Two top health officials on Wednesday urged doctors and patients to adhere to the national Covid-19 treatment protocol, flagging what they said was irrational and rampant use of the antiviral drug molnupiravir that has been approved for marketing but not included in the protocol.

Their appeal comes against the backdrop of the current surge in Covid-19 infections widely expected to surpass the second wave and the approval last month by India’s apex drug regulatory authority for the use of molnupiravir for some subsets of Covid-19 patients.

An expert panel responsible for the national treatment protocol has “unanimously agreed” that molnupiravir for now does not merit inclusion in the treatment protocol on the basis of current evidence, said Balram Bhargava, director-general of the Indian Council of Medical Research.

“We had extensive deliberations… experts present at the meeting opined that there is rampant and irrational use of molnupiravir,” Bhargava said. “Efforts should be made to restrict its use as known and unknown harms far outweigh its claimed benefits.”

Bhargava said molnupiravir had certain risks that warrant caution in its use. “The current clinical window of
application appears extremely narrow, with relevance only to elderly, unvaccinated with other comorbidities,” he said.

“There is no evidence for benefit in diabetes or those previously infected with Covid-19 or those who have been vaccinated.”

Sections of doctors have expressed concern that regulatory approval to molnupiravir and the expert panel’s decision to not include it in the treatment protocol send contradictory signals that could allow market forces to drive medical prescriptions.

The Central Drugs Standard Control Organisation, the regulatory authority, had approved the use of molnupiravir in subsets of Covid-19 patients who are at high risk of hospitalisation or death.

The CDSCO has also granted marketing approval to several domestic manufacturers.

The expert panel has reviewed available evidence four times, said Vinod Paul, chair of the national Covid-19 task force and member (health) in the Niti Aayog, the Centre’s apex think tank, acknowledging the regulatory approval but asserting the need for a “cautious approach”.

“There are risks with molnupiravir — a cautious approach is being adopted,” Paul said. “We’ve also noted the irrational and abundant use of the drug. It is not part of the protocol now. But we will continue to look at new knowledge. Evolving science will dictate how we proceed further.”

Although the UK’s regulatory authority has also approved molnupiravir, Paul said, the Britain’s National Institute for Clinical

Excellence, an agency that guides treatment protocols, has not yet included the antiviral drug in its guidelines.

Paul called for the rational use of other drugs included in the treatment protocol such as steroids.

“We are concerned about the overuse of drugs… we learnt a lesson (during the second wave),” Paul said, referring to the excess use of steroids in some Covid-19 patients that had led to an epidemic of a fungal infection called mucormycosis during the second wave last year.

Their appeal for the rational use of drugs comes amid apprehensions that India’s current wave could surpass the second wave that had peaked at about 400,000 daily new infections in early May last year.

Health authorities on Wednesday recorded 194,720 new Covid-19 cases. The national test positivity rate — a measure of the size of the epidemic — has increased from about 1 per cent 10 days ago to 11 per cent on Wednesday.