(Bloomberg) — The head of India’s main medical research agency said there were “major safety concerns” over Merck & Co.’s Covid-19 drug that may impede its addition to the country’s viral treatment list.
Even though India’s drug regulator last week approved Merck’s molnupiravir for emergency use, Balram Bhargava, the director general of the state-funded Indian Council of Medical Research, said the government has yet to decide on whether to recommend molnupiravir, even as coronavirus infection rates in the country soar to more than 90,000 a day — the highest level since mid-June.
“This drug has major safety concerns,” Bhargava told reporters late Wednesday in Delhi, flagging possible danger to unborn children as well as worries that it can cause cartilage and muscle damage. “As of now the current recommendation stands that it is not part of the national task force treatment.”
India’s hesitation comes after the U.S. Food and Drug Administration approved molnupiravir last month for emergency use, shortly after Pfizer Inc.’s rival Covid medicine was cleared by the same regulator. The FDA however cautioned that Merck’s drug isn’t recommended for use by those who are pregnant.
Molnupiravir “demonstrated a significant reduction in the risk of hospitalization or death in our Phase 3 clinical trial with no observed safety concerns,” Merck said in an emailed response.
Merck’s drug works by introducing errors in genetic material to ultimately stop the virus’s replication, but it may affect growing human cells. The company has established a pregnancy surveillance program for the drug and said men and women should use contraception while taking molnupiravir, if they’re having sex that might result in pregnancy, a warning that Bhargava repeated.
“We have debated on it twice, we are going to have further debate on it,” he said.
Bhargava’s criticism of the drug will also likely concern India’s huge pharmaceutical industry, which has benefited from bumper Covid treatment windfalls during the pandemic. Molnupiravir is set to be manufactured by 13 Indian firms, health minister Mansukh Mandaviya said last week after the drug’s regulatory nod.
(Updates with Merck’s response in the fifth paragraph.)
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