The DCGI has called a meeting of all major industry associations on December 24 to appraise the industry about the latest developments on the issue of giving new definition to counterfeit drugs in the aftermath of the WHO-IMPACT meeting held in Bonn, Germany on November 24 and 25 in which he had represented India. The WHO-funded IMPACT had proposed a new definition of counterfeit drugs as medical products with a 'false representation about their identity, history or source'.
Amid uproars from industry and NGOs to boycott the WHO meeting, senior health ministry officials including DCGI and joint secretary in the Union health ministry Debashish Panda had represented the country in the meeting in Bonn. According to reports, the Indian team had successfully argued before the international community in the Bonn meeting that the new definition may pose a threat to sale and export of legitimate generic drugs and should be modified. Reports suggest that WHO has agreed to reframe the definition and the word 'history' would be dropped in the final draft of the IMPACT definition.
Sources said that DCGI Dr Surinder Singh has invited all the major industry associations like IDMA, OPPI, FOPE, CIPI, IPA, SPIC, etc for the meeting on December 24 as the health ministry wanted to discuss the issue with the industry before the new definition is given a final shape by the IMPACT. The issue of giving new definition to counterfeit drugs had created a furore among the industry and NGOs working in the health sector over the intention of such a move by the WHO.
In fact, the Indian industry had termed the move yet another attempt by the big multinational companies to kill the Indian generic drug makers. The Indian drug industry's apprehension was that the new definition will act against it, especially the generic drug manufacturers as the new definition considers apparent 'trademark violations' as 'counterfeiting' cases. 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 mislabelled 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 labelling information'.