A total ban on the sale of rofexocib formulations in the country is imminent. The newly formed National Pharmacovigilance Advisory Committee (NPAC) under the chairmanship of the Director General of Health Services (DGHS) has advised against the continued use of rofecoxib in the country. Based on its recommendations, the government is set to notify a ban on its sale anytime.

The risk factors associated with the prolonged use of drug came to light after US-based Merck, the patent holder of the drug decided to voluntarily withdraw its blockbuster brand Vioxx from the world market few weeks ago. The hue and cry, which followed the withdrawal, had made the government ask NPAC to give its views on the future of its generic versions that are available in plenty in the domestic market. With the NPAC announcing its decision, the ban is now a foregone conclusion.

The generic versions of the drug, which is prescribed for relief of signs and symptoms of osteoarthritis, is currently enjoying Rs 90-crore market in India.

The NPAC is known to have sought ADR reports from both within the country and outside and has thoroughly studied the facts before taking the decision. Asked about the possibilities of the ban, Ashwini Kumar, Drugs Controller General of India (DCGI) & member secretary NPAC, said that the government was in the process of accepting the NPAC recommendations and issuing necessary notification.

The members of the NPAC, which has advised against the drug are the DCGI, DG ICMR, Director in-charge of Drugs Division, HoD Pharmacology, AIIMS, Dr Nilima Kshirsagar, SGS Medical College, Mumbai, Dr Ranjit Roy Chaudhary, NII, New Delhi, Dr C Adithan, Prof Pharmacology, JIPMER, Pondicherry, Dr T D Dogra, AIIMS, Dr Anoop Mishra, AIIMS, Dr A K Agarwal, RML, New Delhi, Dr S D Seth, chair-in Clinical Pharmacology, ICMR, Brijesh Regal, Former WHO Consultant, Dr Y K Gupta, Director, ITRC, Lucknow, Dr M D Gupte, ICMR Institute of Epidemiology, Chennai, Dr Pramil Tiwari, NIPER, Dr Urmila Thatter, HoD Pharmacoliogy, and B L Nair, Medical College Hospital, Mumbai.

Rofecoxib 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.