ICMR refuses using Molnupiravir for COVID treatment, pulmonologists disagree

The ICMR’s National Task Force for COVID-19 has decided against including anti-viral drug Molnupiravir in the Clinical Management Protocol for COVID-19 as of now. The pill was approved by the Drug Congtroller General of India last month for restricted use in emergencies.

Last week, Dr Balram Bhargava, Chief, Indian Council of Medical Research (ICMR) said that Molnupiravir had major safety concerns. “It can cause teratogenicity, mutagenicity and cartilage damage. It can damage the muscles also,” he said.

The experts of the task force cited safety concerns and argued that Molnupiravir was not of many benefits in COVID treatment to arrive at the decision in a meeting held yesterday.

According to the health ministry, Molnupiravir is an anti-viral drug that inhibits SARS-CoV-2 replication by viral mutagenesis. This anti-COVID pill got the Drugs Controller General of India’s approval on 28th December for restricted use in emergencies.

“Members of the National Task Force for COVID-19 were not in favour of including the drug in the national treatment guidelines citing that it does not have much benefit in the treatment of coronavirus infection and that there were safety concerns,” an official source told PTI.

Dr Bhargava had last week said that Molnupiravir has major safety concerns. He added that WHO and the UK have not included it for treatment.

“We have to remember that this drug has major safety concerns. It can cause teratogenicity, mutagenicity and cartilage damage. It can damage the muscles also.

“Contraception will have to be done for three months for male and female if this drug is given because the child born could be problematic due to teratogenic influence,” he had said.

The UK Medicines and Healthcare products Regulatory Agency had on 4th December granted approval for Molnupiravir under special conditions for treatment of mild-to-moderate COVID-19 in adults who have at least one risk factor for developing severe illness.

The US FDA on 23rd December granted Emergency Use Authorisation (EUA) for the drug for treating mild-to-moderate COVID-19 in adults at high risk for progression to severe disease, including hospitalisation or death, and for whom alternative treatment options are not accessible or clinically appropriate.

According to conditions, the drug should be sold by retail only under the prescription of medical specialists and the recommended dose should be 800 mg twice daily for five days.

At a recent scientific discussion held on “COVID-19: New Treatment Therapies to Tackle Present Crisis,” led by Dr Deepak Talwar, Respiratory Medicine Expert, and attended by other leading pulmonologists of the country unanimously, agreed that there are limited options of medicines used to treat COVID patients and hence the new approved medicines should be given a try under strict treatment regime protocols and ‘daggers should not be drawn so quickly’ unless we have enough data to raise any serious red flags.

Speaking during the discussion, Dr Talwar said, “Physicians have to keep in mind their patient profiles while prescribing any drug. If the patient is high-risk, that is, more than 60 years of age, is obese or having cardiovascular disease, hypertension, and/or has chronic lung or kidney or liver disease, then not treating when the disease is mild or moderate can take extreme turns, putting the patient in risk of hospitalisation and as we have seen at the time of Delta variant, even possible death. We have to use the available therapy rather than counting its side-effects, that too which are potential, but not known.”

Adding to it, Dr Dhruva Chaudhry, MD (Medicine), DNB (Medicine) D M (Pulmonary and Chest Medicine), FICP, FICCM, and a Nodal Officer for COVID-19 at PGIMS Rohtak and Head, Pulmonary and Critical Care Medicine, said, “While giving approval, the FDA, as well as the DCGI, have gone through the safety data of the drug. Only once satisfied, this drug has been approved. Even in the phase-III clinical trials, Molnupiravir, which demonstrated a significant reduction in the risk of hospitalisation or death with no observed safety concerns when compared to the placebo group.”

Dr Vasant Nagvekar, MBBS, MD, infectious diseases consultant, Lilavati Hospital and member of the COVID task force, stated that he has prescribed it to 30 patients since its availability in the market. Symptoms with fever (>60 yrs) and if fever persists 48-72 hours, then Molnupiravir five 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. It is basically to be used in people of >50 years of age and in people with multiple co-morbidities.

Molnupiravir is FDA-approved and has shown to reduce hospitalisation and death in one-third of people. However, it shouldn’t be used indiscriminately. Side-effects of mutagenicity do not matter if the drug is indicated for certain patient profiles, for a treatment course of five days. It is a remote possibility, which is a potential concern, but unknown, said Dr S K Jindal, MBBS, MD (Medicine), FAMS, FCCP, FNCP, Medical Director and Senior Consultant Pulmonology, Jindal Clinics Chandigarh; and Former HOD, Pulmonology Medicine, PGIMER, Chandigarh.

“Molnupiravir is restricted to situations where other FDA-authorised treatments for COVID-19 are inaccessible or aren’t clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalisation or death,” said Patrizia Cavazzoni, MD, Director Centre for Drug Evaluation and Research, FDA.

She added, “As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorisation, while continuing to generate additional data on their safety and effectiveness.”

With inputs from PTI