The ECG curse: India's Quest under lens in ''retrospective'' finding
This article was originally published in Scrip
Just when things appeared to be on an uptick, India's beleaguered clinical research industry may be headed for another trough with yet another leading CRO now under fire over data integrity concerns.
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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.
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.
Dirty data issues continue to plague Indian contract research organizations, denting the reputation of the beleaguered local industry and piling up challenges for marketing authorization holders. The European Medicines Agency (EMA) has now suspended close to 300 products that relied on flawed bioequivalence studies done by the Bengaluru-based Semler Research.