FDA cancels Cipla Pune unit’s drug licence over Reactin Plus: The wider industry impact

The Maharashtra Food and Drug Administration has revoked Cipla’s licenses to sell Reactin Plus Tablets

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. 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. 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.

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.