Introduction

In 2017 the Indonesian Food and Drug Authority (BPOM-Bedan Pengawas obat dan Makanan) began the initial implementation of serialization to fight the impacts of counterfeit drugs in the country. It, in turn, became the first ASEAN member state to implement and begin the serialization process.

By 11th February 2018, the QR codes had already been adopted, and pharmaceutical companies were mandated to start adhering to the serialization standards. They expected to be ready for serialization using GS1 2D matrix systems by 2019. In 2019, there were updates on the modes and standards of barcoding, serialization and reporting requirements. Pharmaceutical companies were mandated to keep up with the emerging regulations that were to be phased from 2020 to 2025.

Aggregation has also been mandated by BPOM in the legislation published in 2020 but no details have been provided yet for the serialized shipping container code (SSCC) carrier. However, this is expected to be included in a revised regulation in Q1 2022.

Key Dates for Compliance Deadlines

By 2023 - All the pharmaceutical products (OTC & Prescription Drugs) should be marked with Identification barcode

By 2025 - All the pharmaceutical products (OTC & Prescription Drugs) should be marked with Authentication barcode

Identification and Authentication Barcodes

The BPOM mandates companies to deploy barcodes that would enable efficacious tracking. These companies can choose to either obtain barcodes from BPOM or make them on their own. These barcodes constructed by companies could either be QR codes or GS1 Data matrix.

Identification barcodes are issued by BPOM and include the Market Authorization Number denoted by NIE (Nomor Izin Edar). These barcodes are applicable to the following.

  • Over-the counter (OTC) medicines
  • Cosmetics
  • Health Supplements
  • Processed Foods

Authentication barcodes on the other hand are more elaborate and are expected to contain;

  • Product identity number such as GS1 GTIN that applies internationally
  • Marketing authorization number usually provided by the BPOM
  • Batch number or production code
  • Expiration date
  • Serialization number

The authentication barcodes are applicable to the following medicines.

  • Prescription drugs
  • Biological products
  • Psychotropics
  • Processed foods
  • Certain type of OTC products

These can be issued by BPOM or the manufacturer themselves but should be readable by the BPOM track and trace application. Pharmaceutical companies are expected to be aware of such requirements.

2D Barcode

Pharmaceutical companies are mandated to use the 2D Authentication barcodes on drug packages and submit 2D Barcode reports to the Indonesian Food and Drug Authority (BPOM). This should be done through the Track and Trace Application. The 2D barcode has to be applied to the primary packaging and included in the secondary packages to enable authentication and efficient tracing of the products.

2D Barcode printed on the packaging should be easy to scan and read by the BPOM Track and Trace application. It should be proportionally put on the packaging with a minimum size of 0.6 by 0.6cm. There are cases of two 2D barcodes which have to be included on the packaging. In such cases, one of the 2D barcodes have to contain the wording, ‘’BOM RI’’ (Hutabarat, et al.2017)

GS1 Standards

The BPOM requires drug manufacturers and suppliers to meet the GS1 standards before administering drugs to the market. These parties are mandated to include GTIN and use the Marketing Authorization number on their products which alternately gives the drugs a unique perspective. Meeting the GS1 standards would enable health businesses to grow and improve efficiency.

The process flow

A typical process flow contains the following.

  • Apply to access the BPOM track and trace application by submitting company documents
  • BPOM reviews the request and grants access.
  • The business must request for the issuance of BPOM barcodes no later than 10 business days before commencement of production.
  • BPOM will then assess and issue the barcode within 5 business days.

In addition, this is important to note that there is a reporting obligation as well. Manufacturers, distribution facilities and pharmaceutical service facilities must submit utilization reports relating to their 2D barcodes and distributed products to BPOM through the track and trace application.

It is interesting to note also that anyone can scan and report 2D Barcodes using the BPOM Mobile Application to participate in the supervision of food and drugs. This enables end users to check the authenticity of medicines and foods. Even though it may seem like a burdensome additional requirement for the food and drugs industry. However, given the prevalence of fake products in the market, this will help businesses to check for fakes in their own distribution chains as well as additional assurance to the government and consumers that they are using a genuine product.

Administrative Sanctions

The BPOM shall impose sanctions if pharmaceutical companies do not adhere to the rules and regulations imposed before putting a drug into the markets. These penalties would ensure the manufacturers do not violate the laws on the serialization process.

Data Serialization Courses

The BPOM has has also enacted online courses that would offer knowledge in how to carry out the serialization process and implement the required standards. As a result, drug manufacturers and suppliers can know what is expected of them to stay away from the wrong side of the law. There has been a high impact in serialization awareness and the knowledge around counterfeit drugs. through such courses.

Further Reading

The TTAC (Track & trace Anti-Counterfeit) Indonesia website manual is available on BPOM's website which explains the steps from registration till uploading the product and serialized information to the portal.

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Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.

 https://www.pom.go.id/new/

 

References
Hutabarat, Ivan Riandi M. “Application of 2D Barcode on Pharmaceutical Product Labels in Indonesia to Improve Drug Control.”
Hermansyah, Andi, Erica Sainsbury, and Ines Krass. “Multiple policies approaches in improving community pharmacy practice: the case in Indonesia.” BMC health services research 18.1 (2018): 1-14.

Tania Lovita - Law, Lore & Practice Spring 2019