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.
You may also be interested in...
Real and perceived barriers have bogged down the Indian clinical trials segment. Senior leaders of J&J, IQVIA and 5AM Ventures say many COVID adaptations should be codified, while a member of India’s NITI Aayog indicates an openness to find solutions to some pain points.
India has proposed establishing a Gene Therapy Advisory and Evaluation Committee that will comprise independent experts to monitor all GTP clinical trials.
AstraZeneca’s Calquence, Pfizer’s Lorbrena and Lilly’s Verzenio, which all address unmet medical needs, have been endorsed by an expert panel in India, paving the way for their potential introduction on the market. But all eyes will be on pricing to ensure access in this largely self-pay market.