The Indian Council of Medical Research has not included Merck's oral antiviral COVID-19 drug Molnupiravir in the national COVID-19 treatment protocol despite the Central Drugs Standard Control Organisation giving it emergency use authorisation on December 28.
Dr. Balrama Bhargava, the Director-General of the ICMR, in the weekly press conference on January 5 announced that the ICMR would not include the drug in its guidelines as the authorities are concerned about the side effects of the drug. He reiterated this same statement in the press conference on January 12.
Although the interim results of the clinical trials earlier showed that the medicine reduced hospitalisation by 50 per cent, Merck corrected the reduction to 30 per cent after the trials ended and the final results were calculated. Owing to this reduction, many experts have expressed caution while using the drug.
The drug designed by scientists at Drug Innovations at Emory, a nonprofit initiative by Emory University, Atlanta, is being developed by Merck in collaboration with Ridge Biotherapeutics. Although Lupin was the first one to launch the drug in the country, several other pharmaceuticals such as Dr.Reddy's. Sun Pharma are also willing to bring the drug to the country.
Molnupiravir is an antiviral medication that inhibits the replication of certain RNA viruses. It is used to treat COVID-19 in those infected by SARS-CoV-2. The recommended dose of Molnupiravir 800 mg is twice a day for five days. A patient needs to take 40 capsules containing 200 mg of medication.
While it has been given emergency use by the US Food and Drug Administration as well as UK's Medicines and Healthcare products Regulatory Agency, the drug has not been included in the treatment protocols. Similarly, the World Health Organisation has said that the treatment protocol for COVID and Omicron is intact without any changes. They have not included Molnupiravir in their treatment protocol.
Issues With Molnupiravir
On January 5, Dr. Bhargava had briefly mentioned that the drug has major safety concerns and it can cause teratogenicity, mutagenicity, cartilage damage, muscle damage. He also stated that couples will have to use contraception for three months so that a probable foetus' health is prevented.
Teratogenicity means the ability to cause defects in a developing foetus. Mutagenicity involves mutating the genome of a foetus which could also lead to potential defects.
Reiterating these points in the press conference on Jan 12, Dr. Bhargava elaborated why the National Task Force chose to not include the drug in the national treatment guidelines.
"We have had extensive discussions with the national task force on the basis of the data of the three trials- the MoVe-In trials which were on 1433 individuals, the MoVe- Out which were prematurely terminated due to business reasons and the MoVe-Ahead trials that are currently ongoing. We also have 12 clinical trials set to start in India which have been registered on the Clinical Trial Registry of India," Dr. Bhargava pointed.
After deliberation, the team made their decision of not including the medicine in the Indian protocols on the basis of five reasons. "Molnupiravir has certain risks that warrant caution in its use. Secondly, experts present at the meeting opined that there is a rampant and irrational use of the drug," the director general noted.
Dr. Bhargava also added that efforts should be made to restrict its use as known and unknown harms far outweigh the claimed benefits of the drug. "The currently available synthesized evidence was reviewed and the members unanimously agreed that it does not merit its inclusion. Emerging evidence will be constantly reviewed."
"Finally, it is further highlighted that the current clinical window of application appears extremely narrow for Molnupiravir with relevance only to the elderly, unvaccinated, or with other co-morbidities. There was no benefit of Molnupiravir in those with diabetes, earlier diagnosed with COVID-19 or vaccinated," Dr. Bhargava listed.
Dr. S P Kalantari, physician and professor of medicine at Mahatma Gandhi Institute of Medical Sciences, Sevagram, Maharashtra has tweeted the anomalies in the research and has shared that there is no significant evidence showcasing the benefits of using the drug and its reduction in hospitalisation among the groups that Dr. Bhargava mentioned.
The physician highlights that effective results are seen among 1 in 33 patients. His other tweets discuss the problem in the MoVe-Out trials.
He has also pointed out that the drug did not benefit men, diabetics, and those with severe heart ailments.