The domestic drug industry is concerned over ongoing World Health Organisation 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 feels that a 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.
If the changes do go through, they say, 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, industry sources explained.
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. However, according to the definition proposed by IMPACT, the Indian product could be rejected as counterfeit, the sources explained.
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 problem, the sources said.
Sensing the potential harm, the Indian Pharmaceutical Alliance of top domestic pharma firms has appealed to the international generic industry, civil society and academia to oppose the creation of another non-tariff barrier in the name of counterfeit drugs.
"The IMPACT definition refers to 'history', which is mischievous. This could lead to generics being treated as counterfeits," said D G Shah, secretary general, IPA.
He also pointed out that 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.
Health ministry officials say that the IMPACT proposal is being studied and that this would likely figure on the agenda of the next World Health Assembly.
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, World Intellectual Property Organisation and World Trade Organisation.
