India will observe October 10 as Good Manufacturing Practices Day


New Delhi :The government, in collaboration with the Indian Drugs Manufacturers Association (IDMA), plans to celebrate the National Current Good Manufacturing Practice Day (CGMP Day) for the first time on October 10, as they focus on improving the poor quality of many Indian medicines.

The pharma industry has been hit by several incidents of child deaths in importing countries due to Indian cough syrup, following which the government has made GMP guidelines mandatory for all drug manufacturers.

Dara Patel, Secretary General, IDMA, said, “This day (October 10) will be dedicated to the entire pharmaceutical industry to create awareness on cGMP guidelines. The image of the Indian pharma industry has been badly affected due to several reports of poor quality cough syrup. Therefore, we want to establish GMP rules as a part of our good practices and routine.”

He said there is no substitute for quality, especially in this sector. GMP regulations are the backbone of pharmaceutical manufacturing operations and help manufacturers prevent non-compliance, thereby protecting the quality of medicinal products.

GMP, mandated by the World Health Organization (WHO), sets the standards required to enhance product quality through control measures related to materials, methods, machinery, processes, personnel, facilities, as well as the environment. Currently, GMP under Schedule M of the Drugs and Cosmetics Rule is subject to amendment, wherein it will become applicable to all pharmaceutical firms.

There are about 10,500 pharmaceutical manufacturing units in the country, of which only 2,000 have WHO GMP certification. Under the proposed amendment to Schedule M of the Drugs and Cosmetics Rules, 1945, the Center has given a period of six months for large companies (whose turnover is more than this). 250 crore) and 12 months for MSME (below). ₹250 crore) to implement advanced GMP standards.

Senior officials from India’s Health Ministry, United States Food and Drug Administration, Drug and Healthcare products Regulatory Agency, CDSCO, pharmacy schools and academia are likely to participate. Questions sent to the Health Ministry remained unanswered.

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