Introduction

A counterfeit medicine is the fake medicine which is mislabeled intentionally and fraudulently with respect to original brand or generic product. The products contain wrong or no ingredients or insufficient ingredients or correct ingredients but wrong dose or may be contaminated or fake packaging.1, 2

Current scenario of global pharmaceuticals industry depicted that they face problems of theft, counterfeiting, diversion and false returns to the manufacturers. The World Health Organization (WHO) reported that counterfeit drugs/medicines are near about 1% of the total distribution in developed countries while 30% to 40% in developing countries. This kind of counterfeiting promotes the crime worldwide.3 In this era of worldwide development, the supply chain for genuine pharmaceutical company has grown longer, and every step in the supply chain offers another opportunity for fraudsters. The challenges facing pharmaceutical manufacturers are several in addressing the problem of the supply chain security which can be categorized into four major areas as shown in the Figure 1 .4 The pharmaceutical industries, governments and regulatory authorities of countries worldwide believe that counterfeiting of drugs and medicines by organized crime can be minimized significantly by implementing serialization and product tracking system.3

Figure 1

Summary of security challenges of supply chain

To handle this issue efficiently, there needs to be a joint effort from the pharmaceutical company, regulatory agencies, stockiest and retailers to establish a possible identification solution. A database where uniquely identifying bar code on each packaged drug product can be verified at the point of dispensing would significantly enhance the ability to track all pharmaceutical products worldwide; there is an urgent need to enhance traceability within the supply chain.5 Serialization needs a comprehensive system and policy to track and trace the passage of prescription drugs and medicines through entire supply chain. By serialization process, it can be possible to assign unique serial number in addition to the origin, batch number and shelf life of every product. This will open the way to trace the product’s lifecycle from production, through distribution and finally to dispensation to the patients at pharmacy store or hospital.3 In order to protect public health interests and the relationship of trust between patients and pharmaceutical product suppliers, the production and supply chain needs to be closely regulated.6

Worldwide Regulatory Framework: History and Recent Scenario

The concept for regulating pharmaceutical traceability date was initiated back to 2000 by the Italian ‘Bollini’ law who required the application of a specific kind of sticker containing a bar code along with serial number to each packaged unit, and the recording and archiving of data. After that, many countries in the European Union (EU) have made their legislative efforts for imposing product serialization standards including the CNK (Code National(e) Kode) in Belgium where a seven digits unique identification number was granted or the 13-digit CIP (Club Inter Pharmaceutique) code in France. Other countries, like China, India, Korea and Turkey (Placed item level serialization requirements in 2010) have actively participated in this global attempt at regulation. In November 2013, the president of the United states signed the ‘H.R. 3204 Drug Quality and Security Act (DQSA)’, a Federal law that preempts the California bill, which initially established a creation of a ‘pedigree’ for each drug product sold in the United states, and implemented item level serialization by November 2017 for all Rx (prescription) drugs sold in the States.4, 7

Serialization Blueprinting in Pharmaceutical Industry

As with any major change, the number of planning steps, strategy and decisions including myriad risks must be undertaken before implementation of any project. Initially, it is necessary for any manufacturing operations to be ready for project implementation. This includes, but not limited to current regulatory and legislative requirements; existing backup and recovery capacity of information technology system; engagement with cloud based servers; data exchange capacity with CMOs and trading partners; schedule and budgetary constraints; resources; impact on routine productivity and distribution; enough space for printing of serialized information on carton or label artwork.8, 6

Serialization project Implementation Plan is basically divided into four stages.

Serialization Barcoding for US FDA-Regulated Products

Demonstration of two-dimensional (2D) Bar code in product label

The GS1 DataMatrix includes the GTIN AI (01) + the serial number AI (21) + the expiration date AI (17) + the lot number AI (10) to generate the DSCSA-compliant product identifier encoded in the 2D Data Matrix bar code.

Figure 0

The encoded data appear as:

AI (01) + GTIN + AI (21) + Serial Number + AI (17) + Expiration Date + AI (10) + Lot Number.

Examples:

Figure 0

Scan of the GS1 DataMatrix symbol above yields the following data:

(01)00312345678906(21)12345678(17)180630(10)ABC123

GTIN Number [GS1 AI(01)]: 00312345678906

Represents “0”- Indicator digit, “0312345”- Company prefix, “67890”- Product code, “6”- Check digit. The properly constructed GTIN that incorporates the product’s NDC.

Serial Number [GS1 AI(21)]: 12345678

Recommends unique alphanumeric serial number of up to 20 characters

Expiration Date [GS1 AI(17)]: 180630

Recommends YYMMDD format.

Batch or Lot Number [GS1 AI(10)]: ABC123

Recommends 1 to 20 alphanumeric characters representing the batch or lot number.

Example of same label with GTIN eliminated from the human-readable text to save space (the GTIN HRI already exists on this label as associated with the UPC-A linear barcode).

Figure 0

Demonstration of inner packs (Bundles)

The DSCSA needs product identifiers in a 2D Data Matrix bar code on the individual saleable units while a 2D Data Matrix bar code or linear bar code on homogeneous cases. It does not need the product identifier to be encoded onto inner packs unless the pack is an individual saleable unit.

For inner packs (also known as bundles, sleeves, trays, etc.), it recommends a minimum, a 2D GS1 DataMatrix and a corresponding human-readable format.

Examples

Figure 0

Scan of the GS1 DataMatrix symbol above yields the following data:

(01)20312345678900(21)12345678(17)180630(10)ABC123

Demonstration of product case label (Homogeneous cases)

Figure 0

For DEA controlled product, it recommends not to use product description.

Figure 0

Scan of the GS1 DataMatrix symbol above yields the following data:

(01)50312345678901(21)123456789012(17)201231(10)123456L9

Conclusion

Counterfeiting in Pharmaceuticals is a critical issue addressed by regulatory agencies of several countries. This needs multiple measures in order to protect the supply chain. The enforcement of the anticounterfeit technologies is a crucial strategy taken up by various pharmaceutical manufacturers and regulatory authorities. The track and trace system and serialization come up with great importance and are acceptable worldwide among all anticounterfeit technologies. This system even plays vital role when managing a product withdrawals or recall, where accuracy and time of reporting is crucial. Moreover, recalls, drug take-backs, returns will be greatly facilitated by both track and trace and serialization. In recent years, track and trace system and serialization have shown to be an effective tool for increasing competitiveness and capacity to prevent thefts and counterfeiting while reducing the frequency and costs of the recall. Because of great importance and current need, it is highly essential to include provisions of security measures in the packaging of pharmaceuticals worldwide specially in the developing and underdeveloped country.

Source of Funding

None.

Conflict of Interest

None.