India to seek latest data on efficacy of Gilead’s Remdesivir following USFDA nod

New Delhi: India’s drug regulatory authority will seek data from US-based Gilead Sciences on the latest finding on the effectiveness of its antiviral drug remdesivir in Covid-19 patients, after the US drug regulator approved it as treatment for the disease.

Remdesivir is the first drug to be cleared by the US Food and Drug Administration for treating Covid-19. The formal approval came on Thursday. While the move indicates that the drug is safe and effective for people hospitalised with Covid-19, India’s Central Drugs Standard Control Organisation (CDSCO) wants to assess the data before making a decision.

“We will be writing to Gilead Sciences to understand the latest evidence on the effectiveness of the drug. We will then review and assess and take any further decision in this regard,” said a senior official of CDSCO.


The antiviral drug, administered intravenously, is already under assessment in India, officials said, in the wake of new evidence by the World Health Organisation (WHO) which suggested that remdesivir appears to have little effect on mortality of hospitalised patients.

“We can’t blindly follow any other country. We have to keep under consideration the results of the solidarity trial too,” the official said.

In India, six pharma companies, including Cipla, Hetero, Zydus Cadila, Mylan, Jubilant and Dr Reddys, market the drug under a licensing agreement with Gilead.
Remdesivir currently costs between ₹2,400 and ₹5,000 per vial in India.

Gilead Sciences told ET that the licences are royalty-free as of now. “We have negotiated longterm voluntary licences with nine manufacturers to supply generic remdesivir to 127 low- and middle-income countries. The licences are royalty-free until the World Health Organization 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, whichever is earlier,” it said.
The FDA said the drug had been approved for adults and pediatric patients aged 12 years and older and weighing at least 40 kg (about 88 pounds) who require hospitalisation for Covid-19.

The FDA had granted remdesivir emergency authorisation in May after a trial by the National Institutes of Health found that it modestly reduced the recovery time in people hospitalised with Covid-19.

US President Donald Trump, too, received the antiviral drug after he began showing symptoms earlier this month.