The Maharashtra Food and Drug Administration (FDA) cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) unit in Pune over serious irregularities related to the Reactin Plus Tablets.
The company, however, did not fully comply with the directions. It seized stock worth Rs 11.19 lakh and directed the company to recall the ‘misbranded’ tablets.
During an inspection in June, officials found that the packaging of Reactin Plus tablets, which is a prescription medicine, carried an unauthorised claim describing it as an “analgesic and antipyretic”. Another inspection of the C&F unit’s drug sale and distribution system found improper storage arrangements, discrepancies between purchase and sale records and actual computerised stock, along with non-compliance with the recall order, according to the FDA statement. “Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law,” said FDA Commissioner Tukaram Mundhe, adding that the department would not show any leniency on issues concerning drug safety and public health.
