India’s drug regulator, the Central Drug Control Standard Organisation (CDCSO) has reportedly granted US pharma giant 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.

The approval process for remdesivir was accelerated in view of the emergency situation and the unmet need for medicines in light of the coronavirus outbreak, a PTI report said.

Earlier in May, Gilead Sciences had signed non-exclusive voluntary licensing agreements with five generic pharmaceuticals based in India and Pakistan to speed up the production and supply of its experimental drug to trade severe COVID-19 patients.

ndian companies Mumbai-headquartered Cipla, Hyderabad-based Hetero Labs and Noida-based Jubilant Life Sciences has signed up the agreement to manufacture the drug and to sell it in 127 countries.

Remaining two firms include US-based Mylan which has a strong base in India and a Pakistan-based Ferozsons Laboratories -have also signed licensing agreements with Gilead, which negotiated long-term voluntary licenses with several generic drugmakers in India and Pakistan to produce remdesivir for developing countries.

A statement from Gilead says these 127 countries nearly all low-income, lower-middle-income as well as several upper-middle and high-income countries.

The statement added that the licenses will also set their respective prices for the generic product they produce.

The licences will remain royalty-free until the WHO declares the end of the public health emergency regarding COVID-19 or a product other than remdesivir or vaccine is approved to treat or prevent coronavirus caused COVID-19, the statement said.

Gilead’s remdesivir had in May received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the treatment of hospitalised patients with severe COVID-19 symptoms.

Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19, said the FDA, adding the drug was still being studied.

Remdesivir was shown in a clinical trial to shorten the time to recovery in some people.

There are no medicines approved by the FDA as safe and effective to treat people in the hospital who have COVID-19. Therefore, the FDA has authorized the emergency use of remdesivir for the treatment of COVID-19 under an EUA, said the agency.

India’s Health Ministry had recently said that it is examining remdesivir, which was used during the Ebola outbreak, as one protocol in the treatment for COVID-19.