In response to concerns about the safety of Molnupiravir, an oral antiviral medication licenced to treat Covid-19, Indian health officials have stated that the drug's advantages outweigh the hazards it may pose in high-risk patients.
The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has licenced it for the treatment of mild-to-moderate Covid-19 in individuals with a high risk of severe disease development, namely those with pre-existing (comorbid) diseases.
The medicine has also been licenced in India, which is seeing an increase in instances of the new Covid version Omicron. The antiviral Molnupiravir was recently licenced for limited usage in emergency conditions by an expert panel of the Central Drugs Standard Control Organization. Thirteen Indian businesses will produce the antiviral medication.
However, according to Balram Bhargava, Director General of the Indian Council of Medical Research (ICMR), Molnupiravir is not included in the national Covid taskforce regimen because of serious safety issues like as teratogenicity, mutagenicity, muscle and bone damage, and others.
"More critically, if this treatment is administered to both male and females, contraception must be used for three months since the kid born may have teratogenic consequences," he added at a news conference.Medical experts, on the other hand, have stated that the drug's advantages outweigh any possible concerns it may pose in high-risk individuals.
However, they argue that because there are few alternatives for treating Covid patients, the new authorised drugs should be given a chance under stringent treatment procedures.
"When prescribing any medicine, physicians must bear in mind their patient profiles." If the patient is high-risk, meaning he or she is over 60 years old, obese, or has cardiovascular disease, hypertension, and/or chronic lung, renal, or liver illness, ignoring treating the condition while it is mild or moderate might lead to serious consequences, including hospitalisation.
Dr. Deepak Talwar, Senior Consultant, Pulmonology and Sleep Medicine, and Chairman, Metro Respiratory Centre, said, "As we saw with the Delta variety, even death is a possibility."
"Rather than calculating its negative effects, which are also probable but unknown," he continued, "we need to employ the current therapy."
He reviewed the drug's safety data before approving it.Youtube/wikipedia
According to Dr. Dhruva Chaudhry, Head Of Pulmonary and Critical Care Medicine at PGIMS, Rohtak, the US FDA and the DCGI reviewed the drug's safety data before approving it. "This medicine will only be authorised after all of the conditions are met."
"Even in phase 3 clinical studies, as compared to the placebo group, Molnupiravir revealed a substantial reduction in the risk of hospitalisation or death with no recognised safety issues," Chaudhry added.
Molnupiravir stops specific RNA viruses from replicating. It will primarily be used to treat Covid-19-infected adults over the age of 50, as well as those with several comorbidities. Molnupiravir 800 mg twice a day for five days is the recommended dosage. A patient must take 40 capsules with a total dose of 200 mg of medicine.
The oral tablet is being developed by more than a dozen pharmaceutical firms, including Torrent, Cipla, Sun Pharma, Dr. Reddy's, Natco, Mylan, and Hetero. Molnupiravir pills are also scheduled to be released in the following weeks by Cipla, Sun Pharma, and Dr Reddy's Laboratories.
(IANS/PR)
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