The company has challenged the order, stating that the matter is currently sub-judice.
Licence Cancellation Takes Effect
The FDA said the cancellation came into effect on August 27, 2026, following inspections of the company’s main warehouse at Wadki in Pune district. The regulator cited multiple deficiencies in the unit’s drug storage and distribution practices.
Packaging Claim Raises Regulatory Concerns
During an inspection conducted around June, FDA officials allegedly found that the packaging of Reactin Plus Tablets, a prescription medicine, carried an unauthorised claim describing the drug as an “analgesic and antipyretic.” The regulator seized stock valued at approximately ₹11.19 lakh, citing violations of the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
Recall Compliance Under Scrutiny
Following the seizure, the FDA directed the company to recall the allegedly misbranded tablets from the market. According to the regulator, the recall instructions were not fully complied with.
A subsequent inspection reportedly identified discrepancies between physical stock, purchase and sale records, and computerised inventory records.
Storage and Expired-Medicine Procedures Flagged
The FDA also highlighted several warehouse-related deficiencies, including medicines being stored directly on the floor, inadequate pallet and rack arrangements, and shortcomings in procedures and documentation for handling expired medicines.
FDA Warns Against Regulatory Violations
FDA Commissioner Tukaram Mundhe said the department would take strict action over violations involving the advertising, sale, storage and distribution of Schedule H prescription medicines. He stressed that drug safety and public health would remain a priority.
Cipla Challenges the Order
Cipla Pharma & Life Sciences said it has contested the FDA’s order and that the matter is under judicial consideration. The company further clarified that the order does not allege concerns regarding the safety, quality or efficacy of its products and does not indicate any patient safety issue.
