EMA circumspect on India

With the regulation of clinical trials in India in flux, EMA says the feasibility of conducting clinical trials in India is a concern for sponsors - not the agency - to address.

Earlier this year, NIH delayed the start of new trials in India and suspended those that were ongoing after the country's Ministry of Health and Family Welfare implemented the new regulations. As part of the rules, sponsors are required to provide compensation to patients who suffer injury or death during a trial, or as a result of the study, including the "failure of investigational product to provide intended therapeutic effect" (see BioCentury, July 29). ...