Regulatory Framework
Impact of Events on the Regime
Possible Changes

The similarities and differences between Western and traditional medicines have come into sharp focus in Singapore following a death caused by a Chinese-herbal pill. This update outlines the regulatory framework for food and medicine in Singapore, and discusses the impact that recent events will have on the regulation of traditional medicines.

Regulatory Framework

Food and medicine products are regulated separately in Singapore.

Food products
The quality and sale of food products are governed by the Sale of Food Act and the Food Regulations, which regulate the wholesomeness and purity of food. The Food Regulations set out food and labelling requirements for different categories of food products, such as dairy products and meat. The Ministry of National Development is responsible for enforcing the legislation.

Medicine is regulated by the Medicines Act and Regulations, which seek to ensure that medicines offered for sale in Singapore are safe, efficient and of good quality. The Ministry of Health and its newly established statutory board, the Health Sciences Authority (HSA), are responsible for enforcing this legislation. Any person wishing to sell, manufacture or import medicines or medicinal products into Singapore must apply to the HSA for a licence, and must also follow the strict labelling requirements required under the medicines legislation.

Traditional medicines
Most of the legislation in relation to traditional medicines deals with the regulation of traditional Chinese medicines. These medicines enjoy a substantial degree of popularity and use in Singapore.

In 1995 a committee set up to investigate the extent to which traditional Chinese medicines are used in Singapore, and to review the need for regulation of those medicines, recognized that Western medicines and traditional Chinese medicines ought not to be forcibly integrated, but should rather be regarded as complementary of one another and forming a comprehensive medical care system in Singapore. The committee recommended that Chinese medicinal materials be grouped into two categories: (i) raw Chinese medicinal materials, which may be subjected to cutting or drying processes but which are otherwise used in their natural state, and (ii) Chinese proprietary medicines (CPMs), which are the finished products (eg, tablets, pills, mixtures and powders) derived from raw Chinese medicinal materials.

Initial recommendations for the regulation of raw traditional Chinese medicines focused on safeguarding the public from toxic substances, and preventing adulteration and exaggerated claims with respect to such medicines. It was thought that raw herbs, in the main, had low toxicity and that herbs containing toxic substances would be controlled under the Poisons Act.

In contrast, the committee made the following recommendations in relation to CPMs:

  • The quality and safety standards for CPMs should be increased. Control measures should be gradually introduced. As a start, a simplified system of product registration, generally referred to as 'listing', should be implemented. This would involve the issuing of product licences to individual products, and licensing local CPM manufacturers and importers/wholesalers;

  • A CPM Advisory Committee should be established under the Medicines Act to advise the Ministry of Health on the evaluation and approval of licences for CPM products, manufacturers and importers/wholesalers. The members of the CPM Advisory Committee would be appointed by the minister of health and would include CPM experts; and

  • A CPM Listing Unit should be set up in the Ministry of Health. This unit would be responsible for processing applications for product listing and licensing of local CPM manufacturers, importers and wholesalers.

New laws for the control of CPMs were passed in September 1998, and a three-step approach to the regulation of CPMs was implemented in September 1999 and completed in September 2001. All dosage forms of CPMs, including tablets, pills and liquid preparations, must now be properly labelled and tested. Further, all dealers of CPMs - whether importers, manufacturers, wholesalers or assemblers - must apply for a licence from the HSA prior to dealing with CPMs.

Impact of Events on the Regime

The recent death of one person and the hospitalization of several others who were taking a Chinese-herbal slimming product have put the existing CPM regulatory under the spotlight. The China-made herbal medicine had been promoted in Singapore as a slimming agent and was launched in December 2001. Its over-the-counter sales were extremely successful, and by the time its was withdrawn from the market in April 2002 about 20,000 bottles of the product had been sold, each containing 120 pills.

Four months after the pills were launched, doctors alerted the HSA that there could be hidden dangers to the product. The HSA responded by taking samples of the slimming pill from the market for testing. An undeclared substance, nicotinamide, was discovered in the product on April 15 2002, which led to the island-wide recall of the product. Further investigation revealed that the product contained two other undeclared substances, fenfluramine and thyroid gland components.

The fact that a Chinese-herbal slimming product containing restricted substances like fenfluramine could be made available for consumption has raised serious questions as to the adequacy of the existing CPM regulations. Suggestions have been made to tighten up three specific areas of regulation:

  • the regulatory framework;

  • the testing methodology; and

  • the distinction between Western and Chinese medicine.

With respect to the first area, it has been pointed out that the existing regulatory framework places the onus on importers of CPMs to ensure that their products do not contain synthetic Western drugs or prohibited ingredients. As long as a laboratory certificate is produced, the importers are allowed to import the new product into Singapore. The loopholes which this approach presents are now being recognized: in the case of the Chinese-herbal slimming product, the laboratory that tested the product was a Chinese laboratory, whose standards and procedures for testing might well have been different to those employed in Singapore. Under this method of verification, there is little assurance of the stringency of the tests or the honesty of the testers.

In relation to the second area, the suggestion is that a negative, rather than positive, testing procedure should be introduced. Instead of testing to ensure that the declared ingredients are present, laboratories should check that prohibited substances - and in particular substances that are banned under the Poisons Act - are not found in the product.

Finally, the assumption that Chinese medicines (which are mainly herbal and have been use for hundreds of years) pose less risk than Western medicines (which are synthetic and chemical-based) no longer appears to be valid. As a consequence of globalization and increasing demand for effective medicines, manufacturing techniques relating to herb-based medicines may involve synthetic or chemical components, which may refute the assumption of low toxicity levels hitherto associated with herbal medicines. Moreover, as many CPMs available today are manufactured in easy-to-use pill or tablet form, it may be argued that today's CPMs more closely resemble Western medicines, and that thus there may no longer be a need to separate the regulation of Eastern and Western medicines.

Possible Changes

It is probable that following this incident the HSA will tighten its controls on CPMs imported into Singapore, and that this may even extend to other traditional medicines that are currently exempt from the licensing requirements.

One area in which more stringent measures of control may be introduced is the testing of products prior to the grant of an import licence. Instead of allowing any laboratory to test the contents of a traditional medicine product, the HSA may demand that they be tested within specific accredited laboratories. The testing procedure may also be changed so that laboratories test not only for declared substances, but also for banned or controlled substances, in order to ensure that these are not added to the product.

The HSA has already implemented a market surveillance system whereby CPMs are periodically tested to ensure that they conform with content and labelling requirements. It is possible that after this incident, market surveillance may be stepped up to ensure that products do not become adulterated once they have passed the initial tests. Random testing of new consignments may also be implemented to keep CPMs in check.

Finally, there may even be stricter controls on exactly which products are sold over the counter. At present, many CPMs are sold over the counter in pharmacies and convenience stores, and there are no procedures in place to check whether the CPM is actually suitable for the prospective consumer. This would place constraints on the market for CPMs, allowing only accredited clinics or shops to sell these 'natural' medicines.

For further information on this topic please contact Lawrence Teh at Rodyk & Davidson by telephone (+65 225 2626) or by fax (+65 225 1838) or by email ([email protected]).