The pharmaceutical industry in Indonesia is increasingly recognizing the importance of halal certification in maintaining the quality and integrity of products on the market. As Muslim consumers become more aware of the importance of consuming products that comply with religious teachings, the halal certification process for medicinal materials has become an increasingly critical issue. Therefore, understanding the critical points of medicinematerials in the halal certification process is crucial for all stakeholders in the pharmaceutical industry, from manufacturers to distributors.
Through Halal Talk 4 organized by IHATEC Publisher, critical points of medicinal materials based on MUI Fatwa in halal certification were discussed in depth. This webinar highlighted several raw materials that often attract attention in the halal audit process, such as the use of stem cells, blood plasma, virus seeds, and raw materials whose halal status may not yet be clear. The following is an in-depth explanation of the critical points of medicinall materials that need to be considered in halal certification, based on the explanation from Dr. Priyo Wahyudi, M.Si, author of the book Halal Certification of Medicinal Products in Indonesia.
Fatwa MUI about Medicinal Material
MUI Fatwa Number 30 of 2013 states that the use of medicines containing impure or haram substances for treatment is considered haram (forbidden).
Use of Halal Animal Placenta
Fatwa Number 30 of 2011 concerning the Use of Halal Animal Placenta for Cosmetics and External Medicine, which contains provisions:
- The use of placenta derived from halal animals for external cosmetics and external medicine is permissible (mubah).
- The use of placenta derived from halal animal carcasses for cosmetics and external medicine is haram.
Blood Plasma Usage
UI Fatwa Number 45 of 2018 concerning the use of blood plasma for medicinal ingredients states that, in principle, blood is considered impure (najis) and thus forbidden to be used as an ingredient in medicines or other products. However, blood plasma, which is a yellowish liquid component of blood where blood cells, nutrients, and hormones are suspended, is treated differently. It is obtained through a centrifugation process that separates the heavier blood cells from the lighter plasma, which rises to the upper layer. Although plasma is a part of blood, it is distinct in terms of color, smell, and taste. Therefore, under specific conditions, blood plasma is considered pure and permissible for use. These conditions include its exclusive use for medicinal purposes, that it must not be derived from human blood, and it must originate from the blood of halal animals.
Alcohol/Ethanol Use
MUI Fatwa Number 40 of 2018 regarding the use of alcohol or ethanol in medicinal ingredients outlines several key provisions. Fundamentally, medical treatment should adhere to Sharia principles, meaning the medicines used must be pure and halal. It emphasizes a clear distinction between liquid medicines and beverages, while beverages are consumed for enjoyment, medicines are used for healing, and thus, the rulings that apply to them differ.
Medicines, whether liquid or non-liquid, that are derived from khamr (intoxicating alcohol) are considered haram. However, the use of alcohol or ethanol that does not originate from the khamr industry, such as alcohol produced through chemical synthesis (e.g., from petrochemicals) or through fermentation processes not involving khamr—is permitted for use in both liquid and non-liquid medicinal products.
The Use of Human Diploid Cells for the Production of Drugs and Vaccines
MUI Fatwa Number 001/Munas X/MUI/XI/2020 on the Use of Human Diploid Cells for the Production of Drugs and Vaccines, with the following provisions:
- Basically, the use of cells derived from human body parts for drugs or vaccines is prohibited, because human body parts (juz’u al-insan) must be glorified.
- In the case of an emergency condition (dharurah syar’iyah) or urgent need (hajah syar’iyah), the use of human diploid cells for medicinal or vaccine ingredients is permissible.
Terms of Use of Human Diploid Cells for Medicine and Vaccine Production Materials
- There are no other ingredients that are halal and have similar properties or functions as ingredients derived from human body cells.
- Such drugs or vaccines are only intended for the treatment of serious illnesses, without which, based on competent and reliable expert testimony, it is believed that greater harm will result.
- There is no harm (dharar) that affects the life or survival of the person whose cells are taken for medicine or vaccines.
- If the human cells used as medicine or vaccine ingredients are derived from embryos, they must be obtained through methods permitted by sharia, such as from fetuses.
- Spontaneous miscarriages or aborted on medical indications, or obtained from the remaining embryos that are not used in artificial insemination or IVF (in vitro fertilization).
- The harvesting of human body cells must be authorized by the donor.
- In the case of body cells from a deceased person, permission from his or her family must be obtained.
- Human body cells that are used to make medicine or vaccines are obtained with the intention of helping (ta’awun), not in a commercial manner.
- The permissibility of utilization is limited to overcoming emergencies (dharurah shar’iyah) or urgent needs (hajah shar’iyah).
Critical Point of Medicinal Materials Based on Source
- Plant sources
- Animal sources
- Microbial sources
- Materials produced through chemical processes
- Materials produced through biological processes
- Materials produced through genetic engineering
- Mineral/mining materials
Critical Points in Medicinal Production Process
- Fulfillment of production facilities: free from impurities
- How to make halal medicine: comply with SJPH
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