The Indian government, in collaboration with the Indian Drugs Manufacturers’ Association (IDMA), is set to observe the first-ever National Current Good Manufacturing Practice Day (cGMP Day) on 10th October. This initiative aims to underscore the importance of adhering to cGMP guidelines in pharmaceutical manufacturing, with a focus on improving product quality and ensuring patient safety.
The Significance of cGMP Guidelines
Current Good Manufacturing Practices, commonly referred to as cGMP, are stringent quality standards mandated by the World Health Organization (WHO) for pharmaceutical manufacturing. These guidelines serve as the backbone of pharmaceutical operations, providing essential standards to enhance product quality by regulating various aspects of the manufacturing process, including materials, methods, machinery, processes, personnel, facilities, and environmental conditions.
The Current Situation
In recent years, India’s pharmaceutical industry has faced criticism and regulatory scrutiny due to multiple reports of poor-quality cough syrups causing harm to consumers, especially children, in importing countries. These incidents have not only compromised the industry’s reputation but have also raised concerns about patient safety worldwide. As a response to these challenges, the Indian government has made it mandatory for all drug manufacturers to adhere to cGMP guidelines.
The Proposed Amendment in Schedule M
Currently, cGMP guidelines fall under Schedule M of the Drugs and Cosmetics Rules, 1945. However, there is a proposed amendment that will make these guidelines applicable to all pharmaceutical firms. This amendment reflects a commitment to raising the bar for pharmaceutical quality across the industry.
Challenges and Opportunities
India is home to approximately 10,500 drug manufacturing units, yet only around 2,000 of them hold WHO GMP certification. This stark difference highlights the existing gap in quality standards and the need for widespread compliance with cGMP guidelines.
Under the proposed amendment to Schedule M, the government has given large pharmaceutical companies (with a turnover exceeding ₹250 crore) a six-month period to implement upgraded GMP standards. Smaller enterprises falling under the MSME category (below ₹250 crore turnover) will have 12 months to comply with the revised standards. This transition period reflects the government’s commitment to supporting the industry in achieving higher quality standards.
Participation and Collaboration
The inaugural National cGMP Day on 10th October is expected to bring together 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 effort aims to create awareness about the significance of cGMP guidelines and foster a culture of quality within the pharmaceutical industry.