The Drug Controller General of India (DCGI) through the state drug control offices across the country has instructed the manufacturers of nimesulide single and combination formulations to submit the complete reports of adverse drug reaction so far generated from the market within a month.

The fresh directive in this regard has come in the wake of increased adverse reports on the use of nimesulide within the country and abroad. There has been an early recommendation by the Drug Technical Advisory Board (DTAB) to control drug abuse as the companies flooded the market with several nimesulide mono as well as combination brands.

The DCGI is learnt to have proposed a detailed analysis of the ADR reports on nimesulide formulations collected during the post market surveillance as quick as possible to decide whether a restriction on the use of the drug or a complete ban is required in the country or not. While speaking to Pharmabiz.com, Aswini Kumar, DCG of India, said that a review of the drug is already started and it is expected to be completed in a month or two.

An analysis of serious hepatotoxic side effects registered with World Health Organization also indicated that nimesulide has the highest rate of side effects amongst non-steroidal anti-inflammatory drugs (NSAIDs). Recently, it has been revealed by Swiss researchers who treated a 57-year-old woman patient with chronic lumbago who died of acute liver failure induced by nimesulide.

Nimesulide has been a subject of controversy regarding its safety and side-effects for the last few years. The drug is used for long periods by patients of osteo-arthritis and rheumatoid arthritis. NSAIDs, as a class is infamous for its hepatic side-effects.

The analysis was done on unsolicited reports reaching the World Health Organisation in relation to the total number of hepatic side-effects in relation to the total number of reported side-effects for any NSAID.

However, Dr M Venkateswarlu, deputy drug controller, India (West), said that though there are known side effects for the drug, banning of this drug is based on a relative benefit -risk assessment. Similarly, a drug banned in a particular country may not invite a ban in another country as the disease pattern and ethnic traits of the populations differ.

Currently, the Indian market for nimesulide formulation is estimated at Rs 200 crore. The leading brands in the segment are 'Nise' of Dr Reddy's Lab with annual turn over of Rs 60 to 70 crore, Panacea Biotech's 'Nimulid' with an annual sales of Rs 25 to 30 crore, 'Pronim' of Unichem with an annual sales of Rs 8 to 10 crore and Alembic's 'Nimegesic'. There are as many as 122 nimesulide single brands and another 32 combination brands available in the country now.

click here to view table showing Nimesulide mono brands