Dr. Priyo Wahyudi, M.Si
Act No. 33 of 2014 concerning Halal Product Assurance (JPH) stipulates that products entering, circulating, and traded in the territory of Indonesia must be halal certified. The stages of the obligation to have halal certification are regulated through Government Regulation No. 39 of 2021 concerning the Implementation of the Halal Product Assurance Sector.
Specifically for medicinal and pharmaceutical products, the obligation for halal certification is regulated through Presidential Regulation No. 6 of 2023, which governs the halal certification of medicines, biological products, and medical devices entering, circulating, and trading in the territory of Indonesia.
Meanwhile, the stages of halal certification are applied according to the group of medicinal products. For traditional medicines and health supplements starting October 17, 2021 to October 17, 2026, over-the-counter drugs and limited over-the-counter drugs are mandatory from 2021 to 2029; hard drugs are excluded; Psychotropics from 2021 to 2034 and biological products, including vaccines, are regulated in the Presidential Regulation.
To get a clearer picture of the challenges of halal certification for medicines, Journal 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 Principal Expert Researcher in the field of 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:
In addition to Food and Beverages, Medicines Must Also Be Halal Certified. What is the Urgency?
As with food and beverages, the urgency of the obligation to certify halal medicines can be viewed from several perspectives or points of view. In terms of faith and piety, consuming food, including halal medication, is an obligation according to Islamic law.
Allah SWT has said in Q.S. Al-Baqarah (2): 168 which means: “O humanity! Eat from what is lawful and good on the earth, and do not follow Satan’s footsteps. He is truly your sworn enemy. This makes consuming anything (including medicine) for humans obligatory that is lawful and thayib.”
In terms of rights, consumers or every citizen also have the right to a guarantee of the halalness of the products consumed. The state guarantees the freedom of its citizens to practice their sharia, so the state requires that every product consumed by the community is guaranteed to be halal. The form of a halal guarantee from the state is a halal certificate. Thus, Muslims get their right to consume halal products as a form of Islamic Sharia practice that they must carry out. The next aspect is the formal legal aspect that all products entering, circulating, and traded in Indonesia must be halal certified. This is regulated in Act No. 33 of 2024 concerning Halal Product Assurance.
When is the Implementation of Mandatory Halal for Medicinal Products, and What are the Stages?
The obligation to certify halal products, according to Act No. 33 of 2014, has stages. Government Regulation (PP) No. 39 of 2021 has regulated the Stages of Halal Certification of Medicines divided into several phases according to the type of drug group, as follows:
1. Traditional Medicines and Health Supplements must be halal certified from October 17, 2021 to October 17, 2026
2. Over-the-Counter Drugs and Limited Over-the-Counter Drugs must be halal certified from October 17, 2021 to October 17, 2029
3. Prescription Drugs except Psychotropics must be halal certified from October 17, 2021 to October 17, 2034
4. Biological Products, including vaccines, are regulated in the Presidential Regulation.
Currently, How Many Medicines Have Halal Certification? What is the Trend, Increasing or Decreasing?
Based on data from LPH LPPOM, from 2017 to 2023, the number of pharmaceutical companies applying for halal certification has continued to increase from year to year. In 2017, there were only 36 companies with 484 halal drug products. In 2020, the number of companies applying for halal certification increased to 138 companies with 2,146 halal drug products.
In 2021, there was the highest increase in the number of companies applying for halal certification to 211 companies with 5,914 halal drug products. From these data, it means that the response and commitment of pharmaceutical manufacturers in Indonesia are very high to certify their pharmaceutical products.
What are the Challenges and Obstacles Faced by the Pharmaceutical Industry in the Halal Certification Process?
Every industrial sector certainly has its challenges. Whether these challenges become obstacles or not is largely determined by the readiness of the parties, not only pharmaceutical product manufacturers but also the parties involved in the supply chain as a whole. In general, the pharmaceutical industry supply chain (drugs) includes:
1. Provision of Raw Materials, Auxiliary Materials, and Additive Materials, the challenge is the still low Domestic Content Level (TKDN) due to the lack of local materials that meet quality standards and competitive prices. Therefore, the provision of raw materials for drugs, auxiliary materials, and additive materials (excipients) is still largely imported.
2. Provision of Packaging Materials: Alhamdulillah most of the supply of primary drug packaging materials has been produced domestically.
3. Production Facilities with challenges in the form of requirements Where all facilities used for the drug production process must be free of impurities and free of pork. This is so that the facilities do not contaminate active ingredients, excipients, and auxiliary materials so that they are infected with pork. If this can be overcome, then production facilities that are free of pork are no longer an obstacle.
4. Logistics and distribution: the challenge is that the storage and distribution of raw materials to drug products must be guaranteed to prevent cross-contamination with materials/products containing impurities/haram materials. This will no longer be an obstacle if all distribution service providers have been halal-certified. Alhamdulillah, currently the interest of drug logistics companies in carrying out certification continues to increase. One of them is PT Enseval Putera Megatrading Tbk (Enseval), which received an award for the Best New Comer Nomination (Services category) from the LPPOM MUI Halal Award 2023.
The government continues to strive to provide convenience to the public, including in consuming medicines. In this case, LPPOM, as a Halal Inspection Body (LPH), is always open to every business actor who wants to carry out halal certification of their products. Get to know LPPOM better by accessing https://halalmui.org/. (***)
