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

 
• By Anju Ghangurde

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.

Clinical trial
INDIA'S NEW TRIAL RULES ARE EXPECTED TO REVIVE SPONSOR INTEREST

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”.

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