Following the National Pharmacovigilance Advisory Committee recommendation against the continued use of rofecoxib in the country, any ban on the drug could have far reaching effect on trade and the manufacturers as it could lead to banning certain other Cox-2 Inhibitors of same category, observe industry sources.
While Refecoxib and its brands constitute about 30 per cent of the market, the same category drugs like Celecoxib and Valdecoxib constitute 60 per cent of the Cox-2 Inhibitor category. The major brands with crores of rupees business include Cipla's Valdixx and Cadilla Healthcare's Valedon brands. Besides, ten per cent of the same category belongs to Parecoxib and its brands, which in effect would make the list a long one, R S Iyer, a senior industry expert in Chennai told Pharmabiz.
Cox-2 Inhibitor drugs have gained widespread prominence in the recent times, especially due to the alleged side effects related to usage of nimesulide among children.
However, the sources said it was a difficult proposition at present to correctly estimate the volume and value of the refecoxib, and similar generic brands floating in the Indian market.
A source pointed out that apart from the ban, the issue also points to lack of effective monitoring mechanisms and data management of drugs in the country. Even the state and the central drug control administrations do not have exact data on the number of refecoxib approvals and brands floating in the market. Apart from the information provided by the companies, which market these brands, no other data has been compiled by any of the monitoring agencies. The issue also becomes complex as Refecoxib and other Cox-2 inhibitor drugs are relatively new drugs.