New Delhi: To boost the supply of remdesivir — an experimental drug that has shown promise in treating Covid-19 — its maker, US-based Gilead Sciences, has announced its entry into the Indian market and said it will sell the drug in the country, despite signing deals with three local pharma companies.
The company announced Wednesday the receipt of approval from the Drug Controller General of India — the apex drug regulatory authority of India — for marketing and selling the drug for the treatment of suspected or laboratory-confirmed Covid-positive adults and children hospitalised with severe symptoms.
“The primary purpose of filing the new drug application (NDA) is to support the voluntary licensees based in India with whom Gilead recently signed non-exclusive voluntary licensing agreements to further expand the supply of remdesivir,” the company spokesperson told ThePrint Thursday.
New drug application (NDA) is filed by a drug-maker to take approvals for marketing a new drug in a country.
Last month, the drug-maker had announced signing of voluntary licensing agreements with three Indian pharmaceutical companies — Cipla, Hetero Labs and Jubilant Lifesciences — to manufacture the generic version and expand the supply of the drug.
While the manufacturers of the generic drug will be free to set their own prices, Gilead said it has “not yet set a price” for its own brand of remdesivir, sold under the brand name Veklury.
The company denied revealing any estimates on pricing, but said “it is our hope and intent that volumes and competition will drive costs down”.
Gilead said it will “work closely with the health authorities in India to provide guidance on anticipated drug supply based on local incidence and severity of disease”.
At present, doses of remdesivir are available only through donations made for several trials, including the World Health Organization’s (WHO) Solidarity Trial, which is ongoing in India in 18 selected locations.
Also read: Not Oxford lab, not US company, Covid solution will come from India, China pharma industry
Global supply of drug to improve by July
There is currently a limited global supply of remdesivir, the company said, which is expected to improve by July and become better by the year-end.
“We anticipate new supply of the drug to start to become available in July (globally), with supply continuing to increase through the end of this year and into next year,” said the spokesperson.
For faster availability of the drug in India, Gilead has a little role to play.
“The timeline to get remdesivir to the Indian patients will depend on the licensees and a process that Gilead does not control,” he added.
“Our individual licensees will also file applications with the Central Drugs Standard Control Organisation to manufacture and sell remdesivir, while waiving the requirement for undertaking local clinical trials,” he said.
The licenses given to the three drug-makers are royalty-free until the WHO declares the end of the Public Health Emergency of International Concern regarding Covid-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent Covid-19, whichever is earlier, added the spokesperson.
Also read: Indian drugmakers aren’t losing sleep despite getting a record 23 warnings from US FDA