The Drug Controller General of India is likely to enforce a systematic ban on rofecoxib under Section 26 A of the Drugs & Cosmetics Act, which will stop further licensing of the drug in the country and also facilitate show cause notices to the existing manufacturers. The sources in the Central Drug Standard Control Organisation (CDSCO) said that the show cause notice to the manufacturers would ask their explanation for why the government should not recall the product from the market within the stipulated time (normally a time period of 2 to 6 months).
The CDSCO learnt to have written to US FDA asking for more details on the adverse drug reaction reports of the drug that prompted the worldwide withdrawal of the drug by the inventor Merck & Company. In case the US FDA data on the ADR gives enough proof to substantiate a sudden ban of the drug in the country, the DCGI may initiate an immediate recall as well, it is learnt.
The CDSCO officials said that since there was not enough data available in India to prove that the drug has shown dangerous side effects as the inventor company reported it, a sudden recall in India would attract injunction from the Court of Law secured by the manufacturers.
However, the DCGI can initiate a recall of all the brands of rofecoxib in case the companies failed to give satisfactory explanation on the safety profile of the drug within the period. Also, under section 26 A, the DCGI can appoint a technical committee to verify the data provided by the companies and also to initiate a crash trial of the drug to analyze the safety profile of the drug within the period.
As it was reported by Pharmabiz yesterday, the companies and their brands that are to be affected include Ranbaxy (Rofibax - Rs 13.5 crore sales), 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).
Rofecoxib, which is currently enjoying a Rs 91-crore domestic market, was approved by the DCGI in India on June 26,2000. The drug prescribed for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.
Though the urgency shown by the innovator company to withdraw the product, and the manner in which it wanted the patients to stop using the product and return the unused packets for reimbursement is indicative of the potential ADR that can be caused by rofecoxib. The industry experts also feel that it may be a planned withdrawal by the inventor to kill the generic competition for the drug to lead the way to a possible launch of another potential drug in the same segment.
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.