Remdesivir approved for restricted emergency use in India

New Delhi, June 3:

Anti-viral drug remdesivir has been approved for “restricted emergency use” on severe COVID-19 patients in view of the crisis posed by the pandemic, the Union health ministry said on Tuesday.

Joint Secretary in the ministry Lav Agarwal said the permission for remdesivir was given following due process based on the available evidence.

On Monday, India’s drug regulator granted US pharma giant Gilead Sciences the marketing authorization for its drug remdesivir for “restricted emergency use” on hospitalized COVID-19 patients, sources said.

The approval process for remdesivir was accelerated in view of the emergency situation and the unmet need for medicines in light of the coronavirus outbreak, a source in the know of the developments told PTI.

The drug has been allowed for restricted emergency use for a maximum five-day period for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children hospitalized with severe symptoms, subject to several safeguards, the source said.

“The drug, which is administered in the form of an injection, has been approved to be sold by retail on the prescription of specialists for use in a hospital or institutional set-up only. It has been approved for use for a maximum of five days as against10 days. Extended use does not seem to have any beneficial effects, based on the evidence submitted at the time of approval.

“The approval process for remdesivir was accelerated by invoking special provisions under the New Drug and Clinical Trial Rules, 2019, which provide for a waiver of clinical trials in special circumstances,” the source told PTI.

Gilead Sciences had, on May 29, applied for the marketing authorization for remdesivir in India. The drug is being touted as a potential treatment method for COVID-19.

The approval was given following consultation with the subject expert committee of the Central Drugs Standard Control Organization (CDSCO).

“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 source said. The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) for the treatment of hospitalized patients with severe COVID-19.

Meanwhile, applications of two Indian pharmaceutical companies – Cipla and Hetero Labs – seeking permission to manufacture and sell remdesivir in India are under consideration.

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