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Halal Pharmaceuticals
By Kenny Peng, MASc, RAC, PEng, and Roziah Hanim Abdul Karim
An estimated 23% of the world’s population are Muslims. While most countries with a
Muslim majority are located in the Middle East and North Africa, one-fifth of the world’s
Muslim population lives in countries where Islam is not the dominant faith. For example,
India has the third-largest Muslim population and China has more Muslims than Syria.1
Halal (‫ )لالح‬is a term designating an object or action as permissible according to
Islamic law; on the contrary, prohibited objects or actions are termed haraam (‫ماَرَح‬‎).2
Halal is used most commonly to refer to foods that are allowed under Islamic guidelines.
In general, Islam prohibits Muslim followers from consuming pork or pork by-products,
blood and blood by-products, alcohol, animals that are not slaughtered according to
Dhabihah (the prescribed method by Islamic law of ritual slaughter of all animals excluding
camels, locusts, fish and most sea-life)3, carnivorous mammals and birds of prey.
Muslim scholars have debated whether medicines should be considered in the same
class as food. Regardless, the principles governing the use of medicine containing ingredients otherwise deemed as haraam are well acknowledged in modern times:
• The medicine containing haraam ingredients must be necessary for the life of the person who takes it.
• A knowledgeable and trustworthy Muslim physician should recommend such types of
medicine containing haraam ingredients.
• The person is not allowed to take this particular type of medicine while there are other
lawful medicines available.
There are no published data on the availability of true halal medicines to the world’s
Muslim population. At the 2009 World Halal Forum Europe held in The Hague, Mohd
Hashim Ahmad Tajudin, PhD, group managing director of Chemical Company of Malaysia
Berhad, Malaysia, presented one of the first comprehensive reviews of the halal
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pharmaceutical industry. That review eventually led to the development of the first published standards in the world: Malaysian Standards MS 2424:2012.4
With the publication of MS 2424:2012, Malaysia, which is already one of the top
exporters of packaged halal foods and one of the first members of the Pharmaceutical
Inspection Co-operation Scheme (PIC/S) in the Asia-Pacific region, is expected to take center stage in the global promotion and regulation of halal pharmaceuticals.
Definition, Scope of Halal Pharmaceuticals
The current scope of MS 2424:2012 is limited to the manufacturing and handling of halal
pharmaceuticals. Accordingly, halal pharmaceuticals are required to adhere to the following aspects of Shariah law:5
• They must not contain any parts or products of animals that are non-halal or are not
slaughtered accordingly.
• They must not contain najs.6
• They must be safe for human use: non-poisonous, non-intoxicating or non-hazardous
to health according to prescribed dosage.
• They cannot be prepared, processed or manufactured using equipment contaminated
with najs.
• They must not contain any human parts or derivatives that are not halal.
• During preparation, processing, handling, packaging, storage and distribution, they
must be physically separated from any non-halal products and najs.
Requirements of the Malaysian Standards
Good Manufacturing Practices (GMPs) for Halal Pharmaceuticals
The primary objective of GMPs for halal pharmaceuticals is to avoid cross-contamination
by non-halal or najs premises, utilities, equipment, materials and ingredients. Specific
requirements are:
• All materials must be clearly defined with evidence of complying with Sharia
requirements.
• All facilities and resources for halal compliance must be provided, including availability
of sufficient qualified personnel, adequate premises and services, dedicated equipment, materials, containers and labels, approved procedures and instructions, and
dedicated storage and transport.
• All records of manufacturing, including deviations, as well as complaints and a system
for vigilance, recall and corrective and preventive actions (CAPA) shall be appropriately
adopted for halal traceability purposes.
Halal Assurance System (HAS)
In addition to GMP requirements, an HAS shall be implemented and shall be appropriate
for the manufacturing of halal pharmaceuticals.
The HAS is a well-established requirement in the halal food industry, with guidelines
published by institutions such as the Indonesian Assessment Institute for Foods, Drugs,
and Cosmetics under the Indonesian Council of Ulama (Lembaga Pengkajian Pangan Obatobatan dan Kosmetika Majelis Ulama Indonesia, or LPPOM MUI).7 Similar to modern Quality
System concepts, the HAS sets forth requirements for management policy, standard operating procedures (SOPs), documentation system, training programs, internal audit system,
corrective action system, etc., but adds requirements for an administration system, socialization program, and internal and external communication systems.
Detailed requirements of a food HAS are beyond the scope of this article. However, for
halal pharmaceuticals, the HAS shall further ensure that:
• The pharmaceuticals are designed and developed in a way that complies with the
requirements of halal and GMPs.
• The production and control operations are clearly specified as in GMPs.
• The processing lines are dedicated to halal pharmaceuticals only, and if converting a
processing line that is contaminated with najs, a ritual cleansing method is required.
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Quality Control
The purchase, handling and sourcing of chemicals, reagents, apparatus, equipment and
other items required for sampling and testing shall not be made from any non-halal source.
Halal Committee
The organization shall establish a committee led by trained Muslim personnel and responsible for ensuring effectiveness in the implementation of the HAS. The committee shall
consist of purchasing personnel and fulfill a minimum two-thirds Muslim quorum.
As in normal GMPs, ongoing training for all personnel in the organization is required
and its effectiveness shall be assessed periodically. The training program shall be available and approved by the Halal Committee.
Premise, Equipment and Ritual Cleansing
The design and location of the premises shall consider the risk of contamination with
non-halal materials or products. For example, the premises shall be separated and well
insulated from pig farming, and avoid the possibility of cross-contamination through air,
water, sewage, personnel and equipment.
If the premises or equipment are contaminated with najs, they shall be washed and
cleansed according to ritual cleaning methods supervised and verified by the Competent
Authority. In brief, ritual cleansing requires seven washes, one of which must be water
mixed with soil.
The soil and water shall both be free from najs and contaminants, as well as not
musta’mal (which means soil or water that has already been used for another purpose).
While some Muslim scholars debate the use of substances equivalent to soil, the exclusive use of soil as an irreplaceable ingredient is widely accepted in the halal industry.
Following ritual cleaning, the premises or equipment shall be cleaned for production
use, subject to validation. Repeated conversion of the line to najs and back to halal products is not permitted.
Ancillary Areas
Prayer rooms shall be available. Animal facilities shall be well isolated from other areas,
with a separate animal entrance, as well as separate air handling facilities.
Materials
Materials of Plant and Animal Origin
All types of plants, plant products and their derivatives are halal.
All land animals are halal except for dogs and pigs, animals with long, pointed teeth
intended to kill (such as tigers, bears, cats and elephants), predatory birds (such as
eagles and owls), pests and poisonous animals (such as rats, cockroaches, centipedes
and snakes), animals forbidden to be killed or eaten in Islam (such as bees, woodpeckers,
donkeys and mules) and farmed halal animals intentionally fed with najs.
All aquatic animals are halal except for most vertebrate amphibians (such as crocodiles, turtles and frogs), as well as animals that live in or are fed with najs.
In rare cases, some products may be declared haraam by local authorities but not by
others. The manufacturer is advised to consult with local competent bodies.
Materials of Genetically Modified (GM) Origin
Whether GM materials can be considered halal remains under debate around the world.8
In December 2010, an international workshop for Islamic scholars, “Agri-biotechnology:
Shariah Compliance,” held in Penang, Malaysia, declared GM foods to be halal as long as
the sources from which they originate from are halal.
However, some Muslim organizations, such as the Islamic Foundation for Ecology and
Environmental Sciences of the UK, insist that GM material is non-halal.
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Materials Containing Alcohol
In general, alcohol for consumption is haraam. The use of alcohol is often necessary in
medicines and, in some manufacturing processes, alcohol is naturally present due to the
nature of the process.
As such, the level of alcohol permitted in food and medicine is debated by Islamic
scholars, and the current MS 2424:2012 does not elaborate on it.
The Fatwa Committee of the National Council for Islamic Religious Affairs Malaysia
held a special discussion in 2011 on the issue of alcohol in foods, beverages, perfumes
and medicines, and issued the following guidelines on 15 July 2011:
• Alcohol derived from wine making or the fermentation process is haraam and najs.
• Processed products not made with the intention to produce alcohol and containing
alcohol below the level of 1% of the total volume can be consumed.
• Products made ​​with the intent to produce alcohol and produced using the process of
fermentation and containing any amount of alcohol or distilled alcohol are haram.
• Products containing natural alcohol, such as fruits, nuts or grains, or its extract, or
containing alcohol produced during the manufacturing process are not najs and can
be consumed.
• Products containing a flavoring or coloring containing alcohol for the purpose of stabilization can be used if the alcohol was not produced through the fermentation process.
The quantity of alcohol in the final product may not be intoxicating and its level shall
not exceed 0.5%.
• Non-fermented alcohol (industrial alcohol) used as a solvent, processing aid or cleaning agent is not najs.
Certification
Like other pharmaceutical products, halal pharmaceuticals are subject to normal premarketing and postmarketing controls by the relevant national pharmaceutical regulator (in the
case of Malaysia, the National Pharmaceutical Control Bureau). However, halal products
require additional certification from Islamic competent authorities.
Countries with large Muslim populations commonly have institutionalized (sometimes
nationalized) bodies designated for certification, such as the LPPOM MUI of Indonesia
and Department of Islamic Development Malaysia (Jabatan Kemajuan Islam Malaysia, or
JAKIM). In other countries, halal certification is granted by diverse bodies with varying
degrees of mutual recognition.
In the UK, halal certification may be granted by the Halal Monitoring Committee, Halal
Food Authority, and Institute of Islamic Jurisprudence, to name a few. In the US, the list
includes the Islamic Food and Nutrition Council of America and Islamic Services America;
in Canada, the Halal Monitoring Authority and Halal Certification Agency. In Australia, the
certification process is even more decentralized.
Opportunities and Challenges
Although there currently are no data on the size of the global market for halal pharmaceuticals, the Association of American Halal Certifiers (AAHC) estimated the global halal
food market—the most closely related market with available data—ranges from $800
billion US to $1.2 trillion annually.9 As global awareness of the specialized needs of the
Muslim population grows, sub-industries such as Islamic finance are being developed. The
rapid growth of these sub-industries indicates immense potential opportunities for halal
pharmaceuticals.
As in any regulated industry, international acceptance and harmonization will be important in unlocking this global market potential and facilitating access to quality products by
Muslim majorities and minorities around the world. MS 2424:2012 has the advantage of
being the first national standard in the world that specifically addresses halal pharmaceuticals and, therefore, faces only the challenge of international acceptance rather than the
more daunting harmonization.
At present, manufacturing of halal pharmaceuticals is largely limited to domestic
manufacturers of generic pharmaceuticals in Muslim-majority countries. The need for
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participation from brand-name pharmaceutical manufacturers and major multinationals
has been acknowledged by some of the original authors of MS 2424:2012.
Conclusion
Muslims comprise a sizable portion—by some estimates, one-quarter—of the world’s
population today.
Malaysia, as one of the major exporters of packaged halal food products, has become
the pioneer by establishing the first national standard for halal pharmaceuticals. This article has discussed the requirements set forth in MS 2424:2012 and market opportunities
as well as ongoing challenges.
How the global market and industry professionals will respond to this opportunity is
yet to be seen.
References
1. Pew Forum. “Mapping the Global Muslim Population.” Pew Research Center. 2009.
2. “Halal.” Wikipedia.org. en.wikipedia.org/wiki/Halal . Accessed 21 August 2012.
3. “Dabihah.” Wikipedia.org. en.wikipedia.org/wiki/Dabihah. Accessed 18 September 2012.
4. Malaysian Standard MS 2424:2012. Halal pharmaceuticals – General guidelines. Department of Standards Malaysia. 2012.
5.Shariah (also spelt Sharia) law is the religious law of Islam. The Shariah law is primarily derived from the Quran, the religious
text of Islam, and from the Sunnah of Prophet Muhammad, which is a collection of his specific words, habits, practices, and
silent approvals.
6. Najs according to Shariah law are:
i. Dogs, pigs, their descendents and derivatives;
ii. Products contaminated or in direct contact with items that are non-halal;
iii. Any liquid and objects discharged from the orifices of human beings or animals, such as urine, blood, vomit, pus, placenta, excrement and sperm and ova of pigs and dogs except milk, sperm and ova of human and other animals;
iv. Maitah or carrion or halal animals that are not slaughtered according to Shariah law; and
v. Khamar (fermented alcohol) and food or drink that contains or is mixed with khamar.
7. The Assessment Institute for Foods, Drugs and Cosmetics. General Guidelines of Halal Assurance System. Indonesian
Council of Ulama. 2008.
8. Aburawa A. “Can GM Foods Be ‘Halal’? Or Kosher?” Green Prophet. www.greenprophet.com/2011/08/gm-foods-halalkosher/. Accessed 20 September 2012.
9. “Halal Market Opportunities.” Association of American Halal Certifiers. www.aahalalcert.org/halalMarketOpportunities.htm.
Accessed 21 August 2012.
Authors
Kenny Peng, MASc, RAC, PEng, is director of Asia for PharmEng Technology, an international consultancy based in Toronto,
Canada. Born in Taiwan and educated in Canada as an engineer, he has spent his career on international projects in North
America and across East and Southeast Asia, and across diverse disciplines spanning GMP engineering, validation, compliance,
as well as manufacturing and commercial regulatory affairs. Contact [email protected]. Roziah Hanim Abdul Karim, BS,
is senior manager, QA, for CCM Pharmaceuticals Division, the second-largest pharmaceutical manufacturer in Malaysia, and a
member of the Technical Committee on Halal Food and Islamic Consumer Goods. She is a contributing member to the Malaysian
Standard MS 2424:2012. Contact [email protected].
© 2012 by the Regulatory Affairs Professionals Society. All rights reserved.
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