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) facility at Wadki in Pune, following a series of regulatory irregularities identified during inspections, including issues related to the packaging and recall of Reactin Plus Tablets. The licences were cancelled with effect from August 27. 

The action followed an inspection of Cipla’s main warehouse in June, during which FDA officials found that Reactin Plus Tablets, a Schedule H prescription medicine, carried the words “analgesic and antipyretic” on its packaging. 

The regulator considered the claim unauthorised under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. 

The FDA subsequently seized Reactin Plus stock valued at approximately Rs. 11.19 lakh and directed the company to recall the affected product from the market. According to the regulator, the company did not fully comply with the recall directions and required measures. 

A subsequent inspection of the C&F facility identified additional deficiencies in drug sale and distribution practices. These included discrepancies between physical and computerised stock records, inconsistencies in purchase and sale records, inadequate storage arrangements and deficiencies in procedures for handling expired medicines. 

Inspectors also found medicines stored directly on the floor and inadequate pallet and rack arrangements. 

Following the findings, the FDA issued a show-cause notice to the licence holder and reviewed the company’s response before deciding to cancel the drug sale licences.

Maharashtra FDA Commissioner Tukaram Mundhe said the regulator would maintain a strict approach towards violations involving drug safety and public health, particularly concerning the advertising, sale, storage and distribution of Schedule H 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. 

Cipla Pharma & Life Sciences has contested the Pune FDA’s order, stating that the matter is currently sub judice.

The company clarified that the FDA order “does not allege any concerns relating to the safety, quality, or efficacy”of its products and does not involve or indicate any patient safety issue. Cipla said it would not comment further while the matter is under judicial consideration.