Development of Innovative Therapeutics and Diagnostics through Genome-Based Biomarkers:An Unexplored Potential

India's pharmaceutical sector is currently undergoing unprecedented change. Much of this is due to the country's introduction, on January 1, 2005, of a system of product patents. Before that, only patents for processes could be issued, a fact that had been instrumental in the domestic industry's huge success as a worldwide exporter of high quality generic drugs. The new patent regime has also led to the return of the pharmaceutical multinationals to India, many of which had left India during the 1970s. Now they are back and looking at India not only for its traditional strengths in contract manufacturing but also as a highly attractive location for research and development (R&D). Indian pharmaceutical industry had not witnessed any impressive success in discovery of new drugs so far. The new patent regime in India, however, promised the changes in priorities for Indian Pharmaceutical companies and we have started to see the results.In September 2013, Indian pharmaceutical company ZydusCadila launched Lipaglyn, a novel drug for treating diabetic dyslipidemia or hypertriglyceridemia in Type 2 diabetes. The drug has been approved by the Drug Controller General of India (DCGI) making it the first Glitazar to be approved anywhere in the world. This is considered to be a major breakthrough as Lipaglyn is considered to be the first successful new chemical entity (NCE) that has been completely developed, starting from the concept stage up to its launch, in India.