Maharashtra has recently announced its decision to procure 10,000 vials of Remdesivir from an allegedly unlicensed Bangladeshi manufacturer of Gilead Sciences. This comes as a surprise to many Indian companies who await the central drug regulator’s authorization to sell this medicine in the country.
Indian corporations, speaking of the venture has stated that the Bangladeshi company with which the Mantralaya is negotiating neither has an import license, nor a manufacturing license from Gilead to sell the drug in India. Rajesh Tope, the Health Minister of Maharashtra had earlier said that the state would buy Remdesivir from Eskayef Pharmaceuticals, a company based out of Dhaka, at $160 per vial, or ₹12,000 per vial, for 10,000 doses. The price of this drug in Bangladesh retail market is around $60-65, as per some Bangladesh pharma companies’ media outlet ET spoke to.
In the recent past, The Union Health Ministry had set out new rules that will authorize the import of unapproved new drugs. As per 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 mentioned 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.
The World Health Organization describes ‘compassionate use’ as the use of unapproved or experimental medicine for the treatment of patients with diseases for which there is no accepted cure. For many patients, these drugs and treatment represent their only hope for life. The rule added also stated that the importer or the manufacturer of unapproved drugs is only allowed to sell them with proper authorization.
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