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Expert panel defers approval for covid pill

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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.

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