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Why ICMR does not recommend Molnupiravar despite getting approval for use

The decision taken by the ICMR has created a bizarre situation as even though the drug has been approved for use, it has not been recommended for use by the ICMR.

Days after molnupiravir, an antiviral drug, was approved for use for Covid-19 patients, the Indian Medical of Medical Research (ICMR) has kept the medicine out of the treatment protocol. The drug which was originally developed by US pharma companies Merck and Ridgeback, is reported to have raised major safety concerns and that is why the ICMR has kept it out of the treatment protocol, the Indian Express reported. Dr Balram Bhargava, head of ICMR, was reported as saying on Tuesday that the drug had “major safety concerns’ ‘. The decision taken by the ICMR has created a bizarre situation as even though the drug has been approved for use, it has not been recommended for use by the ICMR.

Molnupiravir drug

A repurposed Covid-19 drug which was originally developed to treat influenza, has been molded for its use against Coronavirus. The drug is supposed to be administered to patients who are mild or moderately ill with Coronavirus and are likely to face severe infection in the due course. The pill was claimed to have the potential to reduce the chances of serious illness if it is taken during the first five days after contracting the infection. The pill, apart from India, has been approved for use in the United Kingdom followed by the United States.

Potential concerns

The drug is understood to have raised concerns on the basis of two factors-low effectiveness and potential side-effects. However, both the factors were taken into consideration when the drug was approved for use by the drug contoller. The drug was found to be only 30 percent effective in its clinical traisl and much lower than what was previously indicated. The biggest concern with the drug was the way in which it incorporates itself into the RNA of the virus. The drug was aimed at creating several mutations of the virus, thereby hampering the chances of replication of the virus. However, the approach was considered to be pretty risky as several mutations can make the virus more potent and there are chances of the drug creating mutations even in the human DNA.

Will the drug be prescribed?

The doctors in some situations are going to prescribe the drug based on the clinical assessment of the patient under their observation. Also, the primary reason which has led ICMR to not include the drug in the treatment protocol is the fact that the effectiveness of the drug was found to be lacking to override the safety concerns. Moreover, the drug can only be recommended for patients in the first five days of contracting the infection and that too among mildly or moderately ill patients.

Dr Raman Gangakhedkar, who is a former head of epidemiology at ICMR recently said that one cannot take Molnupiravir as a wonder drug but it would not be surprising if a few doctors prescribe the drug as it works in some cases. But he added that patients and relatives must not insist on getting this drug.

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