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India's New Trial Rules Tick Right Boxes, Shed Interim Compensation Clause

 
• By Anju Ghangurde

India’s new trial regulations have set competitive approval timelines, provide for local trial exemption in specific instances and also drop a controversial draft clause pertaining to interim compensation payable by sponsors.

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INDIA NOTIFIES NEW CLINICAL TRIAL REGULATIONS • Source: Shutterstock

India has issued new clinical trial rules that specify time-bound regulatory approvals and provide for local trial exemptions for drugs approved in certain developed countries, subject to specific conditions.

The new rules are also shed certain contentious trial compensation provisions that were part of a previous draft regulation and had made sponsors nervous.

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