In a significant move for public health safety, the Central Government of India has imposed an immediate ban on the manufacture, sale, and distribution of all oral formulations of the painkiller Nimesulide that exceed 100 mg in immediate release dosage form. The decision, announced via an official notification on Monday, comes after a critical recommendation from the Indian Council of Medical Research (ICMR), the nation's apex health research body.
Why the Ban Was Implemented
The government's notification clearly states that it is "satisfied that the use of all oral formulations containing Nimesulide above 100 mg... is likely to involve risk to human beings." Crucially, the authorities noted that safer alternative drugs are readily available in the market, making the continued use of high-dose Nimesulide unnecessary. The action was taken under the powers granted by Section 26A of the Drugs and Cosmetics Act, 1940, following consultations with the Drugs Technical Advisory Board.
Scope and Immediate Effect of the Prohibition
The ban is comprehensive and effective immediately. It targets specifically "All oral formulations containing Nimesulide above 100 mg in immediate release dosage form." The government justified the drastic step, stating it was "necessary and expedient in the public interest" to prohibit the drug's manufacture, sale, and distribution for human use across the country. This decisive action underscores a shift towards greater precaution in pharmaceutical regulation.
Broader Context: Nimesulide's Impact on Wildlife
Interestingly, this is not the first time Nimesulide has been flagged for its dangers. The drug has previously been identified as toxic to wildlife, particularly vultures. The Bombay Natural History Society (BNHS) has reported that dozens of cow shelters in states like Rajasthan and Madhya Pradesh have stopped using veterinary drugs harmful to vultures, including Nimesulide. This change has reportedly helped stabilise populations of these critically endangered birds.
Other drugs discontinued in veterinary use for similar reasons include:
- Diclofenac
- Aceclofenac
- Ketoprofen
These have been replaced with safer alternatives like meloxicam and tolfenamic acid. The human ban on high-dose Nimesulide aligns with this growing awareness of the drug's potential risks beyond human health.
This ban reflects the government's proactive stance on drug safety, prioritising citizen health by removing potentially risky medications when safer options exist. It also highlights the interconnectedness of pharmaceutical use in human and veterinary medicine, and their collective impact on public health and the environment.
