Centre Plans ‘Compassionate Use’ Of Under Trial Drugs For Severe COVID Cases
New Delhi: The Union Health Ministry plans to approve “compassionate use” of experimental drugs for severely ill COVID-19 patients.
This will facilitate the availability of any unapproved drug that is in phase-III clinical trial (human trial) globally for treating coronavirus patients suffering from life threatening diseases, according to a draft notification by the ministry.
The draft New Drugs and Clinical Trials (Amendment) Rules stipulate manufacture and import of unapproved drugs based on a prescription by a hospital or medical institution. A gazette notification in this regard was published on June 5, news agency PTI reported.
As per the notification, 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 (human 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 a limited quantity subject to provisions of the rules.
The new draft rules will be applicable for 15 days during which people can send their objections and suggestions to be considered by the Centre after which the final amended rules will be published in the Gazette of India.