Maharashtra FDA Cancels Cipla Unit's Drug Sale Licences at Wadki 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 regulatory measure took effect from August 27 following an investigation into mislabelling, storage deficiencies, and record-keeping lapses.

The regulatory action originated from an inspection carried out at Cipla's main warehouse in June. During that visit, drug control officials discovered that packaging for Reactin Plus, a Schedule H prescription drug, carried the words "analgesic and antipyretic."

FDA Joint Commissioner (Drug) Ganesh Rokade stated that such labelling is not permitted under the rules. Drug control authorities explained that printing such descriptions on prescription-only medicines could encourage self-medication among consumers and create significant public health risks. Following the initial inspection, the FDA seized stock valued at Rs 11.2 lakh and instructed the pharmaceutical company to recall the misbranded drug from the market.

A subsequent follow-up inspection conducted at the Wadki carrying and forwarding facility revealed several additional regulatory violations. Drug inspectors identified discrepancies between the physical stock stored at the site and the computerized inventory numbers, as well as inconsistencies across purchase and sale records.

The inspection team also uncovered multiple storage deficiencies at the Wadki premises. These included an inadequate supply of pallets and racks needed to store medicines appropriately, along with lapses in maintaining required documentation and following proper procedures for handling expired medicines.

Following the detection of these repeated non-compliances, the state regulatory authority issued orders cancelling the facility's drug sale licences, the FDA confirmed in an official release on Friday.