R&D expenditure has dramatically increased for a segment of the Indian pharmaceutical industry since the mid-1990s when TRIPS came into effect. There has also been a change in the structure of R&D activities of Indian companies. While in the past they were primarily engaged with development of new processes for manufacturing drugs, now they are also involved in R&D for new chemical entities (NCEs) and modifications of existing chemical entities to develop new formulations and compositions. Patenting by Indian pharmaceutical companies has also gone up significantly. The primary incentive to do R&D has not been the product patent regime in India after TRIPS, but the product patent regime in developed countries to which TRIPS has made no difference. While R&D activities have diversified, they are yet to prove their competence in innovating new products. What Indian companies have really demonstrated is the ability to develop generics for the regulated (and other) markets—an ability which they acquired and improved during the pre-TRIPS period.
Keywords: R&D, NCEs, innovation, pharmaceuticals, generics, India, ANDAs, DMFs, NDDS