Health Ministry Publishes New Clinical Trial Rules, Allows Compassionate Use Of Unapproved Drugs That Are In Phase 3 Trials

News date: 08 June 2020Source: https://medicaldialogues.in/news/health/government-policies/health-ministry-publishes-new-clinical-trial-rules-allows-compassionate-use-of-unapproved-drugs-that-are-in-phase-3-trials-66498

According to a gazette notification of the draft rules published on June 5, a hospital or medical institution may import new drug for "compassionate use for treatment of patients suffering from life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need," which has not been permitted in the country, but under Phase-III clinical trial in the country or abroad, by making an application to the Central Drug Regulator.

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.

According to a gazette notification of the draft rules published on June 5, a hospital or medical institution may import new drug for "compassionate use for treatment of patients suffering from life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need," which has not been permitted in the country, but under Phase-III clinical trial in the country or abroad, by making an application to the Central Drug Regulator.
 

Also, if any hospital prescribes a new drug for the same purposes then they may be approved to be manufactured in limited quantities subject to provisions of the rules.The manufacturer intending to manufacture a new drug will have to obtain the consent in writing from the patient to whom the medicine has been prescribed or his legal heirs and make an application to the Ethics Committee of the hospital or medical institution for obtaining its specific recommendation for manufacture of such new drug.