New Delhi, India

The Drug Controller General of India (DCGI) has granted permission to use the anti-viral drug favipiravir for COVID-19 patients.

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However, the drugis only for "restricted emergency use" in mild to moderate cases of COVID-19, according to official sources.

The nod from DCGI came at a point when there has been a rapid increase in the number of coronavirus cases on a daily basis in the country.

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The officials have also granted fast-tracked permission to Glenmark, a  pharmaceutical company, to manufacture and market the anti-viral tablets.

This approval has been granted based on the evaluation of data and in consultation with the Subject Expert Committee, as part of the accelerated approval process, considering the emergency situation and unmet medical need of the COVID-19 outbreak. It is for restricted emergency use in India.

The doctors and hospitals have been told to check that all patients have a signed consent form before the tablets are used for treatment.

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A senior health ministry official told a news agency, "The DCGI has approved favipiravir drug for restricted emergency use for the treatment of mild to moderate cases of COVID-19. This emergency use authorisation has been given on several conditions. The company has to take written consent from each patient. Also, in the first 1,000 patients, the pharma company has to do active post-market surveillance to evaluate the efficacy and safety of the drug being administered."

"The patient will receive a dose of 3,600 mg on the first day as a loading dose. After this, the patient would receive 1,800 mg for some days which will depend upon his/her viral load," he said.

"The drug cannot be given to patients with severe liver and renal diseases including pregnant and lactating mother," added the official.

Now that permission has been granted and the company has to get the license to manufacture from the Central Drugs Standard Control Organisation (CDSCO) under the Drug and Cosmetic Act and Rules. 

(With inputs from ANI)