FDA Cancels Cipla Pune Unit's Drug Sale Licence Over Reactin Plus Irregularities

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding (C&F) unit in Pune over serious irregularities related to the packaging, storage, record-keeping and recall of Reactin Plus Tablets. The cancellation came into effect on August 27 following an inspection of the company's main warehouse at Wadki in Pune district. The regulator found that medicines were stored directly on the floor, there were deficiencies in procedures for handling expired medicines, and Reactin Plus tablets were misbranded with unauthorised claims. Stock worth Rs 11.19 lakh was seized, and the company was directed to recall the drug from the market but did not fully comply. The FDA subsequently issued a show-cause notice, and after examining the company's explanation, found that the deficiencies and recall directions had not been adequately complied with.