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Is Molnupiravir safe to use to treat COVID-19 in adults in India?


Global pharma major Lupin Limited (Lupin) announced the launch of Molnupiravir in India under the brand name Molnulup. This drug has been given emergency use authorization by the Drug Controller General of India (DCGI) for treatment of adult patients with Covid-19, with SpO2 > 93 per cent, and the ones who have a high risk of progression of the disease, including hospitalization, as stated in the media announcement.

 On the other hand, “Antiviral drug Molnupiravir, which recently got approval from the drug regulator and is being launched by several local drugmakers, has serious safety concerns, and thus has not been included in the national Covid-19 clinical protocol recommended by the health ministry, the Indian Council of Medical Research (ICMR)” director-general Balram Bhargava said.

The drug has significant safety concerns; it can cause teratogenicity, mutagenicity and may cause cartilage damage, said Bhargava. Teratogenicity can cause defects in a developing foetus, and mutagenicity denotes permanent transmissible changes in the structure of the genetic material of cells. Molnupiravir was developed initially by Merck pharma, which has reduced hospitalization in the cases.

Internationally, Molnupiravir is an oral antiviral that has got approval from the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (FDA) for the treatment of mild-to-moderate cases of COVID-19 in adults, but ICMR does not approve it.

According to the media release, administered orally, Molnupiravir inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Pre-clinical and clinical data have shown Molnupiravir to be effective against the most common SARS-CoV-2 variants, including Gamma, Delta, and Mu variants. Molnupiravir should be initiated as soon as possible after a diagnosis of COVID-19 and within five days of onset of symptoms.

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