The Indian Health Ministry has issued a draft notification for ‘compassionate use’ of any unapproved drug that is in the Phase III clinical trial across the globe.
The draft New Drugs and Clinical Trials (Amendment) Rules seek to facilitate the availability of experimental drugs for severely ill Covid-19 patients.
A gazette notification of the draft rules was published in this regard.
According to the notification, a hospital or medical institution may import new drugs 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,’ PTI reported.
Additionally, any new drug prescribed by a hospital for the same purposes may be approved and can be manufactured in limited quantity. This is subject to provisions of the rules.
These new rules have been inserted under section 96, which deals with filing an application and issues the license to the importer or manufacturer. The licence will remain valid for one year for manufacturing and importing, from the date it has been issued.
In the case where an importer or manufacturer who gets the license does not comply with any provision of the act and these rules, their license can be suspended or cancelled by the Central Licencing Authority.
The new draft rules will be applicable for a period of 15 days. During this time, people will be able to send their objections and suggestions which will be considered by the central government.
Later on, the final amended rules will be published in the gazette of India.