The NGOs working in the health sector have urged the government to boycott the meeting called by International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO to discuss the issue of giving a new definition to counterfeit drugs. The NGOs alleged that this is an attempt by the big multinational companies to prevent the Indian generic drugs from going to different parts of the world.

DCGI Dr Surinder Singh and joint secretary in the Union health ministry Debashish Panda are to attend the meeting to be held in Germany on November 24 and 25.

Questioning the legitimacy of the IMPACT in changing the definition of counterfeit drugs, the NGOs said that counterfeit is not an IPR issue and this is basically a quality issue which should be discussed in the World Health Assembly.

The NGOs also raised this issue at a government-industry meeting convened by the Union health ministry on November 14 to discuss WHO's proposal to give a new definition to counterfeit drugs which the ministry had earlier turned down due to the resistance of the Indian drug industry. All the major industry associations like IDMA, IPA, FOPE, SPIC, CIPI, etc participated in the meeting.

The industry pleaded with the government 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. The Indian drug manufacturers, especially the small scale sector, are concerned over the WHO proposal 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 IMPACT, apparent 'trademark violations' will be considered as 'counterfeiting' cases which the Indian drug makers said would harm exports of generic drug makers.

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'.