Despite over a dozen domestic pharmaceutical companies manufacturing the anti-viral drug Molnupiravir on affordable prices, the Indian government is against including it in the treatment protocol over safety issues.
The drug has failed to convince the Indian Council of Medical Research (ICMR) for giving it a green signal for inclusion in India's national COVID-19 treatment protocol, although the drug has received an emergency use authorization (EUA) from the Indian drug regulator.
Molnupiravir is for treatment of adult patients with COVID-19, with Sp02 >93 per cent, and who have high risk of progression of the disease including hospitalisation or death. The United States Food and Drug Administration (FDA), the federal agency of the Department of Health and Human Services, has issued an EUA to the drug. Following this, the drug has also received approval in several countries including India.
The issuance of an EUA is different than an FDA approval, however. In determining whether to issue an EUA, the FDA evaluates the totality of the scientific evidence available and carefully balances any known or potential risks with any known or potential benefits of the product. Molnupiravir is limited to situations where other FDA-authorised treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalisation or death. India's issuance of EUA, therefore, in no way means the drug has become a part of the country's accepted treatment protocol.
So why is ICMR against the usage of this drug?
"First of all, the US has approved it based only on 1433 patients, with a 3 per cent reduction in serious disease, moderate disease, and when given in mild cases. However, we have to remember that this drug has major safety concerns," said Dr Balram Bhargava, Director-General at ICMR, Secretary, Department of Health Research a division under Ministry of Health and Family Welfare.
Molnupiravir is not FDA-approved for any use including for the treatment of COVID-19. The FDA has also clearly pointed out that prior to initiating treatment with molnupiravir, one must carefully consider the drug's known and potential risks and benefits.
The FDA had, subsequently, enlisted the potential side effects of Molnupiravir. According to the FDA, possible side effects include diarrhea, nausea, and dizziness. The drug is also not recommended for use during pregnancy because findings from animal reproduction studies have showed that Molnupiravir may cause fetal harm when administered to pregnant individuals.
The FDA argues that Molnupiravir is an investigational drug and it is not authorised for use in patients less than 18 years of age because it may affect bone and cartilage growth. Plus, the drug has also not received an approval from the American watchdog to treat COVID-19 patients.
Bhargava is of the opinion that Molnupiravir has more side effects, such as mutagenicity, which means the induction of permanent transmissible changes in the amount or structure of the genetic material of cells or organisms. "It can cause teratogenicity (the ability to cause defects in a developing fetus) and mutagenicity. And it also can cause cartilage damage and can also be damaging to muscles also," said Bhargava.
"Effective contraception will have to be done for three months, if this drug is given to male and female, because the child born could be problematic with teratogenic influences. So, it is not included in the national task force treatment. The WHO has not included it, the UK has not included it as of now," he added.
Bhargava points out that the government has debated on it twice and it will further debate on it to discuss whether there is any possibility to include the drug in the government's treatment protocol or not.
"We are concerned about risks of the drug in terms of pregnancy, lactation, children's soft tissue injury, reproductive age group. Whatever benefit was found in the clinical trials among 1433 patients in the US was on unvaccinated individuals and only 3 per cent reduction was found in mild to moderate disease. As of now, as per our current recommendation it is not a part of the national treatment plan," he added.
At least 13 firms i.e. Dr Reddy's, BDR Pharma, Natco, MSN, Hetero, Optimus, Aurobindo, Mylan, Strides, Emcure, Cipla, Sun Pharma, Torrent are manufacturing the drug in India starting from Rs 35 per capsule. But the real fate of Molnupiravir, hangs in balance.
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