The Indian drug regulator on Tuesday cleared the first anti-viral Covid-19 pill: Molnupiravir. The drug developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with US Pharma giant Merck -- will now be manufactured by 13 Indian drug manufacturers. The drug, in India, has been cleared for the treatment of adults patients with Covid-19 and “who have a high risk of progression of the disease”. What is molnupiravir? Molnupiravir (MK-4482, EIDD-2801), developed initially to treat influenza, is a repurposed oral anti-viral candidate to treat Covid-19 patients. Molnupiravir is an anti-viral pill that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. Molnupiravir is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules. Has the drug been cleared outside India? Yes. On November 4, the United Kingdom became the first country to approve drug regulator Molnupiravir. The UK regulator said that molnupiravir works by interfering with the virus’ replication. “This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease,” the Medicines and Healthcare products Regulatory Agency (MHRA) said. The MHRA said that molnupiravir has been found to be “safe and effective” following a “stringent review of the available evidence”. On the basis of this, the regulator has authorised the use of molnupiravir in persons with mild to moderate COVID-19 -- and has at least one risk factor for developing severe illness. The risk factors listed by MHRA are obesity, older age (>60 years), diabetes mellitus, or heart disease. What is the status of the drug in the US? On December 23, US drug also cleared Molnupiravir in “certain adults”. The drug regulator said that emergence use authorisation for molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. USFDA also recommends that Molnupiravir is not authorized for use for longer than five consecutive days. It specifically said that Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth. “It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19 because benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19,” the USFDA said. Which Indian companies will be manufacturing the drug in India? Union Health Minister Mansukh Mandaviya said that 13 Indian drug manufactures will be producing the drug domestically. Dr. Reddy Laboratories, Cipla, Natco Pharma, Optimus Pharma Pvt Ltd, Stride, and, Hetero are among the large drug manufacturers that will be manufacturing the drug. Newsletter | Click to get the day's best explainers in your inbox
