@Halal January/February 2022 - Page 20

State of mind Halal status should be in line with many current guidelines on good practices

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Halal Health

@ Halal | January-February . 2022

State of mind Halal status should be in line with many current guidelines on good practices

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HEALTHY BODY is valued highly in Islam . As the saying goes , ' A healthy mind comes from a healthy body '.
Islam advises that health maintenance is prioritised to carry out responsibilities in the best states of mind , spiritually and physically strong in carrying out the task set by Allah the Al-Mighty and cultivating the earth in goodness .
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 the “ avoidance of foul matters ” principle .
The second principle , i . e . “ Guarding
BY FARAHIDAH MOHAMED AND
MOHD AFFENDI MOHD SHAFRI
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 Nonscheduled 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 from animal origins . It is applicable for the APIs , the excipients and the ingredients used to