KOLKATA – The hype generated around the world’s first oral antiviral treatment for Covid-19 has been cut short in India, with worried authorities cautioning against its indiscriminate use amid an ongoing wave propelled by the highly infectious Omicron variant.
The Indian Council of Medical Research (ICMR) has flagged “major” concerns around the safety and effectiveness of molnupiravir developed by Merck and Ridgeback Biotherapeutics in the United States.
It even excluded the drug from India’s Covid-19 treatment protocol less than a fortnight after it secured an emergency authorisation for restricted use on Dec 28 from the Central Drugs Standard Control Organisation. The drug regulator has allowed 13 companies to market generic versions of molnupiravir.
The drug works by introducing errors in the virus’ genetic code, thus preventing it from replicating.
“Molnupiravir has certain risks that warrant caution in its use… Efforts should be made to restrict its use as harms far outweigh its claimed benefit,” ICMR director general Dr Balram Bhargava said on Jan 5.
“It can cause teratogenicity (foetal defects), mutagenicity (genetic damage), cartilage damage and can also damage muscles…We still have concerns about pregnancy, lactation, children, soft tissue injuries,” he added, citing international findings. This warning was repeated by the ICMR last week as well.
The United States Food and Drug Administration (FDA) cleared the drug on Dec 23 for the treatment of mild-to-moderate coronavirus disease in adults who are at high risk for progression to severe Covid-19 and for whom alternative treatment options are not accessible or clinically appropriate.
The FDA has not authorised molnupiravir for patients below 18 because it can affect bone and cartilage growth. Citing findings from animal studies, the agency has also stated that the drug may cause foetal harm and recommended against its use during pregnancy.
However, in India, which has a lax drug regulatory setup and where prescription drug abuse is rampant, molnupiravir has quickly emerged as a manna of sorts, with the drug even being prescribed to those beyond the intended group of patients.
“This is negligence!! Please stop this madness!!” tweeted genomic scientist Dr Vinod Scaria on Jan 6 to express his concern after receiving three calls seeking advice on the use of molnupriavir.
The three individuals who had been prescribed the drug were young and double vaccinated – one was asymptomatic and two had mild symptoms. None of them had any comorbidities, nor had they received explanation detailing molnupiravir’s risks.
Dr Ameet Dravid, an infectious disease specialist, told The Straits Times that many doctors are prescribing the drug widely without adequate information about who it should be administered to. Besides potential harm from its unauthorised use, Dr Dravid said he is worried that such widespread abuse can cause the virus to become resistant to this drug.
“This is why I keep telling people it is not a drug for young people without comorbidities,” he added. “This is a drug reserved for a certain section of people with certain comorbidities.”