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.
Are drug firms being lax when it comes to Phase IV studies in markets like India or are certain arbitrarily determined regulatory requirements largely to blame? Scrip delves into the issue.
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