India Global Trial Hub Dreams Still Distant As Concerns Linger
Indian clinical trial approvals appear to be on the downswing despite government moves to boost the troubled sector, as regulatory uncertainty and negative publicity continue to undermine confidence in the industry.
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Data integrity concerns continue to cloud outlook for India’s contract research sector. The European Medicines Agency’s latest action against Micro Therapeutic Research Labs suspends more than 300 products in the EU over “unreliable” data and the firm tells Pink Sheet this will result in a “considerable dent” in its operations.
Micro Therapeutic Research Labs is now under the scanner over alleged data integrity concerns. European Medicines Agency (EMA) is evaluating medicines based on studies done by the Indian firm.
India's clinical research segment has had a rough time of late. Uncertainties, evolving regulations and compliance deviations have hurt the sector that is now scarred with firms downing the shutter, mistrust and constant speculation. Scrip spoke to a number of CROs who appear to have weathered the storm, but it seems the industry may not be out of the woods just yet.