JAKARTA – Indonesia is preparing to enter a new era in the pharmaceutical industry with the implementation of mandatory halal certification that will be enforced in phases starting in 2026. Based on established regulations, the phasing of mandatory halal certification for pharmaceutical products begins with traditional medicines, quasi-drugs, and health supplements, which must obtain halal certificates starting October 17, 2026.

This policy represents the implementation of Law No. 33 of 2014 on Halal Product Assurance, which significantly impacts Indonesia’s pharmaceutical industry. The pharmaceutical industry must prepare to face this obligation, followed by over-the-counter drugs and limited over-the-counter drugs in 2029, and prescription drugs (except psychotropics) in 2034.

This transformation not only changes the pharmaceutical industry landscape but also creates a new ecosystem involving various stakeholders with interconnected roles and responsibilities. This article will detail the stakeholders involved in Indonesia’s pharmaceutical halal certification process and how they collaborate to create a comprehensive system.

Certification Process Stages and Involved Parties

1. Initial Stage: Application Submission by Business Operators

The halal certification process begins when pharmaceutical business operators submit halal certification applications for their products. Indonesia’s halal certification system involves three main parties: BPJPH, LPPOM MUI as the halal inspection agency (LPH), and MUI. At this stage, business operators must prepare all required documentation, including raw material lists, production processes, and implemented halal assurance systems.

2. BPJPH (Halal Product Assurance Agency): The Main Gateway for Certification

BPJPH, as an agency under the Ministry of Religious Affairs, serves as the main gateway in the halal certification process. After business operators submit applications, BPJPH is responsible for receiving and processing these applications. This institution also coordinates the entire certification process with related parties and ultimately issues official halal certificates.

3. LPPOM MUI: Competent Halal Inspection Agency

After BPJPH receives applications, the next stage involves technical examination conducted by LPPOM MUI as an accredited Halal Inspection Agency (LPH). LPPOM MUI plays a crucial role in conducting:

• Comprehensive audits and examinations of pharmaceutical products
• Laboratory analysis to ensure no contamination from non-halal materials
• Production facility inspections to verify halal assurance system implementation
• Evaluation of raw material supply chains

LPPOM MUI has a team of certified halal auditors experienced specifically in pharmaceuticals, capable of understanding the complexity of drugs and health supplements.

4. Halal Auditors: Field Executors

Halal auditors are certified professionals who serve as LPPOM MUI’s eyes and hands in the field. They conduct direct visits to business operators’ production facilities to:

• Verify the accuracy of submitted documentation
• Examine halal assurance system implementation in daily practice
• Identify potential cross-contamination risks
• Ensure proper separation between halal and non-halal production lines (if any)

After completing audits, halal auditors compile comprehensive reports that serve as the basis for halal recommendations.

5. MUI: Determiner of Halal Fatwa

Based on reports from LPPOM MUI and audit results, MUI then issues halal fatwa. MUI is responsible for determining a product’s halal status, while BPJPH issues halal certificates based on MUI’s halal determination. This fatwa determination process involves MUI’s fatwa commission consisting of religious scholars and experts competent in pharmaceuticals.

6. BPOM: Safety and Quality Supervisor

Although not directly involved in the halal certification process, BPOM (National Agency of Drug and Food Control) plays an important role in this ecosystem. BPOM remains responsible for supervising the safety, efficacy, and quality of drugs and supplements, and coordinates with BPJPH regarding the supervision of halal-certified products. This coordination is essential to ensure that halal products are also safe and of high quality.

7. Final Stage: Certificate Issuance

After MUI issues halal fatwa, BPJPH then issues official halal certificates that serve as legal proof of the pharmaceutical product’s halal status. These certificates are valid for a certain period and must be renewed periodically through re-audit processes.

Inter-Agency Coordination: Key to System Success

The success of Indonesia’s pharmaceutical halal certification system heavily depends on effective coordination between agencies. Each party has specific roles that complement each other:

• BPJPH as the main coordinator and certificate issuer
• LPPOM MUI as the executor of audits and technical examinations
• MUI as the determiner of halal fatwa
• BPOM as safety and quality supervisor
• Halal auditors as field executors

This inter-agency synergy creates a comprehensive check and balance system, ensuring that circulating pharmaceutical products are not only halal but also safe and of high quality.

Challenges and Opportunities

The implementation of mandatory pharmaceutical halal certification presents both challenges and opportunities for the industry. Challenges include the need for significant investment in halal assurance systems, training of human resources, and adaptation of production processes. However, these challenges are accompanied by tremendous opportunities, including increased consumer trust, access to global halal markets, and positioning Indonesia as a leader in the halal pharmaceutical industry.

The pharmaceutical industry must view this mandatory certification not as a burden but as an opportunity to enhance competitiveness and expand market reach. With proper preparation and commitment from all stakeholders, Indonesia can become a global center for halal pharmaceuticals.

Conclusion

The implementation of mandatory pharmaceutical halal certification in 2026 represents Indonesia’s monumental step in guaranteeing Muslim consumers’ rights to obtain halal pharmaceutical products. Through collaboration among the various parties outlined above, the halal certification system is expected to operate effectively and efficiently.

The success of this implementation will not only increase public trust in local pharmaceutical products but also position Indonesia as a global leader in the halal pharmaceutical industry. With thorough preparation from all stakeholders, Indonesia is ready to embrace a new era of the pharmaceutical industry that excels not only in quality but also guarantees halal status.

We hope that through strong inter-agency synergy and full commitment from industry players, Indonesia’s vision as a global halal pharmaceutical center can be realized, providing benefits not only to Indonesian society but also to Muslims worldwide. The future of Indonesia’s pharmaceutical industry lies in its ability to integrate religious values with scientific excellence, creating products that serve both spiritual and physical well-being.

References

Khairuddin. (2021). Progres sertifikasi halal di Indonesia: Studi pada Badan Penyelenggara Jaminan Produk Halal (BPJPH) Kementerian Agama dan Lembaga Pengkajian Pangan, Obat-obatan dan Kosmetika (LPPOM) MUI Pusat. ASAS: Jurnal Hukum Ekonomi Syariah, 13(2), 145-162.

Badan Penyelenggara Jaminan Produk Halal. (2023). Keputusan Kepala Badan No. 20 Tahun 2023 tentang Perubahan Standar Jaminan Produk Halal. BPJPH Kementerian Agama RI.

Kementerian Agama RI. (2024). Masa penahapan usai, kewajiban sertifikasi halal berlaku mulai 18 Oktober 2024. Rertrivied from  https://kemenag.go.id/

LPPOM MUI. (2022). Implementasi sistem jaminan halal pada industri farmasi Indonesia. Journal of Halal Product and Research (JHPR), 5(2), 78-95.

Peraturan Menteri Kesehatan Republik Indonesia Nomor 3 Tahun 2024 tentang Penyelenggaraan Sertifikasi Halal Produk Farmasi. Jakarta: Kementerian Kesehatan RI.

Undang-Undang Republik Indonesia Nomor 33 Tahun 2014 tentang Jaminan Produk Halal. Jakarta: Sekretariat Negara RI.

Rahman, A., & Sari, D. P. (2023). Perkembangan industri farmasi halal di Indonesia: Tantangan dan peluang. International Journal of Halal Research, 8(3), 234-248.

Wijaya, M., & Hartono, B. (2024). Implementasi sistem jaminan halal pada perusahaan farmasi Indonesia. Asian Journal of Pharmaceutical Sciences, 19(4), 156-169.