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) facility at Wadki in Pune, citing serious irregularities found during inspections linked to Reactin Plus tablets.
The action was taken following an inspection of the company’s main warehouse in June. During the inspection FDA officials found unauthorised promotional text on the packaging of Reactin Plus, a Schedule H prescription medicine. “Strict compliance with legal provisions is essential, particularly in the advertising, sale, storage and distribution of Schedule H prescription medicines.
The regulator seized Reactin Plus stock worth ₹ 11.19 lakh and ordered the firm to recall the drug from the market, citing packaging violations as per the provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945.
The words “analgesic and antipyretic” were found on the packaging, according to the FDA. The FDA said such promotion of a prescription medicine could encourage people to take the drug without medical advice, increasing the risk of self-medication. FDA Commissioner Tukaram Mundhe said the department would not compromise on drug safety and public health. Any violation by any part of the drug manufacturing or distribution system will invite strict action under the law,” Mundhe said.
