sunder rajan:Clinical Trials71the patent. This has forced a number of leading Indian drug companies into an r&d-driven business model, whereby they, like their Western counterparts, engage in the much riskier process of new drug discovery and development. Clinical trials become a constitutive part of this busi-ness model, because new drugs cannot be developed without subjecting them to an elaborate regime of safety and efficacy testing. In other words, the Indian pharmaceutical industry has itself served as a spur to the crosector. wtoentry may also have made India a more attrac-tive research destination from the perspective of Western trial sponsors seeking to outsource, since their intellectual property is better protected under such a regime.A third set of actors consists of the regulatory agents of the state. The immediately responsible body in India is the Drug Controller-General of India, roughly equivalent to the usFood and Drug Administration. This
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