Wednesday, July 31, 2013

NIH pulls clinical trials research out of India: but why?

Last month, the National Institutes of Health (NIH) postponed, delayed or scraped nearly 40 clinical trials in India, and it is still not completely clear why. What is clear that it has something to do with the local, Indian regulations governing the conduct of clinical trials, what is called the Drugs and Cosmetics Act. But what about the Act is making the NIH withdraw or suspend its activities is not receiving a clear answer, and creating a vacuum for speculation to enter. Industry experts are talking about an 'unstable regulatory environment' in India, which could mean anything: contradictory policies, bureaucratic cul-de-sacs, or just obstacles to (potential lucrative) drug development. Maybe the Act requires a regulatory structure that the Indian government is not prepared to adequately bankroll: it is always easier to create shiny new regulations than to establish institutions capable of effectively implementing them. Ethics committee chaos can grind research to a halt. Or maybe it has to do with provisions in the Act regarding compensation for research-related harm, that could drive up research costs, precisely in a country that has attracted biomedical research due to its low overhead, ease of recruitment, drug-naive populations, and so on.

India has been a hotbed of concern about global health research ethics for some time. Typically the concerns are about conducting responsible research there among the vulnerable, impoverished sick. But this time it is about the ethics of pulling up stakes and halting research in such circumstances, including (one supposes) research with current or potential benefits for patients. To tap down adverse speculation, you need transparency. Without that, there is nothing to do but watch the rumors freely breed and spread.

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