India New Trial Rules - Sponsors Interested But 'FAQ' Could Help
India’s new clinical trial regulations could revive sponsor interest in the country, but some norms around local Phase III trial waivers appear open to interpretation and could potentially weigh down momentum.
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Novartis’s breast cancer therapy Piqray is endorsed by an expert panel for marketing in India and the Swiss company has emphasized its commitment to value-based pricing for the product.
TAKE Solutions’ managing director outlines in an interview with Scrip a range of issues shaping the clinical research segment, including the "humongous" number of audits firms face against the backdrop of compliance woes in the sector, the “reach-out” from Chinese firms amid evolving regulations and a potential shift to outcome-based pricing in the CRO space.
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.