The Indian government, in collaboration with the Indian Drugs Manufacturers Association (IDMA), is gearing up to mark the inaugural National Current Good Manufacturing Practice Day (cGMP Day) on October 10. This initiative is part of a focused effort to enhance the quality standards of numerous Indian drugs, which have faced criticism due to their poor quality.

The pharmaceutical industry has been marred by incidents where Indian cough syrups caused fatalities in countries importing them. Consequently, the government has made it obligatory for all drug manufacturers to adhere to Good Manufacturing Practice (GMP) guidelines.

Daara Patel, the Secretary General of IDMA, emphasised that October 10 will be dedicated to the entire pharmaceutical sector to raise awareness about cGMP guidelines. He stressed the significance of establishing GMP rules as an integral part of industry practices to counterbalance the tarnished reputation of the Indian pharmaceutical industry, particularly in the context of substandard cough syrups being reported overseas. Quality, Patel emphasised, is paramount, especially in this sector. GMP rules form the cornerstone of pharmaceutical manufacturing operations, aiding manufacturers in preventing non-compliance and safeguarding the quality of medicinal products.

GMP, mandated by the World Health Organisation (WHO), sets essential standards to enhance product quality through meticulous control measures encompassing materials, methods, machinery, processes, personnel, facilities, and the environment. Currently, GMP under Schedule M of the Drugs and Cosmetic Rule is undergoing revision, making it applicable to all pharmaceutical firms.

In India, there are approximately 10,500 drug manufacturing units, but only 2,000 possess WHO GMP certification. The proposed amendment in Schedule M of Drugs and Cosmetics Rules, 1945, allows a grace period of six months for large companies (with a turnover exceeding Rs 250 crore) and 12 months for Micro, Small, and Medium Enterprises (MSMEs) (below Rs 250 crore) to implement upgraded GMP standards.

Key representatives from India's health ministry, the United States Food and Drug Administration, the Medicines and Healthcare products Regulatory Agency, CDSCO, pharmacy schools, and academia are expected to participate in the event. Queries directed to the health ministry remain unanswered at this time.

Source: Mint