In a significant move to safeguard public health, the Union government has imposed an immediate ban on all oral painkiller formulations containing Nimesulide in doses exceeding 100 milligrams. The decision targets immediate-release versions of the drug, which the authorities have deemed potentially hazardous.
Immediate Prohibition Under Drug Act
The Ministry of Health and Family Welfare issued a formal notification on Monday, invoking its powers under Section 26A of the Drugs and Cosmetics Act, 1940. The ministry stated it was convinced that the use of these high-dose formulations is likely to involve risk to human beings. The ban, which covers manufacture, sale, and distribution, was enacted following consultations with the Drugs Technical Advisory Board (DTAB).
The government's order explicitly highlights that safer therapeutic alternatives to Nimesulide are readily available in the market. This factor played a crucial role in the decision to remove the higher-strength oral doses from circulation.
Parallel Move on Drug Rules Amendment
On the same day, the health ministry initiated a separate regulatory action. It published draft rules proposing amendments to the Drugs Rules, 1945. The key change suggested is the omission of the word "syrup" from a particular entry in Schedule K. This schedule lists drugs that are exempt from certain regulatory provisions.
The draft has been made public to invite feedback. The government has stated that objections or suggestions from stakeholders and the public, received within a 30-day period, will be duly considered before finalizing the amendment.
A History of Regulatory Action on Nimesulide
This is not the first time Nimesulide has faced regulatory scrutiny in India. Earlier this year, in January, the Centre banned all formulations of the drug intended for veterinary use. That decision came after scientists at the Indian Veterinary Research Institute (IVRI) in Izatnagar, Bareilly, confirmed the toxicity of Nimesulide to vultures, leading to its prohibition in animal treatments.
The latest ban on high-dose human formulations underscores a continuing effort by Indian drug regulators to evaluate and mitigate risks associated with specific medications, prioritizing patient safety when credible evidence of harm emerges.
