Date:05/06/2008 URL: http://www.thehindubusinessline.com/2008/06/05/stories/2008060551960200.htm

Back India bats for generics, seeks clarity on counterfeits

A clear global definition on counterfeits was necessary, as countries often rely on the World Health Organisation’s norms and definitions when framing their laws.

P.T. Jyothi Datta

Mumbai, June 4 In the global battle against counterfeit medicines, India has sought clarity on the proposed expanded definition of counterfeits, staving off attempts to equate counterfeits with generic medicines.

Counterfeiting is a trademark-related issue that affects branded, patented and generic medicines, the Indian delegation said at the recent World Health Assembly (WHA) in Geneva.

At present, the World Health Organisation defines counterfeits as medicines that are deliberately and fraudulently mis-labelled, regarding identity or source. Also, counterfeits could contain varying levels to no level of the active ingredient of the original medicine. The expanded definition refers to the “history” of the drug, bringing in several implications, a Union Health Ministry source familiar with the development told Business Line.

India has its own norms and punishments on counterfeit medicines and is not opposed to being part of global initiatives to tackle them, the source said. But, a clear global definition on counterfeits was necessary, as countries often rely on WHO’s norms and definitions when framing their laws, and an ill-thought-through definition could cast a shadow on generic medicines, the source said.

Indian drug companies are largely producers of generic drugs or medicines that are chemically similar and are as efficacious as an innovative medicine. And India’s stance at the WHA brought cheer to the local industry, as they feared that the expanded counterfeit definition could be used as a non-tariff barrier against medicine exports from India.

Seeking clarity on the counterfeit definition came as part of the Indian delegation’s efforts to get a resolution deferred on the work of Impact (International Medical Products Anti-Counterfeiting Task Force) — a global coalition on counterfeiting created by the WHO.

The proposal to pass a resolution on the work of Impact, without a reference to the definition of counterfeits, was made by some African countries and the Indian delegation was supported by Brazil and Thailand, among others, in getting the resolution deferred until Impact had completed its work, the Ministry source said. The Indian delegation comprised top brass from the Union Health Ministry.