India grapples with rules on clinical trials
India offers many advantages for drug companies interested in conducting clinical trials. It has a large population of patients with common diseases that affect developing nations, but also has growing numbers of patients with so-called 'diseases of affluence'. Furthermore, many people have never taken drugs for their conditions, simplifying patient enrolment and management.
Several international clinical research organisations have already set up shop and are running projects for European and US clients. But, reports Dinesh Sharma in this article, industry representatives say that India needs to relax its rules governing clinical trials to take advantage of its position.
Critics, however, say that India is not ready for looser regulation. And an expert review panel recently concluded that the government needed to be even more aggressive in its control of clinical trials in the country.
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Reference: The Lancet 363, 9420 (2004)