India supports crisis utilization of Remdesivir to treat COVID-19 patients !!

Gilead Science's remdesivir one of the most highly anticipated drugs being tested against the new coronavirus showed positive results in a large-s

Gilead Science's remdesivir one of the most highly anticipated drugs being tested against the new coronavirus showed positive results in a large-s

South Korea said on Wednesday it has approved the emergency use of Gilead Sciences Inc's remdesivir to treat COVID-19 after a government panel last week cited positive results for the anti-viral drug in other countries.

A month ago, he United States food and medication administrative body Food and Drug Administration (FDA) had allowed crisis use approval (EUA) for remdesivir to treat hospitalized COVID-19 patients.

Now, given the spike in COVID-19 cases and the lack of a proven therapy, Dr. VG Somani, the Drugs Controller General of India, has approved Remdesivir for "restricted emergency use".

Confirming the development, Lav Agarwal, Joint Secretary, Ministry of Health & Family Welfare said, "Based on available evidence the approval has been given, however I do not have access to that evidence". This drug has been allowed only for a five-day dosage.

Approved on Monday, the intravenous drug can be administred into critical Coronavirus patients, from Tuesday onward anywhere in India.

"While there is now limited global supply of remdesivir, the company anticipates new supply of the drug to start to become available in July", Gilead spokesperson was quoted as saying by Reuters.

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"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", said a source to the Press Trust of India. Japanese health regulators have also approved this drug for clinical emergency use.

The marketing authorisation granted to Gilead will allow four Indian pharmaceutical companies, Cipla, Jubiliant, Hetero Labs and Mylan, with non-exclusive licensing to manufacture the drugs in India.

Representational image. China claims that "Remdesivir" is "inefficient" and has "no significant clinical benefit" reports The Lancet.

Remdesivir is an injectable drug and hence has to be administered in a hospital setting under medical supervision. "There is also a potential risk of mortality rate increasing with extended use", a Health Ministry official told The Indian Express. However, multiple trials on this drug are still underway in a few countries.

As part of this, sources say, the drug will be used to treat suspected or laboratory-confirmed cases of COVID-19 in adults and children hospitalized with severe symptoms, with appropriate safeguards.

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