Global Harmonisation Efforts for Track and Trace

Its function of monitoring and documenting the journey of medicines, drugs, and medical products through the supply chain, from manufacturing to distribution and ultimately to the end consumer, ensures their authenticity, safety, and integrity.

This is so vital because the pharma sector is directly responsible for saving and prolonging the lives of hundreds of millions, if not billions of people across the planet. Therefore, no chances can be taken when it comes to the safety of the drugs they rely on.

Many people would, therefore, be forgiven for assuming that the strict regulations governing track and trace for the pharma sector in Asia are the same as the rest of the world i.e. they are based on a uniform, standard set of guidelines used by every pharma manufacturer in every country.

However, the truth could not be more different.

The current regulatory situation in Asia, Pharmaceutical track and trace regulations in Asia, as in the rest of the world, vary by country, each implementing measures to ensure the authenticity, safety, and integrity of pharmaceutical products.

Key country-specific legislation includes:

CHINA China Drug Administration Law:

• Updated in 2019, it mandates stringent track and trace requirements for pharmaceuticals.
• National Medical Products Administration (NMPA): Oversees the Drug Administration Law enforcement.
• China’s Drug Master File (DMF): A centralised electronic tracking system.
• Serialisation Requirements: Unique identifiers for each saleable unit, including 2D barcodes containing product code, serial number, batch number, and expiration date.

INDIA India’s Directorate General of Foreign Trade (DGFT):

• DAVA (Drugs Authentication and Verification Application): Implements the track and trace system for both domestic and export pharmaceuticals.
• Serialization Requirements: Mandated for primary, secondary, and tertiary packaging levels, including 2D barcodes and a unique number for tracking.

JAPAN Japan’s Ministry of Health, Labour and Welfare (MHLW):

• Track and Trace System: Emphasises the use of GS1 standards.
• Serialisation: Unique product identifier (GTIN), serial number, batch number, and expiry date in a 2D DataMatrix barcode.
• Drug Traceability Guidelines: Ensure the integrity of the supply chain.

SOUTH KOREA Korea Ministry of Food and Drug Safety (MFDS):

• Korea’s Pharmaceutical Affairs Act: Requires serialisation and tracking at various packaging levels.
• Serialisation Requirements: GTIN, serial number, and batch number encoded in a 2D barcode.
• Electronic Drug Monitoring System (EDMS): Tracks pharmaceutical products through the supply chain.

THAILAND Thailand’s Food and Drug Administration (Thai FDA):

• Track and Trace Implementation: Regulations are under development to align with global standards.
• Serialisation Requirements: Expected to follow GS1 standards for unique product identification.

INDONESIA Indonesia’s National Agency of Drug and Food Control (BPOM):

• Track and Trace Regulations: Ongoing efforts to implement comprehensive track and trace systems.
• Serialisation Requirements: GS1 standards for unique identifiers on packaging levels are being adopted. Almost conspicuous by its inconspicuousness, there is not a single piece of legislation covering pharmaceutical track and trace that is mandatory for Asian countries. The same is also true for countries across all continents.

The nearest thing is GS1, which provides a comprehensive framework for identifying, capturing, and sharing information in the pharmaceutical supply chain. However, the major stumbling block for GS1 is that the standards are not mandatory—it is up to individual countries and industries to adopt them, although we do see a high take-up from countries across Asia.

Against such evidence, surely, the time must be right to introduce a unified, comprehensive set of global regulatory track and trace standards?

Commonalities across Asia

Although there is no common legislation covering Asia, a start has been made of sorts, with various common themes applicable to all countries.

Most countries require serialisation involving unique identifiers at various packaging levels, with each country having a designated regulatory authority overseeing the implementation of track and trace systems.

Furthermore, many countries adopt GS1 standards for barcoding and product identification, with centralised databases and electronic tracking systems commonly used to monitor the movement of pharmaceuticals through the supply chain. There is also a strong focus on counterfeit prevention to prevent counterfeit drugs and ensure patient safety by enabling the verification of product authenticity.

Key drivers for harmonisation

Harmonisation in pharmaceutical track and trace is driven by many reasons.

Arguably, the chief one is to provide a global standard for tackling counterfeit drugs, an issue which remains a significant global problem, posing serious health risks to consumers. Harmonised track and trace systems make it easier to detect and prevent counterfeit products from entering the supply chain, ensuring that only genuine products reach patients.

A common global system would also ensure that all pharmaceutical products, regardless of where they are manufactured or distributed, meet consistent safety and quality standards. This will protect patients by ensuring that they receive safe and effective medications.

Another key driver is to enhance overall supply chain efficiency. Global harmonisation simplifies supply chain operations by reducing complexity. Consistent processes and standards across different regions reduce the risk of errors and inefficiencies, leading to a more streamlined and cost-effective supply chain.

A global track and trace standard would also help to leverage technological advancements, reduce costs, support public health initiatives, and foster stakeholder collaboration.

Overall, this is a big list – but one that will collectively enhance the integrity and reliability of the global pharmaceutical supply chain, ultimately benefiting both the industry and consumers.

Technological challenges for harmonisation

However, global harmonisation in pharmaceutical track and trace faces several technological challenges that must be addressed.

Some of the key challenges include the issue of interoperability and Integration. Different regions and companies use various systems and technologies for track and trace. Some also use much older, pre-digital machinery that sits alongside the latest, cloud-driven smart machinery. Ensuring these systems can communicate and exchange data seamlessly is a significant challenge. Moreover, variations in data standards, formats, and protocols across countries complicate the integration of track and trace systems.

Another problem is presented by the issue of scalability. The pharmaceutical supply chain generates vast amounts of data. Systems need to be scalable to handle this volume while maintaining performance and accuracy. Furthermore, adequate network infrastructure is essential to support the real-time tracking and tracing of pharmaceutical products. Variability in network capabilities across regions can hinder scalability.

There is also a lack of uniform standards. The absence of universally accepted technical standards for serialisation, and data exchange creates inconsistencies and inefficiencies. While technologies like RFID offer potential benefits, their adoption is inconsistent, and integrating them with existing systems can be challenging.

Cost is also an ongoing issue. The financial investment required to develop, implement, and maintain advanced track and trace systems can be substantial, particularly for smaller companies and developing countries. In a similar vein, there is a need for skilled personnel to manage and operate these complex systems. The shortage of technical expertise can be a barrier, especially in less developed regions.

Ensuring the accuracy and integrity of data throughout the supply chain is also critical. Inaccurate data can undermine the effectiveness of track and trace systems. The real-time synchronisation of data between various stakeholders is essential but challenging, particularly when dealing with cross-border transactions.

Next steps

The challenges given above might seem daunting to solve.

However, the pharma sector is intrinsically linked to the health and wellbeing of the global population. With regulated track and trace being one of the only ways to guarantee the authenticity and provenance of a drug, surely the rules of how track and trace is carried out should be made equal everywhere?

Surely, this must be the case. We urgently need a standard that is applicable across the entire world. One set of rules, one world, one humanity.

How will this be done? One of the answers undoubtedly lies with technology. AI, smart machines and blockchain are here to stay—and will arguably be dominating the way we work in the coming years.

Governments across the world have a duty to collaborate and implement common, shared standards for track and trace. We need to work together—we have a duty to collaborate and a duty to cooperate.

Conclusion

We all share a planet, and we will all, at some point in our lives, require medication or a drug to improve our quality of life.

While we might take it for granted that the drug we are taking is genuine and will help us rather than harm us, for many people across the world this is not always the case thanks to the ongoing damage being caused by those who produce fake medicines.

Global harmonisation in track and trace will go a long way to ensuring we are all protected, no matter whether we live in an urban metropolis or are part of an isolated community. The pharma sector needs to join with governments and regulators to introduce common legislation that will help to protect us all – no matter where we live.