Clinical Trials in India

While Europeans interested in medical research have, ventured into India before, modern-day globalization has washed a wave of researchers and multinational drug companies onto India’s shores. According to Sean Philpott, managing editor of The American Journal of Bioethics, this wave recalls the gold rush frontier. Not only are research costs low, but there is a skilled workforce to conduct the trials. Though drug companies are undoubtedly enticed by the prospects such as bringing down the price of testing by 60% - their work arguably takes advantage of both India’s educated workforce and individuals mired in poverty, who act as guinea pigs under informed consent after lures of 100 US dollars.

While it may not be for outsiders to judge the significance of such sums to South Asia’s impoverished, many, including Philpott, who cautions that individuals may not even realize they are being coerced, worry that the testing borders on exploitation. Pharmaceutical companies conducting research have come under criticism before. In 2004, before the anti-generic drug rules were enacted, two India-based drug companies, Shantha Biotech and Biocon came under scrutiny for conducting illegal clinical trials without proper consent, actions that led to eight deaths.

Although South Asia’s poor are somewhat used to being enticed by the medical community (particularly when it comes to the sale of vital organs), such testing was not always as prevalent in the region. In the past scientists used foreign produced reverse-engineered drugs, a practice halted after March, when India submitted to pressure by the World Trade Organisation to prohibit local companies from creating generic versions of patented drugs. Considering both relatively lax government oversight and the removed threat of domestic competition, many drug companies are now taking advantage of cost-effective testing ground. By 2010 total spending on outsourcing clinical trials to India could top $2 billion, according to Ashish Singh, vice president of Bain & Co., a consulting firm that reports on the health care industry.

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