Back in December 2018, the National Agency of Drug and Food Control, Republic of Indonesia (abbreviated BPOM) issued Regulation 33 for Year 2018, Regarding Application of 2D Barcodes in Drug and Food Control. And the regulation was set into force in the beginning of 2019.
After considering feedback from relevant stakeholders (industries, distribution, local regulatory, etc.), in December 2019 BPOM issued a revision draft to substitute current version. There are some changes and additions to the regulation, the highlights of which are:
- Additional information regarding type of drugs which shall implement serialization
- Mandatory requirement of aggregation
- The deadline for serialization implementation
- Other technical requirements
Which drug categories shall implement serialization?
In Indonesia, the government has decided to mandate the application of 2D barcodes to a large number of products, including all kinds of drugs (prescription, biologics, narcotics, psychotropic, Over-the-counter (OTC), traditional medicines, supplements) as well as cosmetics and processed food. But they define two different contexts that the barcodes will be used for, which are:
- Simple product identification (not serialization)
- The more complex, product authentication (serialization).
If a product category is listed for simple “identification”, no serialization is required. But for those listed in categories for “authentication,” a serial number (serialization) will be required. As you might expect, all prescription, biologics, narcotics, psychotropics must have “authentication barcodes” on them.
Referring to Article 5 paragraph (3) in the current regulation, it is stated that “Certain OTC and foods have to apply 2D barcode with authentication method as a result of risk assessment performed by BPOM”. In the new draft, BPOM provides clarity which OTC products are categorized as high risk & controlled OTC (refer to Appendix 1 of Perka BPOM draft) which require 2D barcode authentication (serialization). These are OTC products containing: Ephedrine; Pseudoephedrine; Potassium Permanganate; and Dextromethorphan HBr.
Aggregation is now mandatory
In the initial regulation, track & trace was mandatory but aggregation was optional. In the new draft version aggregation becomes mandatory. Cited from Article 5A “the Pharmaceutical Industry who applies 2D Barcodes with Authentication method is required to implement aggregation system”.
Deadline of Implementation
The current regulation deadline for implementation of authentication method is no later than 7 years since this regulation was promulgated (December 2018). In the new regulation it is stated that the deadline is 6 years since the regulation is promulgated. It means the deadline still remain as 2025.
There is a shorter implementation deadline which is maximum 2 years after the regulation is issued. This deadline is applicable for the following medicines categories:
- Phychotropics, containing: Alprazolam; Chlonazepam; Nitrazepam; Estazolam; Diazepam; Phenobarbital; and Nimetazepam.
- Prescription drug, containing: Tramadol; Trihexyphenidyl HCl; Haloperidol; Amitriptiline; Chlorpromazin; Misoprostol; Tadalafil; Sildenafil citrate; and Vardenafil.
- OTC products containing: Ephedrine; Pseudoephedrine; Potassium Permanganate; and Dextromethorphan HBr
Other Technical Requirements
There are several technical requirements regarding 2D barcode system, such as:
- The color of 2D barcode printing is no longer only limited to black ink on the white background or other colors background but now it’s possible to use any ink color which is different/contrast to the background color (Article 1, paragraph 7)
- It is required that the 2D barcode should not be easily deleted, removed and damaged. In that case the use of sticker barcode may not be allowed
- 2D barcode printed in proportional size, rectangular shape, minimum 0.6 x 0.6cm
Now as Pharmaceutical MAHs are obliged to begin applying the 2D Authentication barcode on drug packages, drug manufacturer should pay close attention to these requirements and prepare to add the required barcode and reporting to their Indonesia supply in the next few years. These new requirements can be a lot to unpack, but with the right serialization solutions provider, the road to compliance can be a smooth one.
- PerKa BPOM No 33 Tahun 2018 Tentang Penerapan 2D Barcode Dalam Pengawasan Obat dan Makanan
- Rancangan Peraturan Badan pengawas Obat dan Makanan No … Tahun 2019 Tentang Perubahan atas Peraturan Badan Pengawas Obat dan Makanan Nomor 33 Tahun 2018 Tentang Penerapan 2D Barcode Dalam Pengawasan Obat dan Makanan