Molnupiravir COVID pill: Know all about oral anti-viral drug to be manufactured in India

Amid growing concern over the spread of the Omicron variant of Coronavirus, the Central Drugs Standard Control Organisation (CDSCO) approved the emergency use of the antiviral drug Molnupiravir. In addition, the Union Health Minister Mansukh Mandaviya, on Tuesday, stated that CDSCO and Health Ministry has also issued emergency use authorisation (EUA) to two more vaccines - CORBEVAX and COVOVAX.

Subject Expert Committee (SEC) of CDSCO had earlier proposed giving the approval to manufacture and commercialise Molnupiravir, an anti-COVID tablet, for limited emergency use in adult patients infected with COVID-19 with a SpO2 of 93% and a high risk of disease progression. 

What is Molnupiravir?

Molnupiravir is the first oral antiviral drug for the treatment of mild-to-moderate COVID-19 in adults. US-based biotechnology Ridgeback Biotherapeutics collaborated with the Pharma giant Merck Sharp & Dohme to develop the drug. Molnupiravir is also easier to store in comparison to messenger RNA vaccines since it does not require cold storage. The Phase 3 trial conducted by Merck revealed that the drug lowered the rate of hospital admissions and mortality by 50%. In India, the drug has been approved for the treatment of COVID-19 patients who have a high risk of disease progression.

13 Indian drug companies to manufacture Molnupiravir in India

According to Health Minister Mandaviya, the drug will be manufactured in India by 13 different companies. Dr Reddy Laboratories, Natco Pharma, Cipla, Stride, Hetero, and Optimus Pharma Pvt Ltd, are among the prominent pharmaceutical companies that will be manufacturing the drug domestically, he added. The drug will only be sold by retail under the supervision of medical specialists. The medicine is not approved for use in patients under the age of 18 or for the start of treatment in patients who need to be hospitalised immediately owing to COVID-19. Molnupiravir is administered orally as four 200 mg capsules every 12 hours for five days, for a total of 40 capsules. It is not authorized for usage for more than five days in a row or for COVID-19 prevention in pregnant women. 

Molnupiravir recently approved by FDA

It should be mentioned here that Merck's Molnupiravir was recently approved by the US Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 cases in adults who are at risk of severe disease. Earlier in the month of November, the United Kingdom had given conditional approval to the drug. Meanwhile, on December 24, Japan also gave approval for the emergency use of the antiviral pill, making it the first of its kind to be approved in the country, as per Kyodo News. 

Image: AP