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.
By 2020, the BPOM created a new draft version of regulations that began the use of aggregation when it came to product packaging. Aggregation allowed other parties in the supply chain to add their data to products to give them a unique identity as they moved through the supply chain. BPOM has not prescribed the serialized shipping container code (SSCC) carrier for aggregation though but this is expected to be included in a revised regulation.
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. They 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
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)
Identification and Authentication
Identification is meant for those products that are not mandated to be serialized, such as OTC, traditional medicine, cosmetics and processed foods. Authentication, however, is for product sets that require serialization, such as ethical drugs, narcotics and psychotropic drugs and more products that the BPOM is going to add to the list. Pharmaceutical companies are expected to be aware of such requirements.
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.
Data Serialization Courses
The BPOM has enacted online courses that would offer knowledge n 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 of serialization through such courses, which alternately deals with counterfeit drugs.
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.
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.
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.