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Name and Constituency of Member of Parliament
Ms K Thanaletchimi
Nominated MP
Question No. 1275
To ask 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.
Written Reply
1 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.
2 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.
3 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.