Digital Desk, New Delhi. Amid the rising questions on the safety of Molnupiravir, Indian health experts have pointed out that the benefits of the drug far outweigh the potential risks in the case of high-risk patients. has been approved for the treatment.
Developed by US-based pharmaceutical company Merck, Molnupiravir has been approved by the US Food and Drug Administration (FDA) 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 who are at high risk of developing severe disease.
India has also approved the drug amid rising cases of the new Kovid variant Omicron in India. An expert panel of the Central Drugs Standard Control Organization recently approved the antiviral mollupiravir for restricted use in emergency situations. Antiviral drug will be manufactured by 13 companies in India.
However, Balram Bhargava, Director General, Indian Council of Medical Research (ICMR) said in a press briefing that the drug has not been included in India’s COVID treatment protocol due to safety concerns. He has raised concerns about the side effects of Molnupiravir. He said that Molnupiravir has not been included in the National COVID Task Force treatment as it has major safety concerns like teratogenicity, mutagenicity, muscle and bone damage.
This drug can cause teratogenicity and mutagenicity, he said in a recent statement. Teratogenicity means that when a pregnant woman takes this medicine, it can cause fetal disorders or problems with the development of the fetus. Whereas mutagenicity refers to the permanent changes in the genetic material. Both men and women must take contraceptive measures for three months after taking the drug. Because many types of problems can arise in the baby born under the influence of molanupiravir. However, we will also discuss the possibility that this drug should be included in national treatment guidelines.
Dr. Deepak Talwar, Senior Consultant, Pulmonology & Sleep Medicine and Chairman, Metro Respiratory Center said, “Physicians have to keep their patient profile in mind while prescribing any medicine. If the patient is at high risk, who is over 60 years of age, is obese or has cardiovascular disease, high blood pressure or chronic lung, kidney or liver disease, the disease may be mild or moderate if untreated But it can also take an extreme turn, putting the patient at risk of hospitalization and, as we have seen with the delta variant, there is a possibility of even death. Instead of counting the side effects, he said. Available therapies have to be used, also those that are probable but not known.
According to Dr. Dhruv Choudhary, Head of Pulmonary and Critical Care Medicine at PGIMS, Rohtak, the US FDA and DCGI have scrutinized the safety data of the drug at the time of approval and approved the drug only after being satisfied. Choudhary said, Even in phase 3 clinical trials, molanupiravir has demonstrated a significant reduction in the risk of hospitalization or death.
Molanupiravir blocks the replication of some RNA viruses. It is originally intended to be used in the treatment of COVID-19 infected people above 50 years of age and those with multiple comorbidities. The dosage of molanupiravir 800 mg twice daily for five days. A patient has to take 40 capsules containing 200 mg of medicine.
More than a dozen pharma companies including Torrent, Cipla, Sun Pharma, Dr. Reddy’s, Natco, Mylan and Hetero are in the process of manufacturing the oral pill. Cipla, Sun Pharma and Dr. Reddy’s Laboratories are expected to release Molnupiravir capsules in the coming weeks.
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