India Approves Emergency Use Of Remdesivir To Treat Patients With Severe Covid-19

The government of India approved on Tuesday the “restricted emergency use” of the antiviral drug remdesivir to treat Covid-19 patients.

The drug has been approved for treating hospitalized or institutionalized Indian adults and children with severe cases of Covid-19,

Manufactured by Gilead Sciences Inc. (GILD) remdesivir, which is administered intravenously in the hospital, was the first drug to show improvement in Covid-19 patients in clinical trials. Last month, the U.S. Food and Drug Administration granted the drug emergency use authorization. Remdesvir has also received approval from Japanese health regulators.

"[Remdesivir] approved on June 1 under emergency use with condition for five dose administration," said the Drugs Controller General of India, the government regulator.

On Monday, Gilead Sciences said remdesivir exhibited modest improvement in patients with moderate Covid-19 over a five-day course, but for those patients who received it for 10 days it did not show much improvement.

As such, the Indian regulator decided not to extend the use of the drug to 10 days – a maximum regimen of five days was ordered instead.

“As per the data presented by the company so far, administering remdesivir for 10 days as opposed to five doesn’t have any beneficial effects, so why should patients consume it for an additional five days? There is also a potential risk of the mortality rate increasing with extended use, so the authority has been more stringent with its decisions compared to other countries,” said a senior Indian Health Ministry official said. “The approval paves the way for generic voluntary license holders in our country to manufacture remdesivir. The restriction of administration of the drug to five days will save the patients a lot of money.”

Moreover, Remdesivir will have to be administered only with the “written informed consent” of each patient or their representative.

Gilead Sciences had applied for marketing authorization for remdesivir in India only last week – approval was granted quickly due to the urgent need for treatment.

“The drug… has been approved to be sold by retail on the prescription of specialists for use in hospital or institutional set-up only,” a source told Press Trust of India. “The approval process for remdesivir was accelerated by invoking special provisions under the New Drug and Clinical Trial Rules, 2019, which provides for waiver of clinical trials in special circumstances. The drug is given in the form of an injection and that is why it has to be administered under the supervision of a doctor in a hospital setting.”

The drug will be imported into India by Mumbai-based Klinera Global Services from the manufacturing sites of Gilead, Jubilant HollisterStier of Spokane, Wash., and Patheon of North Carolina.

In May, Gilead Sciences signed non-exclusive licensing agreements with five generic drugmakers in India and Pakistan, including Hetero Labs, Cipla Ltd and Jubilant Life Sciences Ltd, to supply the drug.

As of Tuesday, India had just under 200,000 cases of coronavirus and recorded about 5,600 virus-related deaths – however, the actual figures are believed to be much higher.

European and South Korean authorities are also considering regulatory approval for remdesivir.

The Indian Council of Medical Research earlier said that remdesivir, which was also been used during Ebola outbreak, may slow down the Covid-19 replication.

COVID-19 has no approved treatment or vaccine yet.