Study on Readiness Level of Dietary Supplement Manufacturers of Thailand to Adopt ASEAN Agreement on Regulatory Framework for Health Supplements

Abstract

ASEAN has been establishing the ASEAN Agreement on Regulatory Framework for Health
Supplements to support the ASESN’s single market and production base and it is expected to
finalise the draft agreement within 2020. The objectives of this study were to compare Thailand’s
regulations under the Food Act B.E. 2522 that related to dietary supplements versus the draft
ASEAN Agreement (as of 16 May 2017) and to evaluate the readiness level of Thai manufacturers
to adopt the ASEAN Agreement. Comparison of regulations of Thailand and ASEAN was carried
out by content analysis of the secondary data obtained from document study without interpretation
of the regulations being compared. The study of readiness level of the manufacturers was
performed by using a questionnaire survey. The 88 licensees of the dietary supplement manufacturing
were sampled and data collected were analysed by the Technique for Order Preference by
Similarity to Ideal Solution (TOPSIS). The regulatory comparative study showed that 5 articles
of the ASEAN agreement and Thai regulation share some similarities. Six articles of Thai regulations
were prescribed differently from those stated in the ASEAN agreement Thailand doesn’t have
a certain requirement regarding stability test, while it was prescribed in the ASEAN agreement.
The manufacturer’s readiness study revealed that the manufactures had a moderate level of
readiness to adopt the microbial criteria standards (Ci+=0.5) and had the lowest readiness in stability
test requirements (Ci+=0.47), although a 5-year transition period will be applied. To minimize
the impact on the industry in case of the Thai government deposited its instruments of ratification,
It recommends that the Thai government may negotiate with other member states to voluntary
implement the ASEAN agreement along with having certification system for exporting in place.
The existing regulations still mandatory apply to domestic production/distribution of dietary
supplement, meanwhile the ASEAN agreement may be additionally implemented upon the need
of the business. However, in case of dietary supplements that made of herbals was regulated
under the Herbal Products Act of B.E. 2562, re-evaluation should be performed