NIH, industry back out of India as trials slow to standstill

Amid mounting pressure to rein in loosely regulated trials, India has clamped down on approving studies, but the resulting slowdown has scared off CROs, sponsors and other researchers, according to a report.

As India's Live Mint points out, NIH has canceled about 40 ongoing trials around the country, joining medical centers, CROs and drug developers in fleeing for the more predictable regulatory environments of Malaysia, Canada and other countries.

India's Central Drugs Standard Control Organization had approved only 12 clinical trials for the year as of April, The Hindu reported, far below last year's 262 and 2010's peak of 500. Since the ramp up to reform the country's trial regulations, the process of registering an ethics committee slowed to as long as three months, Live Mint reports, leading even those in favor of tighter controls to look elsewhere.

Regulators said the decline in approvals in part reflects a decrease in applications, as sponsors worried about increased costs and delays preempted the country's changing regulations and ditched study plans. Under India's tighter trial laws, studies must be held in a GMP-compliant facility, approved by an ethics committee, registered with regulators and subject to random inspection.

The drop in demand is exactly what opponents of trial reform warned last year, and Quintiles ($Q) India Managing Director Anil Raghavan told Live Mint the dearth of studies hits the country's patients the hardest.

"Given the fact that we have the world's highest disease burden, the most impacted by an unstable regulatory environment are patients for many of whom clinical research provided early access to new therapies and is often the only viable treatment option," Raghavan said.

But former regulator M.K. Bhan told the news agency he believes the recent delays are the result of a temporary "overreaction" by the Indian government in light of the many injuries and deaths stemming from India's previous lax system of trial regulation. "There will be balance soon," he said.

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