Chewable Favipiravir rejected by CDSCO for COVID-19 patients

An expert committee Subject Ethics Committee (SEC) that comes under Central Drugs Standard Control Organisation (CDSCO) has rejected the proposal by Mumbai based pharmaceutical company Macleods Pharmaceuticals of Favipiravir chewable tablets. The Favipiravir is used for the treatment of Covid-19 patients and has been approved for restricted emergency use in India. It is an antiviral medication which is developed in Japan.

The decision about rejection of chewable Favipiravir revealed in the minutes of the meeting which is uploaded on the Central Drugs Standard Control Organisation’s (CDSCO) website.

According to the minutes of the meeting on the website of CDSCO “The firm presented the proposal of manufacturing and marketing of Favipiravir Chewable Tablets 800mg & 1800mg before the committee. In light of the fact that the Favipiravir is approved for restricted emergency use with various conditions and restrictions, the committee observed that justification submitted by the firm in support of the Chewable tablet is inadequate. Hence, after detailed deliberation, the committee did not recommend for approval of Favipiravir Chewable Tablets 800 mg/1800 mg.”