ICMR observation raises question mark on its coordination with DCGI
Days after the Drug Controller General of India (DCGI) gave a green signal for restricted use of anti-viral drug Molnupiravir in emergency situation for Covid patients, Indian Council of Medical Research (ICMR) Director General Balram Bhargava on Wednesday said the drug has major safety concerns, including mutagenicity, muscle and bone damage.
The observation raises a question mark on the coordination between the two major Government health agencies, the DCGI and the ICMR at a time when the country is reeling under the spiraling Covid-19 infections.
“The antiviral Covid-19 pill is not included in the treatment guidelines of the Covid-19 national task force,” said Bhargava, adding that contraceptive methods should be used for three months if the drug is administered to women since the child may have problems.
“Molnupiravir has major safety concerns, including mutagenicity, muscle & bone damage.
If this drug is given, contraception has to be done for three months as the child may have problems,” he said at a press briefing here.
The DCGI last week gave emergency approval to Molnupiravir as the country witnessed a spike in Covid-19 cases following the emergence of the highly contagious Omicron variant. Union Health Minister Mansukh Mandaviya said that 13 companies will make the antiviral drug in India.
Merck has entered into licensing agreements with eight domestic drugmakers, including Dr Reddy’s, to manufacture and supply the generic version of Molnupiravir to over 100 low- and middle-income countries. A spokesperson of Dr Reddy’s Laboratories Ltd said that the drugmaker will launch the Molnupiravir at Rs 35.
Health experts like Dr SP Kalantri, director and professor of medicine at the Mahatma Gandhi Institute of Medical Sciences and Medical Superintendent of Kasturba College, Sevagram, Maharashtra, had already raised concern about the efficacy of the drug as he tweeted, “We must ask why #Molnupiravir hands a raw deal to children. And to couples trying to conceive and to women who are already pregnant…”
Before physicians prescribe #Molnupiravir to at-risk people, they must ensure that the woman is not pregnant and uses contraception during and 4 days after the completion of the therapy, he maintained and said that “We don’t know if the drug could harm the fetus. How do we ensure its safety in rural India?”
Dr Sumaiya Shaikh, founding-editor for Alt News Science and Neuroscientist in Sweden, too in her tweet warned that #molnupiravir is dangerous for pregnant women. Don’t repeat the same mistakes
again, she said referring to the last Covid wave when some drugs were approved which later had to be withdrawn after they were found to cause adverse impact on the patients suffering with Covid.