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Indian Clinical Research Sector: Hope And Despair Amid Shutdowns

 
• By Anju Ghangurde

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.

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India's clinical research sector has been dented amid uncertainties and delays caused by evolving regulations and ongoing trial-related litigation among other factors. (Also see "Indian court sets 3-parameter format for trial applicants" - Scrip, 24 April, 2014.) Compliance issues pertaining to a few local CROs have only compounded problems for the rest of industry. (Also see "Semler Dirty Data: EMA Suspends Over 200 Products; Stings Indian CROs" - Scrip, 25 July, 2016.)

While the Indian regulator has recently tweaked several trial rules as it seeks to clear the logjam of requirements that has been stifling the segment, the situation on the ground appears to be a mix of despair and hope

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