Health Ministry publishes New Drugs and Clinical Trials (Amendment) Rules
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The Union Health Ministry has come up with draft New Drugs and Clinical Trials (Amendment) Rules, inserting provisions for "compassionate use" of any unapproved drug that is in the phase-III clinical trial, either in India or abroad, by importing or indigenous manufacturing. The move is aimed at facilitating availability of new drugs which are in Phase-III clinical trials (human trials) for severely-ill COVID-19 patients in the country.
The Union Health Ministry has come up with draft New Drugs and Clinical Trials (Amendment) Rules, inserting provisions for "compassionate use" of any unapproved drug that is in the phase-III clinical trial, either in India or abroad, by importing or indigenous manufacturing. The move is aimed at facilitating availability of new drugs which are in Phase-III clinical trials (human trials) for severely-ill COVID-19 patients in the country.
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