The Delhi High Court has dismissed the civil writ petition that sought the withdrawal of unapproved nimesulide formulations from Indian market on March 10, 2004 and asked the petitioners to file criminal complaint against the pharmaceutical companies with the Metropolitan Magistrate. The H C verdict is based on the Drug Technical Advisory Board (DTAB) report that vouched for the safety of the drug.

Following the court verdict, Social Jurist, the NGO that had filed a Public Interest Litigation questioning the safety of the nimesulide formulations that are available in the market without the approval from the Drugs Controller General of India (DCGI), has decided to file a review petition in the HC and simultaneously approach the Metropolitan Magistrate.

Social Jurist will also explore the possibilities of approaching the Supreme Court in this regard.

The petitioners had wanted withdrawal of about 200 nimesulide brands which are in the market with approvals from state drug control authorities but not the DCGI, as stipulated by the D&C Act. They had also pointed out the dangerous side effects of the drug which had been reported in other countries and wanted the drug to be used in a restricted manner.

Though the Central government had admitted the presence of more than 200 "unapproved nimesulide formulations", the authorities had maintained that most of these drugs were approved by the state drug control authorities and cannot, prima facie, called "illegal drugs". The government affidavit placed before the HC stated that the reason for the state level approval for new drugs, was on account of certain anomalies existing in the Drugs and Cosmetics Rules. On the efficacy front, the DTAB, which had been asked to look into the matter by the HC, gave a positive response. DTAB was asked to examine whether nimesulide, an anti-pyretic drug banned in many countries, is safe to consume.

The petitioners were of the opinion that DTAB had many of the interested parties as its members and was not in a position to present an objective report.

The HC verdict has come as music to the ears of dozens of domestic pharmaceutical companies including Dr Reddy Laboratories, Panacea Biotech, Ajanta Pharma to name a few.

Interestingly, a separate study carried out by the National Adverse Drug Reaction Monitoring Center at All India Institute of Medical Sciences had also concluded that nimesulide ADR is comparable with any other drug.