Covid: Molnupiravir sales may get hit amid safety concerns flagged by ICMR

Doctors say will prescribe if benefits outweigh risks; Clinicians also feel GoI should clarify its stand on Molnupiravir use

After the chief of India’s apex health research organisation said on Wednesday raised concerns around the safety of using oral antiviral drug molnupiravir, doctors felt that the government needs to clarify its stand. Also, industry sources said that prescription rates may go down among doctors after such safety concerns were raised.

Satyanarayana Mysore, HOD & Consultant-Pulmonology, Lung Transplant Physician and Karnataka Covid-19 task force member told Business Standard that it is strange that two arms of the government are not on the same page. He added that after the Drugs Controller General of India (DCGI) gave approval to a drug, the country’s health research organisation says that there are serious safety concerns.

Speaking to the media, Balram Bhargava, director general of the Indian Council of Medical Research (ICMR) had said on Wednesday that the molnupiravir had serious safety concerns - it can cause teratogenicity (is the ability to cause defects in a developing foetus), mutagenicity , and it can also cause cartilage damage and can also be damaging to muscles.

Mutagenicity refers to permanent transmissible changes in the structure of genetic material of cells.

The drug cannot be given to patients in reproductive age without putting them on contraception for three months at least, as the foetus could have abnormalities as a result.

Mysore said that they have prescribed the drug to some patients, but had asked them to be on contraception. “I feel many patients cannot afford intravenous drugs (like remdesivir) or even hospitalisation. Therefore, if they have some hope with molnupiravir, it can be given, but with abundant precaution,” Mysore added.

Pharma companies felt that prescription rates may fall due to the safety concerns. “Many doctors may now refrain from prescribing the drug after the ICMR chief spoke about safety issues to the media. However, we were not expecting every Covid19 patient to be prescribed this drug either,” said a senior executive of a Mumbai based firm. He added that even if 2-4 percent of the patients are put on molnupiravir, it leads to significant volumes.

“All the companies are on the same boat. There is no available treatment for Covid19, so people are trying to launch whichever becomes available. Ultimately, it’s a clinician’s call,” the executive added.

Mumbai based pulmonologist Dr Agam Vora said that most patients in the recent wave are recovering very quickly. “Most patients are recovering fast, and there is no need for prescribing drugs like molnupiravir. However, if in any case we find the benefits outweigh the risks, we can use the drug,” he said.

The national task force on Covid19 has not included molnupiravir in their clinical management protocol.

Bhargava said that the task force has debated twice whether to include the drug in the protocol, but decided against it. He added that it is not in the WHO or UK protocols either.

“The US has approved it only based on 1,433 patients with a 3 per cent reduction in moderate disease when given in mild cases

Companies have started to launch the drug in India and dispatches have begun to several districts already after the drug regulator approved the medication for use in adults to treat mild to moderate Covid-19 in the last week of December. In fact a price war has begun among companies to price it affordably and reach out to maximum potential patients. The drug is now priced in the range of Rs 1,400 to Rs 2,499 for a course of 40-capsules to be taken over five days.