New Delhi: The Central Government has directed drug manufacturers to carry a mandatory “Box Warning” on the popular painkiller Nimesulide, tightening its usage conditions after the country’s top medical research body flagged safety risks. The warning will be printed on all labels, cartons, package inserts and promotional material, clearly spelling out restrictions around the drug’s use. The move follows deliberations by the Drugs Technical Advisory Board (DTAB), the apex panel that advises on crucial drug safety matters.
In April, reported on a document prepared by the Indian Council of Medical Research (ICMR), which was commissioned by the DTAB to assess Nimesulide’s safety profile in adults. Highlighting serious concerns, the 11-page report titled Executive Summary: Effect of Nimesulide in Adult Humans recommended that the drug be reserved strictly as a second-line treatment, only to be considered after all first-line options had been tried and found ineffective. It also suggested formulations above 100 milligrams should be banned and a “black box” warning made mandatory on all packs.
The DCGI has asked state regulators to ensure all manufacturers prominently display these warnings across packaging and literature. “The move is aimed at protecting patients while keeping the drug available under restricted conditions for those who may benefit from it,” said a senior government official requesting anonymity.
“Nimesulide has never been approved by the US Food and Drug Administration (FDA), meaning it is not marketed in the United States. Also, several EU countries have suspended or withdrawn its marketing at various times (for example, Finland, Spain, Ireland) due to safety concerns, particularly liver toxicity,” the officer said.
The latest order, issued on September 15 to state and Union Territory drugs controllers, draws directly from the findings of ICMR report.
Nimesulide, a non-steroidal anti-inflammatory drug commonly prescribed for pain and fever, has been under regulatory scrutiny for years. Its use in children below 12 was prohibited in 2011 under Section 26A of the Drugs and Cosmetics Act after reports of toxicity.
“The manufacture, sale and distribution of Nimesulide formulations for human use in children below 12 years of age was prohibited under Section 26A of Drugs and Cosmetics Act…” recalled the latest order issued by the Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi.
The DTAB has also endorsed restrictions highlighted in ICMR’s report which are now mentioned in the order issued by DCGI.
“Nimesulide should be used only as a second line drug, only after exhausting first line options,” the latest order stated, quoting DTAB committee recommending ICMR’s findings. It further noted that “Nimesulide should not be used in pregnant, lactating and women planning for pregnancy,” and that “Nimesulide should not be used in patients with renal and hepatic impairment and also should not be co-administered with other hepatotoxic and renal toxic drugs.”
Earlier this year, in February, India had also banned the use of Nimesulide in animals citing similar concerns. Alongside regulatory curbs, the government has been working to sensitise the healthcare community about the risks associated with the drug. With the latest order, the scope of Nimesulide’s use has been further narrowed, making its prescription subject to stricter medical oversight.
