In a landmark collaboration between the Indian government and the Indian Drugs Manufacturers’ Association (IDMA), India is gearing up to commemorate the very first National Current Good Manufacturing Practice (cGMP) Day on October 10th. This pioneering initiative is poised to emphasize the paramount significance of adhering to cGMP guidelines within pharmaceutical manufacturing, with a central objective of elevating product quality and safeguarding patient well-being.
Current Good Manufacturing Practices, commonly known as cGMP, represent a set of rigorous quality standards mandated by the World Health Organization (WHO) for pharmaceutical manufacturing. These guidelines form the cornerstone of pharmaceutical operations, providing essential benchmarks for enhancing product quality by regulating various facets of the manufacturing process, including materials, methods, machinery, processes, personnel, facilities, and environmental conditions.
Recent years have witnessed India’s pharmaceutical industry facing criticism and regulatory scrutiny due to multiple instances of substandard cough syrups causing harm to consumers, particularly children, in importing countries. These incidents have not only cast a shadow on the industry’s reputation but have also raised global concerns about patient safety. In response to these challenges, the Indian government has made it obligatory for all drug manufacturers to adhere to cGMP guidelines.
Presently, cGMP guidelines are encompassed within Schedule M of the Drugs and Cosmetics Rules, 1945. However, a proposed amendment seeks to extend the applicability of these guidelines to all pharmaceutical firms, underscoring a steadfast commitment to elevating pharmaceutical quality standards across the industry.
India boasts approximately 10,500 drug manufacturing units, yet only around 2,000 of them possess WHO GMP certification. This stark contrast highlights the existing disparity in quality standards and underscores the pressing need for widespread compliance with cGMP guidelines.
Under the proposed amendment to Schedule M, the government has granted larger pharmaceutical companies (with an annual turnover exceeding ₹250 crore) a six-month window to implement upgraded GMP standards. Smaller enterprises classified under the MSME category (with an annual turnover below ₹250 crore) will be afforded a 12-month grace period to align with the revised standards. This transitional approach underscores the government’s dedication to supporting the industry in its pursuit of elevated quality standards.
The inaugural National cGMP Day scheduled for October 10th is poised to assemble senior officials from India’s health ministry, the United States Food and Drug Administration, the Medicines and Healthcare products Regulatory Agency, CDSCO (Central Drugs Standard Control Organization), pharmacy schools, and academia. This collaborative endeavor seeks to raise awareness about the pivotal significance of cGMP guidelines and cultivate a culture of quality within the pharmaceutical sector.