5_Sunder Rajan - Experimental Values

5_Sunder Rajan - Experimental Values - sunder rajan:...

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sunder rajan: Clinical Trials 71 the 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 efFcacy testing. In other words, the Indian pharmaceutical industry has itself served as a spur to the cro sector. wto entry 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 us ±ood and Drug Administration. This body, a fairly peripheral presence on the Indian regulatory landscape
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell University (Engineering School).

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