Ground Report | New Delhi: What is Molnupiravir; Days after the country’s drug regulator, the Drug Controller General of India (DCGI), approved Molnupiravir as the first anti-viral COVID-19 pill, ICMR chief Balram Bhargava on Wednesday said the drug has “major safety concerns”.
Addressing a press conference, Bhargava said, “First of all, the US has approved it on the basis of only 1,433 patients with a three percent reduction in moderate disease when given in mild cases. However, we have to remember that there are major safety concerns of this drug.”
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“It can cause teratogenicity and mutagenesis and cause cartilage damage and damage to the muscle. More importantly, if a contraceptive is given to a man or a woman, the contraceptive should be maintained for three months.” Because the child born during that period may have problems with teratogenic effects,” Bhargava said.
“It (molenupiravir) is not included in the national task force treatment. WHO has not included it and neither has the UK yet,” he said.
Expressing concern about the side effects of the drug, Bhargava said, “We are still concerned about pregnancy, breastfeeding, children, soft tissue injuries, reproductive age group, history of infection and vaccination.”
“Since there was only a three percent reduction in mild to moderate diseases, so far, the current recommendations recognize that this is not part of the national task force treatment and we have debated this twice. We will discuss it further whether there is any possibility,” he said.
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What is Molnupiravir?
Molanupiravir is an antiviral medicine that blocks the replication of certain RNA viruses. It is used to treat COVID-19 in people infected with SARS-CoV-2.
As per the terms of the DCGI’s approval, the drug should be sold by retail only under the prescription of medical experts, reported PTI.
According to the conditions, the drug is not authorized for use in patients under the age of 18 years and for initiation of treatment in patients requiring immediate hospitalization due to COVID-19.
However, if the dosage was started before the hospitalization due to COVID 19, it may be continued, sources told the news agency.
It is not authorized for use for more than five consecutive days and for pre-exposure or postexposure prophylaxis for the prevention of COVID-19 for pregnant women. Those in the household with mild to moderate COVID-19 intend to take the pill twice a day for five days.
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