{"id":869039,"date":"2026-10-03T05:00:09","date_gmt":"2026-10-03T05:00:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/869039\/"},"modified":"2026-10-03T05:00:09","modified_gmt":"2026-10-03T05:00:09","slug":"fda-cancels-pune-cipla-facilitys-drug-sale-and-distribution-licences-mumbai-news","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/869039\/","title":{"rendered":"FDA cancels Pune Cipla facility’s drug sale and distribution licences | Mumbai News"},"content":{"rendered":"

\"FDAMaharashtra Food and Drug Administration has cancelled the drug sale and distribution licences of Cipla Pharma’s warehouse in Pune (Representative image) MUMBAI: Maharashtra Food and Drug Administration (FDA) on Friday said it has cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding warehouse at Wadki in Pune over alleged violations, a decision the firm said was “disappointing”.The action was taken after completion of fresh proceedings in compliance with the directions of Bombay High Court, FDA said in a statement.It follows an earlier FDA action taken against the facility on Aug 27 over alleged irregularities involving the packaging, storage, documentation and recall of Reactin Plus Tablets.The FDA had cited unauthorised claims on the packaging of the Schedule H prescription drug and several deficiencies at the warehouse.The latest order was passed on Oct 1 by Assistant Commissioner (Drugs), Division 3, FDA Pune, after the department withdrew its earlier proceedings in compliance with the directions of high court, FDA said.According to the statement, the department issued a revised show-cause notice to the company on Sept 4. Cipla submitted its written reply on Sept 11 and was given a personal hearing on Sept 21. The licensing authority considered the company’s reply, submissions made during the hearing, inspection findings, available records and applicable legal provisions before passing the fresh order.FDA said the latest decision was not merely a repetition of its earlier action but an independent regulatory decision taken after completing the entire process afresh in accordance with the court’s directions.One of the key issues involved Reactin Plus. FDA found the drug’s packaging carrying claims describing it as an analgesic and promoting its use for conditions including headache, muscular pain, backache, joint pain, sprain, body ache and toothache. FDA said the packaging carried a human figure and depicted the medicine as providing relief from muscular pain. It held the claims, wording and illustrations did not comply with statutory provisions and constituted an issue of misbranding under Drugs and Cosmetics Act, 1940. It further listed deficiencies in storage and warehouse management.FDA commissioner Tukaram Mundhe said the latest proceedings had been completed while fully respecting court directions and following principles of natural justice, transparency, an opportunity of hearing and a reasoned decision.In a statement, Cipla said it maintains an unwavering commitment to quality and patient safety. “We find the Maharashtra FDA’s decision regarding our Wadki C&FA in Pune disappointing. We believe our Pune C&FA warehouse operates in compliance with distribution and storage protocols and digital record-keeping standards,” it said. Cipla added it is reviewing the order and evaluating further options. “Cipla remains fully dedicated to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers,” the statement added. 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