Clinical trials in India: Pangs of globalization

A. Bhatt | Indian Journal of Pharmacology | Vol 36, Issue 4 | July-August 2004

Clinical trials in developing countries are exploding. It is estimated that 20-30% of global clinical trial activities are being conducted in developing countries.[1] The 2002 Indian clinical trials market of $30-35 million is projected to grow 8-10 times by 2010 to $ 250-300 million.[2] The availability of a large drug-naïve patient population and well-trained medical professionals, coupled with sophisticated technological infrastructure have made India an attractive destination for conducting global clinical trials.[1],[2] However, a highly critical article discussed concerns about timelines for regulatory approvals, deficiencies in the functioning of the ethics committees (EC), investigators’ unethical approach to the recruitment of subjects and the quality of Indian clinical trials, and concluded that outsourcing clinical trials to India is rash and risky.[3] Let us briefly review the current scenario for clinical trials.

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