While the Indian generic manufacturers of rofecoxib are in a fix whether to withdraw their brands from the market following the innovator company Merck's decision to withdraw its brand Vioxx for side effects, the Kerala drug controller has issued a notification supporting the cause of the Indian companies.
According to the DC's statement, the brand Vioxx is not manufactured and marketed in India by Merck &Co. Rofecoxib should be prescribed only for treating acute pain and swelling related to the symptoms of osteoarthritis. Scientific journals have clearly indicated this drug should not be prescribed to patients suffering from diseases related to kidneys, liver and heart. Further, it should not be prescribed for kids. Merck &Co withdrew the product voluntarily following its scientific studies proved the drug could cause some side effects during prolonged usage.
The Drug Control General of India (DCGI) has clarified the drug has not been banned by the USFDA, and the Indian drug control administration is in the process of collecting elaborate data on the Adverse Drug Reactions (ADR) related to this drug. So far, the drug has not been reported for side effects when used in accordance to the prescription of qualified medical practitioners in short-term treatment process. The drug should be sold only by the prescription of doctors. In these circumstances, the public need not worry for discretionary usage of Rofecoxib, said the DC circular, issued yesterday.
T P Gopinathan, drug controller, Kerala told Pharmabiz the clarification comes in the wake of news reports appearing in a section of the local media portraying Rofecoxib has been banned by the USFDA and the drug with acute ADR is being still manufactured and marketed in the country, which caused panic among the people. Following this, the state drug control administration contacted the DCGI, and the clarification is based on the feedback from the central drug control administration. A clarification in this regard and an alert on selective prescription of rofecoxib has been directed to the state Indian Medical Association, said the DC.
It is to be noted Pharmabiz had reported the DCGI was likely to enforce a systematic ban on rofecoxib under Section 26 A of the Drugs & Cosmetics Act to stop further licensing of the drug and to facilitate show cause notices to the existing manufacturers. The CDSCO also wrote to USFDA asking for more details on the ADRs caused by the drug. Following Merck's decision, some of the Indian manufacturers of rofecoxib had clarified they were not planning to withdraw their brands.