With 26 research institutes, India’s ICMR or “Indian Council of Medical Research ” represents one of the largest and oldest apex medical research bodies worldwide. Overseeing research in the world’s second most populated nation and, according to some sources, the world’s fifth-largest economy as measured by gross domestic product (GDP), ICMR’s declarations as to the safety and efficacy of various investigational medical products carries considerable weight. Despite India’s drug regulatory body—the Drugs Controller General of India (DCGI) clearing Merck’s molnupiravir as the first antiviral COVID-19 orally administrated therapy, ICMR Chief Balram Bhargava has declared publicly that his group has “major safety concerns” associated with molnupiravir.
In a recent press conference, the ICMR chief declared:
“First of all, the US has approved it based on only 1,433 patients with a three per cent reduction in moderate disease when given in mild cases. However, we have to remember that this drug has major safety concerns.”
“It can cause teratogenicity and mutagenicity and cause cartilage damage and be damaging to the muscles. More importantly, if given to a man or a woman, contraception will have to be maintained for three months as the child born during that period could have problems with teratogenic influences.”
Moreover, Bhargava continued “It (Molnupiravir) is not included in the national task force treatment. The WHO has not included it and nor has the UK as of now.”
Main Concerns: Pregnant Women, Children & More
As reported in multiple Indian media, including Indian Express, the top doctor for ICMR expressed concerns about molnupiravir’s possibility for side effects, raising risks for pregnant women, lactation, children as well as the possibility of causing soft tissue injuries in a reproductive age cohort.
Not a Good Drug
Furthermore, demonstrating more medical freedom, Bhargava went on the national record that the drug’s absolute risk reduction is less than desired, declaring, “Since there was only a three percent reduction in mild to moderate diseases, as of now, the current recommendations stand that it is not a part of the national task force treatment and we have debated on it twice. We will have further debate on it to discuss whether there is any possibility,” he said.
Background
Initially developed by a drug development unit within Emory University, the US-based biotechnology company Ridgeback Biotherapeutics licensed the intellectual property and thereafter entered a deal with Merck to co-development and commercialize the investigational product. Merck inked deals with up to 13 generic drug makers to expand use.
TrialSite reported in Vietnam that Ho Chi Minh City’s public health department set up an actual home care program using this drug before even approved—possibly pushing ethical boundaries.