pharmaceutical quality control

India faces significant challenges in providing affordable healthcare to its vast population, with many citizens earning less than $150 USD per month. While India is known as the “pharmacy to the world,” producing affordable pharmaceuticals for both domestic and international markets, not all facilities meet stringent U.S. FDA standards. This article examines the complexities of India’s pharmaceutical landscape, the impact of regulatory measures like Schedule M, and the need to balance high-quality production with economic realities. Understanding these dynamics is crucial for appreciating the contributions and challenges of India’s pharmaceutical industry.