DCGI instructed state drug controllers to issue 'Box Warning' on Nimesulide

MUMBAI: To avert the usage of Nimesulide by patients below the age of 12 years, Drugs Controller General of India (DCGI) has instructed state drugs controllers to ensure ‘Box Warning’ clearly mentioned on label, carton, package insert and other promotional literature of Nimesulide.

In its circular issued to state drug controllers, DCGI Dr. GN Singh specified that the manufacturer of this drug should clearly write the Box Warning such as, “Use of Nimesulide should ordinarily be restricted to 10 days. If longer clinical use is warranted, liver function test should be assessed periodically.”

This directive issued by the DCGI is expected to be highly effective as it is based on the recommendations of Drugs Technical Advisory Board which is the highest decision-making body under the Union health ministry on technical matters. This move is very important as Nimesulide has adverse impact on human health. It has been already banned in 168 countries with the other countries such as US, UK, New Zealand, US, Britain, Canada, Sweden, Denmark, Australia, New Zealand and Japan. However, India has so far not reported any cases of reaction after the use of nimesulide.