America's top medical research center, the National Institute of Health (NIH), has suspended its clinical trials in India in the wake of the country toughening its regulatory norms.
An arm of the US health department and considered as one of the world's best health-related research institutions, NIH is not the only one to take such a decision.
Many in the private sector have taken similar decisions in recent months and have been withdrawing their clinical trials from India.
A month before the NIH confirmed its decision, a McKinsey report prepared for the Boston-based USA India Chamber of Commerce had identified India's clinical trial policies as one of the biggest hurdles to the country's booming pharma sector, which as per current projections is expected to grow to USD 45 billion by 2020 from the USD 18 billion today.
"While both global and Indian industry leaders opine that India's intellectual property (IP) situation needs to be addressed and clarified, they have highlighted that in fact clinical trials infrastructure and policy are the biggest obstacle for India to meet its potential of driving R&D innovation at scale," said the report.
Expressing concern about the new regulations, the NIH in a recent statement said it looks forward to hearing clarifications from India on this important issue.
"The NIH hopes that future changes will enable studies to resume, and that we will be able to continue collaborations with colleagues in India for the mutual benefit of our citizens," a NIH spokesman said.
Similar views were expressed, by industry experts at a recently held US-India Bio-Pharma and Health Care Summit 2013 in Boston organised by the USA India Chamber of Commerce, wherein they said that the current policy and environment is not conducive to clinical trials in India.
An industry expert said under the present policies, "clinical trials in India would be impossible to conduct" as companies could be held liable if a patient receives a placebo or if an investigational product fails to provide its intended therapeutic effect.
