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Gradual Implementation of Serialization Regulations Across Various Countries is Transforming the Track and Trace Solutions Market

   June 8, 2022

Track and trace in the pharmaceutical supply chain is a process under which a drug’s past and current locations are determined. The emerging serialization solutions are becoming an imperative in the pharma supply chain as these solutions help identify pharmaceutical products’ authenticity prior to sale, dispensing, return or recall. The right implementation of track and trace aids in tracking the pharmaceutical products throughout the supply chain. It can also trace back the supply chain in case of product recalls or returns.

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Pharmaceutical companies are at constant risk of supply chain security lapses due to a considerable increase in the trade of counterfeit medical products. Serialization solutions provide end-to-end visibility across the supply chain, protecting patients against counterfeit medicines and fighting reimbursement-related fraud. Policymakers and regulators have introduced serialization guidelines across various countries to enhance visibility in the pharma supply chain and curb the counterfeit trade of medical products. Although serialization guidelines differ for every country, pharmaceutical products in the respective markets will be provided with unique identifiers to ensure end-to-end security in the supply chain. In addition, serialization regulations allow for clearer product identification and improved financial control. An overview of some of the serialization guidelines across the world is provided below:

  1. U.S.

The Drug Quality and Security Act (DQSA) was enacted in November 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), specifies steps for building an interoperable electric system for the identification and tracking of prescription drugs that are distributed in the U.S. to help protect the exposure from counterfeit, contaminated or adulterated drugs by removing them from the supply chain. The DSCSA went into effect in 2015 in the U.S. By the end of 2023, the entire pharma supply chain must be DSCSA compliant, with mandatory complete unit-level traceability, including aggregation.

  1. EUROPEAN UNION

Falsified medicines present a major public threat. In response to the increased risk of counterfeiting, the European Union (EU) commission legislated Directive 2011/62/EU, also referred to as EU Falsified Medicines Directive (EU FMD), in 2013 to introduce track and trace regulations to enable EU wide measures for controlling the supply chain of the medical products. According to the EU FMD requirements, pharma companies, wholesalers, importers, and pharmacies were given a deadline of February 2019 for compliance. From February 2019, as per the directive, medical packs released onto the market carried a 2D data matrix barcode with a unique identifier and tamper-evident packaging to ensure the integrity of the package.

  1. TURKEY

Turkey has one of the longstanding track and trace systems in the world. Drug Tracking System (Ilac Takip Sistemi (ITS) implements serialization and tracking of pharmaceuticals in Turkey. All the pharmaceutical products distributed in Turkey are subject to serialization and aggregation at the unit level.

  1. INDIA

India has taken important primary steps to help ensure the security of the global pharmaceutical supply chain. In January 2011, the Directorate General of Foreign Trade (India) announced adopting and implementing a track and trace system incorporating serialization for exported medical products. Non-small scale industry manufacturers need to serialize the secondary and tertiary packages with products manufactured on or after April 1, 2016. However, small-scale pharma manufacturers must serialize all product packages at the secondary and tertiary levels on or after April 1, 2017. Serialization of the primary package is optional for exported products. In addition, manufacturers must aggregate lower-level packaging to higher-level packaging and upload this information to the Drugs Authentication and Verification Application (DAVA) database, developed and managed by the National Informatics Center (NIC). DAVA database is a country-wide database to store serialization data. On November 1, 2018, the Directorate General of Foreign Trade (DGFT) (India) announced postponing the aggregation and data submission requirements to the DAVA portal to July 1, 2019.

  1. CHINA

China had partly implemented a track and trace regulation for selected products in the essential drug list based on their drug classes with deadlines in 2013 and 2014. All the pharmaceutical products distributed in China are covered under serialization and government reporting regulations from December 2015. A draft guide published by China National Drug Administration (CNDA) in 2018, for a new drug traceability system, states that a traceability system will be established for pharmaceutical manufacturers before 2022.

  1. JAPAN

The Ministry of Health, Labor and Welfare (MHLW Japan) introduced guidelines for barcode labeling for pharmaceutical products. Under this, the serialization deadline was set by 2015 and uptake of aggregation data was set by 2022.

  1. BRAZIL

The Brazilian Health Regulatory Agency (ANVISA) announced its plan to implement a comprehensive nationwide serialization solution. Under this solution, pharmaceutical companies manufacturing or importing pharmaceuticals in Brazil are required to follow the regulations dictated in the National Medicine Control System (SNCM). This solution is aimed at serializing 100% of pharma products by 2022.

  1. SOUTH AFRICA

South Africa plans to phase in and then fully implement serialization of secondary and tertiary packaging by 2022 to mitigate counterfeiting of medicines. In 2018, the South African government replaced EAN-13 barcodes on tertiary packaging (e.g., shipping cases) with GTIN-14 Data Matrix codes containing GTIN, batch/lot and expiration date.

  1. SAUDI ARABIA

A new labeling practice was mandated in 2015, as per which, from March 12, 2017, all domestically produced and imported pharmaceutical products are required to carry a 2D GS1 Data Matrix barcode. Furthermore, effective from 7 February 2019, all the pharma stakeholders, including manufacturers, distributors, importers, and dispensers must register with the Saudi pharmaceutical Track-and-Trace system (DTTS) and report all drug pack transactions.

Thus, the increasing global implementation of serialization regulations is expected to drive the  track and trace solutions market at a CAGR of 8.3% to reach $27.27 billion by 2029, according to the Meticulous Research® report.


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