Days after the Drugs Controller General of India (DCGI), the country’s drug regulator, cleared Molnupiravir as the first anti-viral Covid-19 pill, ICMR Chief Balram Bhargava Wednesday said the drug has “major safety concerns”.
Addressing a press conference, Bhargava said, “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.”
“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,” Bhargava said.
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.
Expressing concerns about the side effects of the drug, Bhargava said, “We are still concerned about pregnancy, lactation, children, soft tissue injuries, reproductive age group, history of infection and vaccinations.”
“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,” he said.
The drug, developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with US Pharma giant Merck, is now being made by 13 Indian drug manufacturers.