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Wednesday, January 26, 2022

Anti-Covid pill Molnupiravir: Approved, not recommended

Molnupiravir, an anti-viral drug developed by US companies Merck and Ridgeback, has been kept out of the treatment protocol recommended by the Indian Council of Medical Research (ICMR). A look at the drug, the risks, and what now

Written by Amitabh Sinha , Harikishan Sharma | New Delhi, Pune |
Updated: January 7, 2022 8:43:26 am
Molnupiravir, developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with US Pharma giant Merck, is now being made by 13 Indian drug manufacturers.

Barely a week after it was approved for early-stage Covid-19 patients, molnupiravir, an anti-viral drug developed by US companies Merck and Ridgeback, has been kept out of the treatment protocol recommended by the Indian Council of Medical Research (ICMR). Dr Balram Bhargava, head of ICMR, said on Tuesday that the drug had “major safety concerns”. This has resulted in a awkward situation: The drug is approved for use, but not recommended.

The drug

Molnupiravir is a repurposed Covid-19 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.

The concerns

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.

Risk vs benefit

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.

What now

It is now likely that doctors would still prescribe it in some situations based on the clinical assessment of the patient. In any case, it can be useful only in very specific situations, during the first five days of infection, and among mild or moderately sick patients.

“We must not treat this as a wonder drug. Molnupiravir is known to have low effectiveness. It can still work in some cases, so I would not be surprised if some doctors prescribe it. But at the same time, patients and their families need not insist on getting this drug,” said Dr Raman Gangakhedkar, a former head of epidemiology at ICMR.

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