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 in order to treat serious COVID-19 patients.
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 PTI report quoting gazette notification of the draft rules published on June 5 says 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 manufacturer to whom the permission is granted shall make use of the new drug only for the purposes specified in the permission and no part of it shall be sold in the market or supplied to any other person, agency, institution or place,” it stated.
The new draft rules will be applicable for 15 days during which people can send their objections and suggestions to be considered by the Central Government after which the final amended rules will be published in the gazette of India, the report said.
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.
For both manufacturing and importing, the licence shall remain valid for a period of one year from the date it has been issued.
Several drugs across the country are in phase III clinical trials phase for COVID-19. Anti-viral drug Remdesivir, last week, was approved for “restricted emergency use” on severe COVID-19 patients.
India’s drug regulator granted US pharma giant Gilead Sciences marketing authorisation for the drug for “restricted emergency use” on hospitalised COVID-19 in view of the crisis posed by the pandemic.