The Maharashtra Food and Drug Administration has cancelled the wholesale drug sale licence of Cipla Pharma and Life Sciences’ warehouse at Wadki in Pune after finding irregularities involving medicine packaging, storage, records and warehouse management.
FDA Commissioner Tukaram Mundhe said the action was taken after completion of the legal and regulatory process. He said the inspection identified issues relating to the packaging and promotion of Reactin Plus Tablets, along with deficiencies in the storage, record-keeping and management of medicines at the facility.
The FDA said Reactin Plus, a Schedule H drug, was found during an inspection of the warehouse. Officials said the product was advertised as an “Analgesic and Anti-inflammatory” offering relief from headache, muscular pain, backache, joint pain, pain caused by sprain, body ache and toothache. The carton also carried an illustration of a human figure intended to show a reduction in muscular pain after use of the medicine.
Girish Hukare, Joint Commissioner (Drug), Pune, said the claims, text and illustration on the packaging did not comply with applicable statutory requirements. “The matter raised issues of misbranding under the Drugs and Cosmetics Act, 1940 which resulted in the regulatory action,” he said.
The inspection also recorded several warehouse-management deficiencies. According to the FDA’s official press statement, the facility did not have the Form 35 inspection book required under the applicable rules. Medicine boxes were stored directly on the floor because of inadequate pallets or racks, while officials also found dust on medicine stocks and shortcomings in cleanliness. The warehouse did not have a clearly designated area marked “Expiry – Not for Sale” for expired medicines.
Other findings included the absence of authorised-person signatures on duplicate copies of sales invoices and discrepancies between computer or SAP records and other documentation. The FDA said its objective was not limited to regulatory action, but included ensuring the safety and quality of medicines and statutory compliance across the drug supply chain.
Cipla said it was disappointed by the Maharashtra FDA’s decision. The company said its Pune carrying and forwarding agent warehouse operated in compliance with distribution and storage protocols and digital record-keeping standards. It said it was reviewing the order and evaluating further options, while remaining committed to uninterrupted access to medicines for patients and healthcare providers.
The latest decision follows an earlier dispute over the cancellation of the warehouse’s drug sale licence. Cipla had contested the earlier Pune FDA order and said at the time that it did not allege concerns about the safety, quality or efficacy of its products or indicate a patient-safety issue.
FDA officials said the earlier proceedings were withdrawn in compliance with directions from the Bombay High Court. A revised show-cause notice was issued on September 4, Cipla submitted its written reply on September 11, and the company was given an opportunity for a personal hearing on September 21. The FDA described the latest action as an independent regulatory decision taken afresh after following the prescribed process, including an opportunity of hearing and a reasoned decision.
