The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd’s Carrying and Forwarding (C&F) unit in Pune, citing serious regulatory irregularities involving the packaging, storage and recall of Reactin Plus Tablets. The cancellation took effect on August 27, 2026, following inspections of the company’s warehouse at Wadki in Pune district.
Why Did Maharashtra FDA Cancel Cipla’s Licence?
According to the FDA, officials inspected the facility in June and found that the packaging of Reactin Plus, a Schedule H prescription medicine, carried an unauthorised claim describing the drug as an “analgesic and antipyretic.”
The regulator said the promotional wording was not authorised and was contrary to provisions of the Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945. The FDA subsequently seized Reactin Plus stock valued at approximately ₹11.19 lakh and directed the company to recall the affected medicine from the market.
Storage and Record-Keeping Lapses Found
A subsequent inspection of Cipla’s C&F operations reportedly found several additional deficiencies in the drug storage and distribution system.
The FDA cited discrepancies between purchase and sales records, computerised inventory and physical stock. Inspectors also reportedly found medicines being stored directly on the floor, along with inadequate pallet and rack arrangements.
The regulator further flagged deficiencies in records and procedures relating to expired medicines and alleged that the company had not fully complied with directions concerning the recall of Reactin Plus tablets.
Following the findings, the FDA issued a show-cause notice to the licence holder and examined the company's response. After considering the explanation, the regulator concluded that the deficiencies and recall-related directions had not been adequately addressed and cancelled the drug sale licences.
Cipla Challenges the FDA Order
Cipla has contested the Maharashtra FDA's order and said the matter is currently sub judice.
The company also clarified that the FDA's action does not allege any concerns regarding the safety, quality or efficacy of its medicines, nor does it indicate a patient-safety issue. Cipla said it continues to maintain its commitment to quality, regulatory compliance and patient safety.
The action therefore specifically concerns the operations of the C&F warehouse in Pune, rather than being described by Cipla as a finding that its medicines are generally unsafe.
Maharashtra FDA Warns of Strict Action
Maharashtra 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.
The regulator's action highlights the importance of maintaining proper storage conditions, accurate inventory records and compliance with medicine recall directions across pharmaceutical distribution networks.
The matter is now under judicial consideration following Cipla's challenge, while the licence cancellation remains effective from August 27.
