India Set To Open Door To Human Challenge Trials

The Indian Council for Medical Research has developed a draft policy addressing the ethical concerns posed by human challenge studies so that such research can be conducted in India.

Epidemic infectious disease outbreak with person analyzing virus strain and worldwide situation. SARS-CoV-2 pathogen causing coronavirus covid-19 pandemic disrupting social and economic life
Human Challenge Trials Can Provide Unique Insights Into Disease Pathogenesis • Source: Shutterstock

The Indian government is inviting stakeholder feedback on a draft policy framework for allowing trial sponsors to undertake controlled human infection studies (CHIS) in which healthy volunteers are intentionally exposed to a specific pathogen or infectious agent under controlled conditions.

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