India New Trial Rules - Sponsors Interested But 'FAQ' Could Help

India’s new clinical trial regulations could revive sponsor interest in the country, but some norms around local Phase III trial waivers appear open to interpretation and could potentially weigh down momentum.

India’s New Drugs And Clinical Trials Rules 2019, which stipulate time-bound regulatory approvals and provide for conditional local trial waivers, appear to have improved the general outlook of large sponsors in the country, though nuances in the new norms offer “subjective interpretation”.

Large sponsors, CROs and sector experts believe that the new rules will buoy sentiment in the Indian clinical research sector, which has been through a rough time, singed by uncertainties and delays caused by evolving regulations, the cascading effect of certain instances of data integrity deviations and ongoing trial-related litigation.(Also see "Indian Clinical Research Sector: Hope And Despair Amid Shutdowns" - Scrip, 26 August, 2016

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