Antiviral drug Molnupiravir is not included in the National treatment task force for COVID-19, said Director General, Indian Council of Medical Research (ICMR) Balram Bhargava on Wednesday.
The decision has been taken after an extensive discussion amongst national experts.
Addressing media persons, Dr Bhargava said, "I think we have had an extensive debate, extensive discussion amongst national experts and we reviewed whatever data is available from the three trials such as move in, move out and move ahead trials. The move-in trial was done on 1,433 patients. The move out trial was prematurely terminated for business reasons. The move ahead trial is underway. There are 12 clinical trials registered on the Clinical Trial Registry of India which are also starting or about to start."
"Molnupiravir has the certain risks that warrant caution in its use. Experts present at the meeting opined that there is a rampant and irrational use of Molnupiravir. Efforts should be made to restrict its use as known and unknown harms far outweigh its claimed benefits. Currently available synthesised evidence was reviewed and the members unanimously agreed that it does not merit the inclusion of Molnupiravir in the national treatment guidelines," explained the ICMR DG.
Dr Bhargava said that emerging evidence will be constantly be reviewed and further highlighted that the current clinical window of the application appears extremely narrow for Molnupiravir with relevance only to elderly and unvaccinated patients with other comorbidities. "There was no evidence for benefit in diabetes, and those who are previously infected with COVID-19 or were vaccinated," he added.
Dr VK Paul, Member, Niti Aayog also cleared several doubts on the usage of the antiviral drug. He said, "We discussed this atleast four times in the national task force, with our scientific committees and groups on vaccination and others. These are proactive reviews in the last meeting. We discussed about Molnupiravir and it has risks. So, there should be a cautious approach. It has been also seen that it is used irrationally. This medicine does not come under the National COVID treatment protocol. This is evolving science and will then dictate how we proceed further."Raising concerns over its uses, Dr Paul said that Molnupiravir should not be given to patients less than 18 years of age. He also said that the drug cannot be given to pregnant women as this can lead to defects in the foetus. However, he added that the drug can reduce hospitalisation from 6 per cent to 3 per cent.
Drugs Controller General of India (DCGI) on December 28 had approved Dr Reddy's laboratories for the emergency-use authorization to manufacture and market the oral anti-viral drug Molnupiravir capsules 200 mg for the treatment of adult patients with COVID-19, with the oxygen saturation level less than 93 per cent and who have a high risk of progression of the disease including hospitalization or death.
Dr Reddy's will be manufacturing and supplying the generic version of Molnupiravir to over 100 low and middle-income countries.
The antiviral pill was recommended by the Subject Expert Committee after providing additional efficacy data by the 13 pharma companies.
( With inputs from ANI )
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