Disclaimer

Serialization and Traceability

Question : What is Serialization? 
Answer: The concept of Serialization is simple. In pharmaceutical serialization it is allocating 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. For more read Serialization for Pharmaceutical Industry: An Overview.

Question: Why serialization is needed?
Answer: 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.

Question : Are there any standards or regulations around it?
Answer: It is estimated that by 2020, more than 75 percent of the world’s pharmaceutical supply will be under serialization regulations.  The United States, the European Union, Argentina, Turkey, Saudi Arabia, India, Russia, Brazil, China, South Korea amongst others, already have or are in the process of implementing regulations.  Several other countries are evaluating how best to protect their patients against the scourge of counterfeiting. Even without regulations, leading companies around the world are adopting serialization as a tool to protect their brands and secure their supply chains.  Whether you are a brand owner or a regulator, taking those first steps in the serialization journey can be daunting.

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). To read the guidelines, please click.

USA, Drug Supply Chain Security Act (DSCSA): The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Read the Drug Supply Chain Security Act. Find a list of DCSCA policy documents and FDA’s implementation plan. Additionally, read the key provisions of the law and find out if you are ready for DSCSA’s requirements.

European Union, Falsified Medicines Directive (FMD) : Following adoption by the European Council and the European Parliament, the Falsified Medicines Directive (Directive 2011/62/EU)  was published on 1 July 2011, and applies since 2 January 2013. It amended Directive 2001/83/EC . This Directive introduces harmonised European measures to fight medicine falsifications and ensure that medicines are safe and that the trade in medicines is rigorously controlled. Measures include:

  • Obligatory safety features  – a unique identifier and an anti-tampering device – on the outer packaging of medicines
  • A common, EU-wide logo to identify legal online pharmacies
  • Tougher rules on import of active pharmaceutical ingredients
  • Strengthened record-keeping requirements for wholesale distributors.

China Serialization Program: The China National Drug Administration (CNDA) is working on a new implementation of serialization guidelines. A first attempt at traceability was suspended in 2016. China’s first serialization plan intended a 20-digit serial number for all products sold domestically, at the individual, bundle, box and pallet level. This serial number was assigned by the government. The data had to be manually uploaded to a platform that could only be accessed from China itself. Furthermore, the code did not conform to the GS1 standard, which is the case in all other international serialization requirements. Due to the large number of complications, implementation was discontinued, and working on a new draft began.

The new proposal on traceability is said to be implemented by 2020. When setting up a new collaborative platform, MAHs should primarily implement the requirements of the drug authority in cooperation with third-party providers. Traceability must be possible from the manufacturer to the end purchaser. Furthermore, the new Drug Traceability Code (DTC) is to consist of letters, numbers and symbols and contain information such as the name of the manufacturer, dosage form, date of manufacture and expiry date.

The new system is to be completed by 2020 and traceability is to be gradually implemented by 2022. Currently, the documents on China’s new serialization draft are only available in Chinese:

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

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.

Question: How is it implemented?
Answer: 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.

Question. What is Traceability / Track and Trace?
Answer: 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.

Question: I am doing serialization / track and trace solution, then why I need tamper verification?
Answer: 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.