Molnupuravir, first anti-Covid pill, has major safety concerns: ICMR after DCGI approval

Concerned about drug’s impact on pregnancy, lactation and soft tissue, says Director-General Balram Bhargava

Aditi Tandon

Tribune News Service

New Delhi, January 5

Days after the Drug Controller General of India approved antiviral drug Molnupiravir, the first oral anti Covid pill, the Indian Council of Medical Research on Wednesday flagged serious safety concerns over the medicine saying the same has not been included in the Indian Covid treatment guidelines yet.

“The Indian Covid 19 treatment protocols do not include Molpupiravir. The UK does not include this drug nor does the WHO,” ICMR Director-General Balram Bhargava said, adding that the drug poses major safety challenges.

He said the US has approved it based on results in 1,433 patients, with only 3 per cent reduction in moderate disease.

“However, this drug has major safety concerns. It can cause teratogenicity, mutagenicity, cartilage damage and muscle damage. Couples must use contraception for three months if this drug has been administered to a pregnant woman because it can harm the child. This drug is not included in the Indian Covid treatment protocols. We are concerned about its impact on pregnancy, lactation, and soft tissue. So, it is not part of the national taskforce treatment guidelines,” Bhargava said.

The Indian experts have twice debated the use of the antiviral in Covid patients but decided against it. The discussions are ongoing.

Around 13 Indian companies, including Cipla and Dr Reddy’s Labs, are manufacturing Molnupiravir developed by US-based Ridgeback Biotherapeutics in partnership with Merck.

While teratogenicity refers to a drug’s ability to harm the fetus and disturb its formation, mutagenicity is permanent damage to genetic materials.

 

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