Medicinal Herbal or Related Items Screening

17 Nov 2008

Question No:  816  

Question

Name of the Person: Ms Ellen Lee Geck Hoon

To ask the Minister for Health whether the Health Sciences Authority screens and tests all medicinal, herbal or related items that are imported from China.

Reply

Reply From MOH

1. It is not practical for the Health Sciences Authority (HSA) to test all medicinal or herbal products imported from China or for that matter, any other country.  Indeed, no country takes such an approach. 

2. Instead, like other leading regulators, HSA adopts an objective, risk-based approach, grounded on latest available scientific evidence.  HSA regulates a number of products but imposes the most stringent controls on the two highest-risk categories of products - ‘Western’ pharmaceutical medicines and herbal Chinese proprietary medicines (CPM).  Its risk-based approach comprises six key elements. 

3. First, all importers and wholesale dealers of these products have to be licensed by HSA.  As part of the licensing requirements, they must comply with internationally established Good Distribution Practice (GDP).  In this way, the licensees are fully reminded of their responsibilities and what they need to do to ensure the safety and quality of the products that they are dealing with.  Currently, there are more than 360 importers on its register.

4. Second, a rigorous pre-market assessment is made before a product is registered and allowed to enter the Singapore market.  HSA will require the submission of the necessary documents and laboratory testing reports and review them.  There are currently more than 5,000 western medicines and more than 8,000 CPM products on its register.  Any importer who intends to introduce a CPM product into Singapore must submit two sets of documents: (a) the full formula of the product, which will help reveal the possible presence of any synthetic chemical or other prohibited substance, and (b) laboratory test reports on the level of any toxic heavy metal, such as mercury and lead, and the microbial content in the product.  There are prescribed limits for these substances which CPM products should not exceed.   Additional attention is paid to higher risk products that are more likely to be adulterated, for example those with claims of sexual enhancement or slimming properties.  For these products, the dealer must submit additional test reports to show that the product does not contain any adulterant or other prohibited substance.

5. Third, after initial approval, each time a batch of CPM products is brought in and before they can be sold, the importer must submit a letter of undertaking to HSA, confirming that the batch does not contain (a) any synthetic chemical or other prohibited substance, and (b) excessive toxic heavy metals and microbial contents.  The appropriate laboratory test reports must accompany the letter of undertaking.   

6. Fourth, an active post-market surveillance programme is carried out after all registered products enter the market.  HSA carries out ongoing post-market surveillance to check on the safety and quality of products being sold.  It has a system for picking up adverse event signals from doctors and hospitals if their patients experience side effects after taking the health products.  This is an important part of post-market surveillance and allows HSA to take quick action to warn the public, investigate, and, in severe cases, recall products that may be causing unexpected side effects.

7. Fifth, HSA carries out sampling and testing of higher-risk products to check that they meet specified requirements.  If testing shows any deviation – for example if a supposedly herbal medicine is found to be adulterated with a synthetic drug – HSA will mandate recall of the product from the market, and can take punitive action against the dealer. 

8. Sixth, HSA maintains an active international network of contacts amongst its overseas counterparts and other relevant scientific laboratories.  In this way, we stay close to developments overseas, and will be able to promptly follow up on any new risk factor that may have emerged elsewhere.

9. Our screening and surveillance system is based on an objective scientific approach in line with international best practice.  However, at the end of the day, we can only minimise risk but not eliminate it totally.  Routine testing of products can only look for known and expected chemical contaminants.  If new, unexpected chemicals are added by an unscrupulous trader, existing tests will not detect them.  This risk is even higher for products sold from dubious sources like back alley shops or the Internet.  People who choose to buy and use such products are exposing themselves to high and unnecessary risks that endanger their own health and safety.  We strongly advise Singaporeans against doing so.