NEW DELHI : The government along with the Indian Drugs Manufacturers’ Association (IDMA) plans to celebrate the first ever National Current Good Manufacturing Practice Day (cGMP Day) on 10 October, as they focus on improving the poor quality of many Indian drugs.
The pharma industry has been hit by several incidents of Indian cough syrups causing the deaths of children in importing countries, following which government has made GMP guidelines mandatory for all drugmakers.
Daara Patel, secretary general at IDMA said, “This day (10 October) shall be dedicated to entire pharmaceutical industry to create awareness on the cGMP guidelines. The image of Indian pharma industry has been affected badly due to multiple reports of poor-quality cough syrups aboard. Hence, we want to establish GMP rules as a part of our good practices and routine.”
He said that quality has no substitute, especially in this sector. GMP rules are the backbone of pharmaceutical manufacturing operations and help manufacturers prevent non-compliance, thereby protecting the quality of medicinal products.
GMP, as mandated by the World Health Organization (WHO), prescribes essential standards to enhance product quality through control measures related to materials, methods, machinery, processes, personnel, facilities, as well as the environment. Right now, GMP under Schedule M of the Drugs and Cosmetic Rule is under revision wherein it will become applicable for all pharmaceutical firms.
There are around 10,500 drug manufacturing units in the country, out of which only 2,000 have WHO GMP certification. Under the proposed amendment in Schedule M of Drugs and Cosmetics Rules, 1945, the Centre has given a period of six months for large companies (with a turnover exceeding ₹250 crore) and 12 months for MSMEs (below ₹250 crore) to implement upgraded GMP standards.
Senior officials from India’s health ministry, United States Food and Drug Administration, Medicines and Healthcare products Regulatory Agency, CDSCO, pharmacy schools, and academia are likely to participate. Queries sent to the health ministry remained unanswered.
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Updated: 08 Oct 2023, 11:59 PM IST