India Won’t Add Merck’s COVID-19 Pill To National Treatment Protocol, Citing Safety Concerns
India’s top health research body announced on Wednesday that it won’t be adding Merck’s COVID-19 antiviral pill molnupiravir to its national treatment protocol, citing concerns over its safety.
The state-run Indian Council of Medical Research (ICMR) said it had become aware of “major safety concerns” that prompted the decision, despite India’s drug regulator in December approving the drug for emergency use.
It comes after France in December also canceled its order for the drug, developed by Merck and Ridgeback Biotherapeutics, following disappointing trial data suggesting its drug was markedly less effective than previously thought.
“Molnupiravir has major safety concerns including teratogenicity, mutagenicity, muscle and bone damage. If this drug is given, contraception must be done for three months as the child may have problems,” ICMR Director-General Balram Bhargava told local media on Wednesday.
Bhargava noted that the United States Food and Drug Administration (FDA) issued an emergency use authorization for Merck’s COVID-19 pill based on 1,433 patients with a 3 percent reduction in moderate disease when given in mild cases. – READ MORE
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