The Central Government has notified the ban on Rofecoxib formulations for human use with immediate effect on December 13, 2004. The notification states that the government has found it necessary to ban the use of the formulations containing Rofecoxib as it involves certain risk to human beings and hence is prohibiting its manufacture, sale and distribution with immediate effect.

"In exercise of powers conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture, sale or distribution of the following drug with immediate effect, namely: "Rofecoxib and its formulations for human use," the notification has said.

Even though all companies that had Rofecoxib formulations stopped its production, the stocks in many retail outlets are yet to be withdrawn. The notification has now warranted immediate withdrawal of the entire stock that is still in the retail outlets.

The generic versions of Rofecoxib, which enjoyed Rs 91 crore cumulative sales in domestic market (MAT, August 2004), had to be withdrawn all of a sudden following the decision of the innovator company Merck to withdraw the product from world market with immediate effect.

The decision of Merck, which came on September 30, 2004, had led to a media outcry against the continued marketing of the drug. This called for an emergency meeting of the National Pharmacovigilance Advisory Committee on October 11, 2004, which recommended for immediate ban on the drug in India.

Two months later, the official notification has come thus sealing the fate of the drug in the country.