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 genuine Indian generics have faced 18 seizures in the EU in last one and half years,? said a stakeholder actively involved in pursuing Indian generic industry?s interest in the global fora.
The domestic industry representatives feel when the definition uses correct ingredients and fake packaging, it makes generic drugs susceptible to seizures, which cause delays, monetary losses, and defamation of the Indian pharma industry, even if the industry is proven right at the end.
?For instance, many generic drugs have similar sounding names to their generic counterparts, which could create suspicions on part of the countries which are neither source or destination but fall en route. Also, fake packaging involves misbranding issues, which implies generic drugs would be always under threat,? said the source.
The industry feels that, earlier, this definition worked as generic producers didn?t pose formidable business threat to Big Pharmas, but times have changed and the definition needs to evolve with time. ?Office bearers within IMPACT and WHO have publicly acknowledged the need to stop using ?counterfeit? for drugs in their medium-term goals in meetings last year and this year. The WHO South East Asia Regional Office passed a resolution emphasising the need to separate issues related to intellectual property enforcement from the safety, quality and efficacy of medicines.?
Even IMPACT agreed on the following in its third general meeting in December 2008, ?Violations or disputes concerning patents must not be confused with counterfeiting of medical products. Medical products (whether generic or branded) that are not authorised for marketing in a given country but authorised elsewhere are not considered counterfeit. Sub-standard batches of, or quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices (GMP/GDP) in legitimate medical products must not be confused with counterfeiting?.