By PTI Jun 8, 2020 8:56:17 AM IST (Updated)
The set of new rules have been inserted under section 96, which deals with filing an application, granting the license to the importer or manufacturer, conditions and suspension of such licenses among others.
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.