Maharashtra FDA revokes licences for Cipla's Pune warehouse over illegal drug claims

Following a Bombay High Court order, the Maharashtra FDA's Pune division revoked the licences of Cipla Pharma & Life Sciences Ltd's warehouse in Vadki, Pune, on October 1. The decision stemmed from findings that the packaging of Reactin Plus tablets, a Schedule H prescription drug, contained unauthorized claims portraying it as a pain-relief remedy for headaches, muscular pain, backache, joint pain, sprains, body ache and toothache, along with a human figure illustration, which the regulator deemed misbranding under the Drugs and Cosmetics Act, 1940.

Additional inspections revealed medicines stored directly on the floor without proper pallets, dust accumulation, inadequate segregation of expired stock, and missing disposal procedures. Discrepancies were also noted between SAP records and physical inventory, including antibiotics, and gaps in purchase and sales invoicing. After reviewing the company's reply, hearing submissions and the inspection findings, the licensing authority issued a reasoned order cancelling the licences. FDA Commissioner Tukaram Mundhe said the action is intended to ensure drug safety, proper storage and statutory compliance throughout the supply chain.