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14 August 2008

The Outsourcing of Clinical Trials

The price of bringing a new drug to market is, on average, $1 billion. Much of that is spent on human clinical trials, the most crucial and time-consuming phase of drug development.

With tight regulations at home and shrinking profits due to expiring drug patents, western drug makers are looking to expedite the process by outsourcing safety and efficacy studies to countries such as India. An amendment proposed last year by the technical advisory committee of India's Health Ministry would allow drug companies to test their products widely on patients in India even before they're proved safe at home. In a country that lacks the medical infrastructure to care for people harmed by untested drugs, this could lead to potentially devastating consequences.

Already, toxic drugs have posed problems. In 2003, researchers from India-based Sun Pharmaceuticals gave the anticancer drug letrozole to 430 young women to see if it would induce ovulation, despite the fact that the drug is known to be toxic to embryos.


* Time August 11, 2008

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