India's drug regulatory body has approved the antiviral drug Favipiravir for the treatment of mild to moderate COVID-19 patients in India. The regulator has given approval to Glenmark Pharmaceuticals for manufacturing and marketing for the oral antiviral drug Favipiravir (FabiFlu).
According to Glenmark, approval was granted based on evaluation of data and in consultation with the subject expert committee, as part of an “accelerated approval process”, considering the emergency situation and the “unmet medical need” of the COVID-19 outbreak. The approval is for restricted emergency use in India.
“Restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation,” according to Glenmark.
The DCGI recommended that the drug should be used only in adults and not on patients with severe liver and renal impairment, or for pregnant and lactating women, PTI reported, adding it should be used with caution in patients having a history of abnormalities in uric acid metabolism or gout.
Dr Shekhar Mande, Director General, CSIR, told THE WEEK that Indian laboratories, as well as the pharmaceutical industry, were preparing to manufacture Favipiravir.
In June, in its revised clinical protocol for COVID-19, the health ministry had listed a few drugs as investigational therapies including Remdesivir (under Emergency Use Authorization) stating that its use may be considered for patients with moderate disease (those on oxygen), unless they fall in some categories such as pregnant women and children, or those with severe renal impairment, among others.
The protocol had also listed Tocilizumab (an immunosuppressive drug used in the treatment of rheumatoid arthritis and arthritis in children), as “Off-Label" to be considered in patients with moderate disease with progressively increasing oxygen requirements and in mechanically ventilated patients not improving despite the use of steroids.