Report: Quintiles closes Indian unit over newfound regulatory hurdles

India's ongoing efforts to tighten clinical trial regulations have stirred controversy among researchers around the globe, and now the world's largest CRO has shuttered one of its facilities in the country, citing a tough regulatory climate.

As India's Financial Express reports, Quintiles ($Q) has closed a Phase I research unit in Hyderabad, formed as part of a partnership with local hospital conglomerate Apollo Group. A "challenging external business environment" made it difficult to keep the operation running, Quintiles India Managing Director Anil Raghavan told the newspaper, and all of the site's roughly 20 employees have been given the option to transfer elsewhere within the company.

Quintiles stressed that the move doesn't spell trouble for the rest of its Indian operations and won't affect its other early-phase sites around the world. Still, the closure comes as more and more sponsors are pulling the plug on trials in India, citing a suddenly heavy-handed regulatory environment that has slowed down the clinical research process.

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. As of April, India's Central Drugs Standard Control Organization had approved only 12 clinical trials for the year, according to local reports, well below 2012's 262 and 2010's peak of 500.

The slump in demand for Indian research is exactly 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 more costly, and many in the industry fear India's stricter guidelines will lead to slower approval and make outsourcing to the country more costly, leading sponsors and CROs to take their business elsewhere.

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