Udayavni Special

COVID-19: US pharma giant seeks marketing authorisation from India for remdesivir


Team Udayavani, May 30, 2020, 11:17 AM IST

New Delhi: A US pharmaceutical giant has applied to India’s drug regulator seeking marketing authorisation for its anti-viral drug remdesivir, which is being touted as a potential treatment for COVID-19.

Gilead Sciences, who is the patent holder of the drug, has the complete data about the pre-clinical and clinical studies for remdesivir, sources said.

“The company has applied seeking marketing authorisation for its anti-viral drug remdesivir to India’s Central Drugs Standard Control Organisation (CDSCO). The CDSCO will examine the application with the help of the expert committee. It will take a final decision based on the recommendations of the expert committee,” a source said.

The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) to treat hospitalised coronavirus 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, sources said. On the basis of approvals granted by USFDA or any other reputed regulator, the Indian regulator can approve the drug by waiving off clinical trials in special circumstances in accordance with the provisions of the New Drug and Clinical Trial Rules 2019, a source in the know of the developments said.

This comes in the backdrop of two Indian pharmaceutical companies -Cipla and Hetero Labs, applying to the drug regulator seeking permission to manufacture and sell remdesivir in India. They have also sought a clinical trial waiver for remdesivir so that the medicine can be made available for the patients faster, an official said. Their applications are still under consideration, the official said.

 

Top News

COVID-19 cases dip below 55,000; recovery rate rises to 69.80 pc

Karnataka govt issues revised guidelines for home isolation of COVID-19 patients

BCCI gets govt approval for IPL In UAE

GoAir told to pay daily to use AAI airports from August 11

Former president Pranab Mukherjee undergoes brain surgery at Army’s RR hospital

K’taka COVID-19 update: 4267 new cases; 5218 discharges; 114 deaths on Aug 10

Govt has betrayed ‘Corona Warriors’: Rahul Gandhi



Related Articles More

Sena questions BJP’s ‘silence’ over Shivaji statue removal in K’taka

Indian users can now create virtual visiting cards on Google Search

COVID-19 cases dip below 55,000; recovery rate rises to 69.80 pc

Army to investigate JK encounter after families allege 3 men missing

Trump abruptly escorted from briefing after shooting near White House

MUST WATCH

Karnataka SSLC Results 2020 Declared | Udayavani

Belthangady : A massive landslide near Mittagabilu village

SSLC results: Nidhi Rao from DK dist amongst second toppers in state

Dr. Dhananjay KVK | Narendra Modi words about Agriculture | Highlights

Ravi Karkala | How to Cultivate Good Quality Mushroom | Udayavani

Latest Additions

RCB players to be quarantined in B’luru for a week before UAE flight

COVID-19 does not directly cause loss of taste: Study

Hong Kong residents buy newspaper to support free press

Koppal: Industrialist celebrates house warming with wife’s silicon wax statue

Sena questions BJP’s ‘silence’ over Shivaji statue removal in K’taka

Thanks for visiting Udayavani

You seem to have an Ad Blocker on.
To continue reading, please turn it off or whitelist Udayavani.