Even as some global experts caution against the use of antiviral drug Molnupiravir in the treatment of Covid-19, Indian health experts say it is being studied further to be included in the treatment protocol, in the wake of the Omicron variant.
The Drug Controller General of India (DCGI) on Tuesday approved Merck’s new drug for restricted emergency use against the coronavirus. But this is the first step in a longer process, they explain.
Some overseas researchers have pointed out that the anti-viral may create new variants of Sars-CoV-2 that escape immunity and prolong the pandemic.
“Molnupiravir has not only been approved by the DCGI but also by the US Food and Drug Administration. Any drug which gets approval is examined by the data generated by Phase 1 and Phase 2 clinical trial which mostly focus(es) on ...preliminary data on efficacy. However, at the population level, the efficacy data is generated by Phase 3 clinical trial. So, before the approval, all these data are submitted to the regulator,” Samiran Panda, Senior Scientist at the Indian Council of Medical Research told
“However, no one knows about the long-term effect of the drug. The mechanism of this particular medicine is such that it creates the kind of mutation in the virus which allows the virus to proliferate but that doesn’t mean that it is a dangerous drug. It is inappropriate to say this from a scientific perspective,” Panda further added.
‘No role to play’
“We know that it works when it is given to a particular individual in the early phase of infection preferably within 4-5 days and it has (been) shown to reduce progression to severe disease which might reduce the hospitalisation cases. So if somebody is diagnosed with Covid after 7-10 days of catching, then this drug has no role to play,” Panda explained.
Sources said it is premature to comment on reports suggesting that Molnupiravir is dangerous and ineffective. A top official at the Department of Biotechnology added, “The DGCI doesn’t give approval to any antiviral drug randomly. It does its own assessment and studies the facts and data before giving a green signal”
Meanwhile, a State-level Chief Medical Officer said the drug’s efficacy is being studied in medical colleges. A drug is included only after it is studied carefully and there is an assurance that it is safe and effective against a particular disease, he added. “Molnupiravir is yet to be included in the health guidelines. Its efficacy is being studied ... So, it will be too early to comment on this drug,” the official further added.