India to Commemorate First National Current Good Manufacturing Practice (cGMP) Day on October 10
Written by Sanjay Kumar
In a concerted effort to enhance the quality of pharmaceutical products and bolster the reputation of the Indian pharmaceutical industry, the government of India, in collaboration with the Indian Drugs Manufacturers’ Association (IDMA), is set to observe the inaugural National Current Good Manufacturing Practice (cGMP) Day on October 10. This significant move aims to address concerns regarding the subpar quality of certain Indian drugs.
The pharmaceutical sector in India has recently grappled with numerous instances of Indian-manufactured cough syrups being linked to tragic incidents of child fatalities in importing countries. As a response to these alarming incidents, the government has mandated adherence to GMP guidelines for all drug manufacturers operating within the country.
Daara Patel, Secretary General at IDMA, expressed the importance of dedicating October 10 to the entire pharmaceutical industry, emphasizing the need to raise awareness about cGMP guidelines. He noted that the reputation of the Indian pharmaceutical industry has suffered due to numerous reports of low-quality cough syrups abroad. The objective of establishing GMP rules as an integral part of industry best practices is to ensure the consistent quality of medicinal products.
Patel emphasized that quality is paramount, especially in the pharmaceutical sector. GMP regulations serve as the foundation of pharmaceutical manufacturing operations and play a pivotal role in preventing non-compliance, thereby safeguarding the quality of medicinal products.
cGMP, as mandated by the World Health Organization (WHO), sets forth essential standards aimed at enhancing product quality through stringent control measures encompassing materials, methods, machinery, processes, personnel, facilities, and environmental factors. Presently, GMP guidelines, governed by Schedule M of the Drugs and Cosmetic Rule, are undergoing revision to make them applicable to all pharmaceutical firms.
India boasts approximately 10,500 drug manufacturing units, yet only 2,000 of them possess WHO GMP certification. Under the proposed amendment to Schedule M of the Drugs and Cosmetics Rules, 1945, the central government has stipulated a grace period of six months for large companies (with a turnover exceeding ₹250 crore) and 12 months for Micro, Small, and Medium-sized Enterprises (MSMEs) (below ₹250 crore) to implement upgraded GMP standards.
The commemoration of National cGMP Day is expected to witness the participation of senior officials from India’s Ministry of Health, the United States Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency, the Central Drugs Standard Control Organization (CDSCO), pharmacy schools, and academia. Despite our attempts to seek comments from the health ministry, we have not received a response at the time of reporting.
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