The coronavirus pandemic has affected over 6.2 million, while the death toll has topped 375,000. While India has reported 1,98,706 total number of cases.
Amid a rise in the number of coronavirus cases, India's drug regulator has granted US pharma giant Gilead Sciences marketing authorisation for its anti-viral drug remdesivir for "restricted emergency use" on hospitalised COVID-19 patients in view of the crisis posed by the pandemic.
The approval process for remdesivir was accelerated in view of the emergency situation and the unmet need for medicines in light of the coronavirus outbreak.
What is remdesivir?
The drug is being touted as a potential treatment for COVID-19. The Indian Council of Medical Research had earlier said anti-viral medication remdesivir, which was used during the Ebola outbreak, may inhibit the SARS-CoV-2 replication and research on its efficacy in the treatment of COVID-19 is a part of WHO's 'Solidarity Trial'.
According to a recently published study in the New England Journal of Medicine, two out of three critically ill coronavirus patients who were on oxygen support showed signs of improvement when they were administered remdesivir.
All new drugs have to undergo trials before getting approval for marketing them in India. But the New Drug and Clinical Trial Rules, 2019, provide for certain clauses, according to which the provision of waiver of local phase-III clinical trials of the drug is approved and marketed in certain countries (as notified from time to time) subject to certain conditions like national emergency or epidemics in public interest.
(Inputs from Agencies)
