New Delhi: India’s drug regulator has approved anti-viral drug favipiravir for “restricted emergency use” in mild to moderate cases of COVID-19, official sources said, as instances of coronavirus infection and fatalities in the country continued its steady upward trend.
Considering the emergency and unmet medical need for COVID-19, the Drug Controller General of India (DCGI) under the fast-tracked approval process granted domestic firm Glenmark Pharmaceuticals the permission to manufacture and market favipiravir (200 mg) tablet.
“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.
“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 anti-viral 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.
Also read: SC asks govt to fix upper limit for Covid-19 test rates, calls for uniform fee across India