The revised Schedule M of the Drugs and Cosmetics Rules is expected to bring Indian quality on par with global standards, according to SM Mudda of the Indian Drug Manufacturers' Association.
The new guidelines, which deal with the good manufacturing practices to be followed by pharmaceutical manufacturing units, were issued on Dec. 28 amid complaints of sub-standard Indian drugs and deaths abroad reportedly due to it. It imposes responsibility on the manufacturer for the quality of the products so that they are fit for the intended use, comply with the licence requirements, and do not place patients at risk due to inadequate safety, quality or efficacy.
The revised guidelines aim to enhance the entire manufacturing process quality and not just the final product quality, Mudda, who is the chairperson of regulatory affairs at IDMA, told NDTV Profit on the sidelines of the Vriddhi 2024 conference in Pune.
"New Schedule M brings Indian quality standards at par with European standards and WHO (World Health Organisation) standards of drug import," the managing director of Misom Labs Ltd. said.
Mudda underscored that the responsibility to see the implementation is on the top management. However, he said, the IDMA would offer consultations to help organisations like medium and small enterprises cope with the new standards and, accordingly, enhance their manufacturing processes.
In a separate panel discussion at the pharma conference, Deputy Drugs Controller Chandrashekhar Ranga highlighted that currently, 42%, or around 2,400, of the manufacturing units in India are WHO GMP-certified and, hence, compliant with the revised schedule.
Ranga said that the compliance status of around 3,000 units is currently unknown, and these may require some upgrading. He pointed out that the Department of Pharmaceuticals is also looking to announce some subsidies towards upgradation and quality compliance.
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