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New Delhi: The fear of generic drugs coming under the definition of ‘counterfeit drugs’ is haunting the Indian pharma industry yet again. The domestic pharma industry has urged the government to play a more proactive role in the issue by raising objection to the repeated use of the word ‘counterfeit drugs’ in the World Health Organisation working papers. In one of its latest working papers, released in October, the 44th expert committee on specifications for pharmaceutical preparations of WHO invites suggestions on measures that should be adopted globally against penetration of counterfeit (drugs) into legitimate supply chain while working on proposal for revision of WHO good distribution practices for pharma products.
The pharma industry representatives met the health ministry officials last week and urged them to register the government’s protest to the definition of ‘counterfeit’ used in the paper and the very use of the word ‘counterfeit’ for drugs. First, they want the word counterfeit to be replaced with either ‘spurious’ or ‘sub-standard’, which captures the essence of fake drug in most appropriate terms. The industry has been opposing the term on the pretext that the generic use of ‘counterfeit’ has an in built intellectual property right connotation in it, when applied to any area other than medicines.
The working paper defines “counterfeit pharma product” as ‘a pharmaceutical product which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit pharmaceutical products and may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging’.
While the pharma industry has commended the fact that WHO has not used the ambiguous term ‘history’ which figured along with ‘identity’ and ‘source’ initially in the working definition of ‘counterfeit product’ by International Medical Products Anti-Counterfeiting Taskforce (IMPACT), an initiative under the WHO, the pharma industry still has other objections.
The domestic industry leaders point out that the definition should clearly specify ‘source’ of ‘what’, the finished formulation or the API (Active Pharma Ingredients), the active chemicals used in manufacturing the drugs. “There should be no scope for loose ends in the definition. It should be precise, clear and crisp. Terms that leave the arena open for interpretations can spread misuse by groups with vested interest. The global generic industry cannot afford open ends in the definition at a time when perfectly...
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