US Pharma major, Gilead Sciences, on Wednesday announced it in talks with some of the world’s leading chemical and pharmaceutical manufacturing companies, including in India, to produce its patented antiviral drug remdesivir, after the drug recently received US Food & Drug Administration authorisation for emergency use in coronavirus disease (Covid-19) patients.
The discussion is taking place about their ability, under voluntary licenses, to produce remdesivir for Europe, Asia and the developing world through at least 2022. A voluntary licence is where a generics drug manufacturer is given permission by the patent holder to make a drug -- for a consideration. India is one of the world’s top generics hubs.
“The company is negotiating long-term voluntary licenses with several generic drugmakers in India and Pakistan to produce remdesivir for developing countries. Gilead will provide technology transfers to facilitate this production. Finally, the company is in active discussions with the Medicines Patent Pool, which Gilead has partnered with for many years, to license remdesivir for developing countries,” said Gilead Sciences in a statement released on Wednesday.
According to the Indian Council of Medical Research (ICMR), during a pandemic, local manufacturers can start production of a patented drug under certain conditions.
{{/usCountry}}According to the Indian Council of Medical Research (ICMR), during a pandemic, local manufacturers can start production of a patented drug under certain conditions.
{{/usCountry}}“Such drugs can be generically manufactured after paying a royalty amount to the patent holder. There are certain provisions during a pandemic that can be made use of to manufacture the drug, if required,” Dr Raman R Gangakhedkar, head, department of epidemiology and communicable disease, ICMR, had said in one of the media briefings.
His reference was probably to a compulsory licence.
India is part of the World Health Organisation’s Solidarity Trials for the cure of Covid-19 and has received 1000 doses of the drug for testing.
The Hyderabad-based Indian Institute of Chemical Technology (CSIR-IICT) also has synthesised the key starting materials for remdesivir, which the first step to develop the active pharmaceutical ingredient in a drug.
Gilead is also in advanced discussions with Unicef to utilize their extensive experience providing medicines to low- and middle income countries during emergency and humanitarian crises to deliver remdesivir using its well-established distribution networks, to further facilitate access in developing countries during this acute health crisis.