Sources said that the approval has been given under “restricted use” in mild to moderate cases of Covid-19 infection.
The approval for Favipiravir 200 mg tablet has been given following the recommendation of special Subject Expert Committee (SEC) on Covid-19.
“Under an accelerated approval process at the Central Drugs Standard Control Organisation (CDSCO), the Subject Expert Committee (SEC) has recommended the grant of permission to manufacture and market Glenmark Pharmaceuticals’ Favipiravir, 200 mg tablet,” sources added.
The approval comes with a caveat that the company will have to submit a copy of the informed consent and report of the ongoing clinical trials within three months. The SEC has also recommended that the drug should be used with caution in patients with a history of abnormalities in metabolism of uric acid.
It also asked the company that post-marketing surveillance should be conducted on the first 1000 patients to access safety and efficacy of the drug.
Glenmark had started Phase III clinical trials after it received permission from the DCGI in May 2020.
Favipiravir, one of the potential drug candidates for the treatment of COVID-19, is also undergoing clinical trials for Covid-19 in various countries including US, China, Japan, Italy, South Korea and Russia.
Earlier Glenmark Pharmaceuticals had submitted a proposal to the DCGI for approval of favipiravir 200 mg tablets for emergency use authorisation (EUA) for Covid-19.
Reportedly, each strip containing 34 tablets of will come at an approximate MRP of Rs 3500. For the treatment 122 tablets will be required for 14 days.
An email sent to Glenmark did not elicit any response till the press time.
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