After almost five years of public outcry against marketing of nimesulide in the country for its serious adverse reactions, the drug has been placed under focused surveillance of the National Pharmacovigilance Programme by the authorities now. Nimesulide, a non-steroidal anti-inflamatory drug, is reported to be inducing a high proportion of severe adverse hepatic reactions in patients compared with other NSAIDs. According to researchers of Zurich University Hospital, hepatotoxicity represents an important risk factor in nimesulide usage. The drug has thus been banned in Spain and Finland in 2001. The drug has not been allowed to be marketed in the US, Canada, UK and Australia for same reasons. Even in Sri Lanka and Bangladesh nimesulide is not allowed to be marketed. The Drug Controller General of India has been aware of the adverse reactions of nimesulide for some years. The expert opinion of Drugs Technical Advisory Board was sought by the Delhi High Court in December, 2002 during the hearing of a Public Interest Litigation. The recommendations of DTAB were then filed before the Court wherein DTAB had opined that there was no ground for banning of nimesulide for adult or paediatric uses. This is surprising. If DCGI has decided to place the drug under pharmacovigilance programme now, it is an extremely delayed action. It should have been done years ago to protect the public from serious side effects which usually go unreported in India. Inaction and delay in banning or restricting the use of harmful drugs by the Indian regulatory authorities after knowing their harmful ADR is highly irresponsible.
Safety of nimesulide has been a matter of public concern worldwide for some years because of its serious side effects and decreasing use in several countries. In India, marketing approval for the drug was granted in 1994 for painful inflammatory febrile disorders but it is being promoted as first line antipyretic therapy. There are more than 80 brands of nimesulide currently marketed in India with no restrictions on their sales. The total market for single ingredient nimesulide brands is about Rs 300 crore and the top brand, Nise, of Dr Reddy's alone has sales of Rs 60 crore or more. Apart from this, there are a dozen irrational combinations of nimesulide with paracetamol floating in the market. The licences for the manufacture of these irrational combinations were issued by various state drug authorities since 1998 despite specific guidelines from DCGI's cautioning about its irrationality. It is surprising that no action has been initiated by the DCGI office to weed out at least these irrational combinations even after eight years of their existence in the market. As it may not be always possible to assess all adverse effects of a new drug before marketing permission is granted, post marketing surveillance is expected to be done by the pharmaceutical companies. But that is not done by most of the companies in India. The establishment of National Pharmacovigilance Advisory Committee in 2004 under the chairmanship of the Director General of Health Services was with the objective of building a comprehensive pharmacovigilance data system in the country. Now NPAC is in place but it has to be fast enough to generate credible data of ADR of new drugs so that DCGI can act in time.