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 entire production process, including the sourcing of raw materials, to demonstrate compliance with halal standards and facilitate traceability.

Examples of materials used in the manufacturing of pharmaceuticals and their corresponding opinion of Islam.

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