The Maharashtra Food and Drug Administration (FDA) has cancelled the carry and forwarding (C&F) drug sale and distribution licences of Cipla Pharma & Life Sciences (CPPL) at Vadki in Pune, citing multiple violations of drug regulations and deficiencies in pharmaceutical storage, inventory management and distribution practices.

The licences were cancelled with effect from August 27, 2026, following an inspection of the company’s main warehouse at Vadki and a subsequent show-cause notice issued by the regulator.

The regulatory action stems from an inspection conducted around June 2026, during which Maharashtra FDA officials found that the packaging of ‘Reactin Plus tablets’, a Schedule H prescription medicine, contained unauthorised wording describing the product as an ‘analgesic and antipyretic.’ The FDA said the wording constituted advertising on the packaging of a prescription medicine and violated provisions of the Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945.

Following the finding, the regulator seized ‘Reactin Plus’ stock valued at approximately INR 11.19 lakh and directed the concerned entity to recall the misbranded product from the market. The FDA later determined that the required recall measures and directions had not been fully implemented.

The inspection also highlighted broader deficiencies in the C&F entity’s drug storage and distribution operations. These included discrepancies between purchase and sales records, computerised inventory data and the physical stock found at the premises.

In some instances, the actual quantity of medicines did not correspond with the quantities recorded in the computerised system. The regulator also found drug stock stored directly on the floor, while the availability and arrangement of appropriate pallets and racks were found to be inadequate for proper pharmaceutical storage.

Further deficiencies were identified in record maintenance and procedures for the handling and management of expired medicines, raising concerns over inventory control and distribution practices.

The Maharashtra FDA subsequently issued a show-cause notice to the concerned licence holder. According to the department, the explanation submitted by the firm did not adequately address the deficiencies identified during the inspection or demonstrate satisfactory compliance with the recall directions concerning ‘Reactin Plus’ and other regulatory requirements.

Based on the inspection findings and the response to the show-cause notice, the FDA cancelled the drug sale and distribution licences under the applicable provisions of the Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945.

The action underscores the importance of compliance across the pharmaceutical supply chain, extending beyond manufacturing facilities to warehouses and distribution centres. Accurate inventory reconciliation, appropriate storage infrastructure, proper management of expired medicines, maintenance of records and timely implementation of regulatory recalls are critical components of pharmaceutical distribution compliance.

Maharashtra FDA Commissioner Tukaram Mundhe said the department would continue to take strict regulatory action against entities that fail to meet statutory requirements concerning medicines.

“The Food and Drug Administration will not show any leniency regarding the safety of medicines and the health of citizens. Strict adherence to legal provisions is mandatory, particularly concerning the advertising, sale, storage, and distribution of prescription drugs such as those under Schedule H. Any entity within the pharmaceutical manufacturing and distribution system found violating regulations will face stringent legal action,” Mundhe said.

The cancellation puts renewed focus on compliance controls at the C&F and distribution level, particularly as regulators continue to emphasise product traceability, proper storage, inventory accuracy and effective execution of market recalls.