Appaji said the current definition of counterfeit medicines by the World Health Organization (WHO) and the one proposed by the WHO-backed International Medical Products Anti-Counterfeiting Taskforce (IMPACT) is leading to such interpretation of in-transit drug consignments from India.
He also claimed that the WHO-IMPACT initiative to combat counterfeiting, which WHO identifies as a serious public health threat, is being used as a shield to protect intellectual property rights.
The European Commission’s spokesperson for taxation and customs, Maria Assimakopoulou, said by email that the issues could not be discussed in detail “as cases are still ongoing in national courts”.
Assimakopoulou also said that “in the EU, customs are empowered by community customs legislation to detain goods that are suspected of infringing a variety of intellectual property rights, including possible trademarks, patents, copyrights... infringements”.
Lack of clarity
Surinder Singh, drugs controller general of India, told Mint that the issue has been taken up with the European authorities concerned. However, he said lack of clarity among enforcing authorities about the correct definition of counterfeit drug is leading to such seizures.
“You should always have a regulatory person to be a part of the oversight. Otherwise the police and the customs will not be equipped to interpret whether it is a counterfeit or not to the extent to which it is required,” Singh said.
Responding to an emailed query, Hans V. Hogerzeil, director of essential medicines and pharmaceutical policies at WHO, said: “The stoppage of generic medicines at European borders is solely based on the European legislation and regulation with regard to counterfeits. This is not dependent on any definition by WHO or by the IMPACT partnership.”
Hogerzeil said, “The WHO and IMPACT definition... is focused on the public health aspects of counterfeit medicines and specifically excludes the misuse of the definition to exclude or hamper the trade in genuine approved generic products.”
WHO defines counterfeit medicines as “medicines which are deliberately and fraudulently mislabelled with respect to identity or source.” It covers both branded and generic products with the correct ingredients but fake packaging, with wrong ingredients, without active ingredients or with insufficient active ingredients.
The key change in the proposed IMPACT definition is that it drops the phrase “deliberately and fraudulently”, adds the term “history” along with identity or source, and changes “fraudulently mislabelled” to “false representation”.
Generic seizure
A consignment valued at some $100,000 (Rs49 lakh) of Ind-Swift in transit for Venezuela was seized in November by customs authorities in the Netherlands under suspicions of being counterfeit.
The product was the generic drug pantoprazole, used for treating ulcers, in the form of pellets that were to be filled in capsules and sold in Venezuela, where Indswift has marketing rights for it.