Disclaimer

Serialization and Traceability

Q : What is Pharmaceutical Serialization? 
The concept of Serialization is simple – allocate a unique identifier (UID) to each package of medicine at the primary (blister pack, aluminium foil, bottle, etc.), secondary (mono carton, multi carton) or tertiary (shipper pack) levels. Often, relationships are created across levels, creating a parent child hierarchy which is stored in a database and accessible at any time. This facilitates tracking and tracing of these medicines as they move through domestic or global supply chains, with authentication / verification / registration at each point in the supply chain.

Q: Why is it needed?
Allocation of a UID to each package prevents a counterfeiter from infiltrating the supply chain with spurious drugs, which would of course either not have the identifier or have a fake identifier that would not pass verification. This not only gives regulators the assurance that every medicine being sold to consumers within their jurisdictions is safe and from a verified source, but also empowers consumers to check for themselves using multiple channels like SMS, web interface, mobile application or a call centre.

Q : Are there any standards or regulations around it?
Countries around the world have passed regulations requiring serialization on all drugs being distributed within their markets:

India, Drugs Authentication and Verification Application (DAVA): In India, the Directorate General of Foreign Trade passed a regulation in 2011 requiring all drug exporters to implement serialization and track-and-trace on primary, secondary and tertiary levels of packaging. This regulation has already been implemented on the tertiary level in 2011, the secondary level in 2013, and is slated to be in effect on the primary level in 2015. Track and trace and government reporting requirements are expected to follow in the coming years. The Indian Government have made a portal for Indian Drugs Authentication, Track and Trace called Drugs Authentication and Verification Application (DAVA).

USA, Drug Supply Chain Security Act (DSCSA): The DSCSA enhances the security of the pharmaceutical supply chain by establishing a national system for tracing and serializing pharmaceutical products and for establishing national licensing standards for wholesale distributors and third-party logistics providers.It was signed into law by President Obama in November 2013, setting in motion a process that within ten years will see product identification, tracing and  verification as well as detection and response processes for prescription drugs in the U.S. supply chain. (Source: fda.gov)

European Union, Falsified Medicines Directive (FMD) :  The European Union passed the FMD in 2011 requiring, among other things, authenticity features on outer packaging of medicines. This directive is in the process of being transposed into national law by EU member states, and will be implemented in the coming years.

Other countries with similar regulations in or about to be in effect include Brazil, China, South Korea, Turkey and Saudi Arabia.

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While many of these regulations require GS1 standards of Bar coding to be used for serialization, some have adopted proprietary standards. This can have the effect of requiring a drug exporter to comply with different standards with potential for implementation complexity on manufacturing lines. Simplicity and reliability of the technology used for compliance is therefore essential.

Q: How is it implemented?
Serialization implementation has a few components:

Format of the UID: The UID is a number or alphanumeric string of varying length (for example, GS1 standards call for it to be upto 21 characters long). It can be sequential (e.g. 0001, 0002, 0003, etc.), but for extra security, we recommend random alphanumeric strings with no pattern that can be used by a counterfeiter to replicate the system.

Representation of the UID: The UID can be represented as human readable text that is printed directly on the package or on a scratch-off label that is affixed to the package. It can also be encoded into a 1-D or 2-D barcode that is printed on the package and read by a scanner or a mobile phone app. Other representations such as RFID are also possible depending on the particular implementation for which serialisation is required.

Printing of the UID: The UID is printed directly on the package (as human readable text or as a barcode) using a commercial printer, usually a continuous inkjet, thermal inkjet or laser printer. The particular printer of choice depends on resolution requirements, printing speeds, cost, space available and other factors. There needs to be a secure system for generation of the UID, transmission to the printer, printing on the package and feedback in order to create parent-child hierarchies and record rejections.

Verification of the UID: The UID can be verified using an SMS gateway, a mobile app, a website, a call center, social media or other methods depending on availability and cost.

Tracing of the UID through the supply chain: Each time the coded package passes a point in the supply chain, such as a wholesaler, a distributor, a shipping port, a retailer, etc., the code on the particular package can be registered using one of the above-mentioned means. These events, taken together, constitute a complete record (Tracking) of the movement of the drug package, which can be stored and provided to regulators or other stakeholders, and investigated(Tracing) in cases of any reported issues.

Q. What is Traceability / Track and Trace?
Traceability/Track and Trace – the complementary use of serialized data. Tracking pharmaceuticals allows each stakeholder to identify the current owner of the product and the pathway the product must take to get to its current location. Tracing pharmaceuticals means recreating the path of a product, from the manufacturer to the current entity/owner. Tracing systems identify where the product has been and which entities have had ownership of the product.

Q: I am doing serialization / track and trace solution, then why I need 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, reclosing 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 must include both serialization and authentication solutions which can help stop re-tampering of product provide tamper verification solutions, thus making it as difficult as possible 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 spurious 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 also 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. 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 always two primary objective one is to provide, safe, genuine drugs to patients while protecting the revenue stream of the brand / pharmaceutical drugs manufacturers and second of course, is to nab the culprits in systems.