Molnupiravir not in national clinical protocol due to safety concerns

ICMR chief says task force has debated twice on whether to include the drug in the protocol, but decided against it

Merck's antiviral drug molnupiravir, which several Indian companies are in the process of launching, has serious safety concerns, and thus has not been included in the national Covid-19 task force recommended clinical protocol, the chief of India’s apex health research organisation said on Wednesday. Balram Bhargava, director general of the Indian Council of Medical Research (ICMR), told the media the task force has debated twice whether to include the drug in the protocol, but decided against it.

“The US has approved it based only on 1,433 patients with a 3 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 (the ability to cause defects in a developing foetus), mutagenicity , and it can also cause cartilage damage and can also be damaging to muscles,” he explained. Mutagenicity refers to permanent transmissible changes in the structure of genetic material of cells.

Bhargava added that more importantly, if someone is prescribed molnupiravir, the person — no matter what their gender — has to be put on contraception for three months because the child born will be problematic with teratogenic influences. “Therefore, it is not included in the national clinical protocol, the WHO has not included it, nor has the UK,” he added.

Bhargava said they are concerned about children, pregnant and lactating women, those in reproductive age, those with soft tissue injury, and with history of infections and vaccinations when this drug is being prescribed. “Whatever benefit was to those 1,433 individuals who were unvaccinated... and only 3 per cent reduction in mild to moderate disease” he said.

Companies have started to launch the drug in India and despatches have begun to several districts already.