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India Bans High-Dose Oral Nimesulide Painkiller Over Health Risks

The Indian government has prohibited the manufacture, sale, and distribution of oral nimesulide painkillers containing more than 100mg in immediate-release form. The ban, enacted under the Drugs and Cosmetics Act, follows a review by the ICMR which found potential health risks. The restriction does not apply to lower-dose oral forms, sustained-release versions, or non-oral formulations like gels and suppositories. Medical experts have welcomed the decision, noting the drug's association with liver and kidney injury and its previous restriction in several other countries.

Key Points: India Bans Oral Nimesulide Doses Above 100mg

  • Ban on >100mg oral doses
  • Exempts lower doses & topical forms
  • ICMR review cited risks
  • Safer alternatives available
2 min read

Nimesulide banned: Centre prohibits sale of oral painkiller doses above 100 mg in immediate-release form

India bans manufacture & sale of oral nimesulide painkillers above 100mg in immediate-release form due to health risks. Lower doses & other forms exempt.

"To ban Nimesulide... is a welcome decision because it was being used rampantly and injudiciously. - Dr. S Chatterjee, Apollo Hospitals"

By Shalini Bhardwaj, New Delhi, December 31

The Government of India has banned the manufacture, sale and distribution of oral formulations of the painkiller nimesulide containing more than 100 mg in immediate-release dosage form.

The ban does not apply to oral formulations below 100 mg, higher strengths in sustained or extended-release forms, or non-oral formulations such as topical gels, creams, and suppositories, a statement from the Ministry of Health and Family Welfare said.

The decision was taken following a review by the Indian Council of Medical Research (ICMR), the country's apex health research body. The government said that higher-dose oral formulations of nimesulide pose potential risks to human health and that safer alternatives are available.

In a notification, the government said, "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 notification further read, "The Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the said drug in the country for human use."

Citing its legal authority, the government notification added, "Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), and after consultation with the Drugs Technical Advisory Board, the Central Government, hereby prohibits the manufacture, sale and distribution of the following drug, with immediate effect."

The notification specifically listed, "All oral formulations containing Nimesulide above 100 mg in immediate-release dosage form."

Medical experts have welcomed the move Dr S Chatterjee, Senior Consultant in Internal Medicine at Apollo Hospitals, said the ban was long overdue, noting that the drug had already been restricted in several countries.

"Nimesulide was banned much earlier in quite a few countries. To ban Nimesulide by the government is a welcome decision because it was being used rampantly and injudiciously to treat high-grade fever without realising the potential side effects of liver injury/damage. Also, kidney injury and gastritis," he said.

- ANI

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Reader Comments

P
Priya S
Finally! My own doctor stopped prescribing it years ago citing safety concerns. It's shocking that it took this long when other countries acted much earlier. Public health should always come first.
R
Rohit P
Good move, but implementation is key. Will chemists actually stop selling existing stock? And what about the lower dose versions? Hope there's proper awareness for doctors and patients about alternatives.
S
Sarah B
As someone who moved to India a few years ago, I was surprised to see this drug so commonly used here. Back home, it was restricted long ago. This is a positive step for evidence-based medicine.
K
Karthik V
My father had liver issues last year, and the doctor suspected long-term use of painkillers like this might have contributed. We need more such reviews of older drugs. Safer alternatives exist, so why take the risk?
M
Michael C
While the intent is good, I hope this doesn't create a shortage of effective pain relief options. The notification seems detailed, allowing lower doses and other forms. Clarity for the public is crucial now.
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Nisha Z
This is the right decision, but it highlights a bigger issue. We often rely on chemists for advice instead of doctors. Self-medication culture needs to change. Let's use this as a lesson. 🙏

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