BackMolnupiravir out of covid-19 clinical management protocol as of now
The experts cited safety concerns and argued that molnupiravir was not of much benefit in the covid treatment
PremiumNEW DELHI : The ICMR’s National Task Force for covid-19 has decided against including antiviral drug molnupiravir in the Clinical Management Protocol for covid-19 as of now, officials aware of the matter said on Tuesday.
The experts of the task force cited safety concerns and argued that molnupiravir was not of much benefit in the covid treatment to arrive at the decision in a meeting held on Monday.
According to the health ministry, molnupiravir is an antiviral drug that inhibits SARS-CoV-2 replication by viral mutagenesis.
This anti-covid pill got the Drug Regulator General of India’s approval on 28 December for restricted use in emergencies.
Mutagenesis is a process by which the genetic information of an organism is changed by the production of mutation.
“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 privy to the development said.
Indian Council of Medical Research (ICMR) chief Dr Balram Bhargava had last week said that molnupiravir has major safety concerns.
He added that the World Health Organization and the United Kingdom have not included molnupiravir for treatment of persons suffering from covid-19.
“We have to remember that this drug has major safety concerns," he said and added that it could cause defects in a developing foetus and 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 [have health problems] due to teratogenic influence," Dr Bhargava had said.
The UK Medicines and Healthcare products Regulatory Agency had on 4 December granted approval for molnupiravir under special conditions for treatment of mild to moderate covid-19 in adults who have at least one risk factor for developing severe illness.
The United States Food and Drug Administration (USFDA) on 23 December granted Emergency Use Authorization for the drug for treating mild-to-moderate covid-19 in adults at high risk for progression to severe disease, including hospitalization or death, and for whom alternative treatment options are not accessible or clinically appropriate.
According to conditions, the drug should be sold by retail only under the prescription of medical specialists and the recommended dose should be 800 mg twice daily for five days.
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