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Itisha Arya

High-Dose Nimesulide Oral Medicines Banned By Centre Over Safety Concerns

nimesesulide

The central government has announced a decisive regulatory move concerning nimesulide, a widely prescribed non-steroidal anti-inflammatory drug used to treat pain, fever, and inflammation. In an effort to protect public health, the Centre has barred the manufacture, sale, and distribution of oral nimesulide formulations that contain more than 100 mg of the drug. The restriction has come into force with immediate effect and applies across the country, as per NDTV.

The decision follows mounting safety concerns linked to high-dose oral preparations of the medicine. According to the official notification issued by the government, doses exceeding 100 mg may pose a risk to human health. The order also notes that safer and well-established alternatives are already available in the market. Given this, the authorities concluded that continuing the availability of high-dose nimesulide does not serve the public interest.

<h2>What Is Nimesulide and Why Is It Prescribed?</h2>

Nimesulide belongs to a group of medicines known as non-steroidal anti-inflammatory drugs, or NSAIDs. Doctors commonly prescribe it to manage acute pain, reduce fever, and relieve inflammation associated with conditions such as musculoskeletal injuries, dental pain, or post-surgical discomfort. The drug works by blocking substances in the body that cause pain and swelling, as per Mayo Clinic.

Despite its effectiveness in symptom relief, nimesulide has remained controversial for years due to questions surrounding its safety, especially when used in higher doses or for longer durations. While it continues to be prescribed in India under regulated conditions, its use has been closely watched by health authorities and medical experts.

The prohibition has been issued under <span>Section 26A</span> of the Drugs and Cosmetics Act, 1940. This provision allows the central government to restrict or ban drugs if they are found to be unsafe, ineffective, or harmful to patients. Before finalising the decision, the government sought the opinion of the Drugs Technical Advisory Board, or <span>DTAB</span>, which is the highest advisory body on technical matters related to drugs and cosmetics in India.

After reviewing available scientific data and expert input, the board supported the move, leading to the issuance of the nationwide ban on high-dose oral formulations, as per NDTV.

<h2>Safety Concerns and Global Position</h2>

Nimesulide has faced sustained scrutiny from regulators and healthcare professionals, primarily due to concerns about liver-related side effects. Several studies and post-marketing surveillance reports have linked the drug to cases of liver toxicity, particularly when used in higher doses.

The World Health Organization has not included nimesulide in its Model List of Essential Medicines, a key reference document that guides countries on priority medicines for basic healthcare needs. This exclusion reflects ongoing global caution around the drug’s safety profile. In fact, regulatory authorities in multiple countries have either restricted its use or removed it from the market altogether after reviewing reports of hepatic injury documented in WHO pharmacovigilance data.

<h2>Indian Regulatory Reviews and Safer Alternatives</h2>

In India, the Central Drugs Standard Control Organisation has reviewed the risk-benefit balance of nimesulide on several occasions. These reviews were prompted by both domestic data and international findings related to adverse effects. Medical experts in the country have consistently highlighted that alternatives such as paracetamol and ibuprofen offer a more reliable safety record when taken at recommended doses.

These commonly used pain relievers are backed by extensive clinical evidence and guidance from bodies like the Indian Council of Medical Research, which supports their use for pain and fever management under standard dosing protocols.

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The central government has announced a decisive regulatory move concerning nimesulide, a widely prescribed non-steroidal anti-inflammatory drug used to treat pain, fever, and inflammation. In an effort to protect public health, the Centre has barred the manufacture, sale, and distribution of oral nimesulide formulations that contain more than 100 mg of the drug. The restriction has come into force with immediate effect and applies across the country, as per NDTV.The decision follows mounting safety concerns linked to high-dose oral preparations of the medicine. According to the official notification issued by the government, doses exceeding 100 mg may pose a risk to human health. The order also notes that safer and well-established alternatives are already available in the market. Given this, the authorities concluded that continuing the availability of high-dose nimesulide does not serve the public interest.What Is Nimesulide and Why Is It Prescribed?Nimesulide belongs to a group of medicines known as non-steroidal anti-inflammatory drugs, or NSAIDs. Doctors commonly prescribe it to manage acute pain, reduce fever, and relieve inflammation associated with conditions such as musculoskeletal injuries, dental pain, or post-surgical discomfort. The drug works by blocking substances in the body that cause pain and swelling, as per Mayo Clinic.Despite its effectiveness in symptom relief, nimesulide has remained controversial for years due to questions surrounding its safety, especially when used in higher doses or for longer durations. While it continues to be prescribed in India under regulated conditions, its use has been closely watched by health authorities and medical experts.Legal Basis for the BanThe prohibition has been issued under Section 26A of the Drugs and Cosmetics Act, 1940. This provision allows the central government to restrict or ban drugs if they are found to be unsafe, ineffective, or harmful to patients. Before finalising the decision, the government sought the opinion of the Drugs Technical Advisory Board, or DTAB, which is the highest advisory body on technical matters related to drugs and cosmetics in India.After reviewing available scientific data and expert input, the board supported the move, leading to the issuance of the nationwide ban on high-dose oral formulations, as per NDTV.Safety Concerns and Global PositionNimesulide has faced sustained scrutiny from regulators and healthcare professionals, primarily due to concerns about liver-related side effects. Several studies and post-marketing surveillance reports have linked the drug to cases of liver toxicity, particularly when used in higher doses.The World Health Organization has not included nimesulide in its Model List of Essential Medicines, a key reference document that guides countries on priority medicines for basic healthcare needs. This exclusion reflects ongoing global caution around the drug’s safety profile. In fact, regulatory authorities in multiple countries have either restricted its use or removed it from the market altogether after reviewing reports of hepatic injury documented in WHO pharmacovigilance data.Indian Regulatory Reviews and Safer AlternativesIn India, the Central Drugs Standard Control Organisation has reviewed the risk-benefit balance of nimesulide on several occasions. These reviews were prompted by both domestic data and international findings related to adverse effects. Medical experts in the country have consistently highlighted that alternatives such as paracetamol and ibuprofen offer a more reliable safety record when taken at recommended doses.These commonly used pain relievers are backed by extensive clinical evidence and guidance from bodies like the Indian Council of Medical Research, which supports their use for pain and fever management under standard dosing protocols.

high-dose nimesulide oral medicines banned by centre over safety concerns

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