Paediatric Nimesulide,Cisapride,PPA face ban

Within two weeks from now,four drugs—analgesic Nimesulide suspension for paediatric use,heartburn drug used in gastroesophageal reflux disease,Cisapride,decongestant used in cold and cough phenylpropanolamine (PPA) and human placenta extract would be banned in India. A blanket ban on Nimesulide,however is not coming so soon. The Drug Controller General of India has forwarded a proposal to the health ministry recommending imposition of ban on the sale of these drugs in the Indian market. The drug regulator has taken the step,based on the final recommendation of a sub committee of Drug Technical Advisory Board (DTAB),which was constituted to form a view on imposing a ban on these drugs. These drugs have been already banned in most regulated markets such as Europe and US,in most cases between 2000 to 2004.

While confirming the development,Drug Controller General of India,Surinder Singh said that the notification on the same is expected soon. Singh added that although Nimesulide for adult usage,has been kept out of the ban for now,it would be put under surveillance in the pharmacovigilance system (that provides data on adverse effect of drugs) that is being streamlined now in the country,and as data starts pouring in the next two years,a final call would be taken on the drug. The DTAB sub-committee,for now has recommended a ban only on the paediatric version of the analgesic drug basing its observation only on global experiences,since adverse drug effect data from India is almost non existent,Singh added.

However,data shows that among the most major companies,barring Panacea Biotec have either exited or are in the process of exiting the paediatric Nimuselide market,which now forms a very small segment of the Rs 300 crore Nimesulide market. While Panacea earns close to Rs 3 crore from its paediatric brand of Nimulid,Dr Reddy’s Lab,the market leader in the overall Nimuselide market,earned only Rs 2 lakh in 2010 from its paediatric brand,Nise. Dr Reddy’s revenues in the specialised segment has seen a year-on-year negative growth of 99% since 2009,leading experts to believe that the firm could be already in the process of exiting the Nimesulide suspension market. Dr Reddy’s total annual revenues from Nimesulide remained around Rs 62 crore in 2010,down from Rs 70 crore in 2009. Panacea’s earnings in the paediatric formulation segment has largely stagnated around Rs 3 crore for last four years,while its overall sale in the segment (inclusive of Nimesulide adult) stands at Rs 15 crore,down from Rs 20 crore in 2006. Unichem,which markets paediatric syrup under brand name Pronim earned a meagre Rs 44 lakh from the brand last year.