It has been estimated that within the next five years India will host more than 20% of the global clinical trials1. Before 1996, USA, Europe and Japan were the major participants in conducting clinical trials following the guidelines set on the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH; http://www.ich.org/cache/compo/276-254- 1.html, 1996). As a result of economic globalization, major pharmaceutical companies have started outsourcing their clinical trials to developing countries, and India is one of the preferred destinations. In a recent report from the Office of the Inspector General, Department of Health and Human Services, FDA, USA, 80% of the drugs approved for sale in 2008 had trials in foreign countries and 78% of all subjects who participated in clinical trials were enrolled outside the US (http://oig.hhs.gov/oei/reports/oei-01- 08-00510.pdf, 2010). Testing of ten drugs approved in 2008 was done entirely abroadand not a single patient from the US was recruited. Although the majority of human participants in these trials were recruited from western Europe, central and South America, India has the potential to provide a hunting ground for pharma multinational companies. Certainly, India has this unique position amongst developing countries due to its vast human resource, improving economy and English-speaking clinical investigators. But there have been reports in the international media and medical journals about unethical clinical trials, that were even termed as new colonialism2,3. An editorial published a few years ago in Lancet emphasized the need for ethical oversight and strict regulation to strengthen clinical research in India and to meet the global standards set by the ICH guidelines4. The editorial highlighted the enforced areas and outlined the persisting weaknesses in the system. The enforcement aimed to bring India on par with international standards such as adoption of good clinical practice (GCP), patent protection as well as removing the phase lag between India and other countries. However, weaknesses persist in the implementation of ethical and regulatory guidelines.
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