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Patient Safety First But India’s ‘Interim Compensation’ Trial Rule May Spook Sponsors

 
• By Anju Ghangurde

India’s draft new drugs and clinical trials rules come with a prickly "no claims" clause pertaining to payment of “interim compensation” by sponsors in specific circumstances, based on an initial causality assessment by ethics committees (ECs). The new rules, at least in their current form, also give ECs near "quasi- regulatory powers" say some experts.

Clinical trial
INDIA'S TRIAL COMPENSATION RULES MAY PUT OFF SPONSORS

India’s draft New Drugs And Clinical Trials Rules 2018 includes several progressive measures aimed at ensuring time-bound regulatory approvals, but contentious norms around compensation payable towards serious adverse events (SAEs) during a clinical trial may put off sponsors, some industry experts say. Blanket medical management requirements for trial participants by sponsors is another key sticking point.

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More from Asia

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• By Lisa Takagi

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