Fake medicines are commonplace in Indonesia
In 2017 the discovery of a counterfeit vaccines network across Indonesia caused a public outcry that meant politicians, bureaucrats and health organisations had to take action.
The Indonesian National Food and Drugs Agency (BPOM) issued Regulation No. 33 of 2018 on Implementation of 2D Barcode for the Supervision of Food and Drugs (Regulation) that came into effect on 7 December 2018. Any food or drug (including traditional medicines, health supplements, cosmetics and processed foods) which is locally produced or imported for circulation in Indonesia must have a 2D barcode affixed on the product label. The purpose of the Regulation is to improve BPOM food and drug circulation standards through the utilisation of track and trace technology and digital reporting.
There are two types of barcode - Authentication and Identification barcodes. Identification barcodes are issued by BPOM and will include the distribution permit number and validity period. This is required for over-the counter (OTC) medicines, traditional medicines, health supplements, cosmetics and processed foods.
Authentication barcodes will include more details such as the distribution permit number, batch number/production code, expiry date and serial number of the product. They are required for prescription drugs (biological products, narcotics, psychotropics, certain types of OTC medicines and processed foods). The
barcode can be issued by BPOM or by the business itself in the form of a QR code which can be read by BPOM’s track and trace application.
To obtain a barcode, a business must first apply to access the BPOM track and trace application by submitting company documents. Once access is granted, the request for the issuance of BPOM barcodes must be submitted no later than 10 business days prior to the commencement of production. BPOM will then assess and issue the barcode within 5 business days.
In addition, there is a reporting obligation. Businesses, distribution facilities and pharmaceutical service facilities must submit utilisation reports relating to their 2D barcodes and distributed products to BPOM through the track and trace application. Non-compliance will attract administrative sanctions.
Interestingly, anyone can scan and report 2D Barcodes using the BPOM Mobile Application to participate in the supervision of food and drugs. This will enable consumers to check the authenticity of medicines and foods. This might seem like a burdensome additional requirement for the food and drugs industry. However, given the prevalence of fake products this will help both businesses to check for fakes in their distribution chain, as well as government and consumers.
Written by Tania Lovita, this article was also published in in Law, Lore & Practice Spring 2019. To see the full publication, click to download below.