With questions being raised on the safety of Molnupiravir - an oral antiviral pill approved for treating Covid-19, Indian health experts have pointed out that the benefits of the drug outweigh the potential risks it may have in the case of high-risk patients. Developed by US-based drug company Merck, Molnupiravir is approved by the US Food and Drug Administration against Covid-19. It is approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of mild-to-moderate Covid-19 in adults with a high risk of progression to severe disease, mainly those with pre-existing (comorbid) conditions.
India has also approved the drug amid rising cases of new Covid variant Omicron in India. An expert panel of the Central Drugs Standard Control Organisation had recently approved the antiviral Molnupiravir for restricted use in emergency situations. The antiviral drug will be manufactured by 13 companies in India.
However, the Indian Council of Medical Research (ICMR) Director-General, Balram Bhargava, said that the Molnupiravir is not included in the national Covid taskforce treatment as it has major safety concerns like teratogenicity, mutagenicity, muscle and bone damage among others.
"More importantly contraception has to be done for three months if this drug is given for males and females as the child born could be problematic with teratogenic influences," he said at a press briefing.
Medical experts, on the other hand, have pointed out that the benefits of the drug outweigh the potential risks it may have in the case of high-risk patients.
But they say as there are very limited options of medicines to treat Covid patients, hence the newly approved medicines should be given a try under strict treatment regime protocols.
"Physicians have to keep in mind their patient profiles while prescribing any drug. If the patient is high-risk that is more than 60 years of age, is obese or has cardiovascular disease, hypertension, and/or has chronic lung or kidney or liver disease, then not treating when the disease is mild or moderate can take extreme turns, putting the patient in risk of hospitalisation and as we have seen at the time of Delta variant, even possible death," said Dr Deepak Talwar, Senior Consultant, Pulmonology and Sleep Medicine, and Chairman, Metro Respiratory Centre.
"We have to use the available therapy rather than counting its side-effects, that too which are potential, but not known," he added.
According to Dr Dhruva Chaudhry, Head - Pulmonary and Critical Care Medicine at PGIMS, Rohtak, while giving approval, the US FDA, as well as the DCGI, have gone through the safety data of the drug. "Only once satisfied, this drug has been approved."
"Even in the phase 3 clinical trials Molnupiravir demonstrated a significant reduction in the risk of hospitalisation or death with no observed safety concerns when compared to the placebo group," Chaudhry said.
Molnupiravir inhibits the replication of certain RNA viruses. It is basically to be used in treating Covid-19 infected people of more than 50 years of age and in those with multiple comorbidities. The recommended dose of Molnupiravir 800 mg is twice a day for five days. A patient needs to take 40 capsules containing 200 mg of medication.
Over a dozen pharma companies including Torrent, Cipla, Sun Pharma, Dr Reddy's, Natco, Mylan, and Hetero are in the process to manufacture the oral pill. Cipla, Sun Pharma, and Dr Reddy's Laboratories are also expected to release Molnupiravir capsules in the coming weeks.