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Cipla Pharma’s Pune warehouse license revoked; FDA takes strict action over illegal advertising on medicine packaging
Pune: The Food and Drug Administration (FDA) has revoked the drug sales license of the main 'Carry and Forwarding' (C&F) warehouse of Cipla Pharma and Life Sciences Limited, located at Vadki (Pune), for compromising drug safety standards. This action came into effect immediately on August 27.
In June, the FDA had raided this warehouse and seized stock worth ?11.19 lakh due to unauthorized advertising on the packaging of 'Reactin Plus Tablets,' a Schedule H painkiller. The packaging bore illegal text describing the drug as 'Analgesic and Antipyretic.' The administration stated that such labeling could encourage patients to self-medicate without a doctor's advice, thereby posing a health risk. Consequently, orders had been issued to recall the stock from the market; however, the company failed to comply with these directives adequately.
A thorough inspection by the FDA revealed several serious irregularities at the warehouse. There were significant discrepancies between computer records and the actual physical stock. Arrangements for necessary pallets and racks were inadequate. Furthermore, the management of expired medicines and the maintenance of purchase and sales records were improper. Although a show-cause notice was issued to the company, the explanation provided was deemed unsatisfactory, leading to the revocation of the license under the Drugs and Cosmetics Act, 1940, and the Rules of 1945. Food and Drug Administration Commissioner Tukaram Mundhe stated, “The administration will not compromise on the safety of medicines and the health of citizens. Strict action will continue to be taken against the illegal advertising, improper storage, and sale of drugs such as those in Schedule H.”
Pune: The Food and Drug Administration (FDA) has revoked the drug sales license of the main 'Carry and Forwarding' (C&F) warehouse of Cipla Pharma and Life Sciences Limited, located at Vadki (Pune), for compromising drug safety standards. This action came into effect immediately on August 27.
In June, the FDA had raided this warehouse and seized stock worth ?11.19 lakh due to unauthorized advertising on the packaging of 'Reactin Plus Tablets,' a Schedule H painkiller. The packaging bore illegal text describing the drug as 'Analgesic and Antipyretic.' The administration stated that such labeling could encourage patients to self-medicate without a doctor's advice, thereby posing a health risk. Consequently, orders had been issued to recall the stock from the market; however, the company failed to comply with these directives adequately.
A thorough inspection by the FDA revealed several serious irregularities at the warehouse. There were significant discrepancies between computer records and the actual physical stock. Arrangements for necessary pallets and racks were inadequate. Furthermore, the management of expired medicines and the maintenance of purchase and sales records were improper. Although a show-cause notice was issued to the company, the explanation provided was deemed unsatisfactory, leading to the revocation of the license under the Drugs and Cosmetics Act, 1940, and the Rules of 1945. Food and Drug Administration Commissioner Tukaram Mundhe stated, “The administration will not compromise on the safety of medicines and the health of citizens. Strict action will continue to be taken against the illegal advertising, improper storage, and sale of drugs such as those in Schedule H.”
In June, the FDA had raided this warehouse and seized stock worth ?11.19 lakh due to unauthorized advertising on the packaging of 'Reactin Plus Tablets,' a Schedule H painkiller. The packaging bore illegal text describing the drug as 'Analgesic and Antipyretic.' The administration stated that such labeling could encourage patients to self-medicate without a doctor's advice, thereby posing a health risk. Consequently, orders had been issued to recall the stock from the market; however, the company failed to comply with these directives adequately.
A thorough inspection by the FDA revealed several serious irregularities at the warehouse. There were significant discrepancies between computer records and the actual physical stock. Arrangements for necessary pallets and racks were inadequate. Furthermore, the management of expired medicines and the maintenance of purchase and sales records were improper. Although a show-cause notice was issued to the company, the explanation provided was deemed unsatisfactory, leading to the revocation of the license under the Drugs and Cosmetics Act, 1940, and the Rules of 1945. Food and Drug Administration Commissioner Tukaram Mundhe stated, “The administration will not compromise on the safety of medicines and the health of citizens. Strict action will continue to be taken against the illegal advertising, improper storage, and sale of drugs such as those in Schedule H.”
