Visibility is of the utmost significance when it comes to the global supply chain, which is a truth that cannot be denied. The sheer amount and complexity of the data that is involved in global commerce might very well open doors to theft, fraud, and counterfeit products. However, there is another reality that must be taken into consideration.
Over the course of the last several years, the pharmaceutical industry has been subjected to a substantial amount of scrutiny due to the fact that many counterfeit pharmaceuticals ultimately make their way into supply chain pathways that are legal.
In accordance with the globe Health Organization (WHO), over $83 billion worth of counterfeit medications are marketed all over the globe each and every year. Ten percent of the medical items that are sold in countries with low and moderate incomes are either counterfeit or of a lower quality than what is considered acceptable. In addition, it is important to keep in mind that counterfeit items could have an incorrect combination of components or even entirely different components and components. Additionally, there is the possibility that the data on their packaging has been falsified, or that the pharmaceuticals or equipment may have been manufactured in an environment that does not comply with the Good Manufacturing Practices that have been established by the World Health Organization (WHO).
As a matter of fact, it is an issue that, in severe circumstances, may end up being the difference between life and death. Within the supply chain, international logistic providers have a responsibility to identify counterfeit goods as soon as they can. This obligation requires them to detect fake goods as soon as possible. In this context, transparency is an important concept to consider. When it comes to the participants in the supply chain, a network that continues to provide visibility throughout not only helps to cultivate consumer confidence and trust, but it also assists them in being in sync with the stricter rules that are being implemented.
The process of serialization
Over the course of many decades, there have been several attempts made to control the problem of counterfeit medical items that is prevalent in the market. When this is taken into consideration, the inelastic demand for the product renders it very vulnerable to counterfeiting.
Positive outcomes have been achieved as a consequence of recent countermeasures taken to address the issue. Serialization, which is a one-of-a-kind serial number that is assigned to every single unit of a pharmaceutical product that is available for sale, has made it much simpler to identify, monitor, and eliminate counterfeit medications from the supply chain. This has been done with the intention of improving the safety of patients.
With pre-packaged medications and ingredients originating from suppliers that are mostly located in other countries, the items are sourced, then tested, and lastly produced before being shipped across several locations and supply chains. This process takes place before the products ultimately reach their final destination. The purpose of serialization is to prevent potential dangers by determining the genuineness of the drug and, more crucially, to make it easier to recall the product when it is required to do so. Having said that, the majority of the standards are not meant to be enforced in every single country across the globe, which means that it is not exactly a stroll in the park for supply chains that are complicated.
It is important to note that government authorities and local authorities have gone on to make serialization laws an obligatory component of the customs procedure for pharmaceutical products. As a result, any sort of holdup might go on to have an impact that is not ideal on the supply chain as a whole.
Significantly, several parts of the globe have been champions of serialization of pharmaceutical products for a considerable amount of time. The European Union (EU) contains laws that are quite stringent, such as the directive on counterfeit pharmaceuticals that was enacted in 2011. The United States of America, on the other hand, has gone on to implement its Drug Quality and Security legislation in 2013. This legislation makes it mandatory for manufacturers and trade partners to have electronic traceability systems that are functional for pharmaceutical medications beginning in November of this year.
In recent times, countries located around the Middle East have also begun the process of introducing their own individualized serialization systems. As an example, the National Health Regulatory Authority in Bahrain has successfully implemented a blockchain-based traceability hub that works from beginning to end for pharmaceutical products. This hub is the first of its type in the Gulf region. Tatmeen, on the other hand, is a highly sophisticated track and trace platform for pharmaceutical and medical goods.
Over the course of the last few months, a number of nations, including Kazakhstan, Uzbekistan, and Brazil, have made it mandatory for pharmaceutical items to comply with serialization systems and procedures via the implementation of mandatory practices. In the case of logistic partners, it is essential to not only get familiar with the regulatory spectrum but also to comply with it in order to maintain a high degree of openness when it comes to the supply chain.
The process of digitalization
When technology and digital systems are used in an efficient manner, it is possible to make the process of navigating turbulent seas far less difficult. The reality of the matter is that investments in technology have the potential to improve the tracking and tracing capabilities of pharmaceutical items. This would result in the elimination of counterfeit goods from the distribution network and would also assist in the progression of the supply chain.
Specifically, technology has the potential to guarantee the achievement of a worldwide and benchmarked approach to serialization, which is an important aspect to consider. Connecting serialization data inside a single database may ensure that countries all over the globe are in compliance with rules. This is especially important in light of the fact that several nations are imposing their own legal frameworks to combat the production of counterfeit prescription products.
As a result of the data being saved on cloud servers, which are instantly available, all of the stakeholders in the supply chain, including distributors, producers, and logistic service providers, have complete insight into the product at any given moment, regardless of where it is located. In addition to this, other verticals such as food and beverage, tobacco, and fast-moving consumer goods are now striving to meet the same regulatory requirements. As a result, information about the working of serialization may be used to assist operations that are of a similar type.
The transparency of the supply chain is increased via digital platforms. In a time when the regulatory environment is very stringent and complicated, they have the potential to make it possible for partners in the supply chain to continue to enjoy the trust of consumers.
One thing that is noteworthy is that the expectations of consumers have shifted over the course of the previous several years, particularly during COVID-19. Serialization and digitalization are both making significant progress toward the goal of guaranteeing that the pharmaceutical supply chain is entirely secure, encased, and transparent at the same time.
