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All Journal Pharmaceutical And Biomedical Sciences Journal (PBSJ) Journal of Food and Pharmaceutical Sciences Obat: Jurnal Riset Ilmu Farmasi dan Kesehatan Borneo Journal of Pharmacy Global Management: International Journal of Management Science and Entrepreneurship
Mohamad Kashuri
The Indonesian Food And Drug Authority
Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Decision Sciences, Operations Research & Management Health Professions Immunology & microbiology Materials Science & Nanotechnology Medicine & Pharmacology Neuroscience Nursing Public Health

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Melindungi Konsumen Melalui Regulasi: Studi Kasus Sosialisasi Peraturan BPOM Tentang Batas Cemaran Kosmetik Kashuri, Mohamad
Pharmaceutical and Biomedical Sciences Journal (PBSJ) Vol 7, No 1 (2025)
Publisher : UIN Syarif Hidayatullah Jakarta

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.15408/pbsj.v7i1.45307

Abstract

This study evaluates the effectiveness of disseminating BPOM Regulation No. 16 of 2024 in enhancing stakeholder understanding and support for regulations designed to protect consumers from unsafe cosmetics. The regulation aims to align national standards with international ones; however, its implementation faces significant challenges. Using a descriptive quantitative approach, a survey was conducted with 528 participants in a hybrid-format dissemination program. The results indicate that the dissemination activities were effective, with an average evaluation score of 5.19 out of 6 for the regulation, and consumer protection aspects receiving the highest score (5.40). The implementation of the activities was rated as excellent (average score of 5.39), reflecting the organizers’ success in reaching a broad audience. However, challenges related to implementation costs were identified as barriers, particularly for MSMEs. These businesses require technical guidance and operational support. The study concludes that the dissemination activities improved stakeholder preparedness, but successful implementation requires a collaborative approach involving technical assistance, adequate time allocation for discussions, and innovative delivery methods. These measures are crucial to support a safe and globally competitive Indonesian cosmetics industry.
Proactive Risk Governance for Pharmaceutical Adulteration in Traditional Medicines: Evidence from Indonesia’s 2022–2025 Recalls Kashuri, Mohamad
Journal of Food and Pharmaceutical Sciences Vol 13, No 3 (2025): J.Food.Pharm.Sci
Publisher : Integrated Research and Testing Laboratory (LPPT) Universitas Gadjah Mada

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22146/jfps.21625

Abstract

Pharmaceutical adulteration in traditional medicines poses a persistent public health risk, particularly in countries with weak regulatory oversight. In Indonesia, recurring violations involving undeclared pharmaceutical substances (Bahan Kimia Obat, BKO) continue to surface despite existing post-market monitoring. This study aimed to examine the extent, trends, and systemic regulatory gaps associated with BKO in Indonesian traditional medicines between 2022 and early 2025. Using a qualitative document-based content analysis, the research reviewed official recall announcements and inspection records issued by the Indonesian Food and Drug Authority (BPOM). The findings revealed a sharp increase in BKO cases from 2022 to 2024, followed by a sudden drop in 2025, raising concerns about surveillance consistency. The adulterants detected became increasingly diverse, including anti-obesity drugs, corticosteroids, and psychiatric agents, reflecting a shift in consumer-targeted illicit formulation. Regulatory challenges identified include fragmented governance, lack of traceability systems, insufficient pre-market screening, and reliance on end-product testing. The study proposes reforms such as mandatory serialization, third-party testing, and realignment of licensing accountability to manufacturers. These insights suggest that current enforcement mechanisms are reactive and incomplete. Strengthening risk governance and integrating socio-behavioral dimensions into regulation are essential to prevent recurrence and protect public health.
Effectiveness Study of BPOM’s Assistance for MSMEs in Natural Medicine and Cosmetics to Obtain Distribution Permits Mohamad Kashuri
OBAT: Jurnal Riset Ilmu Farmasi dan Kesehatan Vol. 3 No. 1 (2025): January: OBAT: Jurnal Riset Ilmu Farmasi dan Kesehatan
Publisher : Asosiasi Riset Ilmu Kesehatan Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.61132/obat.v3i1.945

Abstract

This study evaluates the effectiveness of BPOM’s mentoring programs for Micro, Small, and Medium Enterprises (MSMEs) in the natural medicine and cosmetics sectors in navigating complex regulatory requirements to obtain product licenses. Despite the strategic role of MSMEs in supporting Indonesia’s economy, regulatory compliance remains a significant challenge, particularly due to limited resources and market access. Previous studies have highlighted the need for adaptive regulatory approaches and mentoring programs, but gaps remain in evaluating their long-term impact and inclusivity. This study offers novelty by analyzing the program’s effectiveness across diverse demographic and educational backgrounds, providing evidence-based insights into its impact. Using a descriptive quantitative approach, data were collected through surveys involving 35 MSME participants from the “Rembuk UMKM” event. The Likert-scale questionnaire assessed regulatory understanding, program effectiveness, and its impact on license readiness. Data were analyzed using descriptive statistics, generating insights into participant perceptions. The findings show that the mentoring program is most effective among younger participants (aged 18–25 years), scoring 4.53, while maintaining high effectiveness scores across all age groups. Educational background analysis revealed the highest scores (5.00) from vocational high school (SMK) and master’s (S2) participants, highlighting the program’s inclusivity and adaptability. However, team competence scored relatively lower (4.26), indicating the need for continuous capacity building. The study concludes that BPOM’s mentoring programs significantly enhance MSME compliance and build long-term trust, with strategic recommendations for continuous training, technology-based module development, regional collaborations, and structured feedback mechanisms. These initiatives aim to strengthen program relevance and sustainability, supporting MSMEs in achieving regulatory compliance and contributing to national economic growth.
Analysis of Business Actors’ Satisfaction with BPOM’s One Stop Service in the Registration of Herbal Medicines, Health Supplements, and Cosmetics Mohamad Kashuri
Global Management: International Journal of Management Science and Entrepreneurship Vol. 1 No. 4 (2024): November : International Journal of Management Science and Entrepreneurship
Publisher : International Forum of Researchers and Lecturers

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.70062/globalmanagement.v1i4.30

Abstract

The One Stop Service provided by the Indonesian Food and Drug Authority is designed to streamline the registration procedures for herbal medicines, cosmetics, and health supplements. This service is essential for improving efficiency, accessibility, and user satisfaction; however, empirical evaluations of user satisfaction remain limited. Previous studies highlight that service quality, communication, and responsiveness are key factors influencing satisfaction, but specific research on BPOM’s OSS is scarce. This study aims to evaluate user satisfaction levels, identify key determining factors, and provide recommendations for improving the service. A quantitative approach was employed, collecting data through questionnaires from participants who engaged in the service, both offline and online. The results indicate that most respondents were satisfied, particularly with processing time, ease of access, and staff responsiveness. However, areas requiring improvement include the development of digital features, more equitable service distribution, and enhanced transparency in communication. This study offers novelty by emphasizing the importance of a holistic approach that incorporates dimensions of communication, privacy, and inclusivity.
Regulatory Reform and Policy Mapping in Indonesia’s Traditional Medicine, Health Supplement, and Cosmetic Sectors Kashuri, Mohamad; Yanuar, Arry
Borneo Journal of Pharmacy Vol. 8 No. 4 (2025): Borneo Journal of Pharmacy
Publisher : Institute for Research and Community Services Universitas Muhammadiyah Palangkaraya

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.33084/bjop.v8i4.11055

Abstract

This study systematically analyzed Indonesia's regulatory reforms for traditional medicines, health supplements, and cosmetics (TMHSC) issued between 2020 and 2024. The objective was to map the scope, distribution, and policy orientation of the 35 regulations enacted by the Indonesian Food and Drug Authority (BPOM) within the framework of the National Medium-Term Development Plan (RPJMN 2020–2024). A qualitative policy analysis was employed, combining document analysis, thematic coding, and comparative benchmarking with frameworks from the ASEAN, European Union (EU), and Organisation for Economic Co-operation and Development (OECD). The findings show that 25 regulations were directed toward strengthening regulatory services, nine targeted compliance and Good Manufacturing Practices (GMP), and one supported research and innovation through preclinical testing standards. This distribution reflects a policy trajectory that prioritizes service delivery and compliance assurance, while progressively integrating evidence-based approaches to research and innovation. A comparative analysis revealed a strong alignment with ASEAN harmonization initiatives and an incremental adoption of international benchmarks, such as ISO 22716 for cosmetics and the WHO GMP guidelines for herbal medicines. Overall, Indonesia's TMHSC regulatory transformation demonstrates a balanced and adaptive governance model that safeguards public health, promotes innovation, and enhances regional policy coherence. The results provide practical implications for policymakers, particularly BPOM and ASEAN member states, in developing regulatory frameworks that effectively balance consumer protection, innovation enablement, and market competitiveness within the TMHSC sectors.
Co-Authors Arry Yanuar