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) unit in Pune over irregularities involving the packaging, storage and recall of Reactin Plus Tablets, PTI reported.
The cancellation took effect on August 27, following an inspection of the company's main warehouse at Wadki in Pune district, the FDA said in a statement on Friday.
During an inspection in June, 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".
Stock worth ₹11.19 lakh seized
The regulator seized stock worth ₹11.19 lakh, saying the claim violated provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
The FDA subsequently directed the company to recall the misbranded tablets from the market. However, the regulator said the company did not fully comply with the recall directions and related requirements.
A follow-up inspection of the C&F unit's drug sale and distribution system also found several deficiencies. These included discrepancies between purchase and sale records and the computerised stock, as well as differences between physical inventory and recorded stock.
Cipla contests FDA order
Cipla, however, has contested the FDA's order, saying the matter is currently sub judice.
In a statement, Cipla Pharma & Life Sciences said the order pertains to the operations of a C&F warehouse operated on its behalf and that, as the matter is under judicial consideration, it would not be appropriate to comment further on the proceedings.
The company also clarified that the order does not allege any concerns relating to the safety, quality or efficacy of its products, nor does it involve or indicate any patient safety issue.
"Cipla has been a trusted healthcare organization for nine decades and continues to uphold the highest standards of quality, regulatory compliance, and patient safety," the company said.
Medicines were being stored directly on the floor
The FDA also found that medicines were being stored directly on the floor, with inadequate pallet and rack arrangements. It flagged shortcomings in the storage of medicines and in records and procedures for handling expired drugs.
The regulator issued a show-cause notice to the licence holder and examined the company's response. Following the review, the FDA said the deficiencies and directions related to the recall of Reactin Plus Tablets had not been adequately addressed.
FDA Commissioner Tukaram Mundhe said the department would not show leniency on matters 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.
