ICMR says Molnupiravir has major safety concerns, not included in national protocol for COVID-19 treatment

The Indian Council of Medical Research on Wednesday raised major safety concerns against antiviral COVID-19 drug Molnupiravir and said that it isn’t included in the treatment guidelines of the COVID-19 national task force. Dr Balram Bhargava, director-general of ICMR, said that contraceptive methods should be used for three months if the drug is administered to women since the child may have problems.

Molnupiravir has major safety concerns including mutagenicity, muscle & bone damage. If this drug is given contraception has to be done for three months as child may have problems. So it is not included in national task got treatments: Dr Balram Bhargava, DG, ICMR pic.twitter.com/FubPjGLeOU

— ANI (@ANI) January 5, 2022

Last week, the Drug Controller General of India (DCGI) approved Emergency Use Authorisation (EUA) for the drug as the country witnessed a spike in COVID-19 cases following the emergence of the highly contagious Omicron variant. According to the Union Health Minister Mansukh Mandaviya, 13 companies in India will manufacture the drug approved for restricted use under emergency situation for treatment of adult patients with COVID-19 and who have high risk of progression of the disease. Cipla, Sun Pharma, Emcure, Torrent Pharma and Viatris (earlier called as Mylan), led by Dr Reddy’s have formed a consortium to conduct a five-month collaborative trial to test the safety and efficacy of the drug have received approvals. A spokesperson of Dr Reddy’s Laboratories Ltd said that the drugmaker will launch the Molnupiravir at Rs 35. “Molflu is expected to be available from early next week in pharmacies throughout (India) with particular focus on states with high caseload of COVID-19,” the company had spokesperson said. Earlier on Wednesday, India registered 58,097 fresh infections, taking the active COVID-19 tally to over 2,14,000, the health ministry said. Maharashtra has reported the highest number of confirmed Omicron cases, followed by Delhi, Kerala, Rajasthan, and Gujarat. India also reported its first death due to the Omicron variant on Wednesday. With inputs from PTI