A newspaper report last week had indicated that the adverse drug reactions of nimesulide will be reviewed by the Drug Controller General of India. The report said that the move by the DCGI's office is in the wake of certain ADR reports of the drug and subsequent withdrawal of nimesulide from some of the European markets, Canada and Australia. The fact of the matter is that the drug has not been in use in these countries for some years. Nimesulide is reported to be inducing a high proportion of severe adverse hepatic reactions compared with other non-steroidal anti-inflamatory drugs (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 last year. The newspaper report that a ban on the use of nimesulide in these countries is thus not a recent one. The DCGI has been aware of the adverse reactions of nimesulide for some years after it was cleared for marketing in India in the early nineties. In fact, Pharmabiz has brought this matter to the notice of the DCGI a year ago. If a review of the ADR of the drug has started now in the country, as claimed by the DCGI in the newspaper report that can only be described as an extremely delayed action on the part of a responsible government office. Inaction and delay in banning or restricting the use of harmful drugs by the regulatory authorities after they have shown serious adverse reactions is becoming a matter of serious public concern.

There are more than 80 brands of nimesulide currently marketed in India today with no restrictions on their sales. The total market for single ingredient nimesulide brands is about Rs 250 crore and the top brand, Nise, of Dr Reddy's alone has sales of Rs 60 crore. Besides 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 four years of their existence in the market. It may not be always possible for the regulatory authorities to completely assess the harmful and other adverse effects of a new drug before marketing permission is granted. That is why even in the US there are cases of withdrawal of several new drugs in recent years shortly after marketing permissions are granted. But, withdrawals of harmful drugs are effected with a proper system of post marketing surveillance in these developed countries. The Union health ministry needs to address this issue of withdrawal of harmful drugs and their combinations from the market with no further delay. Machinery for monitoring ADR of new molecules and their combinations should be first in place for this.