New Delhi: Molnupiravir, the first anti-viral Covid-19 pill, has “major safety concerns” although it has been cleared for use in India, ICMR Chief Balram Bhargava said on Wednesday (January 5).
“First of all, the US has approved it based on only 1,433 patients with a three per cent reduction in moderate disease when given in mild cases. However, we have to remember that this drug has major safety concerns,” Bhargava said at a press conference.
“It can cause teratogenicity and mutagenicity and cause cartilage damage and be damaging to the muscles. More importantly, if given to a man or a woman, contraception will have to be maintained for three months as the child born during that period could have problems with teratogenic influences,” he said.
“We are still concerned about pregnancy, lactation, children, soft tissue injuries, reproductive age group, history of infection and vaccinations,” he added.
“It (Molnupiravir) is not included in the national task force treatment. The WHO has not included it and nor has the UK as of now,” he said.
The Drugs Controller General of India (DCGI), the country’s drug regulator, has however cleared Molnupiravir for use in India.
“Since there was only a three per cent reduction in mild to moderate diseases, as of now, the current recommendations stand that it is not a part of the national task force treatment and we have debated on it twice. We will have further debate on it to discuss whether there is any possibility,” Bhargava said.
