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Research And Developement Pharmaceutical Research and Development

Growth of the generic industry in India meant continuous evolution of synthetic process development and formulation development skills within the industry. Till about 1995 much of the research undertaken by pharmaceutical companies in India related to process and formulation development and bioavailability/bioequivalence studies to support the latter, although a few multinational companies possessed research facilities in India that had a wider scope.

India's signing of the GATT/WTO - TRIPS agreement resulted in large generic companies investing in major R&D facilities as part of the realignment of their long-term business model and strategy. Several companies across the traditional and new biotech sectors of the industry now have sizable research facilities involved in drug discovery and early development, and many of these companies have a small pipeline of products in development although no Indian discovery has yet completed development for worldwide commercialization as a result of these endeavors. Some companies have preferred to out-license partially developed products to larger multinationals for further development rather than risk the necessary investments for full development and commercialization.

Another interesting development has been Indian involvement in the global drug development process for multinational companies. Available human resource capabilities for clinical research in India, together with advantages in study start-up time, recruitment speed, comparable quality, and the availability of the requisite physical and electronic infrastructure has resulted in some multinational companies leveraging these to the advantage of the drug development effort through their Indian subsidiaries. Participation in drug development programs has also helped Indian subsidiaries speed up new drug introductions in India besides leading to refinements in local research capabilities and infrastructure that is expected to be of benefit to the growth of the pharmaceutical and healthcare sectors in the country.

More recently the landscape has undergone dramatic change with the emergence of CROs on the scene. There is now a wide selection of CROs with a variety of capabilities and core competence ranging from clinical trial monitoring, site management and data operations, to discovery sciences, toxicology, pharmacokinetics, genomics, and bioinformatics. Many of the CROs with clinical monitoring and data operations capabilities are Indian subsidiaries of larger organizations operating internationally.