The company has contested Pune FDA’s order
FDA subsequently seized stock worth Rs 11.2 lakh and directed the company to recall the misbranded drug from the market. The licence was cancelled with effect from Aug 27, FDA said in a release on Friday. After examining its response, FDA cancelled the drug sale licences under provisions of Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945.
FDA joint commissioner (drug) Ganesh Rokade told TOI that the action followed an inspection of Cipla’s main warehouse in June, when officials found Schedule H prescription drug Reactin Plus carrying the words “analgesic and antipyretic” on its packaging. “Such labelling is not permitted,” said Rokade. Drug authorities said such labelling on a prescription drug could encourage self-medication and pose a public health risk.
A subsequent inspection of the C&F facility found several other irregularities, including discrepancies between physical and computerised drug stocks and purchase-sale records, deficiencies in storage, inadequate pallets and racks, and lapses in maintaining records and procedures for expired medicines. Following the inspection, the company was issued a show-cause notice.
Mumbai: State FDA has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding (C&F) facility at Wadki in Pune following violations detected during a follow-up investigation into the packaging and recall of Reactin Plus tablets.