Dr Balram Bhargava, head of the Indian Council of Medical Research (ICMR) said on Tuesday that Molnupiravir, an anti-viral drug developed by US companies Merck and Ridgeback, has major safety concerns which have resulted in an awkward situation: The drug is approved for use, but not recommended.

Molnupiravir is among the first few therapeutics now being deployed for the treatment of Covid-19. It is meant to treat mild or moderately ill Covid-19 patients who were at risk of developing serious illness and if administered during the first five days after contracting the infection had the potential to prevent serious illnesses. Molnupiravir was first cleared for use in the UK in November, and more recently in the US.

The concern included low effectiveness and some potential side effects. It was only 30% effective in trials which was, much lower than earlier indications. Molnupiravir works by incorporating itself into the RNA of the virus and inducing mutations to hamper replication. But these mutations could make the virus stronger and more dangerous. Still, another bigger worry was the risk of the drug creating mutations in the human DNA itself.

The drug regulators considered these risks as low while approving the drug, which means that these have not been assessed to be significant enough and the prescribed five-day dosage was not considered large enough to pose any serious health concern.

N K Ganguly, former head of ICMR, said that several drugs for other diseases were there in the market which has similar risks but were frequently being prescribed in specific situations based on the clinical assessment of the patient if the doctor felt that the benefits from the drugs outweigh these risks.

But in the case of Molnupiravir, it seems, going by the argument of Dr Bhargava, that benefits do not very clearly outweigh the risks, considering the low effectiveness of the drug.

Dr Raman Gangakhedkar, a former head of epidemiology at ICMR, suggested that Molnupiravir should not be regarded as a wonder drug as it has low effectiveness. Still, it could be used in some cases and would not be surprising if any doctor prescribes the drug. But at the same time, the patients and their families need not insist on prescribing the drug.

So, it is now likely that doctors would still prescribe Molnupiravir in some situations based on the clinical assessment of the patient.

Source: The India Express