Domestic manufacturers' of nimesulide, the non steroidal anti-inflammatory drug (NSAID), are taking a hit as paediatricians all over the country have slowed down in prescribing the drug following the reports that the drug causes toxicity in the liver. Market analysts watching the pharmaceutical industry claim that the manufacturers have seen a drastic fall of 10 to 25 per cent of nimesulide sales in the last one month, which if continues would knock down a part of the topline revenue. Analysts claim that companies like Dr. Reddy's, Alembic to name a few are watching the down slide.

The downslide is witnessed in spite of the fact that The Indian Academy of Paediatrics (IAP) had written to the Drug Controller General of India (DGCI) in January that meta analysis carried out by the academy had led to the finding that the drug is not unsafe like any other anti-pyretic drugs. The IAP had also stated in its communication that the drug could be prescribed for short term use for children for less than 10 days of treatment. It also stated that the data on the effect of the drug on children below six months are limited and hence no definite conclusions could be drawn on the effect of such use.

Analysts however say that the IAP communication may not bring about a turnaround in the prescription of the drug thereby causing loss of revenue to the manufacturers. “The drug is banned in some many countries, and the report of toxicity of the drug has surely caused alarm amongst the paediatrics in the country. They would be more cautious now and wouldn't prescribe the drug for their own safety. This in turn would surely affect the sale of the drug,” a market analyst averred. He further added that the drug is not approved by the US FDA and UK MCA and this would result in the paediatrics not prescribing the drug.

“Manufacturers of the drug would now have tough time promoting the drug. The report of toxicity in liver on long term usage has surely caused the dent, and the manufacturers are feeling the pinch. This would itself play on them when it comes to promoting the drug,” an analyst averred, claiming further that the manufacturers would also be careful not to play it big about the drug with medical practitioners. “It would be premature to tell whether the manufacturers would stop manufacturing the drug since it is a huge market in the country. But certainly there could be chances of reduction in the production of the drug if it continues to bleed the revenues of the manufacturers,” the analyst said.

There has been no response from the companies manufacturing the drug. Analysts feel that the same is due to the fact that the companies don't want to harm their interests and create unnecessary hype. “Companies will continue to play it safe for their own interests. But this will also affect the sales. I don't think the companies will make much noise about the drug at the particular point of time. May be later on they would,” the analysts maintained.