Halal certification for medicinal products

Publication date: October 29, 2024, BY Zaid Adnan Jaber

Cultural and religious challenges for medicinal drugs registration in Islamic countries.  An overview of the market size of the Islamic countries

The Islamic-compliant pharmaceutical market has been emerging significantly. According to the Salaam Gateway report on Halal pharma, Muslims spent around $108 billion in 2022, and this amount is expected to increase to $142 billion by 2027. This growth has led many Southeast Asian and European pharmaceutical companies to form agreements and collaborations with countries like Saudi Arabia and Indonesia. For example, Indonesian pharmaceutical companies have engaged in joint investments with China totaling $120 million, in addition to cooperation with South Korea.

The Middle East and Africa (MEA) market has reached a value of $32.6 billion, with Saudi Arabia being the largest market at $11.6 billion and experiencing a growth rate of 9.1% per year, making it the third fastest-growing country in the MEA region. The UAE ranks as the third-largest market, valued at $4.1 billion, and has seen a growth rate of 16.5% per year, making it the second fastest-growing country in the region.

Other significant pharmaceutical markets to consider include Turkey, with a market size of $7.7 billion in 2022; Malaysia, with a market size of $3.2 billion; and Indonesia, which reached a market size of $10.11 billion in 2021, making it the largest pharmaceutical market in the ASEAN (Association of Southeast Asian Nations) region.

Given the large pharmaceutical market in Islamic countries, it is worthwhile for many companies and governments to invest in this sector. However, to register pharmaceutical products in Islamic countries, companies must comply with local regulations, including submitting a Halal certificate for all ingredients and ensuring that the product itself is approved by the relevant authority.

What is the Halal concept and Halal certificate?

The term “halal” originates from Arabic and means permissible or allowed. According to Islamic law, it signifies purity and cleanliness, encompassing only things and processes permitted for Muslims. “Halal” is the opposite of “haram,” which means forbidden or prohibited. This classification is based on the Holy Qur’an and the Sunnah of the Prophet Muhammad (Peace be upon him).

Halal certification applies to the food, cosmetics, and pharmaceuticals sectors, confirming that a product is manufactured in full compliance with Islamic law, does not contain any forbidden components, and has not come into contact with any substances considered impure. This certification is granted to ensure Islamic consumers that their religious precepts have been respected and that the product maintains a high level of hygiene and safety.

The production of halal products should comply to several main principles:

1) All ingredients must be safe for consumption and free from ethanol, blood, pork, and parts of carnivorous and omnivorous animals, including human parts.

2) Strict hygiene practices should be applied to prevent any contamination with potentially toxic, unclean, or impure ingredients.

3) The whole production process, from cultivation or synthesis to distribution, must comply with halal standards.

4) Halal production lines should be physically separated from the non-halal production lines -if any- to prevent any mixing of them.

5) Any potential cross-contamination between halal and non-halal ingredients and products must be prevented.

Due to the technical complexity and unique implementations of these products, each drug is evaluated independently based on various factors, including formulation ingredients, production methods, and use cases. The Halal certification process for pharmaceutical products is similar to the traditional certification process, with some variations. Halal certification should be granted by Halal certification provider institutions. To determine if a pharmaceutical product can receive a Halal certificate, these institutions evaluate the ingredients, the product development cycle, and the production process against the bioethics of Halal traditions.

The halal certificate requirements can vary from one country to another one, the requirements are usually listed in the Drug and food administration authority or the official authority for the drug registration, it’s important to keep in mind that the rules are unified with some differences between countries.

The ingredients that should not be used in the pharmaceutical product can be classified to the Active ingredient that possess the therapeutic activity in addition to the  inactive ingredients (excipients) that used alongside with the active one to attain the required product characteristics and delivery to the proposed site of action. In the following two sections, a list of most used ingredients that may interfere with the halal concept will be mentioned and elaborated.

What are the possible prohibited excipients and what are alternatives?  

Gelatin

Gelatin is a naturally occurring protein found in mammals’ tendons, ligaments, and tissues, which is a peptides and proteins mixture that are made by collagen hydrolysis that comes from bone, skin, and connective tissue of animals like pigs, cows, fishes, and chickens. It has a wide molecular weight range that depends on the physical and chemical methods of denaturation and the hydrolysis process used in the production.

Moreover, gelatin has a unique amino acid composition and structure that provides various functional properties in many industrial fields such as food, pharmaceutical, nutraceuticals, and cosmetic industries. Gelatin has been used in the manufacture of pharmaceutical items since the 19th century, and possibly earlier. It is used as an excipient in pharmaceuticals of medicinal dosage forms, including capsule shells in both hard and soft shells.

The oral gelatin is usually used as main component in soft gelatin capsules, and hard gelatin capsules and its commonly made from animal sources, and it basically comes from a variety of biopolymer raw materials. For instance, it comes from swine (pig), bovine (cow), poultry (chicken), ovine (sheep), and caprine (goat), the main two sources of gelatin are pigs and cows as they are more economical that other sources.

The swine gelatin is derived from the pig’s skin, bone, and connective tissues. The only advantage of pig gelatin is its cost-effectiveness as well as the availability of its supplies and high breeding rates. However it’s consumption is prohibited (Haram) under the Islamic Sharia as mentioned earlier in this article. Other alternatives can be used like other animal derived gelatin, and plant gelatin.  

Bovine gelatin is prepared similar to the swine gelatin, and has many common properties and disadvantages of the swine one. Poultry gelatin is derived from chicken and it has become a demand due to the switching of consumer preferences, this is because chicken meats are acceptable to most religions and there is a perception that poultry meat is healthier than other types of meat. Moreover, ovine and caprine gelatin are derived from sheep and goats, and they are considered as mammalian sources that can be used to obtain gelatin without any religious or even cultural barriers around the world.

Another alternative can be the plant gelatin, even if there is no plant sources of gelatin, and there is no chemical relationship between gelatin materials referred to as vegetable gelatine. Nevertheless, there are some gelatin-like materials that are prepared from vegetable sources and have different characteristics and can be used in many applications, the most common materials are agar, pectin, konjac, and carrageenan. There are many advantages of the plant source gelatin as they have excellent qualities, very useful and not allergenic because almost all of them are made of safe and non-allergenic polysaccharides.

In summary, the use of gelatin from marine sources and animals that have been slaughtered according to Islamic rules is halal. On the other hand, gelatin which are sourced from pork and its derivatives are still haram even after going the manufacturing process because its chemical substances remain the same and unchanged. Nevertheless, during an emergency, it may be permissible to consume medication containing pork gelatin if there is no replacement or alternative for pork gelatin even if it is from haram sources.

Ethanol

Alcohol is a colorless liquid produced by two processing methods. Firstly, it can be produced by fermentation which is the main process to produce liquor and secondly the chemical process to produce alcohol from petroleum and the product manufactured by this process is known as ethanol or ethyl alcohol. In the medical field, ethanol is used as an antiseptic and solvent in the pharmaceutical manufacturing process, All scholars agreed that alcohol that comes from liquor is prohibited (Haram) because it intoxicates. Halal status of ethanol is controversial and it is rational use is ambiguous.

It should be noted that only ethyl alcohol such as methylated spirits and ethanol, the alcohol found in alcoholic drinks, are intoxicating and are therefore haram. Other forms of alcohol (such as sterile) are not intoxicating. These types of alcohol will not be found in any food or drink due to the fact that they are generally poisonous.

According to the majority of the scholars, the use of forbidden substances or mixing with the prohibited (Haram) materials for medical purposes is prohibited. However, the use of medicine mixed with alcohol in emergency situations is permissible. Medicines containing alcohol would be considered Halal if there were no suitable alternatives available

What are the possible prohibited Products or Active ingredients?  

In addition to the previously mentioned materials that their use may be questionable in the pharmaceutical products, there are some products that may be prohibited under Islamic Sharia due to the prohibition of the active pharmaceutical ingredients (API), or due to some materials that usually used in the manufacturing of these products, the main products are Heparin, and the Vaccines.

Heparin

Heparin is widely used as an anticoagulant drug which is a medicine that used to prevent formation of blood clots for the treatment and prevention of diseases related to anticoagulation problems such as deep vein thrombosis and pulmonary embolism. Heparin can be extracted from several animal organs such as lungs, liver, ileum, skin, lymph, and thymus, mostly from pig intestines and some from cows and sheep.

There are three heparin main types: unfractionated heparin (UFH), low molecular weight heparin (LMWH), and ultra-low molecular weight heparin (ULMWH). UFH can be produced from both porcine and bovine while the porcine intestine is more common, LMWH is merely sourced from porcine, and ULMWH is manufactured by chemical synthesis rather than extraction process and it is free from animal components.

Most popular LMWH that used in clinical therapy are clexane (enoxaparin), dalteparin, tinzaparin nadroparin, certoparin, parnaparin, reviparin, and bemiparin. ULMWH is considered the best anticoagulant type compared to UFH and LMWH because it exhibits high consistency and controllability. The most common ULMWHs are fondaparinux (arixtra), AVE5026, and RO-14, Arixtra was decided permissible to be used as an alternative to enoxaparin (clexane) by the Fatwa Committee Muzakarah of the National Council for Islamic Religious Affairs Malaysia due to the source of clexane, which comes from pigs which is precluded under Islamic Sharia.

Vaccines

Vaccine products usually are combination of active and excipient ingredients, the used materials origin can be from several sources like animal, plant, and synthetic origin. The animal materials may be porcine, or its derivatives, dead animals, or blood. All these are prohibited (haram) under Islamic Sharia. However, the materials are usually used as the basis in producing vaccines.

In order to determine if the vaccine is considered Halal or Haram in Malaysia, more deep knowledge about the products and their components and sources need to be examined. The process also requires technical expertise which contains qualified and trained personnel and know-hows. The halal certification body needs to explain how the process is conducted by developing a detailed manual that describe the procedure for the halal certification to be approved.

A widely used material in the vaccine production is trypsin, trypsin is a catalyst enzyme that promote the hydrolysis of peptide bonds and consequently break down proteins which are polypeptides into peptides. Trypsin is commonly used in biotechnological processes, however, the origin is the digestive system of mammals, generally from the pancreas of pigs. 

Many biotechnological products, including certain COVID-19 vaccines, used trypsin from pig pancreas in the manufacturing process, it is not used in production media and the presence of this pork element will not be detectable using PCR analysis of the final product. 

However, the pig element can be detected from the material used traces. The COVID-19 vaccine which has been declared haram by the MUI Fatwa Commission, based on valid document searches, was proven to use trypsin from pig pancreas.

In summary, the first challenge in implementing halal certification for vaccines is due to the non-halal raw materials used. Alternatively, porcine derivative-free vaccines are recommended unless there is an urgent need to use such products.

Conclusion and summary

In conclusion, navigating the registration of medicinal drugs in Islamic countries requires a deep understanding of cultural and religious principles, particularly the concept of Halal. As the Islamic-compliant pharmaceutical market expands significantly, reaching an anticipated value of $142 billion by 2027, pharmaceutical companies face the dual challenge of meeting regulatory requirements while ensuring product integrity.

Compliance with Halal standards involves rigorous scrutiny of all ingredients and production processes to avoid prohibited substances, such as certain gelatins and alcohols, as well as ensuring that active ingredients are sourced appropriately. This complexity necessitates a collaborative approach between companies and local regulatory authorities to facilitate smooth registration and certification processes.

Ultimately, as the demand for Halal-certified products grows, pharmaceutical companies must prioritize investment in research and development of compliant alternatives. Successfully addressing these challenges not only opens doors to lucrative markets but also fosters trust and loyalty among consumers, aligning business practices with the cultural and religious values of the regions they serve.

 
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