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2_New Colonialism - Nundy et al.

2_New Colonialism - Nundy et al. - PERSPECTIVE A New...

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n engl j med 352;16 www.nejm.org april 21, 2005 1634 PERSPECTIVE trials will not normally be permitted in India. The old rule was designed to protect Indians from be- ing used as guinea pigs in the testing of unproved drugs of foreign origin; trials of domestically dis- covered drugs were not subject to this provision. The change was made in response to vociferous demands from multinational drug companies and private organizations that conduct clinical research for a relaxation of the rules for drug trials — those necessary hurdles whose price tags can run to 40 percent of the cost of drug development. 1 It has be- come increasingly difficult to test drugs in West- ern countries, with their strict regulations, elabo- rate safety and compensation requirements, and small populations, all of which make the recruit- ment of research subjects slow and expensive. Con- sequently, many research-based companies are now outsourcing some of their trials to Third World countries such as China, Indonesia, Thailand, and India. India is a particularly attractive site for such tri- als because of its genetically diverse population of more than 1 billion people who have not been ex- posed to many medications but have myriad dis- eases, ranging from tropical infections to degen- erative disorders. Virtually all Indian doctors speak
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  • Spring '10
  • McGrand
  • Clinical trial, Conducting Clinical Trials in India, domestically discovered drugs, multinational drug companies

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