On May 24, Alembic Ltd issued a circular asking its stockists, wholesalers and retailers to withdraw all stocks of Nimegesic Drops, a pediatric dosage form of nimesulide, throughout the country. Just three days prior to that Dr Reddy's Labs informed DCGI that it had discontinued manufacturing of 4 nimsulide fixed dose combinations. Much before Dr Reddy's action, Blue Cross Labs discontinued manufacturing of its pediatric preparations of nimesulide. These actions by the pharma companies, though appeared voluntary, were actually under pressure. The government and pharma companies were at the receiving end for some time against marketing of nimesulide and its combinations in the country for its widely reported ADRs and withdrawal from other countries. The latest in the series of objections against the drug is a public interest litigation (PIL) filed in the Delhi High court a few months ago challenging the continued marketing of nimesulide in India. The Delhi High Court subsequently instructed DTAB to submit a report on the safety profile of the drug. The report is yet to be submitted to the HC and matter should be decided then by the Court. It will be difficult to say whether any group is behind the PIL. But such legal moves and continuing media reports on the controversial drug may ultimately persuade companies marketing even top brands of nimesulide to withdraw from the market in the interest of their public image.

A section of the drug industry believes that frequent media reports against marketing of nimesulide preparations is part of a campaign sponsored by multinational drug companies as the marketing of this drug and its combinations is dominated by Indian drug companies. Everyone knows that the top paracetamol brand, Crocin, is owned by GSK while Nise, the leading nimesulide brand, belongs to Dr Reddy's. And nimesulide market had grown over the years to touch Rs 250 crore today. In the process a good part of paracetamol market was lost to Nimesulide manufacturers in India in a short span. The theory that is being propagated by the domestic pharma sector is that it is the beginning of a systematic MNC campaign against Indian drug companies and their top brands. This theory cannot be altogether dismissed considering the dubious record of certain multinational drug companies operating in India and other countries. At the same time the safety of nimesulide is indeed a matter of serious public concern considering its serious side effects and decreasing use worldwide. Nimesulide was banned in Spain and Finland in 2001 on reports of its hepatotoxicity. 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. 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. With no ADR monitoring system in place in India, the damage such a drug, not acceptable in several countries, is causing to the general public may be quite heavy.