Why is India reluctant to include Molnupiravir in its arsenal against Covid?

The decision by the Covid-19 National Task Force not to include Covid antiviral drug molnupiravir in the national treatment protocol citing safety concerns, even as the drug finds place in the Maharashtra government's Covid-19 guidelines to treat a small subset of patients, has led to confusion among doctors.

Several doctors ET spoke to said ICMR's decision to not include the drug creates confusion, and questioned what the medical research body was doing when the drug was approved for restricted emergency use by the Drug Controller General of India (DCGI).

"It has definitely created a lot of confusion," said Vasant Nagvekar, an infectious diseases specialist at Mumbai-based Lilavati Hospital and member of the Maharashtra government's Covid-19 task force.

Nagvekar said as per the Maharashtra government protocol the drug may be considered for persons above 65 and those who are at high risk for progressing to severe disease. "We don't have specific treatments for these groups," Nagvekar said.

"Molnupiraivir may have a role in individuals at a high risk of deterioration, especially if unvaccinated," said Lancelot Pinto, consultant pulmonologist and epidemiologist at Mumbai-based PD Hinduja Hospital.

However, Pinto said ICMR's move to not include the molnupiravir is likely to do more good than harm, as drugs meant for use in a very specific subset of the population may often end up being used indiscriminately in India.

"It appears that every other department is working in silos. The ICMR should have had a word with CDSCO/DCGI before the (molnupiravir) approval," said Satyanarayana Mysore, HOD & consultant, pulmonology and lung transplant physician at Manipal Hospitals in Bangalore.

Mysore says (Balram) Barghava's (DG, ICMR) comment on the potential indiscriminate use of the antiviral is an "insult" to clinicians.

"At this point in the pandemic, I feel it's too premature to discard this drug till a well-conducted negative study comes through. More so because there are very few drugs in our arsenal against the Covid-19 fight," said Sanjith Saseedharan, consultant & head, critical care at SL Raheja Hospital.

Swati Rajagopal, infectious disease specialist at Aster CMI Hospital in Bangalore, says that 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 seem right.