Molnupiravir approved, but not recommended

Molnupiravir, an antiviral medicine manufactured by US firms Merck and Ridgeback, has been removed off the Indian Council of Medical Research’s recommended treatment plan just a week after it was authorised for early-stage Covid-19 patients (ICMR). The medicine posed “major safety concerns,” according to Dr. Balram Bhargava, the chairman of the ICMR. As a result, an embarrassing scenario has arisen: The substance is legal to take, but it is not advised.

Molnupiravir is a repurposed Covid drug, originally developed to treat influenza. It is meant for mild or moderately ill Covid-19 patients who are at risk of developing serious illness. The pill, if administered during the first five days after contracting the infection, has the potential to prevent serious illnesses.

The pill is among the first few therapeutics now being deployed for treatment of Covid-19. Molnupiravir was first cleared for use in the UK in November, and more recently in the US.

There have been concerns on two counts — low effectiveness, and some potential side-effects. Both were taken into account by drug regulating agencies while approving them.

Molnupiravir was found to be only 30% effective in trials, much lower than earlier indications. Besides, there have been been worries over its mechanism: The drug molecule incorporates itself into the RNA of the virus, inducing mutations with the objective of hampering replication. But this carries the risk of introducing mutations that can make the virus stronger and more dangerous. A bigger worry is the risk of the drug creating mutations in the human DNA itself.

These risks, very low by all accounts, have been considered by the drug regulators while approving the drug, which means that these have not been assessed to be significant enough. The prescribed five-day dosage is not considered large enough to pose any serious health concern.

Also, N K Ganguly, former head of ICMR, pointed out, there are several drugs for other diseases in the market that pose similar risks.

“Those drugs are frequently prescribed in specific situations based on the clinical assessment of the patients, if the benefits from the drugs are considered by the doctor to be outweighing these risks,” he said.

In the case of molnupiravir, it seems, going by the argument of Dr Bhargava, the benefits do not very clearly outweigh the risks, considering the low effectiveness of the drug.

In the case of molnupiravir, it seems, going by the argument of Dr Bhargava, the benefits do not very clearly outweigh the risks, considering the low effectiveness of the drug.