The union health ministry has turned down the World Health Organisation (WHO)'s proposal to give a new definition to counterfeit drugs on the ground that the new definition will act against the Indian drug industry, especially the generic drug manufacturers as the new definition considers apparent 'trademark violations' as 'counterfeiting' cases.

According to sources, the health ministry has informed the WHO about the Indian government's unwillingness to change the definition of counterfeit drugs. The ministry has taken a decision in this regard in view of the stiff opposition from the Indian drug industry. The drug manufacturers in the country, especially the small scale sector, are concerned over development as they fear the efforts would be another attempt by the big multinational companies to kill the Indian generic drug makers.

As per the proposal by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO, apparent 'trademark violations' will be considered as 'counterfeiting' cases which the Indian drug makers said would harm exports of generic drug makers. "We are concerned over the ongoing WHO negotiations that aim to bring non-health issues, having no direct implications on the safety of a drug, within the ambit of the definition of 'counterfeit medicine', the industry pleaded with the government," the drug makers stated.

The current definition of WHO says counterfeit drugs is 'medicines which are deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines include products with correct ingredients but fake packaging, with wrong ingredients, without active ingredients or with insufficient active ingredients'.

The definition proposed by IMPACT removes the clause 'deliberately and fraudulently' and replaces it with 'a medical product is counterfeit when there is a false representation in relation to its identity, history, or source'. It also says that 'this applies to the product, its container, packaging or other labeling information'.

IMPACT also wants to see that WHO definition on counterfeiting 'can apply to both branded and generic products and include products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging'.

Indian drug manufacturers feel that if the changes go through, foreign drug firms could stall exports of low-cost versions of patent expired medicines to key markets. Today, Indian firms have several brands that sound similar to those of multinational brands. For example, global drug major Pfizer has an erectile dysfunction medicine Viagra, while Indian companies make generic versions of Viagra with similar sounding names. Currently, this would at the most be treated as a trademark violation (under Indian Patent and Trade Mark Act). However, according to the definition proposed by IMPACT, the Indian product could be rejected as counterfeit.

Indian companies, increasingly dependant on exports of cheap off-patented medicines to developed markets to drive business growth, will find this a major roadblock. "The IMPACT definition refers to 'history', which is mischievous. This could lead to generics being treated as counterfeits," the Indian drug industry argued.