Indian drug regulator, Central Drugs Standard Control Organisation (CSDSCO) has granted conditional approval to the US pharma giant Gilead Sciences for its anti-viral drug Remdesivir for “restricted emergency use” on COVID-19 patients. In a view of emergency and unmet medical needs in light of the novel coronavirus, the approval process for Remdesivir was accelerated.
The drug will be used for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children. The drug is in the form of injection and can be sold through retail on the prescription of specialists for use in the hospital or institutional setup only.
Last week, the Clinical Research Organization (CRO) filed market authorisation for Remdesivir in India on behalf of Gilead Sciences. Currently, the drug is approved in Japan for the treatment of patients infected with SARS-CoV-2. Recently, the US Food & Drug Administration (USFDA) had granted its approval for the usage of the drug. The approval comes in the backdrop of two Indian pharmaceutical companies Cipla and Hetero Labs seeking permission to manufacture and sell Remdesivir in India, still under consideration. The firm has also entered into a non-exclusive licensing agreement with three Indian pharma companies, Cipla, Jubilant and Hetero Labs, to manufacture the drug in India. Their application is still pending with the drug controller.
The study published in the New England Journal of Medicine revealed that two out of three critically ill coronavirus patients who were on oxygen support showed signs of improvement when they were administered Remdesivir. The Indian Council of Medical Research had earlier said that Remdesivir is an experimental anti-viral drug that was initially developed by ‘Gilead Sciences’ to work against Ebola and may inhibit the SARS-CoV-2 replication. Research on its efficacy in the treatment of COVID-19 is a part of WHO’s ‘Solidarity Trial’.
