United States (US) pharmaceutical giant Gilead Sciences has applied to India’s drug regulator seeking marketing authorization for its antiviral drug remdesivir.
As per reports, the Central Drugs Standard Control Organization (CDSCO) has already received the application from the pharmaceutical company.
With the help of an expert committee, the CDSCO will examine the application of the company.
The final decision will be taken by the drug regulator on the recommendations of the committee.
Meanwhile, Gilead Sciences have entered into non-exclusive licensing agreements with pharma firms, including three domestic majors Cipla, Jubilant Life Sciences and Hetero, for manufacture and distribution of remdesivir.
The Indian Council of Medical Research (ICMR) had recently said the anti-viral drug Remdesivir may be highly effective in terminating the replication of SARS-CoV-2 which causes COVID-19.
It also said that the potentiality of the drug for the treatment of coronavirus patients is a part of the World Health Organization’s (WHO) ‘Solidarity Trial’.
According to a recent study published by the New England Journal of Medicine, 68 per cent of COVID-19 patients who have taken remdesivir on a compassionate-use basis showed some form of improvement in their conditions.
The US food and drug regulatory body Food and Drug Administration (FDA) had granted emergency use authorization (EUA) for remdesivir to treat hospitalized COVID-19 patients.