Even as Covid cases see a fresh surge in many parts of India, confusion is spreading about a drug believed to have been an important addition to doctors' arsenal.
Just days after India's drugs regulator cleared Covid medicine Molnupiravir, the Indian Council of Medical Research has expressed concerns about its safety. The drug, which claims to hamper the Covid virus' ability to replicate inside the patient's body, has been kept out of the national task force's recommended treatment protocol.
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ICMR director general Dr Balram Bhargava, while addressing the media, said, "The important point regarding Molnupiravir is the following. First of all, the US has approved it only based on 1,433 patients with a 3% reduction in moderate disease when given in mild cases. However, we have to remember that this drug has major safety concerns. It can cause teratogenicity, and what you have mentioned, mutagenicity."
On December 28 last year, the CDSCO had cleared Molnupiravir for restricted use in emergency situations. The Indian regulator cleared a 200 mg capsule of the medicine with a recommended dose of 800 mg twice daily for 5 days. It was meant for adults with oxygen saturation above 93% who are at high risk of hospitalisation or death due to Covid.
It was originally developed by Merck and Ridgeback Biotherapeutics to treat influenza but was repurposed for Covid. It claims to inhibit replication of the virus inside the body by incorporating itself into Sars-CoV-2's RNA and causing mutations. However, concerns have been raised about Molnupiravir possibly causing mutations which make the virus stronger, and even more significantly, causing mutations in human DNA itself. Clinical trials involving high-risk individuals had shown a 30% reduction in hospitalisation and deaths in the early course of the illness.
Listing possible side-effects, Dr Bhargava said that the drug can cause cartilage and muscle damage. "More importantly, contraception will have to be done for 3 months if this drug is given for male and female, because the child born could be problematic with teratogenic influences. So, it is not included in the national task force treatment. We still have concerns about pregnancy, lactation, children, soft tissue injury, reproductive age group, history of infection, vaccinations," he said.
Molnupiravir has also been approved in the UK and US, although ICMR said that it is yet to be included in the treatment plans cleared by the UK and the World Health Organisation.