Schedule M mandate Archives

Resistance to Reform: Punjab Pharmaceutical Manufacturers Push Back Against Modi’s Schedule M Mandate

Brian RogersJune 4, 20240133 views

Prime Minister Narendra Modi’s directive for Indian pharmaceutical plants to achieve WHO GMP certification by the end of 2023 faces significant resistance from some manufacturers. The Pundrug Research Foundation, led by several Punjab-based pharmaceutical companies, argues that the financial and logistical burdens of upgrading to meet these standards are too high, particularly for smaller firms. Despite these challenges, the Indian government emphasizes that such upgrades are essential for ensuring the safety, efficacy, and global competitiveness of Indian pharmaceuticals. The debate underscores the critical need for balancing regulatory compliance with economic realities to maintain India’s position as a leading pharmaceutical producer.

A New Era for Indian Pharma: WHO Certification Mandate by End of 2023

Brian RogersJune 4, 20240408 views

Prime Minister Narendra Modi has set a transformative goal for India’s pharmaceutical industry: by the end of 2023, all pharmaceutical manufacturing plants must adhere to WHO Good Manufacturing Practices (GMP) certification, also known as Schedule M. This directive aims to elevate the quality of India’s pharmaceutical products to meet international standards, ensuring that all medications produced in the country are safe, effective, and of high quality. This ambitious mandate faces significant challenges, including the need for infrastructure upgrades, comprehensive training for personnel, and continuous regulatory compliance. However, the long-term benefits of improved global competitiveness, enhanced industry credibility, and better patient safety make it a crucial move for the Indian pharmaceutical sector.