Halal medicinal products are one of the aspects that are the main concern of the Financial Audit Agency of the Republic of Indonesia (BPK RI). In order to support the study of national health system reform, BPK RI held a discussion with the theme "National Health System Reform to Increase National Resilience" some time ago which was held virtually.
This discussion aims to identify the problems of registration and supervision of halal drug products, as well as enforcement and/or law enforcement efforts, obtaining the latest data related to the results of halal drug product supervision as well as efforts to enforce and/or enforce laws and formulate policy recommendations and strategies at the macro, meso, and micro levels in an effort to reform the national health system in the aspect of drug independence.
Present as a resource person, Dr. H.A. Umar, MA, as Head of the Center for Development and Supervision of Halal Product Assurance bpjph; Dr.. H. Mastuki, M.Ag, as Head of the BPJPH Halal Registration and Certification Center; and Ir. Hj. Muti Arintawati, MSi, as President Director of LPPOM MUI.
Law No. 33 Of 2014 concerning Halal Product Guarantee (JPH Law) in Article 4 states that products that enter, circulate, and are traded in the territory of Indonesia must be halal certified. Article 1 of the same law states that the products in question are goods and/or services related to food, beverages, drugs, cosmetics, chemical products, biological products, genetically modified products, as well as useful goods used, used, or utilized by the public.
Henceforth, based on supreme court regulation (PMA) No. 26 of 2019 concerning the Implementation of Halal Product Guarantees and Government Regulation (PP) No. 39 of 2021 concerning the Implementation of the Halal Product Guarantee Field, it is stated that there is a mandatory staging of halal certification, especially drugs. For traditional medicines and health supplements, the staging of obligations is valid from October 17, 2021 – October 17, 2026, then over-the-counter drugs and limited over-the-counter drugs until October 17, 2029, and hard drugs are excluded from psychotropics until October 17, 2034.
Meanwhile, Muti in his presentation explained, the critical point of medicine where there is a chance of products with non-halal status includes materials, processes, facilities. Critical points in medicinal materials can be found in active ingredients, excipients, auxiliary materials, cleaning agents, and validation media for washing results. This critical point must be verified and assessed for its compliance with certification standards. For a more detailed explanation, LPPOM MUI has issued a halal assurance standard book HAS 23202 on the knowledge of the critical point of halalness of medicinal materials.
The halal certification of medicinal products for the 2017-2021 period continues to experience successive increases. From 2017 to 2021, the number of medicinal products certified halal includes 569, 2.86, 11,862, 4,631, and 6,776 products in 2021.
Especially in 2021, the herbal product group has 2,716 halal-certified products, the supplement and supplement ingredients product group is 1,091 products and for the drug and vaccine product group there are 2,696 products.
There are various challenges faced in terms of halal drug certification, from the consumer side, there are still many consumers who think that drugs are an emergency area so there is no need for halal certification for drugs so as not to encourage pharmaceutical companies to certify their halal products. Meanwhile, from the producer side, finding alternative halal materials is a challenge in itself, in addition to the separation of facilities, the existence of new materials that require MUI fatwas, and also regulations.
With these various challenges, LPPOM MUI provides recommendations, including increasing socialization and education about JPH regulations to all stakeholders, giving time in the implementation of mandatory halal certification requirements for medicinal materials that are not included in the positive list, parallel to the certification process of medicinal materials, and encouraging the development of drugs that have used halal ingredients from the beginning of research. (NAD)
