An expert panel of the Central Drugs Standard Control Organisation on Monday recommended granting permission to manufacture and market anti-Covid pill Molnupiravir for restricted emergency use for the treatment of COVID-19 patients in the country, official sources said.
The emergency use of the drug will be for adult COVID-19 patients with SpO2 93 percent and who have a high risk of progression of the disease including hospitalisation or death subject to certain conditions, they added.
Dr Reddy's Laboratories in consortium with Cipla, Mylan, Torrent, Emcure and Sun Pharma had presented their proposal for approval of Molnupiravir 200mg capsules for approval in the emergency situation along with various supporting documents including clinical data in the country.
"Considering the emergency and unmet medical need in COVID-19, the Committee recommended for grant of permission to manufacture and market Molnupiravir for restricted use under emergency situation in the country for treatment of adult patients with COVID 19, with SpO2 93 percent and who have high risk of progression of the disease including hospitalisation or death subject to certain conditions," a source said.
As per conditions, the drug should be sold in retail only under the prescription of medical specialists.
According to the conditions, the drug is not authorised for use in patients less than 18 years and for initiation of treatment in patients requiring immediate hospitalisation due to COVID-19 at that stage. However, if it was initiated before hospitalisation due to COVID 19, it may be continued, the sources said.
The pill is not authorsied for use for longer than five consecutive days and for pre-exposure or post-exposure prophylaxis for prevention of COVID-19 for pregnant women, they said.
The United States Food and Drug Administration recently authorised Merck's Molnupiravir for treatment of mild-to-moderate COVID-19 cases in adults who are at risk for severe disease.
Before that in November Britain granted conditional authorisation to Merck's coronavirus antiviral, the first pill shown to successfully treat coronavirus.
The pill is intended to be taken twice a day for five days by people at home with mild to moderate COVID-19.
In a clinical trial of high-risk people during the early course of illness, Merck's drug was shown to reduce hospitalisations and deaths by around 30 percent.
