If a drug wasn't safe for use, DCGI wouldn't have approved: Doctors

Bengaluru: With the number of cases increasing across the country and the uncertainty around the new Omicron and IHU variants, states have been put on alert with preparedness initiatives being put in place. The antiviral drug Molunupiravir which got the nod from the Drugs Controller General of India (DCGI) was not included in the national clinical protocol for Covid-19 treatment as issued by the Indian Council of Medical Research (ICMR).

On this note, medical experts share their inputs on the development. Aster RV Hospital, Consultant- Internal Medicine, Dr Aravinda SN said, "Data is not sufficient in proving the benefit of giving the drug in the recovery of covid patients and also there is evidence to suggest high risk to benefit ratio for the patient."

The Aster CMI Hospital, Consultant - Infectious Disease and Travel Medicine, Dr. Swati Rajagopal said, "Molnupiravir is an oral, small-molecule antiviral prodrug that is active against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that has limited or no action against the Omicron variant. It was found to have an action against Delta, Mu and Gamma variants of Covid 19.

It is an oral drug that has actions against other variants of Covid 19 Trials indicates that it was found to be effective when initiated within 5 days after the onset of signs or symptoms in a population of non-hospitalized, unvaccinated adults with mild symptoms who were at risk for progression to severe disease. It is clearly mentioned that Molnupiravir is not recommended in pregnant women and a urine pregnancy test is needed before administration in ladies of childbearing age group.

The clinician should be very clear when and which group of patients we should be using the drug and what variant they are targeting." She added, ICMR has not included this in the protocol. It was mentioned because of the safety concerns of the drug. If a drug wasn't safe for use, DCGI, the body involved in pharmaco vigilance wouldn't have approved the drug.

The guidelines where and why it shouldn't be used are clearly outlined by UK / NIH guidelines and the clinician should weigh the usefulness of the use of the drug and decide. It's fair not to include Molnupiravir in the national guideline as it's not effective against the Omicron variant. I would also think that Ivermectin that time and again has no action should not be in the guideline. The safety of the drug is determined by DCGI and the reason for not including it in the national guideline on grounds of safety doesn't fit in.