NEW DELHI: India has received 1,000 doses of Remdesivir, approved by the US Food and Drug Administration for Covid-19 treatment, as part of solidarity trials by the WHO happening across the globe, but the country’s pharma companies will have to wait for the patent route chosen by US drug maker Gilead to start production here despite Indian scientists achieving synthesis of Key Starting Materials (KSMs) of Remdesivir.
According to Gilead, the results from the global, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases (NIAID) are positive and they show that patients with Covid-19 who received Remdesivir recovered faster than similar patients who received the placebo.
Interestingly, the anti-viral was earlier trialed to treat hepatitis and Ebola, but failed in a number of real-life tests.Union Health Minister Dr Harsh Vardhan on Monday said the synthesis of Key Starting Materials (KSMs) of Remdesivir has been achieved by CSIR-IICT (Council of Scientific and Industrial Research-Indian Institute of Chemical Technology) and technology demonstration to Indian industry is going on.But experts say that no company will touch the molecule (KSMs) as it will infringe on Gilead’s patent for Remdesivir.
“It is for Gilead to decide how it will be bringing the drug to Indian market and which company will make it and by what route. Two routes are available for international patents in India - compulsory licensing and voluntary licensing but it all depends on negotiations by the company,” said CSIR Director General Shekhar Mande.
Last week, Gilead Chairman & CEO Daniel O’Day had said that the company is working to build a consortium of manufacturers to expand its global capacity. “It will be essential for countries to work together to create enough supply. In the event of regulatory action, we are in discussions with various groups about how we might bring Remdesivir to the developing world,” he said.
