(Daily News Scan - DNS English) India gave Green Signal to REMDESIVIR
The top drug regulatory body of India has given a green signal to the use of remdesivir. It will be used as an antiviral medication for the treatment of suspected or laboratory confirmed Covid-19 cases in adults and children hospitalised with severe diseases. This medicine was approved by the Drug controller General of INDIA Dr V G Somani for administration as part of a maximum five-day regimen.
In this DNS we will talk about the remdesivir and how will it be used against COVID -19.
India’s drug regulator has approved the US pharma company 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. It will be imported by Mumbai based Klinera Global Services from the manufacturing sites of Gilead, Jubilant HollisterStier and Patheon Manufacturing Services in the United States.
Remdesivir is one drug that has shown in a rigorous experiment to help fight the coronavirus. A large study led by the National Institutes of Health recently found it could shorten average recovery time from 15 days to 11 days in hospitalised patients with severe disease. The company-led study involved nearly 600 patients who had moderate pneumonia but did not need oxygen support. All were randomly assigned to get five or 10 days of the drug plus standard care, or standard care alone. Patients and their doctors knew who was getting what, which limits the objectivity of the results.
By the 11th day in the study, those on five days of remdesivir were 65% more likely to improve by at least one on a seven-point scale, Gilead said.
The Drug is administered in the form of an injection and it will be sold by retail on prescription of specialists for use in hospital or institutional setup only. The approval of remdesivir escalated by invoking special provisions under the New Drug and Clinical Trial Rules, 2019, which provides for waiver of clinical trials in special circumstances.
Remdesivir is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes COVID-19. The US Food & Drug Administration (USFDA) granted remdesivir an emergency use authorisation for treatment of hospitalised patients with severe COVID-19.
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.
The Central Drugs Standard Control Organisation (CDSCO), have decided against extending the use of the drug to 10 days, based on existing evidence presented to it at the time of approval.
“As per the data presented by the company so far, administering remdesivir for 10 days as opposed to five doesn’t have any beneficial effects, so why should patients consume it for an additional five days? There is also a potential risk of the mortality rate increasing with extended use, so the authority has been more stringent with its decisions compared to other countries,” a senior Health Ministry official close to the development said on condition of anonymity. The restriction of administration of the drug to five days will save the patients a lot of money.
Remdesivir was manufactured in 2014 to treat for Ebola, by US-based biotechnology firm Gilead Sciences. It has since been used to treat for MERS and SERS, both caused by members of the coronavirus family. Current research is looking at whether the drug’s antiviral properties work against SARS-CoV2, the coronavirus that causes COVID-19 disease. SARS-CoV2 replicates itself inside the human cell with the help of an enzyme called RdRp. When remdesivir is injected intravenously, it inhibits this enzyme and effectively blocks replication of the coronavirus.
