Ranbaxy has recently launched India’s first domestically developed drug, Synriam, a fixed dose combination of arterolane maleate and piperaquine phosphate. The drug has been approved in 2011 by the Drug Controller General of India for treating Plasmodium falciparum malaria. Although developed in India, Arterolane itself was not discovered in India, but by a collaborative drug discovery project funded by the Medicines for Malaria Venture (MMV), a Swiss charity, which in 2003 partnered with Ranbaxy to carry out the development, before backing out of developing the drug further in 2007, granting a world-wide license to Ranbaxy.

Glenmark and US partner Salix Pharmaceuticals gained approval by FDA in December 2012 of Crofelemer, for the treatment of non-infectious diarrhea in patients taking antiretroviral therapy for HIV/AIDS. Crofelemer, a purified oligomeric proanthocyanidin (MW up to 9 kDa), isolated from the latex of the South American Croton lechleri tree, has a new mechanism of action, blocking two structurally unrelated chloride channels in the gut, thereby decreasing the excretion of water, and reducing the duration of the diarrhea.

These are only the two first visible signs of India’s growing presence in innovative drug discovery and development, which started in the late nineties, and became rapidly known in the early 2000’s with some high profile licensing deals with Western pharmaceutical companies.

According to the tenth annual Indian Biotech Industry survey by Biospectrum-ABLE (Association of Biotechnology Led Enterprises), the Indian biotech industry passed the 4 Billion US$ mark in 2011-12, growing overall 15 percent compared to the previous year.

The Indian biotech industry has been booming over the past decade, growing from 0.5 Billion US$ in 2002-03 to more than 3.75 Billion US$ in 2010-11, and counting more than seven hundred players. As this includes the pharmaceutical sector with generics, the bioagri industry, bioindustrial applications, the bioinformatics area, equipment providers, and a wide range of bioservices, we felt the need for a better understanding of the potential of Indian biotech companies as actors or contributors to pharmaceutical Drug Discovery and Early Development. Our report summarizes our findings, based on more than two hundred and forty companies.

In the late nineteen eighties, Indian pharma companies started in-house drug discovery activities, aiming at developing the country’s first home-made drug. Pioneers like Ranbaxy and Dr Reddy’s were joined by companies like Glenmark, Biocon, Piramal, Sun, Torrent and Wockhardt. More recent players include Advinus, Zydus Cadila, Suven and a number of much smaller start-ups. Our report summarizes the current Drug Discovery and Development pipeline in India, with a total of more than ninety New Chemical Entities at various stages of (pre)clinical development.