NEW DELHI: Antiviral drug Molnupiravir, which recently got approval from the drug regulator and is being launched by several local drug makers, has serious safety concerns, and is thus recommended by the health ministry as a national COVID-19 clinical trial. It has not been included in the protocol, said Balram Bhargava, Director General, Indian Council of Medical Research (ICMR).
Bhargava said the COVID-19 task force has debated whether to include the drug in the COVID-19 treatment protocol, but decided against it due to concerns.
“The US has approved it based on only 1,433 patients, there is a 3% 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, mutagenicity, and it can also damage cartilage and also cause muscle damage,” Bhargava said.
“More importantly, if this drug is given to a man or a woman, contraception has to be used for three months, as a child conceived during that period may have problems with teratogenic effects. Therefore, it is not included in the national clinical protocol, WHO has not included it, nor is it in the UK,” he said.
Teratogenicity is the ability to cause defects in a developing embryo, whereas mutagenicity refers to permanent permeable changes in the composition of the genetic material of cells.
Bhargava further explained that there are concerns about children, pregnant and lactating women, those of reproductive age, soft tissue injury, history of infection and vaccinations when this drug is being prescribed.
Molnupiravir, originally developed by the pharma company Merck, initially claimed a 50% reduction in hospitalization or death in patients.