The DCGI has asked the industry to give its inputs on the new WHO proposal on giving new definition to counterfeit drugs which was discussed at the Bonn meeting held last month. Senior health ministry officials including DCGI had represented the country in the meeting in Bonn, Germany
As per the new definition discussed at the WHO meeting in Bonn, "A medical product is counterfeit when there is a false representation in relation to its identity or source. This applies to the products, its container, or other packaging or labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components, with wrong ingredients/components without active ingredients, with incorrect amounts of active ingredients, or with fake packaging. Quality defects or non-compliance with Good Manufacturing Practices/ Good Distribution Practices (GMP/GDP) in legitimate, authorized medical products should not be confused with counterfeiting. e.g. (1) any misleading statement with respect to name, composition, strength or other elements, (2) any misleading statement with respect to manufacturer, country of manufacturing, country of origin, marketing authorisation holder, including use of falsified documentation in the manufacture or trade of the product, (3) this refers to ingredients or any other components of a medical product."
The Indian team appears to have made some headway in the Bonn meeting to express the concerns of the Indian pharma industry as the WHO-IMPACT has agreed to reframe the definition and the word 'history' has been dropped in the new IMPACT definition.
Earlier, the Indian industry had taken objection on the word 'history' in the new definition. 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'.
Briefing the industry on the WHO proposal on the issue discussed at the Bonn meeting, DCGI Dr Surinder Singh asked the industry to give its inputs by January 5. The meeting was attended by all the major industry associations like IDMA, OPPI, FOPE, CIPI, IPA, SPIC, etc. After getting the industry response on the issue, the Indian government has to submit a report to the WHO on the issue in the WHO's executive committee meeting on January 19 to 27.
Meanwhile, the industry has welcomed the DCGI's move to evolve a consensus on the issue. "It is a welcome move by the DCGI to involve the industry in this sensitive issue and it will go in the interest of the Indian pharma industry and the country as a whole," said FOPE co-chairman Vinod Kalani.