Indian Drugs Manufacturers Association (IDMA) will soon prepare a sop to handle crisis situations like that arose out of the sudden announcement of Merck to voluntarily withdraw Vioxx (rofecoxib) formulation from the world market.
With almost every fast moving drug manufactured and marketed by Indian companies being the copied versions of molecules that have been originally introduced in the markets by multinational drug giants like Merck, the Association finds it necessary to have its own unified plans to react to such situations so as to minimize the damage that can be caused due to such withdrawals.
While IDMA has no difference of opinion in withdrawing harmful drugs from the market, they want to ensure that such measures were not adopted with ill intention to wipe out competitors, or cheaper versions from the market in the post 2005 era.
Speaking to Pharmabiz.com, Yogin Majumdar, president IDMA said that the decision to "withdraw" rofecoxib so suddenly was taken due to the panic situation that was created by the media reports. "The industry was not prepared to react to the situation. There has to be a standard operating procedure on how to approach such a situation. It must have been a right decision in the case of rofecoxib, but that shouldn't be the general trend," he said.
It should be recalled that the Indian companies had reacted differently to the news of Merck's withdrawal of the drug. Ranbaxy Laboratories, which owns the leading generic brand in the country, had at first decided to continue it for short-term use, while some others expressed willingness to withdraw the drug immediately. The government also came out with a sudden decision, with National Phamacovigilance Advisory Committee recommending total ban on the drug.
The IDMA president pointed out that the industry was not in a position to take appropriate stand during earlier instances also (Nimesulide issue for example) and wanted to build up a system to assess the real situation. In a separate move, the government is also attempting to have in place its own pharmacovigilance system, and the first meeting of experts to finalise the plans are planned on November 16.
Majumdar said that IDMA would take up this matter with other industry associations also and would try to come out with a unanimous "sop" soon. The move gains importance in the wake of increasing anxiety over the safety aspects of other coxibs also.