From ‘Make in India’ to ‘Made in India’: The saroglitazar story

Abstract

Indian pharmaceutical industry is successfully following the ‘make in India’ theme, much before it became a buzz word in governance. India has dominated themanufacturing of generic and bio-similar drugs. A few of the Indian companies have made anti-tubercular, anti-retroviral and anti-cancer drugs available to the vast majority of the world population at a fractionof thecostof theirpatentedcounterparts.Make in India theme has helped the Indian pharmaceutical industry to forge ahead even in difficult economic times clocking an annual growth of >10% for over a decade. It may appear fragmented with around 24,000 estimated players; but it has around 350 companies in the organized sector and nearly one third of the market is dominated by the top ten companies. In terms of volumes, Indian pharmaceutical industry is the third largest in theworld.However, Indianshare is ameager1e2%of theglobal market share and is ranked a distant 10th in terms of value. India entered the global scene mainly through its engineered generic drugs and active pharmaceutical ingredients. For instance, India has 74 US FDA-approved manufacturing units, highest in any country outside the US. Indian industries presence in the patented drugs club is nearly non-existent. After success in the generic market and it (generic market) getting competitive and highly regulated, a few Indian pharmaceutical companies have ventured into the field of new molecule development and have accordingly increased their research and development expenses. Most of the efforts have gone into making innovative processing for existing molecules, making different combination and/or formulations of existing drugs and making bio-similar agents. Some of the most successful combinations that have crossed Indian boundaries include the various poly-pills developed by Indian industries. However, as of date, only a very few new molecules have been developed in India (one of them is the newer anti-malarial e Synriam). In this context, saroglitazar, a