Pune: 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 following serious irregularities linked to the company’s Reactin Plus tablets.
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.
During an inspection in June, FDA officials found unauthorised promotional text on the packaging of Reactin Plus, a Schedule H prescription medicine. The action comes amid the regulator’s continued focus on ensuring that prescription medicines are marketed, stored and distributed in accordance with safety and legal requirements.
