Cipla Pune Unit's Drug Sale Licence Cancelled Over 'Irregularities'

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 irregularities found during the inspection include unauthorised advertising, multiple storage, stock records, and recall-related violations. According to an FDA statement, the licence cancellation came into effect on Thursday.

The FDA said that medicines were stored directly on the floor at the unit, and there were deficiencies in procedures for handling expired medicines.

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". It seized stock worth Rs 11.19 lakh and directed the company to recall the 'misbranded' tablets. The company, however, did not fully comply with the directions.

According to the FDA statement, 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.

Discrepancies were found between physical stock and computerised records, inadequate pallet and rack arrangements, and deficiencies in records and procedures for handling expired medicines.

"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.

Cipla Pharma & Life Sciences issued a statement saying that it has contested the FDA's order.

"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.

Cipla Pharma and Life Sciences Limited is an active public subsidiary or entity associated with Cipla Limited.