US' Gilead Sciences likely to seek nod to market anti-viral drug remdesivir in India

WION Web Team New Delhi, Delhi, India May 21, 2020, 05.36 PM(IST)

Remdesivir for coronavirus Photograph:( Reuters )

Story highlights

The medicine has been issued an Emergency Use Authorisation (EUA) by the United States Food and Drug Administration (FDA) to treat hospitalised COVID-19 patients.

US pharmaceutical giant Gilead Sciences may soon apply to India's Central Drugs Standard Control Organisation (CDSCO) seeking marketing authorisation for its anti-viral drug remdesivir -- being considered as a potential medication for COVID-19.

Officials of the Union Health Ministry, along with the Drugs Controller General of India (DCGI) held a discussion with the representatives of Gilead Sciences on Wednesday to prepare a road map for introducing remdesivir in India.

The US-based company was apprised about the regulatory procedures for granting of approval to a new drug in the country and was assured of total facilitation.

"The company representatives said they will get back after discussion with their board of directors," an official said.

The medicine has been issued an Emergency Use Authorisation (EUA) by the United States Food and Drug Administration (FDA) to treat hospitalised COVID-19 patients.

Regulatory approval under exceptional pathway was granted by the Japanese Ministry of Health, Labour and Welfare on May 7, on the basis of clinical data from the US.

The efficacy of remdesivir was discussed in a recent meeting of the joint-monitoring group (technical committee) headed by the Directorate General of Health Services (DGHS) and the use of the drug on COVID-19 patients was not approved due to lack of enough scientific evidence at that stage.

The Indian Council of Medical Research had earlier said anti-viral medication remdesivir which was used during Ebola outbreak may inhibit the SARS-CoV-2 replication and research on its efficacy in the treatment of COVID-19 is a part of the WHO's 'solidarity trial.'

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 or on ventilators showed signs of improvement when they were administered remdesivir.