Molnupiravir not to be included in COVID clinical management protocol over safety concerns

The ICMR's National Task Force for COVID-19 has decided not to include antiviral drug Molnupiravir in the COVID Clinical Management Protocol as of date. According to the official sources, the decision comes after considering the safety concerns as the experts of the task force did not find Molnupiravir of much benefit in the treatment of COVID. 

According to the Health Ministry, Molnupiravir is an antiviral drug that got the Drug Regulator General of India's approval on December 28 for restricted use in emergencies. as it inhibits SARS-CoV-2 replication by viral mutagenesis.

"Members of the National Task Force for COVID-19 were not in favour of including the drug in the national treatment guidelines citing that it does not have much benefit in the treatment of coronavirus infection and that there were safety concerns," an official source told PTI.

ICMR on Molnupiravir's safety

Earlier last week, Indian Council of Medical Research (ICMR) chief Dr. Balram Bhargava had informed that Molnupiravir has major safety concerns due to which even the WHO and the UK have not included it for treatment.

ICMR chief stated, "We have to remember that this drug has major safety concerns. It can cause teratogenicity, mutagenicity, and cartilage damage. It can damage the muscles also".

"Contraception will have to be done for three months for male and female if this drug is given because the child born could be problematic due to teratogenic influence," he added. 

On Dec 4, the UK Medicines and Healthcare products Regulatory Agency had granted approval to use Molnupiravir to treat COVID under special conditions. As per the conditions laid, the drug can be used for the treatment of mild to moderate COVID-19 in adults who have at least one risk factor for developing severe illness.

Later on Dec 23, USFDA the anti-COVID pill was given the approval of Emergency Use Authorisation for treating mild-to-moderate COVID-19 in adults who are at high risk for progression to severe disease. It must be considered when the patient's condition requires hospitalization and for those who cannot find alternative treatment accessible or clinically appropriate.

As per the conditions, a retailer can sell the drugs only under the prescription of medical specialists. It is also learned that the recommended dose must be 800 mg twice daily for five days.

(With PTI input)