Molnupiravir, the newest antiviral on the market to treat Covid-19, had been submitted to the Indian drug regulatory authorities for approval. Thirteen were given the go light. Despite the fact that doctors will soon have numerous alternatives for this capsule, many in the profession are walking carefully to avoid a repetition of what happened during the second wave, when drugs were “overused.”
Molnupiravir antiviral pill is touted as the first oral medicine effective in the treatment of the novel Coronavirus. It is an orally administered drug that blocks the replication of many RNA viruses, including SARS-CoV-2. The drug works by introducing errors into the genetic code of the highly contagious virus.
The medicine needs to be prescribed “conservatively” and long-term data maintained, given the safety concerns raised in different scientific quarters, they said. In fact, the Indian Council of Medical Research’s Chief Dr Balram Bhargava further stirred the pot recently, admitting to certain safety concerns, including a condition that could affect women planning a pregnancy, as reported in The Hindu Business Line.
In our previous article dated 29 June & 5 October 2021, we reported that five Indian pharmaceutical companies, namely, Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Sun Pharmaceutical Industries, and Torrent Pharmaceuticals, collaborated for clinical trial assessment of oral dosage form of antiviral Molnupiravir on the treatment of mild Covid-19 OPD cases in the country.
The successful completion of the trials of individual pharma companies would then make them eligible for Molnupiravir production and supply after the go-ahead from regulatory authorities. At least three of the companies are eyeing to seek approval for Molnupiravir by the drug regulator this month following the positive outcome from its clinical trials. Non-exclusive voluntary licensing agreements had also been granted to Aurobindo Pharma, Hetero Labs, and Viatris. Now, 13 companies have approval to make to make the drug.
Genome mutations and clinical trials
Dr Gagandeep Kang, virologist, explained, “The drug induces mutations in the virus so that it does not replicate. And the worry is whether it persists and alters the genome of the host, just as it did the virus“, quoted in The Hindu Business Line.
Merck and Ridgeback Biotherapeutics manufacture Molnupiravir, and their clinical trials have aimed to address these safety concerns. Others, on the other hand, are concerned about the dozen or so firms contending for the right to market this medicine at various pricing ranges. As, Dr Reddy’s to launch molnupiravir next week at Rs 35 per capsule and Aurobindo Pharma launches molnupiravir at Rs 50 per capsule.
Dr Emmanuel Bhaskar, professor of medicine with Chennai’s Sri Ramachandra Medical College, urges caution with all antivirals, whether in treating Covid-19 or HIV. With many companies bringing out the product, he cautions against “rampant” use, as that would cause resistance against the drug. Referring to the claim that the drug reduced hospitalisation by 30 per cent, he said there was a difference between absolute risk reduction and relative reduction, and from that standpoint, he did not see a benefit, reported in The Hindu BusinessLine.
With eight pills to be given a day, he said, most patients were unable to finish their Molnupiravir course of five days. Pointing to contraindications and interactions with other drugs, including some chemotherapy medicines, Dr Neha Mishra, consultant (Infectious Diseases) at Bengaluru’s Manipal Hospital, said Molnupiravir had to be “placed rightly” and given only to the profile where it can benefit a patient.
