Cipla Pune facility loses drug sale license after FDA inspection

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale license of Cipla Pharma and Life Sciences Limited’s Carry and Forwarding (C&F) facility located in Wadki, Pune. The decision follows inspections that revealed serious irregularities regarding the Schedule H drug, Reactin Plus.

Regulatory officials discovered unauthorized promotional claims on the packaging of Reactin Plus, which included terms like ‘pain reliever and antipyretic’ without necessary permission. The FDA noted that such advertising for prescription-only medication could encourage self-medication. Although the agency ordered a market recall of the tablets, Cipla failed to comply fully with these instructions.

Further inspections of the Pune facility uncovered significant storage and record-keeping violations. These included discrepancies between physical and computerized stock records, inadequate storage infrastructure—such as medicines being kept directly on the floor without sufficient racks or pallets—and improper management of expired drug records. The FDA seized stock valued at approximately ₹11.91 lakh during the investigation.