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Clinical trials in India – US fallout turns nasty

The regulation of clinical trials in India started a spat of nasty emails 6000 miles away in Washington DC.

According to Live Mint, the US National Institutes for Health has scrapped some 40 clinical trials in India following the Supreme Court’s ruling on the inadequacy of regulation. It is not the increased oversight that the NIH objects to but the unpredictability over how long it will take to get each clearance.

Veteran US biotech journalist, John D Carroll  thought that he would ask the NIH if the Live Mint story was true. They gave him a series of non-answers in emails written by PR people. Carroll was not amused and took to the editorial slot in his FierceBiotech newsletter to write a scathing (and very funny) commentary on the NIH’s failings in communication. He ended, “The NIH plays an enormous role in funding and guiding academic research work. You can imagine how they would like to communicate with investigators who use this kind of cute, circular language. Why anyone at the NIH would think that this is appropriate now, as the agency struggles to come up with a sufficient budget to satisfy grant requests and pay for a shift to translational medicine, makes me wonder about their grip on reality.”

The tighter regulation of trials follows a decision by the Supreme Court in a PIL brought by an activist group in Madhya Pradesh. The Court did not ban trials but demanded that government come up with a new system of regulation (to replace the colonial era rules) and that the Secretary Health personally approve all trials in the interim.

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