Years of lax regulations helped India build a booming market for clinical trials, but a recent move to strengthen patient protections has deflated demand, and last year saw just 19 studies get underway in the country, The Pharma Letter reports.
That's a roughly 93% drop from 2012's 262 trials and a mere fraction of the country's 500-study peak in 2010, and the plunge in activity has allowed China to surpass India as Asia's go-to clinical trial outpost, according to the website.
The slump in demand for Indian research is just what opponents of regulatory reform warned about. Under India's tighter trial laws, studies must be held in a GCP-compliant facility, approved by an ethics committee, registered with regulators and subject to random inspection. That has made the process slower and more costly, leading many in the industry to worry that India's stricter guidelines would spur sponsors and CROs to take their business elsewhere.
And that has begun to come true. 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 believes things will even out once regulators and members of the industry get comfortable with the new rules. The reforms were designed to better protect patients and weed out fly-by-night CROs, not drive legitimate business out of the country, the Central Drugs Standard Control Organization's Ranjit Roy Chaudhury told the Times of India last month. "We want India to once again be the center of clinical trials," he said.
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