Over 30 domestic pharmaceutical companies, including Ranbaxy, Cipla, Nicholas Piramal, Zydus Cadila and Torrent, face a possible ban on the sale of the generic version of Merck's pain management drug in the Indian market.
The United States Food and Drugs Administration arthritis advisory committee has rejected Merck's Arcoxia' (etoricoxib) in the US for its side effects such as heart attack risks.
The concerns stem from the fact that etoricoxib, which belongs to the Cox II inhibitor class of drugs (a new generation pain management drug), is the third one of this category to come under regulatory scanner at the international level.
Of the Cox II drugs -- which include etoricoxib, celecoxib, valdecoxib and parecoxib, two drugs -- rofecoxib (Merck's Vioxx) and valdecoxib (Pfizer's Bextra) -- are already banned by leading drug regulators, including in India.
The National Pharmacovigilance Advisory Committee has also included Cox II inhibitors among the 10 categories of drugs that are specially monitored for possible adverse drug reaction. Any adverse ruling by the US FDA is likely to trigger a corresponding move by the NPAC -- leading to a ban on the drug.
Trade sources said the pain management drug market in India is valued over Rs 1,500 crore (Rs 15 billion) and the banned valdecoxib alone had a market of Rs 80-100 crore (Rs 8 to Rs 10 billion).
Though the ban on the two Cox-2 inhibitors had resulted in doctors preferring to prescribe more safer and older NSAIDS such as ibuprofen, more than 30 Indian companies launched etoricoxib in the market in the last two years, said an industry expert. The Cox II category drugs is roughly estimated to have a market of about Rs 200 crore.
The major companies that manufacture etoricoxib formulations include Ranbaxy (Etrobax), Dr Reddy's, Cipla (etozox), Zydus Cadila (Nocoxia), Torrent (Torcoxia), Emcure, Hetero, Elder Pharma, Alkem (Evaxx), Emcure, Nicholas Piramal (Etody), Sun Pharma, Wockhardt, Unichem, Glenmark (Kretos), Micro Labs and Alembic.