REGULATION OF RISK-BASED BUSINESS LICENSING AND ITS RELATIONSHIP WITH SMALL TRADITIONAL MEDICINE BUSINESSES

Law, Legal, Medical

Risk-based business licensing is a government innovation designed to simplify the licensing process. The Traditional Medicine Small Business (TMSB) falls under this framework in the health sector, governed by Minister of Health Regulation No. 14 of 2021 and Minister of Industry Regulation No. 9 of 2021. However, these regulations assign different risk levels to TMSBs: "High Risk" by the Ministry of Health/NADFC and "Low Medium Risk" by the Ministry of Industry. This research analyzes the regulatory position of TMSB licensing, particularly in light of the Minister of Economic Affairs' letter No. PI.01/433/SES.M.EKON/06/2021, which concerns the Standard Classification of Indonesian Business Fields (SCIBF). The study employs a normative juridical approach, examining legal principles and statutory regulations related to TMSB licensing. Findings indicate a lack of synchronization between the risk levels set by different ministries, potentially leading to public health risks from unsafe pharmaceutical products. The research recommends a coordinated review involving the Capital Investment Coordinating Board, Ministry of Economic Affairs, Ministry of Health, Ministry of Industry, and National Agency of Drug and Food Control (NADFC) to harmonize TMSB licensing regulations and safeguard public health.

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