The drug manufacturers in the country, especially the small scale sector, are concerned over the Union Health Ministry's efforts to give a new definition to counterfeit drugs as they fear the efforts would be another attempt by the big multinational companies to kill the Indian generic drug makers.

Expressing concern over the issue, the Rajasthan Pharmaceutical Manufacturers Association (RPMA) said that the proposal by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO to consider apparent "trademark violations" as "counterfeiting" cases would harm exports of generic drug makers. "We are concerned over the ongoing World Health Organisation (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", it said.

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.

This attempt to widen the definition of counterfeit medicine is happening at a time when a deliberate attempt is being made to label India as a major source of counterfeit medicines. Indian companies, increasingly dependant on exports of cheap off-patented medicines to developed markets to drive business growth, will find this a major road. "The IMPACT definition refers to 'history', which is mischievous. This could lead to generics being treated as counterfeits," the RPMA said.

The proposed definition, if read with EC Regulation Article 2.1 (c) of the European Union, could amount to a serious threat to India's pharma exports. The EC Regulation allows seizure of counterfeit products even in transit.

The current definition of WHO says counterfeit drugs are "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 the correct ingredients but fake packaging, with the 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".

IMPACT has representatives from 22 organisations including Interpol, Organisation for Economic Co-operation and Development (OECD), World Intellectual Property Organisation (WIPO) and World Trade Organisation (WTO). IMPACT wants to play in the hands of big pharma companies and if this definition approved then it is quite harmful to SSI sector of Indian pharma, RPMA said.