ICMR Chief Dr Balram Bhargava said on Wednesday, January 5, that COVID-19 antiviral drug Molnupiravir has major safety concerns and has not been included in the national protocol for treatment of coronavirus. During a press briefing, he said the World Health Organisation and the UK have not included it for treatment. "We have to remember that this drug has major safety concerns. It can cause teratogenicity, mutagenicity and it can also cause cartilage damage and can also be damaging to muscles also. Contraception will have to be done for three months for male and female if this drug is given because the child born could be problematic due to teratogenic influence," he told reporters.
Bhargava said the US has approved it based on only 1,433 patients in which three percent reduction was observed in symptoms in patients with mild to moderate disease. He stressed that it is not part of the national treatment protocol for COVID-19. "We have concerns about the drug and its use during lactation, in children, soft-tissue injuries, reproductive age group," he said, adding that they have debated on its usage twice and will further debate over it.
India's drug regulator Central Drugs Standard Control Organisation on December 28 had approved Molnupiravir for restricted use in emergency situations. "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.
Molnupiravir is an antiviral that inhibits SARS-CoV-2 replication by viral mutagenesis. The UK MHRA on December 4, 2021, granted approval for Molnupiravir under special condition for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness, an official statement had said.
The US FDA on December 23 had granted EUA for Molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalisation or death, and for whom alternative COVID-19 treatment options authorised by the FDA are not accessible or clinically appropriate.
The CDSCO had received 22 applications for manufacture and market of the drug Molnupiravir in the country. "Considering the emergency and unmet medical need in COVID-19, 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 five days for restricted use under emergency situation in the country for treatment of adult patients with COVID-19, with SpO2 over 93% and who have high risk of progression of the disease including hospitalization or death subject to various conditions," the statement said.
According to the conditions, the drug should be sold by retail only under prescription of medical specialists and the recommended dose should be 800mg twice daily for five days.