The Drugs Controller General of India (DCGI) has asked the state drug controllers to issue directive to the manufacturers of nimesulide containing formulations for use in patients of 12 years and above to incorporate 'Box Warning' in a conspicuous manner on label, carton, package insert and other promotional literature of the drug.
In a directive to all the state drug controllers, DCGI Dr GN Singh has asked them to ensure that the manufacturers of nimesulide incorporate the Box Warning “Use of nimesulide should ordinarily be restricted to 10 days. If longer clinical use is warranted, liver function test should be assessed periodically” on label, carton, package insert and other promotional literature of the drug.
The DTAB in its 60th meeting held on 10.10.2011 considered the use of nimesulide in population of 12 years and above and after deliberations recommended that the following 'Box Warning' should be mentioned on label, as well as package insert and other promotional literature of formulations containing nimesulide, DCGI in his directive to the state drug controllers said.
Earlier, in a gazette notification dated February 10, 2011, the union health ministry had banned the non-steroid anti-inflammatory drug nimesulide suspension (below 12 years of age), along with three other drugs, due to its adverse effects on human health.
The health ministry's rather belated decision in this regard came following the Drugs Technical Advisory Board (DTAB)'s recommendation to the ministry to ban these drugs after it was found by the Board that these drugs will have adverse effects on human health. The DTAB is the highest decision-making body under the Union health ministry on technical matters and its recommendations are normally followed by the ministry.
Earlier, the then DCGI had brought these controversial drugs under the radar of the DTAB in the wake of serious concern raised by the medical experts in the country over the side-effects of the drug.
Nimesulide was a controversial drug as even though it was banned in US, Britain, Canada, Sweden, Denmark, Australia, New Zealand, Japan and other 168 countries, the drug was freely available in India, being aggressively marketed by prominent drug companies. Though the drug was banned in most of the countries following information suggesting an increased risk of liver toxicity compared to other drugs in the same class, the then drug authorities in India claimed that no adverse drug reaction report had been received on the use of nimesulide in the country so far to necessitate a ban.