The Delhi High Court has directed the Drug Technical Advisory Board (DTAB) to examine the safety aspects of nimesulide drug and submit a report by May 26, 2003. In a hearing on the Public Interest Litigation (PIL) filed by Social Jurist, a voluntary organization, a division bench comprising justice Devinder Gupta and justice B D Ahmed asked DTAB to examine whether nimesulide, an anti-pyretic drug banned in many countries, is safe to consume.
With the directive of the HC, nimesulide issue, which was sidelined by the government due to the "absence of any reported adverse reactions" will have to be taken up again. It was just a couple of days back the government had stated in the Parliament that the drug has been cleared by a majority of experts and that no serious adverse reaction was reported even in children. The decision was helpful to as many as 20 domestic pharma companies, including Dr Reddy's Laboratories and Ajanta Pharma, for which nimesulide is a fairly important product in terms of sales. Nimesulide has an estimated domestic market of around Rs 200 crore. Dr Reddy's formulation "Nise" alone has annual sales of around Rs 60 crore.
The HC also directed the government to stick to its deadline to implement the ban on Astemizole and Terfenadine. The counsel for the Union government had submitted that the two banned drugs would not be allowed to be manufactured and sold from April 1. The court wanted the government to stick to the deadline.
The court had in January asked the government to explain why it had deferred implementation of a notification banning the two commonly used harmful drugs till August 1. Three pharmaceutical companies which manufacture and market the drugs were asked to submit their responses also.
The Union Health Ministry through a notification issued on October 29 had banned the two medicines but had deferred the implementation till August.