HSA allows sale of Chinese medicines containing berberine in S'pore

Photo above: Dangerous substances controlled by the Poisons Act. These products either have mercury, lead or berberine.

SINGAPORE - The Health Sciences Authority (HSA) will be allowing the sale of Chinese Proprietary Medicines (CPM) containing berberine in Singapore starting from January 1, 2013.

CPMs refer to TCM medicinal products that have been manufactured into finished dosage forms. Examples of these include tablets, capsules and pills.

This was announced today by Health Minister Mr Gan Kim Yong at a traditional Chinese medicine (TCM ) forum by overseas experts.

Berberine, a naturally occurring substance in certain herbs, is used in TCM for its 'heat-clearing' and 'dampness-drying' properties.

It was previously controlled under the Poisons Act when the Ministry of Health (MOH) received concerns that berberine could cause severe jaundice and brain damage in glucose-6-phosphate dehydrogenase (G6PD) deficient babies.

Since then, HSA has been monitoring the situation and conducting scientific reviews together with an expert committee to ascertain the safety of berberine.

This includes the surveillance of adverse reactions reported in TCM-practising countries such as China, Taiwan and Hong Kong.

The latest review conducted by the Berberine Expert Panel indicates that there are no major safety concerns when berberine is used appropriately, HSA said.

However, it should still be avoided in infants, G6PD deficient individuals of all ages, and pregnant and breastfeeding women.

HSA said it considers the current safeguards in-place sufficient, such as the pre-market approval of CPM products and the compulsory registration of TCM practitioners.

As such, it will be adopting a phased approach in the lifting of the prohibition on berberine in Singapore.

Precautions

Precautions

Berberine products will be subjected to the current regulatory regime whereby HSA will review the safety and quality of these preparations before they are placed in the local market.

Additional labelling, in the form of cautionary statements warning at-risk individuals not to use the medication, will be a requirement for these products.

In the absence of major safety issues, the HSA will review the possible further lifting of prohibition on Chinese herbs containing berberine by 2015.

HSA said it will continue to monitor the situation closely for any adverse reactions.

As a safety precaution, educational programmes will be conducted to inform TCM practitioners how to report adverse reactions and the precautions they should take when dispensing berberine-containing products.

HSA will engage the TCM industry, including Chinese medical halls and retailers, to provide them with the relevant safety information.

Dialogue sessions will also be conducted to educate the industry on the relevant technical requirements for berberine-containing CPMs, HSA said.

yamadak@sph.com.sg

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