The Drugs Controller General of India (DCGI) on Tuesday approved and granted marketing authorisation to US-based Gilead Sciences Inc’s antiviral drug Remdesivir. This has been approved for “restricted emergency use” in five doses to treat suspected and ICMR-laboratory-confirmed COVID-19 patients with severe symptoms.
The approval came after a series of consultation undertaken by the Ministry of Health and Family Welfare (MoHFW) with experts, said the Central Drugs Standard Control Organisation (CDSCO). Lav Agarwal, Joint Health Secretary said, “We have reviewed the evidence on the basis of which Remdesivir has been given emergency approval for use in Covid-19 patients.”
In an email statement to the media, DCGI said, “[Remdesivir] approved on June 1 under emergency use with the condition for five dose administration”. This drug has been allowed only for a five-day dosage. However, each patient has to submit a written consent to allow the drug to be administered.
Gilead Sciences had reported that the drug has shown modest benefit in patients with moderate symptoms given a five-day regimen. According to worldwide reports on Remdesivir, it is the first drug to show any improvement in treating COVID-19 positive patients. It has been reported that United States’ Food and Drug Administration (FDA), last month, allowed the usage of this drug for emergency purpose throughout the nation. Japanese health regulators have also approved this drug for clinical emergency use.
The marketing authorisation granted to Gilead will allow four Indian pharmaceutical companies, Cipla, Jubiliant, Hetero Labs and Mylan, with non-exclusive licensing to manufacture the drugs in India. In India, this drug is a part of the World Health Organization’s (WHO) solidarity trials. A report suggests that this drug can be procured only by government hospitals and cannot be sold to any individual for self-medication as it is under clinical trial.
Expressing the concern over a ten-day dose of the drug, a senior health ministry official told The Indian Express, “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 decision compared to other countries.”
This drug was earlier developed for treating Ebola, but since it has shown a significant effect in treating COVID-19 patients, it remains at the forefront. However, multiple trials on this drug are still underway in a few countries. The US National Institute of Allergy and Infectious Disease (NIAID) has claimed that the drug could have positive effects in fighting the Coronavirus but China claims it to be “inefficient” and have “no significant clinical benefit” reports The Lancet.