Health Ministry relaxes norms for import of unapproved drugs for 'compassionate use'

The Union Health Ministry has recently drafted new rules that will allow the import of unapproved new drugs. According to reports, these unapproved drugs will only be for ‘compassionate use’ and will be used to treat patients under New Drugs and Clinical Trials Rules, 2019. These new rules allowing for the import of unapproved drugs 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 an unapproved new drug for compassionate use.

Keeping hope for patients alive

The World Health Organization describes ‘compassionate use’ as the use of unapproved or experimental therapy/ medicine for the treatment of patients with illness for which there is no accepted cure. For many patients, these experimental drugs and treatment represent their last hope for life. The rule added also states that the importer or the manufacturer of unapproved drugs is only allowed to sell them with proper permission and authorization.

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Under section 96D, it states: "Where any medical officer of a hospital or medical institution prescribes a new drug for compassionate use for the treatment of patients suffering from a 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".

Section 96C of the draft states that hospitals and medical institutions that dispense unapproved drugs for compassionate use to patients must submit a report to Central Licencing Authority four times a year detailing the specifics about the status of the unapproved drugs.

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Anti-viral drugs like Remdesivir, Favipiravir, 'Pegylated Interferon Alpha-2b are currently in the clinical trial phase. They have been hinted as a potential treatment for coronavirus