Pharmaceutical Track and Trace Solutions
Pharmaceutical track and trace is the most common digital-based technology which is used to combat drug counterfeiting. Many people cannot access efficient treatment in the countries which do not benefit from this system, and the countries also have difficulties coping with health spending. The increasing number of patients compared to the steady growth in the world’s population and the increasing pharmaceutical product sales over the internet have made counterfeiting in the industry to an incredible extent. According to the statistics from Statista, the turnover of the global pharmaceutical industry in 2019 is $ 1.25 trillion. Additionally, according to data obtained from the International Institute for Drug Safety in Statista, counterfeit drug traffic has increased by about 69% over the last 5 years. What is more crucial than the economic reflections of this terrifying rate is the health loss of people who cannot be cured. According to the statistics from World Health Organization (WHO), counterfeit drugs risk 100 thousand to 1 million humans’ lives every year.
In order to combat drug counterfeiting, the pharmaceutical industry and countries’ health authorities started making pharmaceutical track and trace technology a global standard in the early 2000s. The practices that can be named as pharmaceutical track and trace have started to take place in the literature. After the implementation of the first large-scale pharmaceutical track and trace project in Turkey in 2010, many countries and entities such as the European Union, the United States of America and the Russian Federation have included traceability in their pharmaceutical product safety regulations. In these countries, standards developed by global organizations such as GS1 have been adopted and a large part of the supply chain has been ensured by the pharmaceutical track and trace in a very short time period. Although pharmaceutical track and trace solutions are still in their infancy in many countries, they are spreading rapidly all over the world.
The Global Pharmaceutical Track and Trace Regulations
The United States passed the Drug Supply Chain Security Act (DSCSA) in November 2013 so as to prevent drug counterfeiting. The second section of the act is a federal framework that addresses the safety of the supply chain. It is expected to be completed in 2023 to cover the entire pharmaceutical industry.
In the implementation used by the USA, there is no authority where traceability data is stored. That is why all stakeholders have to keep track of the products they own. For the pharma track and trace system that is tried to be implemented in the United States, it can be interpreted as “independent from the authority and managed by the industry” when compared to European and other countries. In short, the pharmaceutical track and trace system used in America operates with a little more self-control logic. More detailed information about the implementation can be found here.
With the Falsified Medicines Directive (FMD) published in 2011, the European Medicines Agency (EMA) started to set the traceability standards of the countries gathered under the umbrella of the union. The regulation had been accepted by the European Nations by 2015. In 2015, the directive clarifying the obligations of supply chain stakeholders was completed. As of 2019, all of the pharmaceutical products have to fully meet the FMD obligations. Until 2025, EU countries with a separate system such as Greece and Italy must be fully compliant with the pharmaceutical track and trace regulation.
According to the directive, a unique 2D code that singularizes each product should be used and a security label should be applied to the product packaging. Besides, the 2D code must contain the batch number, product number, expiration date, serial number, national refund number if requested by other EU countries. In case the code is damaged, this information must also be written in a readable form. Although it may seem a bit complicated, FMD has made significant progress in terms of end-to-end traceability of the supply chain with its advanced pharmaceutical track and trace system.
Russia uses Chestny Znak tracking system for the traceability of various product groups such as tobacco, fur and shoes, including medicines. Registrations to the system started in 2019 for high-cost medications, and as of July 1, 2020, it has become mandatory for all medications.
Unlike the US pharmaceutical track and trace system, the Russian’s system is a central one. Manufacturers, customs, importers, wholesalers, marketers, pharmacies, and patients are the actors of the supply chain. While CRPT is the institution responsible for serialization in Russia, MDLP supervises the circulation of pharmaceuticals and OMS supervises the generation of serial numbers and 2D codes. By applying the 2D code, which includes the global trade item number (GTIN), serial number, crypto key and crypto code, each product becomes singularized. The pharmaceutical track and trace solutions which are used by companies should also be able to apply these standards.
Russia applies a crypto key and crypto code, as well as applying the information required by US and European regulations to the product packaging (GTIN and serial number). Thus, it can identify more data to the product in the pharmaceutical track and trace system in a more secure way.
Turkey, to prevent counterfeiting and fraud by focusing on human health, has conducted a project so as to make pharmaceutical track and trace solutions real on a national scale. The Pharmaceutical Track and Trace System that Turkey uses (ITS) went into action in 2010 with the feature of being the first in the world. The Pharmaceutical Track and Trace System aspires to ensure safe delivery of pharmaceuticals to the consumer, which is the last link of the supply chain.
ITS enables by taking the advantage of using 2D code technology to be aware of the past and current status of pharmaceuticals in the supply chain. All the movement of the product throughout the supply can be tracked by stakeholders.
The Pharmaceutical Track and Trace System, manages conformably with GS1 standarts. The system, which provides traceability by implementing 2D codes into the packages, has largely prevented counterfeiting and tax evasion crimes. A great amount of savings has been achieved under favour of this situation.
Brazilian Health Regulatory Agency (ANVISA) implements a comprehensive pharmaceutical track and trace system throughout the country. All of the pharmaceutical manufacturers involved in the supply chain must comply with the regulations in the National Pharmaceutical Control System (SNCM). After the law on pharma traceability was published in 2009, ANVISA determined the program schedule in 2016. Accordingly, pilot implementation started in 2017 and ended in 2019. After the evaluations, by 2022, it is aimed to be completely traceable through the pharmaceutical track and trace solutions.
Through collecting the data in the supply chain in a central database, SNCM allows authorized stakeholders (manufacturer, warehouse, pharmacy, hospital, etc) to question the database. SNCM provides traceability 2D code printing with GS1 standards. GTIN, ANVISA registration number, serial code, expiry date, batch number must be on the product packaging. Thanks to the internationally compatible pharmaceutical track and trace system, it is aimed to increase exports and most importantly, to protect nearly 215 million Brazilian citizens from counterfeit drugs.
China National Medical Products Authority (NMPA – formerly CFDA) launched digital traceability for sustainable pharmaceutical safety in 2018. By the 30th August of 2020 the NMPA has indicated the implementation start date of serialization and aggregation requirements as the 31st December of 2020. NMPA has carried out studies on the printing features of the codes implemented in early 2021.
China actively uses two types of codes for pharmaceutical traceability. While barcodes with AliHealth eCode are used, QR codes in GS1 standards are also used. New regulations and label applications are progressing through the codes in the GS1 standard. Companies that want to improve their processes in line with regulations attach importance to the use of pharmaceutical traceability solutions.
In 2020, the Ecuadorian government published its regulations on traceability practices. Ecuador, which still works on pharmaceutical safety, has authorized the National Agency for Health Regulatory Control and Surveillance (ARCSA) for pharmaceutical traceability practices. As of November 2020, the National Health Regulation, Control, and Surveillance Agency (ARCSA) which is the authorized body for the pharmaceutical track and trace system, has given 6 months for the identification of products with a traceability code and 9 months for the application of the traceability code on the packaging.
Companies that follow the regulations of the Ecuadorian official authorities have started to enter the implementation phase for pharmaceutical traceability solutions. Accordingly, products should be serialized with 2D code or SSCC barcode in GS1 standards. It is mandatory to include GTIN, lot, serial number and expiry date information. Companies that carry out their processes with pharmaceutical track and trace solutions comply with the regulations of official authorities as well as ensure brand reliability.
The National Department of Health (NDOH) is authorized for pharmaceutical track and trace applications under development in the Republic of South Africa. In the text published in the Official Gazette on 15th September of 2017, it is stated that the traceability requirements will be met with international standards. The details of the data matrix application, which includes GTIN, lot/lot and expiry date for serialization, are also mentioned in the published content.
The deadline given by the South African National Department of Health (NDOH) for pharmaceutical traceability applications is 30 June 2022. Progressing step by step for pharmaceutical traceability applications, official authorities aim to prevent counterfeiting and increase the transparency of the supply chain.
The increase in the number of people whose health is endangered, the spread of counterfeiting and economic losses are causing the spread of pharmaceutical track and trace implementations around the world. Day by day, countries start to use pharmaceutical track and trace implementations, and companies are making efforts to use pharmaceutical track and trace solutions in their process.
Saudi Arabia advanced the pharma traceability process, which it started with SFDA in 2015, by implementing serialization in 2017. Today, the aim is to expand the scope of serialization by targeting the year 2030.
In 2019, the Egyptian authorities piloted the pharma traceability planned by the Egyptian Pharmaceutical Track and Trace System (EPTTS) in 2016. By 2020, the authorities decided to expand and continue the traceability studies in the light of the data obtained from the implementation.
Argentina’s relevant authority, the National Drug, Food and Medical Technology Administration (ANMAT), achieved effective results of traceability practices in product groups in 2013. In line with the results, it expanded its serialization practices in 2015.
In India where fraud has reached serious levels, the National Information Center (NIC) has designed a pharma tracking system called Drug Authentication and Verification Application (DAVA), which is GS1-compliant. In 2011, serialization was made for export for the first time. India, which provides traceability with 2D code, has made significant progress with pharmaceutical track and trace solutions in preventing counterfeiting today.
Countries such as Ukraine, Japan, South Korea, Indonesia, Malaysia, Pakistan, Qatar, the United Arab Emirates, and Jordan have also implemented as a pilot scheme or implemented traceability technologies extensively. Countries that have identified a key role in preventing counterfeiting have started to use traceability technologies effectively.
Serialization methods differ due to reasons such as legal regulations of countries and distinctions in cartons. The scope for serialization is global GS1 standards. With its experience gained in Turkey, VISIOTT has improved its solutions to cover the pharmaceutical track and trace system regulations of other countries, especially the USA, EU, Russian Federation, Brazil, Saudi Arabia, following the requirements of GS1. VISIOTT is one of the rare global companies that has successfully realized the serialization and aggregation of more than ten billion drugs worldwide with its pharmaceutical track and trace system solutions. Our pharmaceutical track and trace system solutions are highly used by pharmaceutical companies in the international market. You can perform serialization, aggregation, and notification operations following government standards through using our software and hardware for your pharmaceuticals. VISIOTT is an adequate solution partner with Level 2, Level 3, and Level 4 software designed for operational management and official notifications. Our team, which aims to provide the best pharmaceutical track and trace solutions to its customers by considering human health, targets to keep customer pleasure at the highest level in all industries. You can review our solutions developed according to your needs below, and click here for more detailed information.
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