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Chinese Proprietary Medicine in Singapore

Regulatory Control of Toxic Heavy Metals and Undeclared Drugs

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Abstract

Traditional Chinese medicine (TCM) is gaining popularity as a form of complementary and alternative medicine. Reports of efficacy of TCM are increasing in numbers. TCM includes both crude Chinese medicinal materials (plants, animal parts and minerals) and Chinese proprietary medicine (CPM) [final dosage forms]. Despite the belief that CPM and herbal remedies are of natural origin, unlike Western medicine, and are hence safe and without many adverse effects, there have been numerous reports of adverse effects associated with herbal remedies. Factors affecting the safety of herbal medicines include intrinsic toxicity, adulteration, substitution, contamination, misidentification, lack of standardisation, incorrect preparation and/or dosage and inappropriate labelling and/or advertising. Hence, new regulations on the control of CPM were enforced in Singapore with effect from 1 September 1999. These include licensing and labelling requirements, as well as control of microbial contamination. This article also reviews reports of excessive toxic heavy metals and undeclared drugs in CPM in Singapore between 1990 and 1997. The names, uses, toxic heavy metal or drug detected and the year of detection are tabulated. Information on the brand or manufacturer’s name are provided whenever available. The public and healthcare professionals should be better informed of the basic concept of TCM and its usefulness, as well as the potential adverse effects associated with its use. Greater control over the safety and quality of CPM could be achieved through good manufacturing practice, regulatory control, research, education, reporting usage of Chinese medicine (as in drug history) as well as reporting of adverse events.

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Acknowledgments

This work is supported by an academic research fund (RP3972353) from the National University of Singapore. The support of the Department of Scientific Services of the Institute of Science and Forensic Medicine is acknowledged. The assistance of the National Pharmaceutical Administration of the Ministry of Health, Singapore in providing some of the data is greatly appreciated. The authors are indebted to the reviewers for their constructive and useful comments.

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Authors and Affiliations

  1. Department of Pharmacy, Faculty of Science, National University of Singapore, 10 Kent Ridge Crescent, Singapore, 119260, Singapore

    Hwee-Ling Koh

  2. Department of Scientific Services, Institute of Science and Forensic Medicine, Ministry of Health, Singapore

    Soo-On Woo

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  1. Hwee-Ling Koh
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Correspondence to Hwee-Ling Koh.

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Koh, HL., Woo, SO. Chinese Proprietary Medicine in Singapore. Drug-Safety 23, 351–362 (2000). https://doi.org/10.2165/00002018-200023050-00001

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