Indian Council of Medical Research (ICMR) chief Dr Balram Bhargava on Wednesday said that the antiviral drug Molnupiravir has not been included in the national protocol for the treatment of COVID-19 as it has major safety concerns.
He said that “Molnupiravir can cause teratogenicity, mutagenicity and cartilage damage and can also be damaging to muscles.”
While teratogenicity is the capability of producing foetal malformation, while mutagenicity refers to permanent transmissible changes in the structure of the genetic material of cells.
“If this drug is given to a male or female, contraception will have to be done for three months because the child born could be problematic due to teratogenic influence," Bhargava told journalists.
The World Health Organisation and the UK have not included it for treatment, he pointed out.
Bhargava said the US has approved the drug based on only 1,433 patients in which three per cent reduction was observed in symptoms in patients with mild to moderate disease.
He said they have debated on its usage twice and will further debate over it.
India's Drug Regulator, Central Drugs Standard Control Organisation had approved Molnupiravir for restricted use in emergency situations on December 28.
"Molnupiravir will now be manufactured in the country by 13 companies for restricted use under emergency situations for treatment of adult patients with Covid-19 and who have high risk of progression of the disease," Union Health Minister Mansukh Mandaviya had said at the time.
"Considering the emergency and unmet medical need in Covid, the SEC on December 27 recommended for grant of permission to manufacture and market the Molnupiravir 200mg capsule with recommended dose of 800 mg twice daily for 5 days for restricted use under emergency situation in the country for treatment of adult patients with Covid-19, with SpO2 over 93 per cent and who have a high risk of progression of the disease including hospitalisation or death subject to various conditions," the official statement had said.
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