Readiness and Impacts of Traditional Medicines Manufacturers in Thailand on Registration for ASEAN Harmonization

Abstract

This study was aimed to investigate readiness and impact of ASEAN Traditional Medicines and Health Supplements (TMHS) Harmonization on traditional medicines manufacturers. Data was collected from 269 registered manufacturers of traditional medicines from November 2015 to January 2016, using developed questionnaire. The data was then analyzed using descriptive statistics  such as percentage, mean and standard deviation. In terms of readiness to comply with the ASEAN TMHS requirements for implementation, it was divided into three areas  as quality and safety, efficacy and claimed benefits, and labeling. The forecasted impacts were designed to present in capital cost,  selling price, product quality and reliability, number of proposed traditional medicine registration,  duration of preparation of registered documents, product sales,  product potential competition and export ability.

The data derived from 183 respondents showed that an overall readiness to comply with the requirements of ASEAN TMHS is in moderate level (x̄= 3.02, SD = 0.78). Appropriated training and time were required for implementation readiness. An average  duration that the drug manufacturer expected to be ready in preparation for readiness was 5.25 years (SD = 1.55, max = 10, min = 1). The study on the compared impacts of ASEAN TMHS standard with the current standard showed that the drug manufacturers believed that it will not have an impact on the number of proposed traditional medicine registration, the duration of preparation of registered documents, the product sales, the product potential competition, and the exporting ability. Further, these impacts might have effects on the increasing of capital cost, selling price, and product quality and reliability. In summary, the opinions of entrepreneurs on the registration requirement of traditional medicines in accordance with the ASEAN approach show that the requirement is interesting. The approach is to increase the assurance of the products. But the  duration of  preparedness to comply with the standard is needed. The results of this research can be used to determine the availability of potential entrepreneurs  for further traditional medicine manufacture development.