SAFETY REMAINS PARAMOUNT
As the Omicron variant of Coronavirus sweeps across several countries worldwide, the number of cases continues to increase every day reaching record new heights with each passing day, albeit with fewer hospitalisations than initially projected in several of those countries. The antiviral drug Molnupiravir, claimed to slash hospitalisations and deaths caused by COVID-19 is considered to be an important milestone in the fight against the pandemic, after the vaccines, which started becoming available about a year back.
Molnupiravir, developed by Merck in the US and Ridgeback Biotherapeutics, an American biotech company, received emergency use authorisation from the USFDA in December 2021. Considering that it could become a game changer and breakthrough drug its demand has been increasing, requiring scaling up of its production. Several countries have shown interest or have planned to produce Molnupiravir with local partners.
A UN-backed agency has entered into a deal with over 30 generic drug makers from China, India, Bangladesh, some other Asian countries, Middle East and Africa to make low cost versions of Molnupiravir for poorer nations. The medicine produced from these companies would be distributed to 105 less developed countries and they may start receiving it from the current month itself. Two Southeast Asian countries, Thailand and Indonesia, have also announced their plans to produce the antiviral pill in their countries with local partners.
In India, Cipla planned to launch it 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 lined up to manufacture the oral antiviral drug. 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. Prior to that, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) had already approved it.
But experts are still divided over its use. Even the USFDA approved it with only a very narrow margin of 13 to 10. While granting EUA, the USFDA had made it amply clear that it must be prescribed only when other authorised 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.
The Indian government’s medical research wing, the Indian Council of Medical Research (ICMR) has recommended that 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.
Member (Health) of India’s NITI Aayog has also expressed concern over its misuse and overuse. In India the tricky situation is that two wings of the government have differing opinions over the use of the drug. While the regulatory body, CDSCO has approved the EUA, the public health department’s research wing, ICMR has opposed its use. Experts sounding off divergent views are not totally unwarranted as this is first generation anti-viral. Hence medical professionals and hospitals must exercise caution and use the drug only for those patients that might benefit. It is true that despite the two differing opinions of experts, the pill’s usage cannot be totally stopped as we must put an end to the pandemic before long. But, its unchecked use may give rise to some unpleasant outcomes, including triggering a new disease or resistance to the drug.
The differences of opinion among experts must not derail the treatment protocols for COVID-19 and put citizens in further jeopardy.