COUNTERFEIT DRUGS A GLOBAL-LEVEL AND A MULTI-BILLION-DOLLAR PROBLEM
From the colour, shape, and size of the products, to the packaging – which looks like the real thing – these bogus pharmaceuticals either contain small amounts of active ingredients, or none at all. Not only does this reduce trust in the healthcare system, but it puts patient safety in danger as well.
To counter this worldwide problem, many countries have started developing an end-to-end track and trace system to facilitate chain-wide drug visibility, thereby preventing the distribution of fake products. Indonesia, the South-Asian island nation, has been one of the latest additions to this list of countries, featuring a quite unique set of serialisation requirements.
Non-compliance with serialisation requirements can lead to heavy fines, and, in the most serious cases, legal consequences. Therefore, it’s essential that everyone working in the pharmaceutical chain – distributors, manufacturers, packagers, etc. – be aware of the guidelines.
To help you out, here are all the key points regarding Indonesia’s serialisation and traceability regulation:
- All pharmaceutical manufacturers must pack their products with a 2D barcode to facilitate tracking and tracing
- The barcodes used must be in line with GS1 standards
- Pharmaceutical companies can generate the barcodes on their own, or obtain them from the Indonesian Food and Drug Authority, aka BPOM-Bedan Pengawas obat dan Makanan
- Two barcodes will be used for serialisation – Identification Barcode and Authentication Barcode
- By 2023, all eligible pharma products must be marked with an Identification Barcode
- By 2025, all eligible pharma products must be marked with an Authentication Barcode