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Halal Pharmaceuticals: A Complex Alien World Category: Pharmaceuticals

By Dr. Mahvash Hussain-Gambles

The preservation of human well-being and health has been prescribed by Allah, and with modern advances in pharmaceutical industry, most diseases can be cured. The question is whether Muslims should continue to consume medicines designed to safeguard life without asking questions or should we now be challenging the industry about the origins of many of these ingredients and whether or not they are compliant with an Islamic lifestyle.

As narrated by Abu Darda, a companion of the Prophet Muhammad (peace be upon him, p.b.u.h), “The Prophet (peace be upon him) said Allah has sent down both the disease and the cure, and He has appointed a cure for every disease, so treat yourselves medically, but use nothing unlawful.”

The problem is that many drug formulations are so complex that even trained chemists cannot ascertain with accuracy the origin of some of the ingredients used in pharmaceutical preparations. The solution lies in either directly asking the manufacturers for the origins of the mashbooh or dubious ingredients, or buying Halal certified pharmaceuticals.

Currently, there are only a handful of companies marketing Halal-certified pharmaceutical products, one of which is CCM Pharmaceuticals of Malaysia, and in the absence of a Halal Pharmaceuticals Standard, Halal food standards have been referred to as a proxy guide by manufacturers.

“Whilst the Halal Food Standard sets out clear parameters that are in line with the principles of Shariah, they are not tailored to the nuances and peculiarities of the pharmaceuticals sector,” states Mr. Darhim Dali Hashim, CEO of International Halal Integrity Alliance Ltd (IHI Alliance), an international non-profit, non-governmental organisation created to uphold the integrity of the Halal market concept in global trade through recognition, collaboration and membership.

He adds, “This is the reason why we have broken down the IHI Alliance Halal standard into modules, each of which addresses a specific sector in the entire supply chain – from animal feed and welfare to downstream products including pharmaceuticals.”

Twenty years ago we may not have been in the fortunate position to choose medicines which are Shariah compliant or Halal, but with an increasing choice of vegetable-based pharmaceutical ingredients on the market – thanks largely to the Vegetarian/ Vegan lobbying around the globe, there are now plenty of choices available. The demand for non-animal ingredients stems not so much from growing numbers of traditional vegetarians, but also from people who are concerned about diseases in certain animal species. Scares such as mad cow disease or BSE in cattle, and Foot and Mouth disease and avian flu in poultry have also prompted consumers to buy animal-free drugs and supplements meaning ingredient manufacturers now have to develop synthetic or vegetarian alternatives.

There is no reason why similar pressure should not be applied to the pharmaceutical manufacturers for Halal alternatives. At the very least, efforts should be made to inquire about some of the ingredients in the medicine, and if alcohol or any other dubious ingredients are present, checks should be made with the doctor or pharmacist whether there is a suitable Halal or vegetarian alternative available.

Identifying dubious or potentially Haram ingredients in the long list of medicinal ingredients, however, is not an easy task. This article will attempt to provide some basic information on modern medicines and explore some ingredients which may be of dubious nature and potentially Haram. As there are thousands of ingredients commonly used in medicinal products, it is beyond the scope of this article to list them. It is also impossible to ascertain whether they are of plant or animal origin. This information can only be obtained from the manufacturer of each ingredient.

Medicines can be tablets, capsules, drops, ointments, injections, syrups, suppositories and nasal drops. All medicines should have an active substance or medicinal ingredient (usually first on the ingredient list), and excipients which are the other ingredients used in the formulation to hold the active together or dissolve the active in a solution or make the active disperse in the cream base.

Tablet: A tablet is a mixture of active substances and excipients, starting off as a powder and then compressed into a tablet. The excipients include binders, glidants (flow aids) and lubricants to ensure efficient tabletting. Disintegrants are put in to ensure that the tablet breaks up in the digestive tract; sweeteners or flavours may be added to mask the taste of the active substance; and sometimes colours or coatings are put on tablets to make uncoated tablets visually attractive.

Below is an example of the ingredients used in a simple medicinal tablet.

Active Ingredients: Paracetamol 500mg.

Also contains Pre-gelatineised Maize Starch, Sodium Metabisulphite, Magnesium Stearate.

The first ingredient in the list, Paracetamol, is the active and the tablet contains 500mg of this active. The rest of the ingredients are excipients, used to hold the active in place so it does not crumble. A wide variety of binders are used to hold tablets together, and many of these may be Shariah compliant such as lactose powder, dibasic calcium phosphate, sucrose, corn (maize) starch and variants of cellulose (a plant-based material).

Small amounts of lubricants are also added to the tablets such as magnesium stearate, stearic acid (stearin), and sodium stearyl fumarate. But some of these may be of animal origin usually from cows or pigs.

One of the more well-known ingredients in pharmaceutical preparations is gelatine, which is derived from the bones/ cartilages of animal carcasses (cows, pigs and horses), and therefore possibly Haram depending on both the source and other factors such as Halal slaughter, and so on. It can also be produced from fish bones (sometimes certified as Kosher) and therefore potentially acceptable by Muslims. This is discussed in more detail later, but in the above list, Pre-gelatineised maize starch just means that the starch is ‘pre-cooked’ to form a gel-like structure. Starches have a property of gelatineisation where the starch molecules unwind, disperse and cross-link to thicken up a liquid (like gravy sauce for example). This natural process is called gelatineisation.

In the above example of ‘Pre-gelatineised Maize Starch’, the gelatineisation is a natural process from Maize Starch itself, and being vegetable-derived, this is acceptable and Halal compliant. However, this example clearly illustrates the difficulty faced by consumers when interpreting the ingredients list on medicines.

Capsules: The two main types of capsules are hard-shelled, which are normally used for dry, powdered ingredients; and soft-shelled capsules, used for oils (such as flaxseed oil, cod liver oil, and royal jelly to name a few) and for active ingredients that are dissolved or suspended in oil. Both of these classes of capsules are made from either gelatine or plant-based gelling substances such as Carrageenans (carrageenins), agar-agar (seaweed), pectin, konjak or modified forms of starch and cellulose. Hypromellose (short for hydroxypropyl methylcellulose or HPMC; E-Number: E464) isolated from natural sources (such as plant materials or bacterial cell cultures) as starting material is a vegan-acceptable alternative to animal gelatine, but is a lot more expensive to produce and is generally used for health supplements suitable for Vegans. Since gelatine is derived from animal bones, skin and tendons, it is likely to be Haram unless it is from animals or birds allowed to be eaten by Muslims which have been slaughtered in a Halal way, as mentioned above, and there are many other factors that could possibly make it Haram.

As narrated by Abu Hurayrah, who was a companion of the Prophet Muhammad (p.b.u.h), “The Apostle of Allah (peace be upon him) prohibited unclean medicine.”

There is Halal certified bovine-based gelatine in the market, but unless the capsule manufacturers make this clear on their packaging and seek approval/ certification by a third party (in this case a Halal certifier which is a well-recognised Muslim organisation), it is best to go for vegetable/ plant-based alternatives.

A typical capsule may contain the following ingredients:

Active Ingredients: 5 Hydroxytryptophan 50mg.

Also contains Dicalcium Phosphate, Microcrystalline Cellulose, Capsule Shell (Gelatine), Magnesium Oxide, Silicon Dioxide, Magnesium Stearate, Stearic Acid, and Vitamin B6.

In this example, the capsule shell is made from gelatine, and as the product is not Halal certified, it is therefore hard to tell whether the origin is from Haram or Halal animals. This information can only be obtained directly from the manufacturer.

Dicalcium Phosphate and Microcrystalline Cellulose are the bulking agents in this preparation, providing a quantity of material which can accurately be formed into a capsule. Other lubricants in the above example such as Magnesium Stearate can be of animal or vegetable origin, and only the manufacturer, with a third party Muslim organisation approval, can advise about the religious status of this ingredient.

Creams: Many pharmaceutical preparations come in the form of creams or suppositories.

The first ingredient in the example below, Terbinafine Hydrochloride, is the active drug and the cream contains one per cent of this active by weight.

Contains: Terbinafine Hydrochloride 1% w/w.

Also contains Sodium Hydroxide, Benzyl Alcohol, Sorbitan Stearate, Cetyl Palmitate, Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60, Isopropyl Myristate, purified water.

It takes a chemist to really know which of the ‘alcohol’ excipients in the above example are actually intoxicating and therefore Haram. If we go through each of the excipients in detail we can see the complexity of the situation.

Benzyl alcohol is produced naturally by many plants and is commonly found in fruits and teas. It is also found in a variety of essential oils including jasmine, hyacinth, and ylang-ylang. It is used as a bacteriocide (bactericide) in formulations and it does not cause any intoxication, therefore it is Halal, even though its chemical name contains ‘Alcohol’.

Sorbitan Stearate, Cetyl Palmitate, Stearyl Alcohol and Cetyl Alcohol are emulsifiers, meaning they help the active ingredients dissolve evenly in the cream. All of them could be Halal, even though the name suggests otherwise, because if ingested, they are not intoxicating. Cetyl Alcohol for example is a hard wax-like substance obtained from palm oil. However, there is no way of knowing if they are originally derived from animals or vegetables and thus a well-recognised, scientifically sound third party Muslim approval is of great importance.

These medicinal ingredients are still ‘alcohol-free’. The reason for the apparent confusion is the difference between the terms used by scientists and those used by the general public. To the layman, beers, wines, spirits, and so on contain alcohol; to the scientist, they contain ethanol. To the layman, alcohol is a single substance, but scientifically speaking, the term describes a whole group of chemical substances or ingredients with differing properties.

Simple alcohols, like ethanol, are defined as having a general chemical formula of CnH2n+1OH, where n equals any number from one upwards. If n=1, the compound is CH3OH or methanol (often used as anti-freeze), or methyl alcohol. In the case of ‘alcohol’ (ethanol), n=2 and the formula is C2H5OH. This group of chemicals is also known as ‘Aliphatic Alcohols’ and they cause intoxication when ingested, and therefore classed as Haram.

In summary, the layman’s ‘alcohol’ means ‘ethanol’, and products that are ‘alcohol-free’ are actually ‘ethanol-free’. In medicinal preparations, ethanol is listed on the label as ‘alcohol’, or ‘alcohol denat’ and since it causes intoxication, it is Haram.

As a general rule, most actives are chemically manufactured as it suits the manufacturer to keep control of the process and maintain the purity of the active. There are exceptions such as insulin used to treat diabetes, which is derived from animal source, usually from pigs. Human-based insulin which is genetically engineered is available, but it is a lot more costly than porcine insulin. Collagen (the starting material in gelatine making) is another medicinal active used in arthritis, and derived from the bones of animals, and some very effective hormonal medical preparations containing Oestrogen and Oestradiol are produced from female hormones from pregnant mares. Heparin, a blood anti-coagulant drug is responsible for saving millions of lives; however, pharmaceutical grade heparin is derived from mucosal tissues of porcine intestine or bovine (cow) lung.

Typically, in drug formulations, it is usually the excipients that are of doubtful nature, as many can be derived from animals, or are alcohol-based. If you look at Botox, which is a medicine originally used for medical reasons, the active is produced from bacteria, and it can be argued that it is Halal. However, it is usually combined with porcine-derived ingredients (excipients), thus making it Haram. Glycerine is another commonly used excipient in syrups, and can come from animal or vegetable source, and its origin can only be verified by its manufacturer along with approval from a third party Muslim organisation.

Syrups: Many medicinal actives are suspended in a solution such as cough remedies, mouth washes or children’s medicines. The easiest and cheapest way to dissolve or suspend an active in such preparations is to use alcohol.  Since alcohol is an excipient and not an active, it can easily be avoided in many drug formulations as there are alternatives in the market.

Contains: Guaifenesin 100mg, Levomenthol 1.1mg

Also contains liquid glucose, sucrose, ethanol 5 vol %, ponceau, sodium.

The first two ingredients in the example above, Guaifenesin and Levomenthol are the actives. Glucose and sucrose are plant-based excipients, sodium is a salt, and ponceau is a synthetic colouring agent. However, the medicine also contains ethanol at a level equivalent to 5 ml of beer or 2 ml of wine per 5 ml dose.

From an Islamic perspective, it could be argued that the use of alcohol in medicine is Haram, no matter how small the quantity is, especially when there are known alternatives.

As reported by Ahmad Abu Dawud and At-Tirmidhi, “Of that which intoxicates in a large amount, a small amount is haram” and “If a bucketful intoxicates, a sip of it is Haram”.

However, let us also be mindful of what Allah has prescribed for us in the Quran (surah Al-Baqarah, verse 173):

“But if one is compelled by necessity, without wilful disobedience, nor transgressing due limits, then he is guiltless. For Allah is Oft-forgiving Most Merciful.”

To summarise, we have discussed that many of the excipients contain stearates or glycerine, which often comes from animal sources, as well as capsules made of gelatine.

The principle of Shariah is to preserve the well-being of life. If there is no substitute and the medicine is necessary, under these circumstances it would be allowable, based on the same principle that allows Haram foods in cases of necessity. Ultimately it falls upon us Muslims in the pharmaceutical profession to carry out research into this issue and come up with Halal alternatives for excipients or even actives, so that the question of the dubious nature of medicinal ingredients does not arise. Responsibility also falls on the rest of the Ummah to lobby for more Halal ingredients in medicinal preparations.

Featured in The Halal Journal Jan/Feb’10 Issue p.30

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