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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...

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