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.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. 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.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. Some medicines were also found stored on the floor.Following the inspection, the company was issued a show-cause notice. After examining its response, FDA cancelled the drug sale licences under provisions of Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945.A spokesperson for Cipla Pharma & Life Sciences said the company had contested the Pune FDA’s order. “As the issue is under judicial consideration, it would not be appropriate to comment further on the proceedings at this stage. We would, however, like to clarify that the order does not allege any concerns relating to the safety, quality or efficacy of our products, nor does it involve or indicate any patient safety issue.”
