ABSTRACT
This chapter addresses the regulatory challenges to India's booming pharma industry. It outlines some of the major challenges in medicine regulation in India from a scientific point of view. The key features of the pharma market in India are fairly well established as regards pricing: The same medicine is sold at a range of prices, also by the same company. The World Health Organization (WHO) in 2006 formed a global coalition of stake holders named the International Medical Products Anti-Counterfeiting Task Force (IMPACT) to address the issue of counterfeiting of medical products. The chapter suggests merging Schedule M and WHO good manufacturing practices (GMP) as an initial step, leading to clear guidelines for quality and good manufacturing practices that do not require second guessing by manufacturers hereafter. Quality also means quality at the level of manufacturing of a medicine—the pharmaceutics and the behavior during a formulation's life span.
