The Indian Pharmaceutical Alliance (IPA) has urged the DCGI to exclude infringement of patent rights, parallel importation of original goods from a third country where they have been sold by the appropriate right-holder and the diversion of supplies of authorized items from the scope and definition of counterfeit medicines.

Union Health Ministry is making efforts to give a new definition to counterfeit drugs as per the proposal of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO. In this regard, the DCGI had convened a meeting and asked the industry to give its suggestions.

Giving its suggestions to the DCGI, the IPA said that since the focus of the issue is on public and personal health implications of use of counterfeit medicines, the new definition should not include infringement of patent rights, parallel importation of original goods from a third country where they have been sold by the appropriate right-holder and the diversion of supplies of authorized items.

Calling upon the developing countries to unite at the WHO to establish one and uniform definition of counterfeits for medical products, the IPA has said that the IMPACT background document had defined its scope and stated, 'the focus of these principles is on public and personal health implications in relation to counterfeit medical products.' Therefore, it should not address infringement of aspects of intellectual property rights (IPR) related to patent rights, or parallel importation of original goods from a third country where they have been sold be the appropriate right-holder and explicitly cover other illegal activities such as diversion of supplies of authorized medical products, or theft of authorized medical products.

The IPA suggests that the WHO defines counterfeit medicines as 'medicines which are deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with wrong ingredients, without active ingredients or with insufficient active ingredients'. The problem with this definition is that it clubs 'substandard' medicines with 'counterfeit' medicines.

The IMPACT defines 'a medical product as counterfeit when there is a false representation in relation to its identity, history or source. This applies to the product, its container, packaging or other labeling 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'. The problem with this definition is that besides clubbing 'substandard' with 'counterfeit', it adds a new dimension to definition by inserting the word 'history' without being specific. This raises concerns of the public health activists and the generic industry that it may be interpreted in a manner that will create barrier to generics, IPA said.

The EU Council Regulation (EC) No. 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights had included 'goods which, in the Member State in which the application for customs action is made, infringe a patent under the Member State's law'. However, as the counterfeit relates to violation of trademark and not to patent infringement, the scope of the provision exceeds focus on counterfeits.

The SECURE seeks to extend the scope of Customs IPR legislation from trademark and copyright to 'other intellectual property rights' (Re: Standard 2 read with Para 1 of Introduction: Working Draft, 13 February 2008). The intention is obviously to bring patent infringement under its purview.

The USTR initiative for Anti Counterfeiting Trade Agreement (ACTA) endorsed by G-8 is aimed against all types of counterfeits namely books, CDs DVDs, pharmaceutical products, etc. The agreement addresses three primary areas, such as strengthening international co-operation, improving enforcement practices and providing a strong legal framework for intellectual property enforcement. The use of 'intellectual property' instead of 'trademark' or 'copyright' is a matter of concern for the public health administrators, activists and the generic industry as it suggests enlarging the scope of anti-counterfeiting activity.