Cipla Pune Facility Hit By Licence Revocation Following Alleged Drug Sale Irregularities

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) unit in Pune following alleged regulatory irregularities linked to Reactin Plus Tablets. The action came into effect on Thursday after officials identified multiple violations during an inspection of the facility. The findings included issues related to unauthorised advertising, storage practices, stock records and compliance with a drug recall directive.

According to a statement issued by the Maharashtra FDA, officials inspected the Pune facility in June and found that the packaging of Reactin Plus Tablets, a prescription medicine, carried an unauthorised claim describing the product as an “analgesic and antipyretic”. The regulator treated the labelling as a misbranding violation and subsequently seized stock of the tablets valued at around Rs 11.19 lakh. The company was also instructed to recall the affected stock from the market.

The inspection reportedly identified additional deficiencies in the manner medicines were being stored and managed at the facility. The FDA said medicines were found stored directly on the floor, raising concerns about adherence to proper storage and handling requirements. Officials also found deficiencies in procedures for dealing with expired medicines. Such procedures are intended to ensure that expired or unusable pharmaceutical products are properly segregated, identified and disposed of without creating a risk of accidental distribution.

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The regulator also flagged problems involving stock records and recall-related compliance. After the FDA directed Cipla Pharma & Life Sciences to recall the allegedly misbranded Reactin Plus Tablets, the company did not fully comply with the directions, according to the regulator. The reported failure to completely implement the recall instructions became one of the factors behind the action against the C&F unit. Drug regulators routinely require manufacturers and distributors to maintain accurate records so that affected medicines can be traced and removed efficiently when a safety, quality or labelling issue is identified.

The cancellation of the licence means the Pune C&F facility can no longer carry out drug sale activities under the cancelled licence. The action represents a significant regulatory measure, particularly because the findings covered several aspects of pharmaceutical distribution and compliance rather than being limited to the packaging issue involving Reactin Plus. The FDA's inspection also highlighted the importance of maintaining prescribed storage conditions and documented procedures for expired medicines, inventory management and product recalls.

The action comes amid regulatory scrutiny of pharmaceutical companies and their distribution networks to ensure that medicines reaching patients comply with applicable standards. In this case, the Maharashtra FDA's findings centred on the unauthorised claim on the Reactin Plus packaging, storage of medicines on the floor, shortcomings in expired-medicine handling, stock-record issues and incomplete compliance with the recall order. The FDA has therefore cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd's Pune C&F unit, with the decision taking effect on Thursday.

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