FDA Cancels Drug Sale Licence Of Cipla Pharma & Life Sciences's Pune Carry And Forwarding Unit

The Maharashtra Food and Drug Administration has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding (C&F) unit in Pune for serious irregularities related to the packaging, storage and recall of Reactin Plus Tablets, the regulator said.

The cancellation came into effect on August 27 following an inspection of the C&F unit's main warehouse at Wadki in Pune district, the FDA said in a statement on Friday.

The company stated that it had challenged the order and the matter was sub-judice.

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

During an inspection around June this year, officials found that the packaging of Reactin Plus tablets, a prescription medicine, carried an unauthorised claim describing it as an "analgesic and antipyretic", the FDA alleged.

It seized stock worth ₹11.19 lakh on the ground that such advertising violated the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.

The FDA subsequently directed the company to recall the 'misbranded' Reactin Plus Tablets from the market. However, the company didn't fully comply with the directions, it alleged.

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 recall directions, according to the statement.

The FDA also found discrepancies between physical stock and computerised records, inadequate pallet and rack arrangements, and deficiencies in records and procedures for handling expired medicines.

The department issued a show-cause notice, and after examining the company's explanation, the FDA found that its directions concerning the recall of Reactin Plus Tablets had not been fully complied with, the authority claimed.

FDA Commissioner Tukaram Mundhe said the department would not show any leniency on issues concerning drug safety and public health, particularly in the advertising, sale, storage and distribution of Schedule H prescription medicines.

"Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law," he said.

In its statement late in the evening, Cipla Pharma & Life Sciences said 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 company said.