Pharmacovigilance in Singapore: an example to follow

AYLMER (PasseportSanté.net) February 17, 2006 – Faced with the popularity of Traditional Chinese Medicine, the Singapore authorities decided a few years ago to regulate products resulting from this therapeutic approach. Take a look at a successful and efficient integration.

“In our small country of around 4.2 million people, health care is mostly Western medicine. However, 75% of the population also uses traditional medicine, especially Traditional Chinese Medicine, ”said Chan Cheng Leng, director of the Drug Regulatory Center of the Singapore Ministry of Health.

She presented her government’s pharmacovigilance approach to natural health products (NHPs) during a symposium on drug, food and natural health product interactions.¹.

“This process was undertaken in 1999 with the aim of protecting the public, and not to restrict the development of Traditional Chinese Medicine,” Chan Cheng Leng insisted. We recognize that this medicine is an integral part of healthcare in Singapore. “

At first, acupuncturists and TCM practitioners had to comply with certain criteria in order to be entered in a register. Then, the NHPs resulting from this medical approach were identified and evaluated according to two criteria: their safety and their quality on the basis of information provided by the manufacturers.

Only products evaluated and approved by the Ministry of Health can be legally sold in Singapore. Sporadic analyzes are also carried out on marketed NHPs. “From 2000 to 2005, the rate of non-compliance of the products analyzed went from 7% to 2%,” said Chan Cheng Leng.

Efficient tools

The Ministry of Health has even created a specific document for the declaration of adverse effects related to TCM products. Result of the whole process: the authorities are well equipped to react quickly in the event of a problem and to adequately inform the population through newspapers, television and radio.

For example, less than a month elapsed between the first report of adverse reactions to “Slim 6”, a TCM product for weight loss, and its withdrawal from the market. Tests carried out on this NHP, which had been approved and introduced to the market a few months earlier, revealed that it contained a substance derived from a drug (nitrosofenfluramine). This adulteration caused serious hepatotoxic effects which in one case resulted in a liver transplant.

The diligence and efficiency of the Singapore health authorities also made it possible to prevent other serious cases, especially in China where “Slim 6” was also distributed.

It should be noted that the serious side effects of medicinal plants and other TCM products are mainly linked to fraudulent practices. Unscrupulous manufacturers may, for example, add foreign substances to them, including drugs. “In these cases, the toxicity is attributable to fraud and not to the natural ingredients they contain,” said Pierre Haddad, professor of pharmacology at the University of Montreal.

Françoise Ruby – PasseportSanté.net

1. This event, entitled Health Canada International Symposium on Drug, Food and Natural Health Product Interactions, was held on February 9 and 10, 2006 in Aylmer, Quebec. It brought together more than 250 people from the health field, the medicinal plants industry, as well as researchers, representatives from various branches of Health Canada and some consumer groups.