Challenges of Global Track and Trace in the Pharma Industry

What are the main challenges of global track and trace?

The challenges of global track and trace remain important because, as we have previously talked about, the ultimate goal of serialization and track and trace technology is to create a global pharma network. In an ideal future, medicines would be fully traceable no matter where they are. This would spell doom for international counterfeiters and create a safer and more transparent industry, benefiting both businesses and their customers.

Unfortunately, the road to achieving this is long and difficult yet. Obstacles remain that halt the progress of both individual and collaborative serialization projects. These challenges persist not only in the process of implementing serialization and track and trace systems but linger for a while afterwards, too.

In this article, we will discuss these challenges and take a look at what ultimately needs to be either solved or worked around in order to achieve a truly global serialization and tracking system. Solutions will be provided where possible but know that there simply are not many easy ways to tackle many of these issues as of yet.

1. Diverse regulations across different countries

One of the most obvious challenges of global track and trace implementation is that most countries have different compliance requirements for meeting serialization and track and trace standards. Some of these are similar but some of them can vary wildly. The 2023 DCSCA deadline features a different set of demands for companies to meet it than similar deadlines from the EU FMD, for example.

This presents a big challenge for manufacturers. What is the best approach to take? Trying to cater to every market individually can leave them spreading too their effort too thin and sacrificing other aspects of production such as packaging quality. On the other hand, consolidating every country’s compliance requirements into a single set of rules might be too reductionistic and leave certain unique needs of specific nations and markets unmet.

2. The limitations of IT infrastructure 

Although technology has come a long way and revolutionized the field of pharma serialization, there are still certain obstacles that remain to a truly globalized track and trace system. Alongside storage upgrades, integrated AI technology, and even the use of blockchain, there remain issues with globalizing the way IT equipment is currently employed in the pharma world.

The software used across different countries to perform similar tasks can vary widely. The formats they use for storing data can also sometimes be mutually incompatible. Without a massive adjustment of all or at least some of the big players in the global pharma world, the challenges of global track and trace persist. This is all not to even mention the varying requirements for different technologies in the first place, depending on market size and reach.

3. Packaging design and dosage norms

Different places in the world have different norms when it comes to the design of the packaging of medicines. Some countries vary widely, from using plastic cups to simple, 10-piece pallets per pack. Even the exact same chemical compound can look completely different from the outside. While this may not present a strictly practical issue compared to the other challenges listed here, it can certainly cause confusion.

Standard dosage can also vary by country and can create more confusion. This can be solved by more carefully reading the instructions and information on meds, of course, but an ideal system would not purely rely on that to ensure patient safety.

4. The need for trust and transparency

For such cooperation to happen on a global scale, there needs to be greater trust and transparency between nations when it comes to their pharmaceutical production, practices, and requirements. Currently, some transparency does exist, especially between countries with strong international cooperation, but it would have to be greatly expanded upon.

The reason this is one of the most pressing challenges of global track and trace efforts is that it directly reflects on things such as how much countries are willing to match and consolidate their track and trace practices or make their IT systems more compatible.

5. Integration with existing systems

The serialization and track and trace systems of the future will not exist in a vacuum. They will be implemented into a world full of existing infrastructure for controlling the production, transportation, and selling of medicines.

This is why care has to be taken when thinking about integration practices. When speaking on a global level, fairness needs to be accounted for. Countries who feel that the new system the worldwide community wishes to select as the norm requires too much time and resources to change might be turned off from the idea altogether. The alternative idea of wiping the slate clean and starting from scratch is also tempting, although will result in an even greater loss of resources worldwide, which flies in the face of global sustainability efforts.



In conclusion, then, it is worth pointing out that the challenges of global track and trace are both present and not simple to surmount. It is probable that a truly global serialization and track and trace setup will not happen in this decade. That said, there are already efforts towards this goal and the system we have today is far from fragmented. For example, the EU has a standardized set of requirements across all of its members (minus the exceptions (insert link here when that blog article is published)) and many countries are trying to at least somewhat adapt their track and trace practices to be more applicable to other places. If nothing else, it is good for business to be able to export products with less effort.

For those of you who have read this article and are looking for ways to improve your pharmaceutical operations, then we at Nubinno are here for you. Read up on some of our other articles or get in touch with us to gain use of powerful service packages we have such as Assessment and Accelerator.


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