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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.
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