The Maharashtra Food and Drug Administration (FDA) has taken action against Cipla Pharma & Life Sciences Ltd by cancelling the drug sale licenses for its Carry and Forwarding (C&F) facility located in Wadki, Pune. This decision follows the discovery of serious irregularities associated with the company’s Reactin Plus tablets. The FDA’s move highlights ongoing concerns regarding compliance and safety in the pharmaceutical sector.
During an inspection in June, FDA officials found unauthorised promotional text on the packaging of Reactin Plus, a Schedule H prescription medicine. The regulator seized Reactin Plus stock worth more than Rs 11 lakh and directed the company to recall the drug from the market, citing violations of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
The words “analgesic and antipyretic” were printed on the packaging despite not being permitted. However, the company did not fully comply with the recall order, the FDA said. Promotional claims on the packaging of a prescription medicine could encourage consumers to take the drug without medical advice, increasing the risk of self-medication, according to the regulator. FDA Commissioner Tukaram Mundhe said the department would take a strict approach to violations involving drug safety and public health, particularly in the advertising, sale, storage and distribution of Schedule H prescription medicines.
