The conflict of opinion between the country’s apex medical research body ICMR and drug regulator DCGI has divided the medical fraternity over the use of the antiviral pill molnupiravir. The new drug developed by US-based biotechnology company Ridgeback Biotherapeutics in collaboration with American pharma giant Merck was being touted as the magic bullet and a game changer that could cut the risk of hospitalisation and death by third among those infected by the coronavirus.
While some doctors believe that molnupiravir is the best bet in the fight against Covid-19, many others feel that there is no magic bullet in the treatment of the viral disease. In a weekly press briefing on January 5, Indian Council of Medical Research (ICMR) director-general Dr Balram Bhargava further strengthened the viewpoints of the latter when he announced that the oral drug has “major safety concerns”.
Molnupiravir remains approved by the Drugs Controller General of India (DCGI), so its use is legal and, hence, doctors are free to prescribe it using their own wisdom. However, the word of caution from ICMR has ended up dividing the medical fraternity.
Why not prescribe molnupiravir?
According to Dr SP Kalantri, professor of medicine and medical superintendent at Mahatma Gandhi Institute of Medical Sciences, Maharashtra, doctors need to separate hype from hope.
“The drug does not prevent Covid infection, nor does it help seriously ill people. It might help only those who have mild to moderate illness and have comorbidities,” he said.
Even among them, the benefits are modest, he added. “If 33 such patients swallow molnupiravir pills for five days, only one of them would be spared of getting admitted to the hospital.”
The drug – according to ICMR chief Dr Bhargava – could trigger abnormalities in foetus development apart from other side effects such as damage to muscles and cartilages.
Echoing similar concerns, Kalantri said, “People must know that the drug’s use could trigger birth defects, put people at risk of potential cancer and might lead to mutations in the virus. Given small benefits, and potential large risks, I would err on the side of caution and follow the restrictive approach—refraining myself from prescribing the drug.”
Sumit Ray, head of the department of critical care at Holy Family Hospital, made similar observations.
“Molnupiravir was considered effective in reducing hospitalisation in a restricted subset of Covid-19 patients, who were unvaccinated and had certain severe comorbidities, and the disease was caused by variants before the Omicron variant,” he said.
However, Ray pointed out, in a surge dominated by Omicron and a large percentage of the population vaccinated, the hospitalisation rates are already very low. “To add to that, the drug has significant side effects. Hence, prescribing this drug does not make any sense at this point.”
Why prescribe?
However, another subset of health experts of the country has pointed out that the benefits of the drug outweigh the potential side effects it may have in the case of high-risk patients.
Dr Vasant Nagvekar, infectious diseases consultant, Lilavati hospital, said he has prescribed it to 30 patients since its availability in the market.
“Symptoms with fever and if fever persists 48-72 hrs, then molnupiravir 5 days’ therapy is also receptive. Molnupiravir should be administered as soon as possible after a diagnosis of Covid-19 has been made, and within five days of symptom onset,” he said, adding that the drug is basically to be used in people above 50 years of age and in those with multiple comorbidities.
The pill shouldn’t be used indiscriminately, experts emphasised.
“Side effects of mutagenicity don’t matter, if the drug is indicated for certain patient profiles, for a treatment course of 5 days. It is a remote possibility, which is a potential concern but unknown,” said Dr SK Jindal, former head of department, pulmonology medicine, at PGIMER Chandigarh.
Dr Dhruva Chaudhry, head of pulmonary and critical care medicine, Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, believes that when the pill has been approved by the country’s apex drug regulatory body, then it should be trusted.
“While giving approval, the FDA, as well as the Drugs Controller General of India (DCGI), have gone through the safety data of the drug,” said Dr Chaudhry.
Only once satisfied this drug has been approved, he said. “Even in the phase-3 clinical trials, molnupiravir demonstrated a significant reduction in the risk of hospitalisation or death with no observed safety concerns when compared to the placebo group.”
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