Clinical trials and healthcare regulation in India

Clinical research is an important aspect of universalising healthcare, enabling the development of better drugs, tests, vaccines, devices, surgical procedures and other medical interventions and protocols for their safer and more rational use. However, today it is viewed merely as a business investment with high returns. This view has been strengthened by the global trend to marginalise public sector involvement in drug development, a trend that has reduced the potential for non-profit use of the gains of research. Moreover, the growth of clinical research as a global industry has not been matched by an increase in expertise in regulating the complex arrangements that have emerged through the process of outsourcing and
off-shoring clinical trials.

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