Erring drug companies to face stricter action as rules to improve mfg standards come into effect today
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The industry was expecting the government to extend the implementation of the new standards.
But the «government has not given any extension notice yet, which means the industry will have to comply with the provisions or face action,» a senior government official said. The industry now has to comply with the newly notified Schedule M norms for manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products, with provisions for annual product quality review, quality risk management, and pharmaceutical quality system.
Industry leaders had earlier met the health minister and sought an extension as they are facing several issues like delay in procurement of machinery and update of infrastructure. The industry said it needed more time to ensure survival of micro, small and medium enterprises (MSMEs). Schedule M of the Drugs and Cosmetics Rules, 1945, prescribes the good manufacturing practices (GMP) for pharmaceutical products such as a prompt product recall system for products known or suspected to be defective. The health ministry had in January 2024 notified the revised Schedule M.
Laghu Udyog Bharati (LUB), an affiliate of RSS, and Federation of Pharma Entrepreneurs (FOPE), which represents MSME pharma units, had also written to health minister JP Nadda, asking him to defer the implementation of
