States » WestPosted at: Oct 2 2026 8:37PM


FDA Cancels Cipla Pharma’s Pune C&F Wholesale Drug Licences Following HC Direction

Mumbai, Oct 2 (UNI) The Maharashtra Food and Drug Administration (FDA) has cancelled the wholesale drug sale licences of M/s Cipla Pharma & Life Sciences Ltd at Godown No. A, Wadaki, Pune, following directions of the Bombay High Court.
FDA Commissioner Tukaram Mundhe said the action was taken after completion of the prescribed procedure in Writ Petition No. 11376/2026.
Following the High Court's directions, the earlier action was withdrawn and a revised show-cause notice was issued on September 4. The company submitted its written reply on September 11 and was given a personal hearing on September 21.
After considering the company's reply, submissions made during the hearing, inspection findings and applicable legal provisions, the Assistant Commissioner (Drugs) and Licensing Authority, Circle-3, Pune, cancelled the C&F wholesale licences on October 1.
During inspection, the FDA found several regulatory and storage-related lapses.
The inspection found stock of Schedule H drug Reactin Plus carrying packaging claims describing it as an "Analgesic & Anti-inflammatory" offering quick relief from various types of pain, along with a human-body illustration depicting muscle pain relief. The authority treated the packaging as misbranding under the Drugs and Cosmetics Act, 1940, and held that the marketer could not avoid responsibility by relying solely on the manufacturer.
The inspection also found that the prescribed Form 35 inspection book was unavailable, drug boxes were stored directly on the floor, and there were dust and sanitation-related deficiencies.
The FDA further noted the absence of a clearly identified area and board for expired drugs, as well as a lack of standard operating procedures and records relating to their disposal.
Other deficiencies included purchase invoices without serial numbers, lapses in signatures of the competent person on sale invoices, and discrepancies between computer/SAP records and physical stock, including antibiotics.
The order observed that maintaining records in SAP does not exempt a licence holder from maintaining statutory records and complying with requirements relating to safe storage, hygiene and inspection documentation.
Mundhe said the FDA's objective was not merely enforcement but also ensuring drug safety, quality and statutory compliance across the pharmaceutical supply chain.
He said the action was completed in accordance with the High Court's directions and after providing the company with an opportunity to respond and be heard.
The FDA would continue to take action as per law to ensure quality and safety, he added.
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