India notifies tweaked trial compensation rules
This article was originally published in Scrip
Executive Summary
India has notified a slew of much awaited modifications in its clinical trial compensation regulations including clarifications concerning injury or death due to an investigational product not having its intended therapeutic effect and on the requirement of free medical management for trial-related injury.
You may also be interested in...
India's New Trial Rules Tick Right Boxes, Shed Interim Compensation Clause
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.
Patient Safety First But India’s ‘Interim Compensation’ Trial Rule May Spook Sponsors
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.
B-Ingelheim India Chief On Strategy, Jardiance Challenge, Gender Balance In Pharma
Boehringer Ingelheim’s Country Managing Director for India Vani Manja outlines how she expects to shape the German group’s growth trajectory in the country, while also dealing with the unexpected pre-expiry challenge to the Jardiance patent. The executive also discusses her personal career journey, learnings from her prior role in the US and gives advice to women executives seeking to move up to the higher echelons of the corporate world.