Standard Bar Code Label on Drugs as Safeguard
Ministry of HealthSpeakers
Summary
This question concerns Ms K Thanaletchimi’s inquiry on mandating standard bar codes on drug unit packs to enhance traceability and supply chain integrity. Minister Gan Kim Yong explained that while bar-coding is beneficial, there is currently no internationally harmonised standard for drug manufacturers and suppliers to adopt. He highlighted that the Health Sciences Authority already requires licensed suppliers to maintain records and include product names, batch numbers, and expiry dates on packaging. Imposing a specific local bar-code requirement could lead to companies passing on additional costs to patients or deterring them from the small Singaporean market. Minister Gan Kim Yong affirmed that the government will monitor international developments while continuing to enhance current systems for drug safety and traceability.
Transcript
55 Ms K Thanaletchimi asked the Minister for Health whether it can be made mandatory for all manufacturers or suppliers of drugs to have a standard bar code with product name, batch number and expiry date on its unit pack before they are imported, registered and sold in Singapore so as to safeguard the integrity of the drugs and to facilitate drug traceability.
Mr Gan Kim Yong: Today, the Health Sciences Authority (HSA) requires all manufacturers, importers and wholesalers of drugs to be licensed. To ensure traceability and supply chain integrity, they will need to keep records for every receipt and supply of drugs and comply with standards in distribution. A drug's product name, batch number, expiry date and registration number will have to be indicated on each unit pack. In addition, HSA carries out post-market surveillance on quality or safety concerns arising from drugs.
HSA agrees that a standardised bar-coding system can further improve drug traceability. Unfortunately, there is yet to be an internationally harmonised bar-coding standard for drug manufacturers and suppliers. Given our small market size, imposing our own requirement for all drug manufacturers and suppliers to adopt a standard bar-code could lead to companies being deterred from bringing their drugs into Singapore or passing on the additional cost to patients. This would not be beneficial to Singaporeans.
HSA will continue to monitor international developments in this area. At the same time, it will continue to improve on its current system on drug safety and traceability.