INDIAN CLINICAL TRIALS RAISE CONCERNS
June 28, 2005
India's government recently began allowing drug companies to conduct clinical trials in the country simultaneously with trials elsewhere, according to the New England Journal of Medicine. Cheap labor and low infrastructure costs there lower the expense of clinical trials by up to 60 percent.
But critics cite safety concerns due to lack of experience among Indian doctors and officials. For example:
- India's Drug Controller General (the equivalent of the U.S. Food and Drug Administration) is short-staffed and without a medically qualified doctor; as a result, they lack expertise in evaluating protocols for clinical trials.
- Out of India's half-million doctors, only about 200 have been trained in good clinical practice; furthermore, only 150 of India's 14,000 hospitals have proper infrastructure to conduct trials.
- Illiteracy among India's citizens creates ethical issues -- citizens may consent to trials without really knowing what risks are involved.
Moreover, India may not necessarily reap economic and health benefits from hosting clinical trials:
- Out of $33 billion spent on clinical trials by U.S. drug companies last year, only $30 million was spent in India, which is the equal to the value of the computer software India exports in just one day, but without the risks.
- Sponsors of clinical trials do not guarantee that new drugs tested in India will be available for its citizens at an affordable price; a 10-mg tablet of tadalafil (for erectile dysfunction) costs $9.00 in the United States, the equivalent of four days wages in India.
Finally, few trials have taken place in India that produce drugs to cure diseases prevalent there, such as leprosy, tuberculosis and water-borne illnesses.
Source: Samiran Nundy, M. Chir., and Chandra M. Gulhati, "A New Colonialism? Conducting Clinical Trials in India," New England Journal of Medicine, Vol. 352, No. 16, April 21, 2005.
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