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India’s highest advisory body on drugs had discussed a mechanism to end the menace of fake medicines at a meeting recently, according to some reports. According to the proposals discussed at the Drug Technical Advisory Board meeting, consumers will be able to check whether the medicines that they have purchased are genuine by texting a unique code to be printed on the medicine’s package to a number, as per sources.
According to them, the government is planning to initially build a data bank of 300 medicine brands and their consumption pattern in various parts of the country. “Drug companies will then be asked to print a unique 14-digit alphanumeric code on the package of the drug. Consumers buying the medicine can then inquire via a text message whether the code—and therefore the medicine—is genuine or not,” the sources said.
This is an excellent initiative by the Indian Government to fight fakes. In India, serialization is already mandatory for exports medicines. While in the past industry had expressed concerns regarding the investment involved in implementation of an anti-counterfeiting system, solutions are available today to cater to all budgets, and this should no longer be considered an obstacle to adoption of a solution.
The silver lining: Serialization
When implementing a serialization system, pharmaceuticals have various issues to keep in mind. There are several challenges in achieving true serialization in the pharma supply chain. Serialization is more than a simple print and apply process of a label to a product. The challenge with serialization, especially in a price-competitive market like India, is ensuring affordability for small-scale industries that may have to make investments in hardware to implement serialization regulations.
Tamper verification
Indeed, while serialization verifies the authenticity of the pack of medicine, counterfeiters can easily collect used genuine materials and refill them with fake drugs, re-closing the original packaging and passing the product off as genuine. This has been seen in China, where counterfeiters obtain genuine boxes from patients leaving pharmacies. This reinforces the need for a multi-layered security approach, to provide protection for both the packaging and the contents inside. Tamper verification shows whether the packaging has been opened or altered since it left the manufacturer, ensuring that the content of the packaging is authentic. It provides the end user with confidence, allowing them to personally judge that the product they are opening is genuine and originates from the legitimate manufacturer. Anti-counterfeiting technologies like security hologram play a vital role in protecting packaging from tampering as well as important authentication tool at various levels for consumers, enforcement and drug manufacturers. Security hologram can be used and integrate with cartons, tapes or specialist labels.
Layered approach: Authentication plus traceability
Diversion of legitimate product outside authorized distribution channels is another problem. The optimal approach to protect against counterfeiting will include both serialization and authentication solutions which can help stop re-tampering of product provide tamper verification solutions, thus making it difficult for counterfeiters and the illicit trade to succeed.
A good example of physical and digital security coming together, is European Union Falsified Medicine Directives (FMD) mandate, which requires both serialization and tamper-evident feature. The FMD is designed to protect patients by minimizing the chances of counterfeit medicines entering the established medicines supply chain across Europe. It will enable manufacturers, wholesalers, distributors and everyone who supplies to patients to verify the authenticity of a medicinal product, identify individual packs, and check whether the outer packaging of medicines has been tampered with. It introduces a system to track legitimate medicines from manufacturers to patients. Manufacturers will be obliged to apply safety features to each pack: a tamper-proof security seal and a 2D barcode. The pharma brand owners can refer ISO standards DIS 21976 to understand the requirement of tamper verification features on medicinal products packaging.
The layered approach is always better. As an authentication association, we are committed & continuously working to provide cost effective new generations anti-counterfeiting solutions to brand owners. In the last year, ASPA had started a series of programs such as “Make Sure India” and “Brand Protection Awareness Program” for brand owners across the country. We are ready to work as brand partners with pharmaceutical manufactures to curb this menace and together we can.
There are no fool proof processes or systems. There, are however, complexities within processes and systems that can deter the professional and not-so-sophisticated counterfeiters. There are two primary objectives: one is to provide, safe, genuine drugs to patients while protecting the revenue stream of the brand / pharmaceutical drugs manufacturers and the second of course, is to nab the culprits in the system.
(The author is, Secretary, ASPA)
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