NEW DELHI: Two domestic pharmaceutical firms--Mylan and Jubilant Life Sciences have approached the country's top drug regulator--Drug Controller General of India (DCGI) to seek its approval to manufacture and sell anti-viral drug 'Remdesivir' in India to combat COVID-19.
On Tuesday, ANI has reported that the Central Drug Control Standard Organisation (CDCSO) office of DCGI gave its permission to US-based Gilead Sciences for marketing authorisation of its anti-viral drug Remdesivir for "restricted emergency use" on hospitalized COVID-19 patients.
"Mylan and Jubilant Life Sciences, have submitted their applications to the DCGI. Our subject experts committee reviewed it thoroughly and further recommended to the DCGI for its consideration," said a senior government official familiar with the development.
However, these recommendations have been given on certain conditions, the official said.
In the recent past, Gilead had signed non-exclusive voluntary licensing agreements with four generic pharma firms -- Cipla, Jubilant Life Sciences, Hetero and Mylan to manufacture and distribute Remdesivir, a potential antiviral therapy for COVID-19.
Following which in May, the three other domestic pharma giants--Cipla, Hetero Labs and BRD also approached to India's drug regulator to make and sell Remdesivir.
According to Gilead, under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for Remdesivir to enable them to scale up production quickly.
"The licensees also set their own prices for the generic product they produce. The licenses are royalty-free until the World Health Organization (WHO) declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than Remdesivir or a vaccine is approved to treat or prevent COVID-19," the company said in a statement.
Remdesivir, an investigational antiviral therapy developed by Gilead, received Emergency Use Authorization (EUA) by the United States Food and Drug Administration (USFDA) to treat Covid-19.
However, multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of Remdesivir as a treatment for COVID-19, Gilead said.