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Indian Journal of Emergency Medicine

Volume  6, Issue 3, July – September 2020, Pages 185-190
 

Review Article

Emergency Approval of Remdesivir for Covid-19 Infection in India

Subhrojyoti Bhowmick1, Sanket Bandyopadhyay2, Suddha Chatterjee3, Debarati Kundu4, Pankaj Kumar Singh5, Indraneel Dasgupta6

1Clinical Director, Department of Academics Quality Assurance and Research, Peerless Hospital and BK Roy Research Centre, Kolkata, India, 2PG Student, Department of Biotechnology, Ramaiah College of Arts Science and Commerce Bangalore, 3PG Student, Department of Microbiology, St. Xavier’s College, Kolkata, India, 4Clinical Research, 5Senior Resident, 6Clinical Director, Department. of Emergency, Peerless Hospitex Hospital and Research Center Ltd, Kolkata-700094, India

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DOI: http://dx.doi.org/10.21088/ijem.2395.311X.6320.6

Abstract

Novel Coronavirus or SARS-CoV-2 has brought the entire pharmaceutical industry to a halt. The whole world is still awaiting the news of an established treatment modality or a prophylactic vaccination schedule for COVID-19. Researchers all over the world are working tirelessly to find a cure or a vaccine as early as possible to assure humankind of a recovery from this life threatening disease. On the downside, people are desperate to find a solution to this crisis and this has led to introduction of certain drugs in the market that claim to be a remedy for COVID 19. US pharmaceutical company Gilead Sciences Inc. which holds patent of antiviral drug Remdesivir joined hands with Hetero Labs Ltd. and Cipla Ltd., two major pharmaceuticals
companies in India for launching the drug. On June 21, 2020 Hetero Labs Ltd. got the nod from Drugs Controller General of India (DCGI) to market the investigational antiviral medicine Remdesivir for “restricted emergency use” on COVID-19 patients. Remdesivir did not undergo any human clinical trials on Indian patients before its launch which is the protocol for launch of any investigational new drug as per the Central Drugs Standard Control Organization (CDSCO) of India. The medicine has been issued by the FDA with an Emergency Use Authorization (EUA). But it is still concerning if the decision was good enough to use the drug on Indian patients who have an entirely different ethnic background than the American patients. This article is a quick review of the efficacy and safety issues known about Remdesivir till date.


Keywords: Remdesivir Emergency; Approval; Covid 19; India


Corresponding Author : Subhrojyoti Bhowmick, Clinical Director, Quality and Research Departments, Peerless Hospital and B K Roy Research Centre Kolkata -700094, India