The halal certification of pharmaceuticals and supplements requires theological and technical expertise as the standards and regulations governing these categories are unique. AHF’s deep understanding of pharmaceuticals and supplements, from clinical trials to private labeling, helps companies globally navigate this industry. This page serves as an introductory primer on the subject.
Emphasis on Health
All Abrahamic traditions place great importance on taking care of your physical and spiritual health. Through the advancement of science and medicine, we can prevent, treat, and cure ailments to live healthier lives. However, modern commercial production methods and ingredients are often complex and opaque, leaving consumers in a delicate situation balancing their spiritual values with their physical health needs.
A pharmaceutical product is a substance intended to use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Pharmaceutical drugs are manufactured from materials of plant, animal, chemical, and mineral sources involving simple to very complex manufacturing processes. They are classified by how they work in the body (pharmacological effect) and therapeutic use. Generally, they are manufactured or prepared in three forms: consumable, injectable, and topical.
Pharmaceutical products are approved by a government regulatory body to be manufactured on the condition that there is enough evidence to demonstrate the safety and efficacy of the product. The manufacturing process has ‘control’ to assure the quality of the product. The ‘controls’ represent a set of “admissible operating conditions” that provide an assurance of quality, accounting for variation in the materials and manufacturing processes.
In the United States of America, the FDA (US Food and Drug Administration) is the regulatory body that oversees the manufacturing and distribution of pharmaceuticals and regulates all facets of the product lifecycle.
According to the FDA, (dietary) supplements are products taken by mouth containing a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates and may be found in many forms such as tablets, capsules, soft gels, gelcaps, liquids, or powders.
It is important to note that while these products are generally consumed for the improvement of health, they are not subject to FDA regulations as they pertain to efficacy and safety. They are, however, subject to general GMP regulations.
General Principles of Halal
The most basic heuristic to use in evaluating halal status is if the product is free from non-halal animal derivatives and ethanol. A more detailed study on the principles of halal can be read on the “What is Halal?” page.
Common Questionable Ingredients
- Soft gels
- Stearic acid
- Heparin sodium
The above ingredients are commonly used in pharmaceuticals and supplements and are of major concern to halal consumers as they may be from haram sources.
Topical Application Products
For topically applied products, there are some leniencies in terms of halal regulations on a product-by-product basis. For example, products that are for external application only may contain ethanol residuals. These cases are evaluated individually by AHF’s team of technical and religious advisors.
The Critical Need for Halal Pharmaceutical and Supplement Certification
Of all the industries the American Halal Foundation (AHF) serves, there is probably none more critical than the pharmaceutical and supplement industry. From both a practical and principles perspective, the pharmaceutical and supplement industry is critically important to AHF.
Practically, there is a large asymmetry between the supply and demand for halal pharmaceuticals. With nearly 1 in every 4 consumers globally adhering to halal, less than 5% of all pharmaceutical drugs are halal.
From a perspective of principles, AHF is “committed to building a safer, healthier, and more inclusive world.” and there is no higher moral imperative than saving a life.
To this end, AHF believes the largest untapped market in halal is currently the pharmaceutical industry.
Halal Certification Process for Pharmaceuticals and Supplements
The halal certification process for pharmaceutical products is similar to the traditional halal certification process, but it does have a few salient differences. Due to the technically complex and unique applications of these products, each drug is independently evaluated based on its formulation, production method, use case, and other important factors.
Additionally, AHF looks at the product development cycle and production process and evaluates it against bio-ethics of the halal tradition. Certain pharmaceutical drugs may receive conditional certification (see “principle of necessity below”) for products that may generally not be consumable.
The halal certification process for supplements is generally in accordance with the standard halal certification process of evaluating the product compliance from a perspective of ingredients and process of production to ensure the integrity of the halal identity is not compromised at any stage of production. AHF seeks to integrate with existing quality systems such as GMP to ensure the process is as efficient as possible.
Halal Certification Involving Contract Manufacturers
The process of certification when involving contracted 3rd party manufacturers (CMOs) is detailed here.
The fundamental principles of evaluation will remain the same while adding some contractual adjustments to ensure the manufacturer is contractually obligated to be compliant with halal certification requirements. AHF seeks to dynamically create adaptive systems that enable clients to add manufacturers and products to their halal certificate/license by establishing a framework for evaluating and adding products and manufacturers.
The Principle of Necessity
An important point to note is that most modern theological scholars agree that under certain dire circumstances, products that would be typically considered unlawful “haram” can be consumed.
In terms of invoking this principle as it pertains to the use of pharmaceuticals, the conditions on an individual basis are as follows:
- The necessity must be life-threatening
- There must be no halal alternative to the product
- A trained Muslim doctor must recommend the use of
- the pharmaceutical
- There must be a certainty that the product will be a source of cure
AHF evaluates such products on a case-by-case basis and consults with clinical, technical, and theological experts before granting conditional approval. Besides the aforementioned circumstance, halal compliance is a prerequisite for consumption for 1.9 billion halal consumers for every pharmaceutical and supplement product.
Note: Generally, this principle will not apply to health supplements.
Commercial Prospect of Halal Pharmaceuticals and Supplements
Through halal certification, companies can gain access to international markets. Countries like Indonesia would require the product to be halal as a prerequisite for importation. Similarly, Malaysia’s governing halal authority, JAKIM, has a specific standard in MS2424:2012 that relates to halal pharmaceuticals.
From a consumer perspective, the availability of a halal-certified pharmaceutical or supplement product relative to a non-halal-certified product plays a critical role in purchasing behavior as halal certification is the number one driving factor in purchasing behavior for halal consumers globally.
How to Obtain a Halal Certificate/License for Pharmaceutical and Supplement Products?
Reach out to AHF by completing the contact form below, and a halal certification expert will guide you.