FDA cancels drug sale licences of Cipla Pharma & Life Sciences's Pune Carry and Forwarding unit

Maharashtra’s Food and Drug Administration has cancelled the drug sale licenses of Cipla Pharma & Life Sciences Ltd’s Pune Carry and Forwarding unit after finding serious irregularities tied to Reactin Plus Tablets. The regulator said the cancellation became effective Aug. 27 following an inspection of the unit’s main warehouse in Wadki, in the Pune district. Officials found medicines stored directly on the floor and deficiencies in procedures for handling expired products. During an inspection around June, the FDA also flagged unauthorized claims on the packaging of Reactin Plus, a Schedule H prescription medicine, describing it as an “analgesic and antipyretic.” The agency seized stock worth Rs 11.19 lakh and ordered a market recall, but said the company did not fully comply. A later inspection identified storage and recordkeeping problems, discrepancies between physical stock and computerized records, and non-compliance with recall directions. FDA Commissioner Tukaram Mundhe said the department will take strict action on violations affecting safety and public health, especially for Schedule H advertising, sale, storage and distribution.