Maharashtra FDA Cancels Drug Sale Licences for Cipla's Wadki Facility in Pune
The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd's carrying and forwarding facility located at Wadki in Pune. The action came after authorities identified violations during an investigation into the packaging and recall of Reactin Plus tablets.
The regulatory action followed an inspection of Cipla's main warehouse in June, during which officials found that the Schedule H prescription drug Reactin Plus bore the words "analgesic and antipyretic" on its packaging. FDA Joint Commissioner (Drug) Ganesh Rokade stated that such labelling is prohibited on prescription medications.
Drug control authorities noted that displaying such labelling on a prescription medication could encourage self-medication and create public health risks. Following the discovery, the FDA seized stock valued at Rs 11.2 lakh and ordered the company to recall the misbranded medication from the market.
The licence cancellation took effect on August 27, the FDA announced in an official release.
A subsequent inspection of the Wadki C&F facility revealed several additional irregularities. These included discrepancies between physical drug stocks and computerised inventory and purchase-sale records, inadequate storage conditions, a lack of sufficient pallets and racks, and lapses in maintaining standard procedures and records for expired medicines.
