MUMBAI: The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) unit in Pune over serious irregularities in the packaging, storage and recall of Reactin Plus Tablets, the regulator said on Friday.The cancellation came into effect on August 27 following an inspection of the company’s main warehouse at Wadki in Pune district, the FDA said in a statement.The regulator found medicines being stored directly on the floor and flagged deficiencies in the procedures for handling expired medicines, news agency PTI reported.During an inspection conducted around June this year, officials found that the packaging of Reactin Plus Tablets, a Schedule H prescription medicine, carried an unauthorised claim describing it as an “analgesic and antipyretic”, the FDA said.The regulator seized stock worth Rs 11.19 lakh, saying the claim was contrary to provisions of the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.The FDA subsequently directed the company to recall the misbranded Reactin Plus Tablets from the market. However, the company did not fully comply with the directions and required measures, the regulator said.A subsequent inspection of the C&F unit’s drug sale and distribution system found deficiencies in storage arrangements, discrepancies between purchase and sale records and actual computerised stock, and non-compliance with the recall directions, according to the statement.The FDA also found discrepancies between physical stock and computerised records, medicines stored directly on the floor, inadequate pallet and rack arrangements, and deficiencies in records and procedures for handling expired medicines.The department issued a show-cause notice to the licence holder.After examining the company’s explanation, the FDA found that the deficiencies and directions concerning the recall of Reactin Plus Tablets had not been adequately complied with.FDA commissioner Tukaram Mundhe said the department would take strict action over violations affecting drug safety and public health, particularly in the advertising, sale, storage and distribution of Schedule H prescription medicines.“Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law,” he said.(With agency inputs)