Maharashtra FDA Cancels Cipla Pharma's Pune Licence

The Maharashtra Food and Drug Administration has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding unit in Pune. This decision was made due to serious irregularities related to the packaging, storage, and recall of Reactin Plus Tablets.

The FDA's inspection of the main warehouse at Wadki in Pune district revealed that medicines were stored directly on the floor. The regulator also found deficiencies in procedures for handling expired medicines. The cancellation of the C&F drug sale licence came into effect on August 27.

During an inspection in June, officials found that the packaging of Reactin Plus tablets carried an unauthorised claim describing it as an 'analgesic and antipyretic'. The FDA seized stock worth Rs 11.19 lakh, stating that such advertising was contrary to provisions of the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.

The FDA directed the company to recall the misbranded Reactin Plus Tablets from the market. However, the company did not fully comply with the directions and required measures. A subsequent inspection found deficiencies in storage arrangements, discrepancies between purchase and sale records, and non-compliance with recall directions.

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 to the licence holder and, after examining the company's explanation, found that the deficiencies had not been adequately complied with.

FDA Commissioner Tukaram Mundhe stated that the department would not show any leniency on issues concerning drug safety and public health. He said that any violation of rules by entities involved in the manufacture and distribution of medicines would invite strict action as per law.

The cancellation of the licence is a significant step towards ensuring public health and safety. The FDA's actions demonstrate its commitment to enforcing regulations and holding companies accountable for their actions. This incident highlights the importance of strict adherence to rules and regulations in the pharmaceutical industry.

The Reactin Plus Tablets case has brought attention to the need for proper storage, handling, and recall procedures in the pharmaceutical industry. The FDA's inspection and subsequent actions have ensured that the public is protected from potentially harmful products.

In conclusion, the Maharashtra FDA's decision to cancel Cipla Pharma's Pune licence is a significant step towards ensuring public health and safety. The incident highlights the importance of strict adherence to rules and regulations in the pharmaceutical industry and demonstrates the FDA's commitment to enforcing regulations and holding companies accountable for their actions.