SINGAPORE: From January 1, 2013, the Health Sciences Authority (HSA) will allow the sale of Chinese proprietary medicines (CPM) containing berberine in Singapore.
This was announced on Saturday by Health Minister Gan Kim Yong at a forum on traditional Chinese medicine by overseas experts.
Berberine is an alkaloid naturally present in some herbs such as Rhizoma coptidis and Cortex phellodendri, and used in traditional Chinese medicine (TCM) for its "heat—clearing" and "dampness—drying" properties.
The prohibition of the use of berberine, as controlled under the Poisons Act, was implemented by the Ministry of Health in 1978, arising from local safety concerns that berberine could cause severe jaundice and brain damage in glucose—6—phosphate dehydrogenase (G6PD) —deficient babies.
G6PD deficiency is a genetic disorder that results in the breakdown of red blood cells leading to anaemia, when one is exposed to certain medicines or chemicals.
The HSA, together with its expert committees, has been monitoring the situation and conducting ongoing scientific reviews on the safety profile of berberine.
This includes literature review of scientific publications on the safety of berberine, and surveillance of adverse reactions reported in other places which practise TCM such as China, Taiwan and Hong Kong.
The feedback from the local TCM community and developments in the local regulatory landscape were also factors considered in the review of berberine.
The latest review conducted by the Berberine Expert Panel indicates that there are no major safety concerns when berberine is used appropriately.
However, it cautioned that it should still be avoided in infants, G6PD—deficient individuals of all ages, pregnant and breastfeeding women.
Professor Ng Han Seong, chairman of the Berberine Expert Panel, said: "There are various factors that led to the lifting of the ban. I think one is... (that the) Ministry of Health started, in 1965, a screening process for all babies... so we know which babies are deficient in G6PD. And so the mothers were given adequate education and all the warnings of the use of herbs."
Some physicians have hailed the authorities’ move to lift the ban.
Wong Chin Nai, president of the Singapore Chinese Physicians’ Association, said: "In future, we can freely use herbs containing berberine to treat patients. This can hopefully bring about better outcomes and benefit patients."
Based on the recommendations of the Berberine Expert Panel and taking into consideration that there are sufficient safeguards in place, HSA, in consultation with MOH, will adopt a phased approach in the lifting of the prohibition on berberine in Singapore.
For a start, the use of CPM containing berberine, for example in capsules, oral liquid preparations, powders and granules used by TCM practitioners in their dispensing, would be allowed with effect from January 1, 2013.
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 to safeguard public health, CPM containing berberine 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 requirements, in the form of appropriate cautionary statements to warn against use in infants, G6PD—deficient individuals of all ages, pregnant and breastfeeding women, will be imposed on these products.
With the lifting of the ban, HSA will continue to monitor the situation closely for any occurrence of adverse reactions.
In addition, educational programmes to TCM practitioners to share on adverse reactions reporting and the precautions that should be taken when using CPM containing berberine will be conducted.
HSA will also engage the TCM industry to provide them with the relevant safety information, so as to reach out to Chinese medical halls and retailers, as well as conduct dialogue sessions with the industry on the relevant technical requirements for these CPM.
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