On 27 January 2026, Indonesia’s Food and Drug Supervisory Agency (BPOM) released a draft regulation introducing a List of Pharmaceutical Ingredients Used in Natural Medicines, Health Supplements, Quasi-drugs, and Certain Cosmetic Products.
The draft regulation identifies specific ingredients that must meet pharmaceutical-grade standards when used in designated: Natural medicines, Health supplements, Quasi-drugs and Certain cosmetic products.
The proposal follows BPOM Regulation No. 26 of 2025, which entered into force on 3 October 2025 and introduced a risk-based framework for ingredient assessment. Under that regulation, ingredients used in certain high-risk dosage forms are required to comply with pharmaceutical-grade standards.
For cosmetic products, pharmaceutical-grade quality refers to compliance with the Indonesian Cosmetics Codex, or other recognised standards where the Codex does not apply.
The draft regulation’s appendix lists the specific ingredients and product categories that trigger the pharmaceutical-grade requirement, which includes 14 ingredients commonly used in dental and oral care products. These would be required to meet pharmaceutical-grade standards if the draft is adopted.
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‡Photo by Radoslav Bali on Unsplash

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