Regulasi dan Implementasi Sertifikasi Halal pada Produk Farmasi di Indonesia: Analisis Yuridis dan Tantangan Kontemporer

Abstract

Halal certification for pharmaceutical products in Indonesia is mandated by Law Number 33 of 2014 concerning Halal Product Assurance. However, its implementation faces higher legal and technical complexities compared to the food sector. This study aims to analyze the regulatory framework for pharmaceutical halal certification, identify the gap between legal norms and implementation realities, and formulate adaptive policy recommendations. The research employs normative legal research with a library research approach, utilizing primary and secondary legal materials. The findings indicate that while the regulatory framework is progressive, overlapping authorities persist among BPJPH, MUI, and BPOM. Critical halal points include active pharmaceutical ingredients, excipients such as gelatin, and the risk of cross-contamination. Contemporary challenges encompass the limited availability of imported halal raw materials, a lack of competent human resources, high certification costs, repeated obligation postponements until 2026, and weak post-certification supervision. This research offers novelty through a contemporary juridical analysis approach that integrates regulations, production technology, and public health rights. In conclusion, the study recommends mutual recognition of halal certification, human resource capacity building, service digitalization, and independent raw material research to achieve a sustainable halal pharmaceutical ecosystem in Indonesia