US firm Gilead in talks with Indian drug companies for Remdesivir production
US Pharma major, Gilead Sciences, has announced that it is in talks and some of the leading Indian drug companies to produce its patented antiviral drug Remdesivir. It drug has recently received US Food & Drug Administration authorization for emergency use in coronavirus disease (Covid-19) patients. The company is willing to issue a voluntary license to generic drug manufacturers to produce its antiviral drug Remdesivir in bulk for Europe, Asia, and the other developing of the world through at least 2022.
Gilead added that it has plans to build a conglomerate of partners manufacturing the drug to help increase its global supply, which requires scarce and special raw materials and dedicated and specialized manufacturing units with a very limited global capacity. The company also said that any interruption in the supply chain impacting the scarce raw materials could actually lead to a reduction in the quantity of Remdesivir drug produced and could also lead to an increase in the time taken.
Gilead said that it was negotiating with several generic drug makers in India to produce remdesivir and it would provide technology to assist the production. There are few reports that the companies involved in the discussions include Dr. Reddy’s Laboratories, Glenmark, and Cipla Ltd.
Gilead also said it will donate the first 1.5 million doses of the Remdesivir drug, and it is focused on making the drug accessible and affordable to as many people as possible upon approval.
Remdesivir has earlier been tested by Gilead Sciences, Inc for Ebola and is now showing a potential treatment for coronavirus infected patients and is currently popular for its probability to treat the disease. The experimental drug Remdesivir is being studied in several international ongoing clinical trials, but the efficacy of the drug for the treatment of Covid-19 patients is not yet established fully. However, data based on an observational study shows that the drug is effective.
Despite the drug still under clinical trials, countries like the US have given emergency approval to use it for their critical COVID-19 patients. The US Food & Drug Administration (FDA) last week had issued an emergency use authorization for Rremdesivir to treat the patients suffering from Covid-19.
Gilead also said it was in advanced talks with UNICEF to deliver Remdesivir to low- and middle-income countries during the bad times using its distribution networks.
According to news reports the company is also in a serious discussion with the Medicines Patent Pool, United Nations-backed international organization to license Remdesivir for developing countries.
As per the Indian Council of Medical Research (ICMR), local manufacturers can start production of a patented drug under certain conditions during any pandemic.
Dr. Raman R Gangakhedkar, head, department of epidemiology and communicable disease, ICMR said, “Such drugs can be manufactured after paying a royalty to the patent holder. Certain provisions can be made use of to manufacture the drug if required during a pandemic.”
India is also a part of the World Health Organisation’s Solidarity Trials for Covid-19 cure and it has received about 1000 doses of the experimental drug for testing.