Maharashtra FDA cites packaging, storage, stock and recall violations at Pune facility
The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd’s Carrying and Forwarding (C&F) unit in Pune over serious regulatory irregularities linked to Reactin Plus Tablets. The cancellation came into effect on August 27 following an inspection of the company’s main warehouse in Wadki.
During an inspection in June, FDA officials found that the packaging of Reactin Plus, a Schedule H prescription medicine, carried an unauthorised claim describing it as an “analgesic and antipyretic“. The regulator seized stock worth around Rs 11.19 lakh and directed the company to recall the affected tablets. The FDA later said the recall directions were not fully complied with.
Further inspections flagged discrepancies between physical stock and computerised records, deficiencies in purchase and sales records, and improper storage practices. Medicines were reportedly found stored directly on the floor, while the FDA also pointed to shortcomings in procedures for handling expired medicines.
The FDA said the violations involved the packaging, advertising, storage, sale and recall of prescription medicines. FDA Commissioner Tukaram Mundhe said the department would not show leniency over violations affecting drug safety and public health.
Cipla has challenged the FDA’s order, saying the matter is currently sub judice. The company also clarified that the order does not allege any concerns regarding the safety, quality or efficacy of its products, nor does it indicate a patient safety issue.
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