Ranbaxy Laboratories Limited (Ranbaxy) has decided to discontinue the production of Rofecoxib formulations with immediate effect. The company's brand Rofibax is the market leader in the segment with Rs 13.5 crore sales as per latest MAT figures Ranbaxy is the third company after Micro Labs and Juggat Pharma to announce voluntary discontinuation of their rofecoxib brands from the market.
According to Ranbaxy statement, the company would also discontinue the marketing of the product in other countries also. Rofecoxib is currently being marketed by Ranbaxy also in Peru, Myanmar and Jordan, where it has a small marketshare. The company's decision has come in the wake of the Central Government's decision to ban the drug with immediate effect. While the notification is on its way, Ranbaxy, just like the other two companies decided to withdraw it voluntarily. "The decision is in conformity with its firm commitment to ethical business practices," the statement said.
With the centre's notification effecting the ban expected any time now, other companies who are promoting the formulation will also have to follow suit. There are about 40 brands that are being marketed in India. Some other leading brands are Unichem (Roff - 12.7 crore), Torrent (Torrox - 6.15 crore), Lupin (Rofaday - 5.35 crore), Dr Reddys (Mcrofy - 4.26 crore), Aristo (4.26 crore), Macleods (Rofica - 4 crore), Cipla (Rofixx - 3.75 crore) and Sun (Rofact - 3.5 crore).
The innovator of the drug, Merck had withdrawn the product from world market few weeks ago. It was this decision of Merck that compelled Indian companies to discontinue the production of the copycat versions of the drug. Earlier Ranbaxy had announced that it intends to promote only short-term use of Rofecoxib, whilst data was being reviewed.
According to Merck's own submission, the product poses an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx. The study, which revealed the seriousness of the side effects was published in the US based journal "Circulation" (issue dated April 19, 2004).
The study, meant to see if the drug prevents colon cancer was carried out on 2600 subjects and came out with startling observation that the drug (25 mg) doubles the risk of heart attack in placebo and becomes three times more if the dose is doubled to 50 mg. Though Merck had not introduced 50 mg doses in the market, Indian drug authorities are known to have given approval for both the strengths, thereby explaining its presence in the domestic market.