Cipla Pharma Pune Unit Drug Sale Licence Cancelled

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale and distribution licences of the Carrying and Forwarding (C&F) warehouse of Cipla Pharma & Life Sciences Ltd

at Wadki in Pune, citing alleged regulatory violations. The fresh cancellation order was issued on October 1, 2026, after the regulator completed proceedings directed by the Bombay High Court. Reactin Plus Tablets The case primarily relates to Reactin Plus Tablets, a Schedule H prescription medicine. According to the FDA, inspections found that the medicine’s packaging carried promotional or therapeutic claims, including the words “Analgesic and Antipyretic,” which the regulator considered inconsistent with applicable provisions of the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The FDA also cited alleged deficiencies involving storage conditions, documentation, inventory management and the handling of expired medicines. Regulatory dispute The regulatory dispute has a significant procedural history. An earlier licence cancellation issued in August was withdrawn after the Bombay High Court questioned the procedure followed by the FDA and directed that Cipla be given a proper opportunity to respond. The regulator subsequently issued a revised show-cause notice on September 4. Cipla submitted its written response on September 11 and was granted a personal hearing on September 21. After reviewing the company’s submissions and inspection records, the FDA issued the fresh cancellation order. Cipla’s response Cipla has described the latest decision as disappointing and said it is reviewing the order. Importantly, the company has maintained that the regulatory action does not raise concerns about the safety, quality or efficacy of its medicines or indicate a patient-safety issue. The development highlights the increasing regulatory focus on compliance across pharmaceutical packaging, warehousing, documentation and distribution operations.