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An Overview of Regulatory Process for Pharmaceutical Sector in India.

Suresh S, SB Puranik, and Phatru Patel

India is about one-third the size of the USA in terms of area. India is a pool of diverse population base of more than 1.2 billion and is a home for a numerous diseases, Institutions and hub of contract manufacturers and researchers. Indian economy stand as the third largest based on the Purchasing Power Parity (PPP) and in terms of globally eleventh largest by nominal Gross Domestic Product (GDP). India is today one of the top emerging markets in the global pharmaceutical scene. The sector is highly knowledge based and its steady growth is positively affecting the Indian economy. The organised nature of the Indian pharmaceutical industry is attracting several companies that are finding it viable to increase their operations in the country. Further, India is home to about 10,500 manufacturing units and over 3,000 pharma companies. India exports all forms of pharmaceuticals from APIs to formulations, both in modern medicine and traditional Indian medicines. This article provides a perspective on the Indian pharmaceuticals regulatory process from pre-independence era to till date.