Halal Pharmaceutical Excipients: Unveiling the Legal Normative Gap in Indonesia’s Halal Product Assurance System for the Pharmaceutical Sector
DOI:
https://doi.org/10.21580/halalin.2026.3.2.34Keywords:
halal pharmaceutical, halal product assurance, pharmaceutical excipients, pharmaceutical lawAbstract
The expansion of halal product assurance into the pharmaceutical sector has not been fully accompanied by a legal framework capable of addressing pharmaceutical excipients as integral components of drug formulations. Existing regulations remain oriented toward halal status at the product level, while the origin, processing, traceability, and use of excipients with halal concerns remain insufficiently regulated. This study aims to examine the adequacy of Indonesian regulations governing pharmaceutical excipients and to formulate a normative reconstruction for strengthening halal assurance in pharmaceutical products. Employing a qualitative normative juridical method, this study applies statutory, conceptual, and comparative approaches to secondary data comprising primary, secondary, and tertiary legal materials, which are analyzed through qualitative-prescriptive analysis. The findings demonstrate normative insufficiency and regulatory fragmentation concerning the legal status of pharmaceutical excipients, risk-based control, verification of sources and processing, traceability, ḍarūrah-based exceptions, and institutional coordination. The novelty of this study lies in proposing a normative model that integrates halal assurance with pharmaceutical regulation through explicit recognition of excipients, risk-based regulation, traceability, controlled ḍarūrah exceptions, and continuous oversight. The model contributes to a more coherent, measurable, and adaptive halal product assurance framework for Indonesia's pharmaceutical sector.
References
Abu-Hussin, M. F., Zafar, M. B., Norzilan, N. I. M., Hehsan, A., & Junaidi, J. (2026). From religious obligation to market strategy: The politics of halal certification in Malaysia. Journal of Islamic Marketing, 1–24. https://doi.org/10.1108/JIMA-12-2024-0572
Al-Laṭīf, ʿAbd al-Raḥmān bin Ṣāliḥ al-ʿAbd. (2003). Kitāb al-Qawāʿid wa al-Ḍawābiṭ al-Fiqhiyyah al-Mutaḍamminah li al-Taysīr. Ḥuqūq al-Ṭabʿ Maḥfūẓah.
Blundell, R., Butterworth, P., Charlier, A., Daurio, D., Degenhardt, M., Harris, D., Hancock, B., Johnston, M., Kasina, R., Kaye, J., Kelly, R., Lienbacher, P., Meehan, L., Melnick, J., Ojakovo, P., Schoell, J., Schimmelle, B., Tobyn, M., Wagner-Hattler, L., … Wiedey, R. (2022). The role of titanium dioxide (E171) and the requirements for replacement materials in oral solid dosage forms: An IQ Consortium Working Group review. Journal of Pharmaceutical Sciences, 111(11), 2943–2954. https://doi.org/10.1016/j.xphs.2022.08.011
CNN Indonesia. (2025). Sertifikat vaksin meningitis palsu beredar di jemaah umrah Sumbar. CNN Indonesia. https://www.cnnindonesia.com/nasional/20250104181416-20-1183766/sertifikat-vaksin-meningitis-palsu-beredar-di-jemaah-umrah-sumbar
Decision of the Fatwa Commission of the Indonesian Ulema Council Number 80 of 2022 Concerning Products and/or Materials Requiring Laboratory Testing. (2022).
Devi, Y. S., & Fatimah, P. L. R. (2025). Integrating the Tetrapreneur framework for enhanced halal regulation. Iqtishoduna, 21(1), 73–88. https://doi.org/10.18860/iq.v21i1.30631
Doerine, J. Postma, P. A. G. M. De Smet, A. K. Mantel-Teeuwisse, H. G. M. Leufkens, & K. N. (2025). Upstream pharmaceutical supply of 10 high-use pharmaceuticals in the Netherlands: A cohort study. BMJ Open, 15(1), 1–9. https://doi.org/10.1136/bmjopen-2025-099697
Fatwa of the Indonesian Ulema Council Number 30 of 2013 Concerning Medicines and Medical Treatment. (2013).
Fatwa of the Indonesian Ulema Council Number 47 of 2012 Concerning the Use of Hair, Bristles, and Horns from Animals That Are Halal but Not Slaughtered in Accordance with Islamic Law for Food, Medicines, and Cosmetics. (2012).
Fauzi, M., & Rodin, D. (2024). Assessing the effectiveness of the Halal Assurance System 23000. Journal of Digital Marketing and Halal Industry, 6(2), 261–279. https://doi.org/10.21580/jdmhi.2024.6.2.31101
Friedman, L. M. (1975). The legal system: A social science perspective. Russell Sage Foundation.
Ghadi, F. D., Khan, A. S. A., Wadekar, S. M., Jambhale, D. P., & Divekar, D. G. (2025). The role of excipients in pharmaceutical formulation: Extended brief review. Advanced International Journal for Research (AIJFR), 6(5), 1–3. https://doi.org/10.63363/aijfr.2025.v06i05.1183
Government Regulation Number 42 of 2024 Concerning the Implementation of Halal Product Assurance. (2024).
Haider, R. (2023). International trade in pharmaceutical products. International Journal of Applied Economics, Accounting and Management (IJAEAM), 1(4), 227–250. https://doi.org/10.59890/ijaeam.v1i4.913
Hayani, Y., Rispawati, Sawaludin, & Yuliatin. (2025). Implementasi Peraturan Daerah No. 1 Tahun 2022 tentang penyelenggaraan perizinan berusaha berbasis risiko. Journal of Civic Education, 8(1), 11–22. https://doi.org/10.24036/jce.v8i1.1137
Herdiana, Y., Gozali, D., Putriana, N. A., Muchtaridi, Shamsuddin, S., & Sofian, F. F. (2026). Beyond side effect: Immuno-ethical risk analysis of animal-derived ingredients in pharmaceuticals. Risk Management and Healthcare Policy, 19(1), 1–21. https://doi.org/10.2147/RMHP.S584055
Heri Nurranto, U. S. (2025). Ketertelusuran rantai pasok bahan baku farmasi sebagai upaya peningkatan kualifikasi dan keamanan pemasok. An-Najat: Jurnal Ilmu Farmasi dan Kesehatan, 3(1), 127–138. https://doi.org/10.59841/an-najat.v3i1.2356
Irfany, M. I., Nekha, A., Tieman, M., & Haq, D. A. (2025). Halal procurement strategy for the halal pharmaceutical industry in Indonesia. Journal of Islamic Marketing, 16(4), 1073–1094. https://doi.org/10.1108/JIMA-09-2023-0274
Kankala, R. K., Xu, P.-Y., Chen, B.-Q., Wang, S.-B., & Chen, A.-Z. (2021). Supercritical fluid (SCF)-assisted fabrication of carrier-free drugs: An eco-friendly welcome to active pharmaceutical ingredients (APIs). Advanced Drug Delivery Reviews, 176. https://doi.org/10.1016/j.addr.2021.113846
Khan, M. A. A., & Rauf, A. (2024). Promoting local production and active pharmaceutical ingredient (API) industry in low- and middle-income countries (LMICs): Impact on medicines access and policy. Journal of Pharmaceutical Policy and Practice, 17(1), 1–10. https://doi.org/10.1080/20523211.2024.2323683
Latiff, J. A. (2020). Halal certification procedure in Malaysia and Indonesia: A study on criteria for determination of halal pharmaceutical products. Petita: Jurnal Kajian Ilmu Hukum dan Syariah, 5(2), 121–132. https://doi.org/10.22373/petita.v5i2.102
Latiff, J. A., Zakaria, Z., & Man, S. (2021). The challenges in implementation of halal vaccine certification in Malaysia. Journal of Food and Pharmaceutical Sciences, 9(1), 366–371. https://doi.org/10.22146/jfps.1147
Latiff, J. A., Zakaria, Z., & Man, S. (2023). An escalating transition towards halal vaccine certification in Malaysia. Journal of Shariah Law Research, 8(1), 87–102. https://doi.org/10.22452/jslr.vol8no1.4
Latiffa, N. H. M., Adnan, A. H., Aziz, M. A. A., Muidnudin, A. H. H. M., Adnan, A. A., Rajib, A. H. A., Ahmad, M. H. A., & Faiz, A. A. N. A. (2026). MS 2424:2019: A mini review on contemporary issues and challenges of halal pharmaceuticals in Malaysia. Halalsphere, 6(2), 85–90. https://doi.org/10.31436/hs.v6i2.156
Law Number 17 of 2023 Concerning Health. (2023).
Law Number 33 of 2014 Concerning Halal Product Assurance. (2014).
Li, R. (2023). Reevaluating excipients in pharmaceuticals. Dean & Francis, 1(2), 1–2. https://doi.org/10.61173/04tryy04
Lutfia, R. V., Aisiyah, R. M., Cahyani, R. A. S., Jaenudin, & Hidayat, A. A. (2025). Supervision of halal certification in the pharmaceutical industry in Indonesia. Journal of Halal Product and Research (JHPR), 8(1), 112–123. https://doi.org/10.20473/jhpr.vol.8-issue.1.112-123
Masri, E., Irianto, S., Masriani, Y. T., & Falah, S. M. S. (2025). Halal product assurance as legal protection for Muslim consumers in Indonesia. Al-Ahkam, 35(1), 205–234. https://doi.org/10.21580/ahkam.2025.35.1.26384
Mihajlović, B., & Micovic, A. (2024). Consumer right to food information. Economics of Agriculture, 71(4), 1325–1338. https://doi.org/10.59267/ekoPolj24041325M
Nekha, A. (2023). Halal pharmaceutical development in Indonesia. Islamic Economics Methodology, 2(2), 1–7. https://doi.org/10.58968/iem.v2i2.353
Presidential Regulation Number 6 of 2023 Concerning Halal Certification of Pharmaceuticals, Biological Products, and Medical Devices. (2023).
Probo, F. E., Widyawati, A., & Suprapti, D. D. (2025). Criminal law policy of illegal pharmaceutical preparations in the Health Omnibus Law. Multidisciplinary Output Research for Actual and International Issue (MORFAI), 4(4), 1566–1571. https://doi.org/10.54443/morfai.v4i4.2428
Putri, R. G., & HM, P. (2025). Studi peran SMIIC dalam transformasi industri halal di wilayah otonomi khusus Mindanao, Filipina. Jurnal Muqoddimah: Jurnal Ilmu Sosial, Politik, dan Humaniora, 9(3), 1570–1579. https://doi.org/10.31604/jim.v9i3.2025.1570-1579
Radbruch, G. (2006). Five minutes of legal philosophy. Oxford Journal of Legal Studies, 26(1), 13–15. https://doi.org/10.1093/ojls/gqi042
Regulation of the Food and Drug Supervisory Agency Number 13 of 2022 Concerning Amendments to Regulation of the Food and Drug Supervisory Agency Number 21 of 2020 Concerning the Organization and Work Procedures of the Food and Drug Supervisory Agency. (2022).
Romli, R. A., Hardyansah, R., & Saputra, R. (2023). BPOM’s role in Muslim consumer protection against non-halal medicines. Journal of Social Science Studies, 3(2), 121–130.
Yu, Y. B., Taraban, M. B., Briggs, K. T., Brinson, R. G., & Marino, J. P. (2021). Excipient innovation through precompetitive research. Pharmaceutical Research, 38, 2179–2184. https://doi.org/10.1007/s11095-021-03157-y
Zulfa, E. A., Ismail, T. Q., Hayatullah, I. K., & Fitriana, A. (2023). Regulation and law enforcement on the protection of halal products in Indonesia. Cogent Social Sciences, 9(2), 1–13. https://doi.org/10.1080/23311886.2023.2273344
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2026 Adzanah Mariska Salsabila, Zaky Anggara
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
The copyright of the received article shall be assigned to the journal as the publisher of the journal. The intended copyright includes the right to publish the article in various forms (including reprints). The journal maintains the publishing rights to the published articles. Therefore, the author must submit a statement of the Copyright Transfer Agreement.*)
In line with the license, authors and third parties (readers, researchers, and others) are allowed to share and adapt the material. In addition, the material must be given appropriate credit, provided with a link to the license, and indicated if changes were made. If authors remix, transform or build upon the material, authors must distribute their contributions under the same license as the original.
________
*) Authors whose articles are accepted for publication will receive confirmation via email and send a Copyright Transfer Agreement.
