In cases where someone is being tested with an illness , Islam encourages that treatment is sought . However , the methods of applying the treatment and the materials and accessing the treatment must be halal .

In the hadith from Abu Darda ’ ( Allah be pleased with him ), the Prophet ( peace and blessing upon him ) said : “ Indeed , Allah has sent down both illness and its cure , and He has appointed a cure for every illness , so treat yourselves medically , but use nothing unlawful ”, the book of hadith by Abu Dawud .

In this hadith , there are two explicit messages , namely : ( i ) If one is afflicted by illness , it is incumbent upon the person to find medicine to treat the diseases ; and

( ii ) it is incumbent on the person to find halal medicines to cure the diseases . Concerning the hadith , there are five essential stakeholders equally responsible for advocating , researching , funding , support and prioritising the use of halal pharmaceuticals .

THREE principles and THREE aspects

It is now established the halal status of a pharmaceutical product could confer advantages and added value that is not limited to Muslims only . There are three basic principles of halal concerning the use and production of medicine in the holy Quran , namely : i ) avoidance of foul matters ; ii ) guarding against harm , and iii ) maintaining health .

As the product ’ s halal status must consider all these principles , the halal status should be in line with many current guidelines on good practices of industries and laboratories . For this reason , halal is often being considered equal to the state of cleanliness , high-quality product , ensured level of safety , and may even be extended to cover effectiveness .

It is a regulatory requirement for all pharmaceuticals to manufacturing them in a Good Manufacturing Practice ( GMP ) - certified factory . The principle of “ avoidance of foul matters ” is of utmost importance . It is implemented by having Standard Operating Procedures ( SOPs ) to test the incoming raw materials quality .

The quality testing includes investigations on the identity and purity of the active pharmaceutical ingredients ( API ) and the additives , presence of microorganisms and presence of heavy metals typically .

Suppose water is used to make pharmaceutical products . In that case , the water quality must conform to pharmaceutical grade water , which has very rigid specifications for several parameters , including the conductivity , Total Organic Carbon ( TOC ), pH and microbial limit .

Quality of air throughout the manufacturing process must also comply with Clean Room grade . All these are part of

BY FARAHIDAH MOHAMED AND

MOHD AFFENDI MOHD SHAFRI

the “ avoidance of foul matters ” principle .

The second principle , i . e . “ Guarding against harm ”, is in principle part of the regulatory requirement mandating the toxicological study in animals and safety study in a human clinical trial to be conducted for any New Chemical Entity ( NCE ) or New Drug Abbreviation ( NDA ). Upon establishing a safety profile in human clinical trials , the NCE or NDA would be approved as a marketed drug or pharmaceuticals .

The third principle mentioned in the Holy Quran regarding medicine is related to the holistic purpose of treatment , i . e . “ maintenance of health ”. Ideally , treatment or the process to cure ailment should only be temporary . It should cover only the period of illness and be stopped once cured .

Prolonged or continuous use of drugs will incur effects that may be damaging . The westernised concept of medicine nowadays is heavily tuned on treating the symptoms instead of the underlying cause of the diseases .

One of the consequences of this concept is medicine for chronic use to maintain “ symptoms under the radar ” rather than to cure the disease .

Don ’ t neglect the three aspects

In discussing halal pharmaceuticals , three aspects should not be neglected . They are : i ) Ingredients : It is in effect similar to halal dietary law . The halal evaluation of pharmaceuticals focuses on five halal-related ingredients issues - prohibited animal parts or derivatives , the prohibition of blood , the rule on the slaughtering of permitted animals , the ban of carrion , and the

prohibition of intoxicants . ii ) Process : It refers to the manufacturing of pharmaceuticals . Halal pharmaceutical refers to any dosage forms including solid , semisolid , syrups and suspensions for any route of drug administrations ( parenteral , topical , transdermal and pulmonary delivery systems ) of conventional or modified release preparations that are produced from halal raw materials . The latter involves both the API and the excipients ( additives ). Halal critical points demand that one be mindful during pharmaceutical preparation , processing , handling , packaging , storage and distribution . Halal pharmaceuticals shall not be “ prepared , processed or manufactured using equipment contaminated with najs ( filth ) according to Shari ’ ah ”.

The halal pharmaceutical products shall also be physically separated from any other products decreed as non-halal and najs by Shari ’ ah . The pharmaceuticals shall be packaged using halal packaging materials to ensure the highest standard of medicines is delivered to the patients . During the processing , these materials shall not be cross-contaminated with tools or carriages that have been in contact previously with non-halal materials . iii ) Product : In a National Standard MS 2424 : 2019 Halal Pharmaceutical – General Guideline , ( the only world halal guideline to be based on when applying halal certification for pharmaceutical , initiated by the Department of Standards Malaysia ), it is stated that the “ Product ” must be “ safe for consumption , non-poisonous , non-intoxicating or non-hazardous to health according to prescribed dosage ”. Pharmaceuticals or medicine is an item that involves formulation using an active substance known as “ poison ’. This poison or drug is listed either as Scheduled or Non-scheduled Poisons and are governed by the Poison Act 1952 in Malaysia , indicating their high risk of causing harm .

To qualify as halal pharmaceuticals , “ the Product ” containing the poison must be registered first with the Drug Control Authority [ National Pharmaceutical Regulatory Agency ( NPRA )]. The latter is responsible for evaluating the safety and efficacy of the poison according to the prescribed dosage .

Upon satisfactory evaluation , the NPRA will issue the registration number to “ the Product ”, and subsequently , halal certification can take place . It indicates that before anyone can apply for halal certification for pharmaceuticals , “ the Product ” must first get the clearance from the NPRA manifested by the registration number obtained from NPRA .

In other words , only registered pharmaceuticals can apply for halal certification . The halal certification process as practiced in Malaysia is illustrated in the infographic .

Halal issues in pharmaceuticals

It is stated in the Drug Registration Guidance Document ( DRGD ) of the NPRA that the manufacturer of drug products shall declare the source of any ingredients derived