Health Ministry drafts rules to help COVID-19 patients access new drugs

Monday, 8 June 2020Newsdesk

Seeking to facilitate availability of experimental drugs for severely-ill COVID-19 patients, the Union Health Ministry has issued a draft notification for "compassionate use" of any unapproved drug that is in the phase-III clinical trial globally. 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

New Delhi, 08 June 2020

As per news report of PTI, 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 (human trial) in the country or abroad, by making an application to the Central Drug Regulator.

Source -ptinews.com