Halal Compliance Process
To become a certified halal pharmaceutical drug, manufacturers must comply with a set of requirements that ensure the product aligns with Islamic principles. While specific regulations may vary depending on the certifying body and the country, here is a general overview of the requirements:
- Ingredients: All ingredients used in the drug must be halal, meaning they must be permissible under Islamic law. Ingredients derived from non-halal sources, such as pork or animals not slaughtered according to Islamic principles, are strictly prohibited. Additionally, any alcohol content should be minimal and only used if there are no suitable halal alternatives.
- Production process: The entire manufacturing process, including the sourcing of raw materials, should adhere to halal standards. Cross-contamination with non-halal substances must be avoided, and equipment used in production should be dedicated to halal products or cleaned thoroughly before use.
- Quality control and hygiene: Halal pharmaceuticals must comply with Good Manufacturing Practices (GMP) and adhere to strict hygiene and quality control standards to ensure the final product is safe for consumption.
- Packaging and labeling: Halal pharmaceutical products must be properly labeled to indicate their halal status, and the packaging materials used should also be halal-compliant.
- Storage and transportation: Halal pharmaceuticals must be stored and transported separately from non-halal products to avoid cross-contamination.
- Documentation and traceability: Manufacturers should maintain detailed records of the production process, including sourcing raw materials, to demonstrate halal compliance and facilitate traceability.
Table 1. Components of growth media and their corresponding opinion of Islam:
| Category | Example | Opinion of Islam |
| Human-derived product | Insulin, transferrin, albumin, xeno-free media, etc. | Haram for consumption as human parts/derivatives are pure materials that must be respected and not being exploited or commercialized. |
| Animal-derived product | Amino acid, lipid (cholesterol, steroid, fatty acid), growth factor, ydrolysate (animal tissues, milk), hormones, carrier protein, etc. | Halal if sourced from halal and religiously slaughtered animals (chick, bovine, fish) Haram if sourced from non-halal animals (e.g., porcine, wild animals, amphibians) or non-slaughtered animals (e.g., bovine) |
| Plant-derived product | Hydrolyzate (soy, wheat, rice), glucose, maltose, vitamins, lipid, etc. | All plant-based products except those from poisonous, intoxicant, or hazardous plants are halal to be consumed. |
| Blood-derived product | Serum, plasma, platelet-derived product, albumin, etc. | Haram as blood is considered as filth material which stringently forbidden for any consumption. |
| Chemical synthesis product | Inorganic salts (CuSO4, KCl CaCl2,), trace elements, selenite, sodium bicarbonate, etc. | All chemical-based or chemical synthesized products except poisonous, intoxicant, or hazardous chemicals are halal to be consumed. |
| Fermentation/Microbial product | Amino acid, vitamins, yeast ydrolysate, glutathione, etc. | Halal if the materials (e.g., growth media) and microbes used in the fermentation are sourced from halal resources. |
| Recombinant product | Insulin, transferrin, etc. | Recombinant products expressed using genetic materials (e.g., plasmid, DNA, RNA) originated from halal and slaughtered animals or microorganism are considered as halal. Otherwise, will be considered as najs which are haram for consumption. |
Table 2. Opinion of Islam on various types of host cells used for influenza virus propagation:
| Host Cell | Origin | Source | Opinion of Islam |
| MDCK | Dog | Kidney b | Categorized as a carnivorous animal with fangs and claws, thus, haram to be consumed. |
| Vero | Monkey | Kidney b | Categorized as a wild animal with fangs and claws, thus, haram to be consumed |
| BHK-21 | Hamster | Kidney b | Categorized as a dirty and disgusting animal, thus haram to be consumed |
| Sf9 | Insect (fall armyworm) | Ovarian cell c | Categorized as a dirty and disgusting animal, thus haram to be consumed |
| HEK 293 | Human | Embryonic kidney or neuronal cell b | Human is a pure creature that must be respected, thus haram to be consumed |
| PER.C6 | Human | Embryonic retinoblasts b | Human is a pure creature that must be respected, thus haram to be consumed |
| EB66 | Duck | Embryonic stem cell b | Categorized as a bird without fangs and claws, which is halal to be consumed only if slaughtered with the name of Allah. Otherwise, will be considered as carcasses which are haram to be consumed |
| AGE1.CR | Duck | Embryonic retina b | Categorized as a bird without fangs and claws, which is halal to be consumed only if slaughtered with the name of Allah. Otherwise, will be considered as carcasses, which are haram to be consumed |
| DuckCelt-T17 | Duck | Embryo d | Categorized as a bird without fangs and claws, which is halal to be consumed only if slaughtered with the name of Allah. Otherwise, will be considered as carcasses, which are haram to be consumed |
| PBS-1 | Chick | Embryo b | Categorized as a bird without fangs and claws, which are halal to be consumed only if slaughtered with the name of Allah. Otherwise, will be considered as carcasses, which are haram to be consumed |