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India's Giant Leap in Drug Discovery

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Indian pharmaceutical companies' entry into the drug discovery and development field dates back to the early 1990s when India announced the signing of the World Trade Organization(WTO) agreement that introduced a product patent system from Jan. 1, 2005.Changes in the regulatory environment in the same year led to other developments with the emergence of the country as a favourite destination for ‘chemistry'outsourcing followed by collaborative drug discovery as contract agencies where inhouse strengths in chemistry of local companies was augmented with focus biology.

Since the initiation of drug discovery by major companies in the 1990s, Indian pharmaceutical R&D efforts have resulted in over 200 preclinical and clinical stage development compounds, of which very few have reached the market. While this illustrates that new chemical entity (NCE) research has been taken up by Indian companies over last three decades, there still are issues like skill gap, insufficient understanding of tech transfer and IP protection, regulatory uncertainty regarding clinical trials, pricing uncertainties, and a lot remains to be done if we are to reposition India as a drug discovery powerhouse. The private sector has thus far allocated most of its investment to ‘development' better manufacturing technology, highend plants, reverse engineering, etc. rather than ‘research'. Despite thousands of crores spent on research and development, we still have not been able to come up with any significant new molecule. Most importantly, certain diseases (like malaria and tuberculosis) are unique to India and other low and middle income countries. Since they do not draw the attention of global pharmaceutical companies, research for such diseases will have to be driven by Indian companies.

Taking the matters in their own hands, India's premiere and startup pharma companies alike have stepped up clinical trials making sure innovation and research never meets a bottleneck. This edition is throwing the light on several such drug discovery & development companies who have transformed the industry and created a stir to bring India to terms with its potential.