Singapore Chinese Physicians' Association

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Singapore Health Sciences Authority (HSA) implementation of new measures to the import and export of Chinese proprietary medicine

The Singapore Health Sciences Authority (HSA) made an announcement on the import and export of Chinese proprietary medicine on 25th April 2003. In order to meet the requirements of the China State Food and Drug Administration (SFDA) on China's domestic production of traditional Chinese medicine as well as to consolidate the China market and co-ordinate national laws andregulations on TCM, the Singapore Ministry of Health will take all the medicine imported from China for further controlmeasures, starting from January 2004. All Chinese proprietary medicine (including health supplements) imported from China must attain Chinese national standards before they can be imported into Singapore and sold.

Under the new rules, as the proprietary medicine mixtures used in Singapore are not commonly used in the Chinese market, few Chinese manufacturers have been awarded official approval. Therefore, these manufacturers must be willing to invest heavily and to re-apply under the new regulations, in order to obtain official approval. In other words, after the new regulations have been officially implemented, the proprietary medicine mixtures used in Singapore will gradually disappear.

Coordinating Committees from various Singapore TCM organisations, after learning the news from the Singapore Chinese  Medicines Association in October 2003, immediately held a meeting,  and later, along with the Singapore  Federation of Chinese organizations held a joint  consultation meeting. After the meeting, the  two groups wrote a joint letter to the Head of the Health Sciences Authority, Dr Chen Chu Xian, explaining their views and called upon the HSA to suspend the implementation of the new consolidation and planning measures.

Since  the fifties, Singapore has been importing extracts of Chinese herbs, mainly for the improvement and upgrading of Chinese medicine formulations, as the preparation of Chinese herbal medicine takes time, and if boiling is not done properly, would reduce  the efficacy of the herbal medicine. Hence, the scientifically refined extracts are not only easy to use, but have stable performance and are able to satisfy the patient's needs and saves time and effort. After

50 years of widespread clinical use, their safety and clinical efficacy have also been fully proven, and are widely welcomed  by patients. The new initiatives will create a chain reaction. The Singapore charitable TCM organisations have been using these medical formulations as the main form of treatment for decades, and it is estimated that Singapore charitable TCM organisations see an estimated 2000 patients per day. Once the new initiatives are implemented, these Singapore charitable TCM organisations as well as TCM clinics that depend heavily on these medical formulations will face severe medicine shortages and be unable to continue treating patients. This will bring about great inconvenience and problems for the patients as well as the nation's healthcare system as a whole.

On October 22, 2003, Singapore senior parliamentary secretary Chan Soo Sen led a dialogue session with the representatives of the TCM Coordinating Committee, and in the session, the TCM Coordinating Committee expressed its views on the HSA's soon-to-be implemented initiative with the Chinese SFDA, and requested for new regulatory measures to be taken. Members also exchanged views on this topic with the HSA.

On November 12, 2003, Head of the Health Sciences Authority, Dr Chen Chu Xian conducted an in-depth discussion on the topic of medicinal mixtures with  Coordination Committee members, Dr Neo Say Hai and Dr Teo Eng Kiat.

On December 24, 2003, the Singapore TCM Coordination Committee wrote to the Head of the Health Sciences Authority, Dr Chen Chu Xian again and reiterated its position.

On January 20, 2005, Head of the Health Sciences Authority, Dr Chen Chu Xian wrote to the TCM Management Committee Chairman, Dr Dr Neo Say Hai, with the following main points:

1. It was a pleasure meeting you, and after consideration of the feedback from your Council and the Singapore TCM Coordination Committee, the Health Sciences Authority has agreed to temporarily  allow the continued import and sale of Chinese manufactured medicinal mixtures that do not possess the free sale certificate. The transition period will last three years, and will not be extended,  and this will be reviewed after one year.

2. However, the following conditions must be followed:

a)     These products can only be supplied to TCM clinics, and be prescribed by registered TCM practitioners.

b)     Products must be accompanied with warranties from the importers and Chinese manufacturers and do not contain synthetic ingredients or Western medicine. In addition, importers must be responsible for product quality and safety.

c)     The prescribing TCM physician must bear responsibility for the patient consuming these products.

d)     Each product must have the following English label that states the following:  "Allowed for sale as a Chinese Proprietary Medicine (CPM)".

 "This product is not registered nor allowed to be freely sold in the country of origin (China).

This product does not meet full CPM product listing requirements but has been allowed for supply to TCM practitioners in consideration of the special situation of TCM practice in Singapore. HSA bears no responsibility for the product approval. The importer and distributor(s) are responsible for the safety and quality of this product.

The TCM practitioner is fully responsible for the use of this product on his/her patients and is obligated to inform them about the status of this product. Not for retail sale."