Even as the number of COVID-19 cases in Maharashtra is increasing with each passing day and urgently needs remdesivir injections for critically ill patients, the Mumbai-based VJ Farma has sought no objection certificate (NOC) from Drugs Controller General of India (DCGI) for importing 5,000 remdesivir vials from a Bangladesh firm Eskayef Pharmaceuticals. VJ Farma is the Indian C&F Agent of Eskayef.
All India Drug and License Holders Foundation (AIDLHF) has tied up with VJ Farma to supply the vials to hospitals with each vial costing Rs. 7,000. These vials will then be provided to COVID care hospitals in Maharashtra on a cost-to-cost basis or at the price of landing cost.
“VJ Farma would like to import remdesivir injection for Maharashtra state and will supply this injection on a cost to cost basis (no profit no loss). We would also like to inform you that Eskayef Pharmaceuticals, Bangladesh has agreed to provide us 5,000 vials from their ready stocks. We need your NOC in Form 10 or 12 A for importing the drug in the interest of larger patient interest and safety. We would be happy to provide documents that you may require. Kindly grant us permission on an urgent basis if possible within the next 24 hours in the interest of COVID 19 patients,” as per the letter addressed to the DCGI from VJ Farma.
Eskayef is allowed to manufacture remdesivir under World Trade Organisation’s (WTO) drug patent waiver. It is manufacturing the drug under the brand name of Remivir. Remdesivir is an anti-viral manufactured in 2014 to treat Ebola. There are certain sections, like 47 and 100 of the Patents Act that allow the government in a national emergency situation to import and use a product despite it being patented in the country as per provisions of TRIPS.
Following the approval of Covifor, the generic of remdesivir by DCGI, Hetero Healthcare Limited, a group company of Hetero has already supplied 10,176 vials in Maharashtra. C&F agents in Bhiwandi, Pune and Nagpur were supplied 7,774 vials, 2016 vials and 386 vials respectively. Following Cipla Limited announcement of the launch of generic version of remdesivir under its brand name Cipremi, the drug would be available by July 9, 2020. Cipla has been granted regulatory approval by the DCGI for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need.
In May, Gilead Sciences Inc. extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla's generic version of remedisvir called Cipremi.