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, citing violations related to the packaging, recall and storage of medicines, including Reactin Plus tablets, a Schedule H prescription drug.
The licences were cancelled with effect from August 27, the FDA said in a statement issued on Friday, following an inspection of its main warehouse at Wadki.
“Strict compliance with legal provisions is essential, particularly in the advertising, sale, storage and distribution of Schedule H prescription medicines. Any violation by any part of the drug manufacturing or distribution system will invite strict action under the law,” FDA commissioner Tukaram Mundhe said.
The action followed an inspection of the company’s main warehouse at Wadki in June, during which officials found unauthorised promotional text on the packaging of Reactin Plus tablets.
According to the FDA, the packaging described Reactin Plus as an “analgesic and antipyretic”, a description the regulator said was not permitted for the prescription medicine. The FDA seized stock of the drug worth ₹11.19 lakh, saying the packaging violated provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945.
The regulator said such promotion of a Schedule H medicine could encourage consumers to take the drug without consulting a doctor, potentially increasing the risk of self-medication and consequent public-health concerns.
{{/usCountry}}The regulator said such promotion of a Schedule H medicine could encourage consumers to take the drug without consulting a doctor, potentially increasing the risk of self-medication and consequent public-health concerns.
{{/usCountry}}The FDA subsequently directed the company to recall the affected Reactin Plus stock from the market. However, the department said the company did not fully comply with the recall-related directions and other measures prescribed by the regulator.
A subsequent inspection of the company’s C&F operations, undertaken to verify its drug sales and distribution system, found several other deficiencies, according to the FDA. These included discrepancies between physical and computerised stock records, gaps in purchase and sale records and non-compliance with the directions relating to the recall of medicines.
Inspectors also found medicines stored directly on the floor and inadequate arrangements of pallets and racks required for proper storage. The FDA also flagged shortcomings in the records and procedures for managing expired medicines.
The regulator issued a show-cause notice to the licence holder over the violations. After examining the company’s response, the FDA concluded that the deficiencies identified during the inspection and the directions relating to the Reactin Plus recall had not been adequately complied with. It subsequently cancelled the drug sale licences under the relevant provisions of the Drugs and Cosmetics Act and Drugs Rules.
A statement by Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) read, “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. Cipla has been a trusted healthcare organization for nine decades and continues to uphold the highest standards of quality, regulatory compliance, and patient safety.”