Dr. Priyo Wahyudi, M.Si
Act No. 13 of 2014 concerning Halal Product Assurance (UU JPH) requires medicines to have halal certification as a form of government effort to provide peace of mind to the community, especially Muslims in Indonesia. Essential medicines are encouraged to be halal certified because they have a critical point. In addition, the availability of halal raw materials for medicines in Indonesia is still minimal.
To get a clearer picture of the challenges of halal certification for medicines, Jurnal Halal magazine interviewed Dr. Priyo Wahyudi, M.Si, a lecturer at the Faculty of Pharmacy and Science, Prof. DR. Hamka Muhammadiyah University (UHAMKA) Jakarta. He serves as a Laboratory Service Expert at LPPOM MUI. In addition, Dr. Priyo also has experience as a Lead Expert Researcher in Biotechnology at the Agency for the Assessment and Application of Technology (BPPT) (1995-2021) and the National Research and Innovation Agency (BRIN) (2021-2022). Here is an excerpt:
What elements make a drug potentially non-halal?
Halal products are produced from halal materials and processed in facilities free from impurities. Halal products can only be produced if they come from sourced halal materials that are not mixed or contaminated with impurities. Production facilities that come into contact with materials and products must be impure-free.
What are the critical haram points in drug and pharmaceutical products?
Drugs are products that must be certified halal according to Act No. 33 of 2014 concerning JPH. This is because drug products have critical haram points in raw materials, additional materials, process aids, and production facilities from contamination of impurities/haram materials. For example, drugs in the form of hard or soft capsules contain gelatin. Gelatin is one of the critical ingredients because it is made from animal derivatives, namely bones or skin. The raw materials for making gelatin must come from halal animals that are slaughtered according to Islamic law. In addition to halal bone sources as raw materials, production facilities must be guaranteed to have never been in contact with pigs.
In addition, the production of active pharmaceutical ingredients classified as microbial ingredients, such as the antibiotic amoxicillin, also needs to be considered. The critical point of microbial products produced through the fermentation process lies in the source of microbes, growth media materials, and all materials that come into direct contact during the processing process (raw materials, auxiliary materials, additional materials).
The source of microbes used must be non-hazardous and not mixed with Najis. Meanwhile, if it is a recombinant microbe (genetically engineered), then the gene source must not come from pigs and/or humans.
Materials for microbial growth media, additional materials and/or auxiliary materials are required not to come from pigs and their derivatives. Microbial products used as raw materials, active ingredients, additives, and/or auxiliary materials for halal drug product processes must be pure or free from impurities.
What is checked during the halal examination of drug products? Should it be through laboratory testing? What is the role of the laboratory in halal certification of drugs?
Knowledge of the critical point of haram for drug ingredients is carried out through examination of the halal certificate document of the ingredient or through examination of supporting documents for the ingredient, which include process flow diagrams, certificates of analysis results (CoA), composition, statements of pork-free facilities, and product specifications. The JPH Law stipulates that laboratory testing is required if there are ingredients whose halalness is in doubt in the case of product examination. Laboratory testing is required to authenticate the halalness of ingredients or products containing animal ingredients, such as gelatin, collagen, placenta extract, or chondroitin.
One of the requirements for establishing a Halal Research Institute (LPH) is to have a laboratory or a cooperation agreement with another institution with a halal testing laboratory. LPPOM, as one of the LPHs, has had a laboratory accredited with SNI ISO/IEC 17025: 2017 since 2016, becoming Indonesia’s first halal testing laboratory.
Is it true that currently, drug raw materials still have to be imported? What are the implications for the halal certification process?
Regarding raw materials for drugs, we can only provide an overview of hypertension drugs. Hypertension is called a silent killer with a prevalence of 26.5% (in 2023), which has decreased from 34.1% (in 2018), meaning that 3 out of 10 people suffer from hypertension. So, if we calculate, around 70-80 million Indonesians (270 million) suffer from hypertension.
The drug to lower high blood pressure is Amlodipine, included in the calcium channel blocker group. This drug works by relaxing and widening blood vessels, lowering blood pressure and making it easier for the heart to pump blood. From the data on Amlodipine ingredient producers recorded in CEROL (registered with LPH LPPOM as of March 2024) originating from India, there are 12 producers, Spain 1 producer, China 1 producer, and Indonesia 1 producer.
The second example is Cholesterol Medication, namely Atorvastatin, which lowers bad cholesterol (LDL) and bad fat (triglycerides) in the blood and can prevent and reduce the possibility of heart disease and stroke. The prevalence of cholesterol in Indonesians is 28%. The raw material for Atorvastatin can only be produced at PT Kimia Farma Sungwun Pharmacopia, the rest is imported from India, China, and Israel. The third example is antibiotic raw materials. One of the antibiotics with a high level of use in Indonesia is Amoxicillin trihydrate; imported from China, there are 5 producers, and in India, there are 2 producers. There are no Amoxicillin producers in the country yet. Not to mention the Cephalosporin antibiotics that have several generations, namely:
- 1st generation Cephalosporins: Cefadroxil, Cefalecin, Cefazolin
- 2nd generation Cephalosporins: Cefuroxim, Cefprozil, Cefaclor
- 3rd generation Cephalosporins: Cefotaxime, Cefixime, Ceftriaxone, Cefoperazone, Ceftazidime
- 4th generation Cephalosporins: Cefepime, Cefpirome (injectable preparations)
- 5th generation Cephalosporins: Ceftaroline fosamil, Ceftolozane/Tazobactam (injectable preparations)
All are still imported. The implications for halal certification are not that much of an obstacle because, generally, the production process for the raw materials for these drugs meets high standards, and manufacturers are able to meet the adequacy and validity of the supporting documents for their halal status.
What is often complained about as one of the obstacles to the provision of halal drugs is the availability of raw materials. How is the availability of raw materials for drugs in the country?
The government, through the Indonesian Ministry of Health, comprehensively together with the national drug raw material industry and the national pharmaceutical industry, continues to strive to increase the production capacity of raw materials for drugs towards independence and realizing the resilience of pharmaceutical preparations and medical devices. The Ministry of Health’s target is to increase the number of drug products with a TKDN of more than 52%, which is a priority in procurement, especially government procurement of goods/services. However, no objective evidence exists to provide domestic pharmaceutical raw materials. National drug manufacturers still import almost all pharmaceutical raw materials (active ingredients and excipients).
How should the government implement policies to encourage the domestic availability of halal drug materials?
To strengthen the resilience of the pharmaceutical industry, the government needs to focus on the upstream chemical industry. Since 2022, the Ministry of Health has facilitated the change in the source of the use of domestic drug raw materials through local production at the PT Kimia Farma Sungwun Pharmacopia facility. Currently, Indonesia is still predominantly dependent on imports of raw drug materials. According to the Deputy Minister of Health (Wamenkes), 90% of raw materials for medicines in Indonesia are still obtained from abroad. Of the 10 active ingredients of medicines that are the largest domestic needs, only four medicines can be produced domestically, namely Paracetamol, Clopidogrel, Omeprazole, and Atorvastatin by Kimia Farma Sungwun Pharmacopeia. Meanwhile, active ingredients of medicines such as Cefixime, Amlodipine, Candesartan Cilexetil, Bisoprolol, Lansoprazole, and Ceftriaxone cannot be produced domestically. (***)
