India government set to tighten regulation of clinical trials
The government of India is now mandating that ethics board committees for clinical trials not only by registered but also accredited.
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 […]
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.
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