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Many checks in place for TCM products
Mon, Feb 11, 2008
The Straits Times

I REFER to Ms Lee Yuet Lai's letter, 'Are checks made on TCM products sold here?' (ST, Jan 30).

The Health Sciences Authority (HSA) oversees the regulation of medicinal products sold in Singapore. For traditional Chinese medicines (TCM) in finished dosage forms (for example, capsules, pills), HSA regulates the safety and quality of such products, which are also known as Chinese proprietary medicines (CPM).

All local manufacturers, importers and distributors of CPM products are required to be licensed by HSA, and these dealers must ensure their CPM products, whether manufactured locally or imported from overseas, comply with stipulated safety and quality standards (for example, limits on microbial contamination, toxic heavy metal content) before they are marketed in Singapore.

In addition, CPM products must be labelled in English, disclosing trade or brand name, ingredients, batch reference, expiry date, and names and addresses of manufacturer and wholesaler or importer.

In addition to controls at the pre-market stage, HSA has various checks and control measures to monitor CPM products post-market. These include periodic sampling and testing of CPM products in the local market, a monitoring system to detect reports of adverse effects and product defects, and investigations into public feedback and complaints about CPM products.

There are no licensing requirements for the import and sale of raw herbs currently sold in the local market, including those herbs commonly consumed in food. These herbs are regarded as safe and freely available in the local market. Herbs containing toxic or potent ingredients are already regulated under the Poisons Act and are not permitted to be sold in the local market.

Manufacturers who use such herbs in the manufacture of their products must ensure the quality of these herbs, as this will affect the quality of the finished product, for which they are held responsible.

Similarly, TCM practitioners and herbalists as well as retailers in general who sell such herbs directly to the public must ensure the goods they supply are of the quality their customers expect.

Members of the public can engage the services of private laboratories and send samples of their own medicines or food products for testing. However, they should be aware of the complexities involved in the chemical analysis of such products and specify the kind of tests they want carried out.

HSA advises consumers to exercise discretion and buy TCM products, whether CPM products or TCM herbs, only from reputable sources. Consumers should also seek expert opinions from health-care professionals when in doubt.

Yee Shen Kuan
Senior Deputy Director
Centre for Drug Administration
Health Products Regulation Group
Health Sciences Authority

This letter was first published in The Straits Times on Feb 6, 2008.

 

 
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