Maharashtra government on Saturday said that it has decided to procure the repurposed Ebola drug remdesivir to treat critical Covid-19 patients in the state at a price of Rs 12000 per vial. Since the Indian manufacturers of the drug are yet to have the marketing authorisation for the drug and its innovator Gilead is yet to launch in the market, the state government is open to procuring it from Bangladesh.
Maharashtra has registered more than 80,000 cases of Covid-19 and is the worst affected state in the country.
Maharashtra health minister Rajesh Tope said that the state government has decided to procure 10,000 vials of remdesivir. “It will cost around Rs 12 crore and will be purchased through corporate social responsibility (CSR) funds of corporates. Remdesivir has been used effectively against SARS and has also been recommended by the World Health Organisation (WHO),” Tope said. This works out to Rs 12000 per vial. It is not clear if Maharashtra will ask the drug majors to supply the drug under CSR or would seek help from big corporates to donate the drug to state run hospitals for free.
The minister also added that the drug will be provided to critical patients in the state and if required it will be procured from Bangladesh.
Bangladesh is, in fact, the first country in the world to sell a generic version of this much in focus drug. Dhaka based Beximco Pharmaceuticals became the world’s first firm to sell the generic version of the drug. Reports suggest that the firm has said it will sell the drug for $71 per vial to private clinics. Another company Eskayef has also started distributing the drug to Bangladesh hospitals.
Under World Trade Organisation provisions, lesser developed countries like Bangladesh can produce generic versions of patented drugs without seeking a license.
A Gilead spokesperson said, “Gilead has signed non-exclusive voluntary licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir. The agreements allow the companies – Cipla Ltd., Ferozsons Laboratories, Hetero Labs Ltd., Jubilant Lifesciences and Mylan – to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access.”
The company clarified that it has not provided a license to Eskayef Pharmaceuticals or any other company in Bangladesh to manufacture remdesivir. Gilead cannot comment on or verify the authenticity or effectiveness of this product as it is not manufactured by Gilead or one of our licensed partners.”The primary purpose of filing the NDA to the DCGI to import and market Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, is to support the Voluntary Licensees based in India with whom Gilead recently signed the non-exclusive voluntary licensing agreements to further expand supply of remdesivir,” the spokesperson said.
It also added that Gilead Sciences has not yet set a price for remdesivir.
US major Gilead got restricted emergency use approval from the Indian drug regulator for remdesivir recently. So far, only Gilead has the approval to launch in India from the Drug Controller General of India (DCGI).
Industry sources indicate that for launching a completely new drug, animal toxicology data is required and they are waiting for clarity on that from the Indian regulator.
Meanwhile, the Indian drug pricing regulator is keeping a close watch on the launch of the drug and its pricing. Indian firms are free to price the drug when they launch their generic versions.
Indian players are ready with the drug and are awaiting the regulator nod to start commercial manufacturing.