The Maharashtra Food and Drug Administration (FDA) has revoked the drug sale license for Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) unit located in Pune. This action was taken due to serious irregularities associated with the Reactin Plus Tablets.
The company, however, did not fully comply with the directions. “As the issue is under judicial consideration, it would not be appropriate to comment further on the proceedings at this stage. We would, however, like to clarify that the order does not allege any concerns relating to the safety, quality or efficacy of our products, nor does it involve or indicate any patient safety issue,” the statement read.
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.
