FDA cancels Cipla Pune unit's licence over Reactin Plus storage, record lapses

The action was taken after an inspection of the company's Wadki facility found discrepancies between physical stock and computerised records, lapses in stock management and inadequate storage arrangements.FDA cancels Cipla Pune unit's drug licenceMaharashtra's Food and Drug Administration (FDA) has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd.'s C&F facility in Pune over alleged irregularities linked to the storage, record-keeping and distribution of Reactin Plus Tablets.The action was taken after an inspection of the company's Wadki facility found discrepancies between physical stock and computerised records, lapses in stock management and inadequate storage arrangements. The FDA also found expired medicines were not being managed as per the prescribed procedures.PRESCRIPTION DRUG ADVERTISING FLAGGEDThe FDA found that Reactin Plus Tablets, a Schedule H prescription medicine, carried a reference to its analgesic and antipyretic properties on its packaging without the required permission. The regulator said such activity was contrary to provisions of the Drugs and Cosmetics Act, 1940, and relevant drug rules.Following the findings, stock worth around Rs 11.91 lakh was seized. RECALL INSTRUCTIONS NOT FULLY FOLLOWEDThe FDA had also directed the company to withdraw misbranded Reactin Plus Tablets from the market. However, the subsequent inspection found that the recall instructions and other regulatory requirements had not been fully complied with.A show-cause notice was issued to the company, and after examining its explanation, the FDA cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd., Wadki, Pune, with immediate effect from August 27, 2026. The Maharashtra FDA said it would not tolerate lapses concerning drug safety, quality and lawful distribution, particularly in the case of Schedule H prescription medicines.- EndsPublished On: Aug 28, 2026 19:36 IST