ICMR experts reject inclusion of Molnupiravir in COVID-19 treatment guidelines for fourth time citing safety concerns

Experts of the ICMR's National Task Force on COVID-19 for the fourth time have unanimously rejected the inclusion of anti-viral drug Molnupiravir in the coronavirus treatment guidelines saying its "known and unknown harms far outweigh its claimed benefit".

Responding to a question over Molnupiravir's inclusion in the treatment guidelines amid doctors prescribing it, ICMR Director General Dr Balram Bhargava said experts have had extensive debate and discussions and reviewed the data available from three trials on the drug on Monday.

"We had extensive deliberation and the final conclusion was that Molnupiravir has certain risks that warrant caution in its use. Experts present in the meeting opined that there is a rampant and irrational use of Molnupiravir. Efforts should be made to restrict its use as known and unknown harms far outweigh its claimed benefit," he said on Wednesday.

"The currently available synthesised evidence was reviewed and the members unanimously agreed that it does not merit the inclusion of Molnupuravir in the national treatment guidelines for COVID-19," Bhargava said.

The emerging evidence will constantly be reviewed, he added.

"And lastly it was further highlighted the current clinical window of application appears extremely narrow for Molnupiravir with relevance only to the following --elderly, unvaccinated, with other comorbidities.

"There was no evidence of benefit in diabetes and those who were previously infected with COVID-19 or were vaccinated," he said.

India's drug regulator on December 28 had approved the anti-Covid pill for restricted use in emergency situations.

Molnupiravir is an antiviral that inhibits SARS-CoV-2 replication by viral mutagenesis, the health ministry earlier had said in a statement.

The UK MHRA on December 4 granted approval for Molnupiravir under special condition for treatment of mild to moderate COVID-19 in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness.

The USFDA on December 23 granted Emergency Use Authorisation (EUA) for Molnupiravir for treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalisation or death, and for whom alternative COVID-19 treatment options authorised by the FDA are not accessible or clinically appropriate.

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