Centre brings fresh rules for import of unapproved new drug for 'compassionate use' to treat patients
Jun 07, 2020
By Priyanka Sharma
New Delhi [India], June 8 : The Union Health Ministry has drafted the new rules for import of unapproved new drug for only 'compassionate Use' for treatment of patients by hospitals or medical institutions under New Drugs and Clinical Trials Rules, 2019.
The World Health Organization defines compassionate use (CU) as a "program that is intended to provide potentially life-saving experimental treatments to patients suffering from a disease for which no satisfactory authorized therapy exists and/or who cannot enter a clinical trial. For many patients, these programs represent their last hope."
These new rules have been inserted under section 96 starting from 96A to 96I which deals with filing an application, granting the license to the importer or manufacturer, conditions and suspension of such license granted for the import or manufacture of unapproved new drug for compassionate use.
The amended rule also states that 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.
Under section 96D, it states: "Where any medical officer of a hospital or medical institution prescribes a 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 under Chapter X of these rules, but under Phase-III clinical trial in the country or in any other country, then, such new drug may be approved to be manufactured in limited quantity subject to provisions of these rules".
It is pertinent to note anti-viral drugs like Remdesivir, Favipiravir, 'Pegylated Interferon Alpha-2b are in process of clinical trial for the potential treatment of coronavirus (COVID-19).
Under section 96C of the draft says that the hospital or medical institution shall submit to the Central Licencing Authority, a quarterly report which was half-yearly under the previous rules about the status and stock of new drugs imported, utilized and destroyed.
