New Delhi, January 12
In its second warning against the use of Molnupiravir, the world’s first anti-Covid oral pill developed by Merck, the Indian Council of Medical Research on Wednesday said the harms of the anti-viral pill far outweigh its benefits.
The ICMR noted irrational use of the pill which the Drug Controller General of India approved on December 28 last year and said while the pill has been approved in the UK and Denmark, it has not made to the Covid treatment guidelines there also.
In India, the national task force experts have for the third time unanimously rejected the inclusion of the drug in the Indian Covid-19 treatment guidelines.
“We had extensive discussions among national experts and reviewed whatever data was available from three trials – one on 1433 patients in the US; one which was prematurely terminated for business reasons and another that is ongoing. The conclusion is that Molnupiravir has certain risks that warrant caution in its use. Experts present at the meeting opined that there is a rampant and irrational use of the pill. They said efforts should be made to restrict its use as known and unknown harms far outweigh its claimed benefit,” ICMR chief Balram Bhargava said today.
He said currently available synthesized evidence was reviewed and members unanimously agreed that the medicine does not merit inclusion in the national Covid treatment guidelines.
The emerging evidence will be constantly reviewed, ICMR chief said.
He also said the current window of application appeared extremely narrow for Molnupiravir with relevance only to the elderly and the unvaccinated with other comorbidities except diabetes.
“There was no evidence of benefit in diabetes, those previously infected with Covid 19 or those who were vaccinated,” said Bhargava.
The health ministry said the medicine, approved by DCGI is to be administered conditionally and is not to be given to people under 18 years and to pregnant women. It has evidence of harm to the fetus and to genetic materials, said ICMR adding that even in the US where the medicine has been approved for use, its administration is conditional.