Counterfeit definition debate causes concern in India

World Health Organization attempts to introduce a broader new definition of counterfeit medicines have come under fire from the Indian government. A draft resolution on the new definition was presented at the 61st World Health Assembly in May 2008; this has been the subject of intense discussion, as was a WHO Secretariat report on the matter. The change from the current terminology has been promoted by the International Medical Products Anti-Counterfeiting Taskforce, a WHO unit set up in 2006.

The new definition could cause the registration of drugs in various territories to be an issue, as countries could link the issue of substandard drugs with intellectual property infringement. A major concern of the countries such as India is that legitimate generic medicines may become targets in the enforcement of counterfeit goods. According to a Business Standard report, the Indian Pharmaceutical Association has expressed concern that generic medicines that are legal in some countries could be classified erroneously as fake. This, combined with tougher enforcement of intellectual property rights elsewhere in the world, could mean that goods passing in transit may be seized for being fake, on the grounds that they are not registered.

A decision on the matter is unlikely before May 2009. Before then however, the office of the Drug Controller General of India is likely to come up with its own definition to promote to the WHO; this would incorporate recommendations from domestic manufacturers and is therefore unlikely to be a radical departure from the existing definition.

Perhaps of even more concern to India and other countries in the South Asia region is the new Anti-Counterfeiting Trade Agreement (ACTA) being negotiated between the United States, the European Union, Japan, South Korea, Canada, Mexico, Australia and New Zealand. By negotiating between themselves, these countries could undermine the WHO discussions and could simply ignore India’s objections. Treaty negotiations are still at a preliminary stage however, and no draft has been released to date; while this is a good sign for India that agreement is still not close, the secrecy will not help to allay its fears.

Jonathan Way - Editor, World Generic Markets