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Ishita Roy

India Bans Nimesulide Drugs Over 100mg Over Health Concerns, All That You Need To Know

Nimesulide (over 100 mg), a commonly used non-steroidal anti-inflammatory drug (NSAID) which is prescribed for pain and inflammation is now banned in India. This is to safeguard public health. 

<strong>What Exactly Happened? </strong>The Centre has prohibited the manufacture, sale and distribution of oral formulations of nimesulide which contains more than 100mg, with immediate effect, across the country. 

As per the government notification, oral formulations of nimesulide that contains more than 100 mg have been banned as such high-dose could be risky for human health. The order states that safer alternatives to this drug is available in market, and thus in public interest, the continued availability of this drug at such high dosage is not justified. 

The ban is issued under the Section 26A of the Drugs and Cosmetics Act, 1940. This section empowers the Centre to restrict or prohibit drugs that pose a risk to patients. The government also consulted the Drugs Technical Advisory Board (DTAB), which is also country's apex advisory body on technical matters related to drugs and cosmetics. 

<h2>Why Did Government Ban Nimesulide?</h2>

The drug had long been under regulatory and medical scrutiny. The major concern is the liver toxicity, which is one of the side effects of this high-dose drug. In fact the World Health Organization (WHO) has no included nimesulide in its Model List of Essential Medicines, all due to the global caution around it. Several other countries too have either restricted or completely withdrew the drug. 

The Ministry of Health and Family Welfare in a notification said that the Central government is "satisfied that the use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form is likely to involve risk to human beings and that safer alternatives to the said drug are available". 

The restriction on certain nimesulide formulations follows recommendations made by the Indian Council of Medical Research (ICMR) after reviewing the drug’s effects in adults. These recommendations were accepted by an expert committee under the apex drug regulator. Nimesulide is known to cause liver toxicity in some cases.

ICMR had also advised that nimesulide be used only as a second-line treatment when other medicines fail or cannot be prescribed. It recommended against its use in pregnant or lactating women, those planning pregnancy, and patients with liver or kidney impairment. The drug should also not be used alongside other medicines that are toxic to the liver or kidneys. Nimesulide is already banned for children under 12 years of age.

The committee has further asked ICMR to review the impact of the drug across different age groups, including adolescents and older adults.

Read: <a href="https://www.healthandme.com/health-news/cough-syrup-row-death-toll-rise-to-22-as-2-more-children-succumb-article-152967962" data-type="tilCustomLink">Cough Syrup Row: Death Toll Rise To 22 As 2 More Children Succumb</a>

<h2>What Are The New Development On Drug Ban In India?</h2>

The Ministry also removed cough syrups from the list of over-the-counter medicines. While lozenges, pills or tablets for cough continue to remain on the list. This has come in the backdrop of 22 children who died in Madhya Pradesh after they consumed contaminated cough syrups.

<strong>Disclaimer: <em>Health and Me's report is based on the notice issued in public knowledge and is not a substitute for prescribed drugs. Always consult your doctor before making changes in your medicines.</em></strong>

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Nimesulide (over 100 mg), a commonly used non-steroidal anti-inflammatory drug (NSAID) which is prescribed for pain and inflammation is now banned in India. This is to safeguard public health. What Exactly Happened? The Centre has prohibited the manufacture, sale and distribution of oral formulations of nimesulide which contains more than 100mg, with immediate effect, across the country. As per the government notification, oral formulations of nimesulide that contains more than 100 mg have been banned as such high-dose could be risky for human health. The order states that safer alternatives to this drug is available in market, and thus in public interest, the continued availability of this drug at such high dosage is not justified. The ban is issued under the Section 26A of the Drugs and Cosmetics Act, 1940. This section empowers the Centre to restrict or prohibit drugs that pose a risk to patients. The government also consulted the Drugs Technical Advisory Board (DTAB), which is also country's apex advisory body on technical matters related to drugs and cosmetics. Why Did Government Ban Nimesulide?The drug had long been under regulatory and medical scrutiny. The major concern is the liver toxicity, which is one of the side effects of this high-dose drug. In fact the World Health Organization (WHO) has no included nimesulide in its Model List of Essential Medicines, all due to the global caution around it. Several other countries too have either restricted or completely withdrew the drug. The Ministry of Health and Family Welfare in a notification said that the Central government is "satisfied that the use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form is likely to involve risk to human beings and that safer alternatives to the said drug are available". The restriction on certain nimesulide formulations follows recommendations made by the Indian Council of Medical Research (ICMR) after reviewing the drug’s effects in adults. These recommendations were accepted by an expert committee under the apex drug regulator. Nimesulide is known to cause liver toxicity in some cases.ICMR had also advised that nimesulide be used only as a second-line treatment when other medicines fail or cannot be prescribed. It recommended against its use in pregnant or lactating women, those planning pregnancy, and patients with liver or kidney impairment. The drug should also not be used alongside other medicines that are toxic to the liver or kidneys. Nimesulide is already banned for children under 12 years of age.The committee has further asked ICMR to review the impact of the drug across different age groups, including adolescents and older adults.Read: Cough Syrup Row: Death Toll Rise To 22 As 2 More Children SuccumbWhat Are The New Development On Drug Ban In India?The Ministry also removed cough syrups from the list of over-the-counter medicines. While lozenges, pills or tablets for cough continue to remain on the list. This has come in the backdrop of 22 children who died in Madhya Pradesh after they consumed contaminated cough syrups.Disclaimer: Health and Me's report is based on the notice issued in public knowledge and is not a substitute for prescribed drugs. Always consult your doctor before making changes in your medicines.

india bans nimesulide drugs over 100mg over health concerns, all that you need to know

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India Bans Nimesulide Drugs Over 100mg Over Health Concerns, All That You Need To Know