MUMBAI : T he subject expert committee (SEC) of India’s drug regulator has deferred the approval of the much-awaited covid-19 antiviral pill Molnupiravir as clinical trial data from companies remains inconclusive on the efficacy of the drug.
The decision comes a week after the USFDA’s expert panel narrowly recommended it for emergency use authorization (EUA) with a caveat that the nod will be revoked if a better drug comes through.
The Indian SEC asked companies why should they be granted a EUA when the efficacy of the drug is so low. It has asked companies to submit details of a risk mitigation plan in case of an adverse event.