ITB School of Pharmacy Professor Explains Halal Assurance Strategy for Pharmaceutical Products
By Adi Permana
Editor Adi Permana
Prof. Dr. ap.t Slamet Ibrahim Surantaatmadja, DEA. (ITB School of Pharmacy professor and General Head of Salman ITB Center for Halal Studies) explained about the halal assurance strategy for pharmaceutical products in a webinar held by the Pharmacy Postgraduate Student Association "BIFOSFONAT" ITB (HMPF ITB), Sunday (6/3/2022).
Prof. Slamet began his presentation by first describing how the halal concept in sharia Islam is classified to two aspects; the material aspect which covers objects, materials and products, and the Mukallaf Charity (Muammalah) aspect. The material aspect can be classified further to different types in detail.
“Raw materials in pharmacy are active pharmaceutical ingredients that can be in the form of chemical reactions and have an effect on consumers. Additionally, the pharmaceutical field also has additional ingredients called pharmaceutical excipients. Enzymes and catalysts also act as supporting materials," Prof. Slamet said.
According to Government Regulations No. 33 year 2014 regarding the guarantee of halal products, medicinal or pharmaceutical products are included as part of products that are required to be certified as halal. “To be certified as halal, products have to be halal and be produced by using ingredients and processes in accordance with Islamic sharia,” Prof. Slamet firmly states. However, there is a certain challenge of halal statuses being uncertain, considering the possibility that halal certification is not required in the country where the product is made from.
Prof. Slamet also explained about the Law of Material Origins. “According to Al-Quran Surah Al-Baqarah: 29 and Al-Jasiyah: 13, everything on this earth can basically be used by humans as khalifa or leaders. Usulul Fiqh states that the legal origin of all materials is permissible as long as there is no evidence that forbids it and the legal origin of useful materials is permissible as well, and the legal origin of harmful materials is haram," said Prof. Slamet.
Surely, in order to ensure products, especially pharmaceutical products, are halal, standardization needs to be done. “Standardization is a process of formulating, establishing, implementing, and revising standards in an orderly manner through a consensus or cooperation with all parties in charge,” Prof. Slamet explained.
The halal standard is made up of halal requirements, production guidelines, criteria, and testing methods. The criteria for halal products must meet various stages such as halal production processes and facilities, certainty that all materials, storage and distribution systems are halal, and there is no contamination with haram goods too.
In the case of pharmaceutical products, various legal aspects of drugs have to be met. Firstly, the pharmaceutical supplies and health products have to be safe, useful, and of good quality in accordance with Government Regulations No. 36, Article 98, 2009. Medicine and its raw ingredients must also fulfill the requirements of the Farmakope Indonesia or other books of standards in accordance with Government Regulations No. 36, Article 105, 2009. Traditional medicine must also comply with Farmakope Herbal Indonesia. Pharmaceutical tools and products must also have a distribution permit and a halal certification.
In order to have the halal assurance strategy succeed for pharmaceutical products, the concept Halal by design was introduced. “Halal by Design is a systematic approach to halal products. Starting with planning, selection, materials, production processes, to assuring halal products based on halal management according to Islamic sharia, " Prof. Slamet states. The Halal by Design concept was first invented by adopting the Quality by Design firstly introduced by Dr. Joseph M. Juran, which was then combined with quality risk management.
The implementation phase of Halal by Design starts from the target of halal products, halal product assurance system, development and analysis of critical points, determination of halal materials, selection of production facility and distribution, strategy application, until a halal certificate is obtained. "The success rate of this concept is very dependent on determination, intention, and strong efforts to implement a good and halal product production strategy," said Prof. Slamet.
Titled as “One Big Event: Indonesia’s Readiness as the World’s Halal Industry Center, Specifically Pharmaceutical Sector”, this webinar also presented the Head of Center for Halal Registration and Certification of the Ministry of Religious Affairs Halal Product Assurance Agency, Dr. H. Mastuki, M.Ag., and Quality and Halal Management Group PT Paragon Technology and Innovation, Elvira Aninda Sati Zein, S.Si., M.M. as its speakers.
Reporter: Yoel Enrico Meiliano (Food Engineering, 2020)
Translator: Hanna Daniela Ayu (Faculty of Mechanical and Aerospace Engineering, 2021)