Regulatory compliance index of traditional medicine and health supplement companies in Indonesia

Center for Food and Drug Policy Analysis–The Indonesian Food and Drug Authority, Indonesia

^* Corresponding author: sri.astuti@pom.go.id

Abstract

The traditional medicine and health supplement sectors are growing in Indonesia, driven by public interest in natural and preventive health solutions. Regulatory compliance is essential to ensure the safety, quality, and efficacy of these products. This study aims to assess the compliance level of traditional medicine and health supplement companies or business actors with applicable regulations and standards in Indonesia. The measurement was conducted by The Indonesian Food and Drug Authority (The Indonesian FDA), which supervises the entire life cycle of these products. The method involved a quantitative analysis of data from the inspection of production facilities, distribution, advertising, and labelling, conducted by Indonesian FDA Regional Office in 34 provinces. The data were classified into compliant and non-compliant categories, then analyzed by measuring the proportion of comply facilities out of the total facilities, and weighted using the Analytical Hierarchy Process approach. Results showed that health supplement companies have higher and more stable compliance than traditional medicines companies. The compliance index for traditional medicines during 2020-2024 ranged from 66.83-85.26, while health supplements ranged from 90.73-97.80. Fluctuations in index values in the traditional medicine sector indicate the need to strengthen guidance and stricter regulatory supervision. This study is an important instrument to evaluate the effectiveness of The Indonesian FDA control and support the improvement of national industry competitiveness.