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As the Omicron variant sweeps the country, the number of cases has been increasing every day, albeit with fewer hospitalisations than initially projected. In the wake of this rise, the Indian Council of Medical Research (ICMR) has recommended that Merck’s new anti-viral drug Molnupiravir not be used as it’s not been included in the national COVID taskforce treatment citing several safety concerns.
Experts pointed out that there is rampant and irrational use of this drug. Its use should be restricted as known and unknown harms outweigh its claimed benefits. Its safety concerns are related to teratogenicity, mutagenicity and bone damage. Even the NITI Aayog member (Health) has expressed concern over its misuse and overuse.
Warnings by NITI Aayog and ICMR are not unwarranted since during the second wave, unchecked use of medicines was largely responsible for mucormycosis cases across India. Medical professionals and hospitals must exercise caution and use it only for those patients that might benefit.
The Central Drugs Standard Control Organisation (CDSCO), India’s drug regulatory organisation had granted Molnupiravir an emergency use authorisation (EUA) in the last week of December 2021 for restricted use in emergencies. The US Food and Drug Administration (USFDA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have already approved it. Following CDCSO’s approval, Cipla planned to launch it here under the brand name Cipmolnu. Aurobindo Pharma is another company that introduced Molnupiravir in India under the brand name Molnaflu. It said that it was for hospitalised adult patients under certain conditions. Dr. Reddy’s Laboratories also announced that it would soon launch its generic version. In all 13 companies are in queue to manufacture the antiviral oral drug.
Merck’s claim in Phase III trials that Molnupiravir cuts the hospitalisation risk and deaths by half, indicated that it could become a game changer and breakthrough drug. But experts were still divided over its use. Even the USFDA approved it with only a very narrow margin of 13 to 10. While giving
EUA, the USFDA made it clear that it must be prescribed only when other authorised treatments are inaccessible or not clinically appropriate.
The USFDA statement makes it clear that the new pill must be prescribed only when other USFDAauthorised treatments are inaccessible or not clinically appropriate. However, another expert feels that its benefits outweigh the potential risk it may have in high risk patients. They cite the approvals granted to it by drug regulatory authorities in different countries after going through safety data.
Though the experts are divided over the issue, it is not a good sign that two wings of the government – one involved in research and another in regulation have different views on the same drug. The regulator approved it but the researchers are warning against it.
These differences in opinion of the two wings are particularly detrimental when there are reports that the government is planning to amend New Drugs and Clinical Trials (ND&CT) Rules 2019 to allow producing unapproved new drugs when they are being developed, with certain conditions. The Drug Technical Advisory Board (DTAB) has recommended such an amendment. In such a situation both the wings of the government should have unified opinion, resolving their differences internally. Regulator approving the drug, allowing pharma companies to produce it even when the clinical trials are on and accordingly, pharma companies producing it, but then the research wing not including it in its protocol can give rise to complex situations which must be avoided.
Such opposing views and opinions may baffle the pharma producers, enough to affect their decision over producing the drug. It can also create confusion in the minds of common people who may not exactly be privy to the responsibilities of the two organisations.
The two organisations, not seeing eye to eye, must not derail the treatment protocols for COVID-19 and put citizens in further jeopardy.