The drug will be sold under the name FabiFlu, and is the first oral version of favipiravir for treating COVID-19 patients.

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Coronavirus Coronavirus Saturday, June 20, 2020 - 15:31

The Drug Controller General of India (DCGI) has approved the use of an antiviral drug, favipiravir, for “restricted emergency use” in mild to moderate cases of COVID-19. The DCGI, under fast-tracked approval process has granted permission to the domestic firm Glenmark Pharmaceuticals to manufacture and market favipiravir tablets.

According to official sources, this has been done in view of the continuing increase in instances of coronavirus infection and fatalities across the country.

"The drug has been approved for restricted emergency use in the country for the treatment of mild to moderate cases of COVID-19," an official source in the know of developments told PTI.

Following this approval, Mumbai-headquartered Glenmark Pharmaceuticals will make a separate application to state regulators to get a manufacturing license under the provisions of the Drugs and Cosmetics Act and its rules. They will be producing 200 mg tablets of the drug at present.

Favipiravir is an antiviral drug that has been used in Japan to treat individuals infected with SARS-CoV-2, the virus which causes COVID-19. It acts by inhibiting an enzyme called RNA polymerase, which is required for the virus to replicate and spread in an infected person.

"This emergency use authorisation has been granted with certain conditions which include taking written informed consent from each patient or his/her representative. Besides, the company will have to conduct active post-marketing surveillance on the first 1,000 patients to assess the safety and efficacy of the drug," the source said.

The marketing authorisation was given based on the interim report of phase three clinical trials to ensure early availability of the antiviral drug in the country.

While the trials are still ongoing, the DCGI approved the drug as the interim results so far have been encouraging, the source said.

The patient will be given a 3,600 mg dose for the first day as a loading dose and subsequently followed by 1,600 mg for maximum up to 14 days depending upon the viral load.

The DCGI had recommended that the drug should be used only in adults and not on patients with severe liver and renal impairment and pregnant and lactating women, the source said, adding it should be used with caution in patients having a history of abnormalities in uric acid metabolism or gout.

Glenmark pharmaceuticals was the first company in India to initiate phase three clinical trials on favipiravir for COVID-19 patients in India.

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