Contradictory advices can create confusion on use of anti-Covid medicine Molnupiravir: Health experts

Contradictory advice from two wings of the Union Health Ministry could create confusion on the use of anti-Covid medicine Molnupiravir, health experts warned on Friday, even as its manufacturers asserted that the medicine had demonstrated a significant reduction in hospitalisation and deaths with no observed safety concerns.

The Central Drug Standards Control Organisation on December 28 approved the drug for manufacturing by 13 Indian companies on the basis of a recommendation by an expert panel, which cleared it for treating Covid-19 in adults who have a high risk of progression of the disease including hospitalisation or death subject to certain conditions. Union Health Minister Mansukh Mandaviya too welcomed the approval.

But earlier this week ICMR director general Balram Bhargava aired a stern warning on the medicine when asked why Molnupiravir was not a part of the national treatment protocol.

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“Molnupiravir has major safety concerns including mutagenicity, muscle and bone damage. If this drug is given, contraception has to be done for three months as the child may have problems. So it is not included in the national task force’s treatment (protocol),” he said.

Doctors admit that Molnupiravir is a medicine that needs to be administered with caution but it is useful in reducing the risk of hospitalisation or death in a section of patients.

“As per law of the land, CDSCO is the drug regulator and enjoys full powers to approve new drugs. If it has any concern on any aspect of drug approval it should take up the issue with CDSCO rather than rushing to the mass media,” Chandra M Gulhati, a former WHO consultant and editor, Monthly Index of Medical Specialities told DH.

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The US FDA recognised the risks that Bhargava mentioned but still went ahead to clear the medicine observing that its benefits outweighed the risks. The medicine also received regulatory approval in the UK, Australia and New Zealand.

"There is some truth in what Bhargava said. But such a statement should come from the Drugs Controller General of India and not from DG, ICMR. Let's not confuse the medical community,” said Abdul Ghafur, an infectious disease specialist and a consultant to Apollo Hospital, Chennai.

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The US Food and Drug Administration documents show a relative risk reduction of 30% in people who took Molnupiravir as against the placebo. Interim analysis of phase-3 of the clinical trial data, on the other hand, showed a 50% reduction in death and hospitalisation.

“We are confident in the clinical profile of Molnupiravir, which demonstrated a significant reduction in the risk of hospitalization or death in our Phase 3 clinical trial with no observed safety concerns when compared to the placebo group,” MSD, the manufacturer of the drug, said in a statement reacting to the ICMR chief’s comment.

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