Center notifies revised schedule M guidelines for pharma industry

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Dr Deepali Bhardwaj

The Union Health Ministry on Saturday notified the Revised Schedule M guidelines under which pharmaceutical companies will have to intimate the licensing authority about recalling a drug and also report product defects, deterioration or faulty production.

Schedule M part of Drugs and Cosmetics Act 1940 deals with ‘Good Manufacturing Practices’ to be followed by pharmaceutical manufacturing units in the country. The revised Schedule M has been notified as rules to ensure good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products.

Prior to this, there was no provision for informing the licensing authority about drug recall. The new guidelines issued on December 28 state the manufacturer must be responsible for the quality of the products so that “they are fit for their intended use, comply with the requirements of the licence and do not place patients at risk due to inadequate safety, quality or efficacy”.

“The licensing authorities shall be informed if a manufacturer is considering action following the faulty manufacture, product deterioration, a suspect product or any other serious quality problems with a product,” the new guidelines read. These guidelines come against the backdrop of complaints of sub-standard Indian drugs and deaths abroad reportedly due to it since 2022.