India further tightens clinical trial rules as demand plummets

After years of allowing loosely regulated clinical trials that often put patients at risk, the Indian government has taken a 180-degree turn, now further strengthening its rules by mandating that ethics committees must be registered and accredited before a study can begin.

As The Times of India reports, the government's latest hurdle for researchers is a new accreditation council, designed to vet and approve ethics committees looking to oversee trials in the country. The plan is one of 23 recommendations submitted by a government-appointed group last year designed to reverse India's lax regulations amid public scrutiny and mounting deaths and injuries.

However, while it's unclear whether the stricter laws have made clinical research safer, they have certainly dampened demand for India's once-booming outsourcing scene. In October, Quintiles ($Q) closed a Phase I research unit in Hyderabad citing a "challenging external business environment." And, over the summer, NIH canceled at least 40 ongoing studies in the country, joining medical centers, CROs and drug developers in fleeing for the more predictable regulatory environments of Malaysia, Canada and other countries.

The government has acknowledged the dip in trial approvals and research demand, "but this is set to change," CDSCO's Ranjit Roy Chaudhury told the Times. "We want India to once again be the center of clinical trials."

In the end, the government believes that stronger, more predictable regulations will weed out fly-by-night CROs and attract more and more serious researchers and drug developers.

- read the story

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