Thread by @drmssm

The statement of ICMR chief Balaram Bhargav regarding Molnupiravir is without scientific rigour and must be withdrawn immediately. Please read this 🧵
#Molnupiravir #Merck #icmr @DonitaJose @AneeshaBedi @KanizaGarari @vinodscaria

Regarding mutagenicity of Molnupiravir, the initial test for any molecule is the Ames test which if negative indicates that the molecule in question has no mutagenicity. For Molnupiravir it was positive. If Ames test is positive, further tests are done for confirmation.

The in vivo MN study was negative. The Sprague-Dawley Rat Pig-α Assay was equivocal. But the conclusive test called Transgenic Rodent Assay in Big Blue Rat was unequivocally negative.

That’s why the CDER (Centre for Drug Evaluation and Research) of USFDA has ruled that “it would seem that neither parent pro-drug nor the initial metabolite NHC are in-vivo mutagens”.

The other concern was not muscle and bone damage, but cartilage and bone annormalities in lab animals at a dose of >750mg/kg. Molnupiravir is not approved in children nor at these doses, so it is not a worrisome problem.

If any new mutagenicity concerns are there, the DCGI shouldn’t have approved the drug.

The ICMR chief Dr. Balaram Bhargav should also
tell the people of India why Favipiravir, 2Dg, Itolizumab, and pegylated interferon alpha are all approved, but are not included in the ICMR treatment plans. Are there safety concerns with these molecules as well??

This is a botched up response with antagonism of DCGI and ICMR. Instead they should have reserved Molnupiravir for people who have completed child bearing.

Molnupiravir is not a wonder-drug. It is only modestly effective. But Omicron doesn’t respond to monoclonal antibodies available in India now and Paxlovid is not yet available in India. Molnupiravir will reduce hospitalisation in 30% and will be useful in specific populations.