The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd’s Carrying and Forwarding (C&F) unit in Pune over serious irregularities related to the packaging, storage, record-keeping and recall of Reactin Plus Tablets. Cipla has contested the order, saying the matter is currently sub judice and clarifying that the FDA’s action does not allege any concerns relating to the safety, quality or efficacy of its products.
The licence cancellation came into effect on August 27, following an inspection of the company’s main warehouse at Wadki in Pune district, according to the FDA.
In a statement, Cipla said the FDA order pertains to the operations of a C&F warehouse operated on behalf of Cipla Pharma & Life Sciences and is currently under judicial consideration. The company said 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,” Cipla said.
The company added that it has been a “trusted healthcare organisation for nine decades” and continues to uphold the highest standards of quality, regulatory compliance and patient safety.
The FDA’s action follows findings of multiple regulatory lapses in the company’s drug storage and distribution system.
During an inspection conducted around June this year, FDA officials found that the packaging of Reactin Plus Tablets, a Schedule H prescription medicine, carried an unauthorised claim describing it as an “analgesic and antipyretic”, according to the regulator’s statement cited by PTI.
The FDA said the claim was made without the required permission and was contrary to provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
The regulator subsequently seized Reactin Plus stock worth around Rs 11.91 lakh in connection with the violation.
The FDA directed the company to recall misbranded Reactin Plus Tablets from the market. However, the regulator said the company did not fully comply with the recall directions and other measures required in the matter.
A subsequent inspection of the C&F unit’s drug sale and distribution system found discrepancies between purchase and sale records and actual computerised stock, along with non-compliance with the directions issued for recalling the affected medicines.
The FDA also found medicines stored directly on the floor and inadequate arrangements for pallets and racks required for proper storage. It further flagged deficiencies in records and procedures for handling expired medicines.
Following the findings, the FDA issued a show-cause notice to the licence holder and examined the company’s explanation.
After considering the response, the regulator concluded that the deficiencies identified during the inspections, as well as the directions concerning the recall of Reactin Plus Tablets, had not been adequately complied with.
The FDA subsequently cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd’s C&F unit at Wadki, Pune, with effect from August 27.
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,” Mundhe said, according to PTI.
Cipla, however, has maintained that the order does not involve or indicate any patient safety issue and has reiterated its commitment to quality, regulatory compliance and patient safety.