Days after the country’s pharma authority, the Drugs Controller General of India (DCGI), approved Molnupiravir as the first anti-viral Covid-19 pill, ICMR Chief Balram Bhargava claimed the medicine has “serious safety issues.”
“First and foremost,” Bhargava stated at a news conference, “The United States has approved it based on only 1,433 patients with a 3% reduction in moderate disease when administered in mild situations.” However, we must keep in mind that this medicine poses significant safety risks.”
â€œIt 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,â€ Bhargava said.
He added, â€œIt (Molnupiravir) is not included in the national task force treatment. The WHO has not included it and nor has the UK as of now,â€ he said.
Expressing concerns about the side effects of the drug, Bhargava said, â€œWe are still concerned about pregnancy, lactation, children, soft tissue injuries, reproductive age group, history of infection and vaccinations.â€
â€œSince 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,â€ 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.