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.
The draft new rules, currently in an advanced stage of consideration, stipulate that sponsors will need to pay an interim...