Health

Ministry of Health: India ‘has not yet updated molnupiravir to its treatment regimen’


The above content was announced by the Ministry of Health on the afternoon of January 11 after receiving information about ICMR “removing the drug molnupiravir from the list of drugs to treat Covid-19 due to concerns about side effects”.

The Ministry of Health leads the news page India.com, published on January 5, citing the opinion of Dr. Bhargava, General Director of ICMR – the agency responsible for developing Covid-19 treatment regimens in India, about the fact that ICMR is still Molnupiravir has not been updated to the list of drugs to treat Covid-19 yet do There are concerns about some side effects such as genetic mutations, damage to muscles and bones, which can lead to risks for pregnancy and for the baby.

Before that, some press agencies such as RT and Bloomberg information ICMR removed the antiviral drug molnupiravir from the list of drugs to treat Covid-19 due to concerns about side effects. According to ICMR, the drug can cause birth defects and cell changes. “The drug can cause teratogens and genetic mutations, as well as damage to cartilage and damage to muscles. More importantly, users of the drug will have to use birth control for three months, because if they become pregnant during During this time, the child can be deformed,” the agencies quoted ICMR Director General Balram Bhargava.

In December 2021, the Drugs Administration of India (CDSCO) licensed the production and marketing of molnupiravir to a number of manufacturers. Information about the above side effects has been specified in the marketing authorization.

According to the Ministry of Health, this drug has been granted conditional marketing authorization in the UK, approved for emergency use in the US and Japan, and approved for use in a number of other countries to treat Covid-19. The US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have issued recommendations for the use of molnupiravir.

Specifically, the drug is used to treat mild to moderate Covid-19 in adults who are nCoV-positive and have at least one risk factor for severe disease progression.

Molnupiravir is used in patients with symptom onset less than 5 days, not used more than 5 days in a row, not used to prevent Covid-19 infection.

The drug is not recommended for use during pregnancy. Women should use effective contraception during treatment and for 4 days after the last dose of molnupiravir. Based on the potential for adverse effects in the neonate from molnupiravir, authorities recommend not breast-feeding during treatment and for 4 days after the last dose.

Molnupiravir is also not authorized for use in patients under 18 years of age because of possible effects on bone and cartilage growth. In addition, molnupiravir may affect sperm, although the risk is considered low. Therefore, men who are sexually active with women of childbearing potential should use a reliable method of contraception during treatment and for at least 3 months after the last dose.

Recently, there has been a situation where molnupiravir is being sold at drugstores in Hanoi, where people buy floating antiretroviral drugs at high prices. The Ministry of Health has requested the Hanoi Department of Health to check the information and handle it.

The drug molnupiravir in Vietnam is being used in Controlled treatment pilot program for mild cases of Covid-19, distribution area, not sold on the market. The Ministry of Health has allocated a total of more than 400,000 doses of molnupiravir to this program. The program has been implemented in Ho Chi Minh City since mid-August and is currently expanding to 53 epidemic-affected localities.

On the afternoon of January 5, the Advisory Council for issuance of circulation permits for drugs and medicinal ingredients proposed the Ministry of Health to grant conditional circulation permits for 3 drugs containing the active ingredient molnupiravir. After being granted a registration number, businesses will begin to manufacture molnupiravir in the country.

Recently, the Ministry of Health announced the results of the molnupiravir trial, which recorded that nearly 100% of patients taking the drug had a low viral load, a very low rate of severe disease, and no deaths.

The Ministry of Health warned, to ensure safety and effectiveness, only use molnupiravir with a doctor’s prescription in accordance with the indications, usage limits and warnings and cautions of the drug. Do not arbitrarily buy or use floating drugs of unknown origin or origin on the market.

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