Expert Analysis Reveals Complex Challenges and Growing Industry Response

Indonesia’s pharmaceutical sector is navigating a comprehensive transformation as the country implements mandatory halal certification for medicinal products across different categories. The regulatory framework presents both opportunities and challenges for pharmaceutical manufacturers operating in the world’s largest Muslim-majority nation.

Regulatory Framework and Implementation Timeline

The mandatory halal certification for medicines stems from Act No. 33 of 2014 concerning Halal Product Assurance, which requires all products entering, circulating, and trading in Indonesia to obtain halal certification. Government Regulation No. 39 of 2021 and Presidential Regulation No. 6 of 2023 specifically govern the implementation phases for pharmaceutical products.

The certification requirements follow a staggered timeline based on product categories:

Traditional medicines and health supplements must comply between October 17, 2021, and October 17, 2026. Over the counter and limited over the counter drugs have until October 17, 2029, while prescription drugs (excluding psychotropics) have until October 17, 2034. Biological products, including vaccines, are governed by separate presidential regulations.

Religious and Legal Justification

Dr. Priyo Wahyudi, M.Si, a pharmacy expert at Prof. DR. Hamka Muhammadiyah University (UHAMKA) Jakarta and Laboratory Service Expert at LPPOM MUI, explains the multifaceted urgency behind halal medicine certification. From a religious perspective, consuming halal products, including medicines, represents an Islamic obligation based on Quranic guidance in Al-Baqarah (2):168.

Beyond religious requirements, the certification addresses consumer rights, ensuring citizens can access products aligned with their religious practices. The formal legal aspect mandates that all products in Indonesia’s market must carry halal certification, making compliance both a religious and legal necessity.

Industry Response Shows Strong Growth

The pharmaceutical industry’s response to halal certification requirements has been overwhelmingly positive, with participation rates increasing dramatically over recent years. In 2017, only 36 companies offered 484 halal-certified drug products. By 2020, this expanded to 138 companies with 2,146 certified products.

The most significant growth occurred in 2021, when 211 companies achieved certification for 5,914 pharmaceutical products. This trend demonstrates the pharmaceutical industry’s strong commitment to meeting regulatory requirements and consumer expectations.

Supply Chain Challenges Require Comprehensive Solutions

The pharmaceutical industry faces several complex challenges in achieving halal certification across its entire supply chain. Raw materials present the most significant obstacle, as Indonesia’s low Domestic Content Level (TKDN) forces manufacturers to rely heavily on imported ingredients that may not meet halal standards or competitive pricing requirements.

Packaging materials show more promise, with most primary drug packaging now produced domestically, simplifying the certification process for this component.

Production and Distribution Considerations

Manufacturing facilities must ensure complete freedom from impurities and pork contamination to prevent cross-contamination of active ingredients, excipients, and auxiliary materials. This requirement necessitates comprehensive facility audits and potentially significant operational modifications.

Logistics and distribution present additional complexity, as storage and transportation systems must guarantee protection against cross-contamination with non-halal materials. The growing interest among logistics companies in obtaining halal certification helps address this challenge. PT Enseval Putera Megatrading Tbk received recognition as Best New Comer in the Services category at the LPPOM MUI Halal Award 2023, indicating positive industry movement.

Strategic Implications for Market Access

The mandatory halal certification represents more than regulatory compliance—it ensures continued market access in Indonesia’s substantial pharmaceutical market. Companies that successfully navigate the certification process position themselves advantageously in serving Indonesia’s predominantly Muslim population while potentially accessing broader global halal pharmaceutical markets.

The comprehensive nature of these requirements, covering everything from raw materials to distribution, reflects Indonesia’s commitment to ensuring complete halal integrity throughout the pharmaceutical supply chain. This approach sets a precedent that may influence halal certification standards in other Muslim-majority markets worldwide.

Original Article:

Yana. (2025, August 31). Ask the expert part 1 – from regulations to certification challenges of halal medicines. LPPOM MUI. Retrieved from https://halalmui.org/en/ask-the-expert-part-1-from-regulations-to-certification-challenges-of-halal-medicines/