Knowing How the Stages of Indonesia Halal Obligations for the Drug Industry

Currently, the implementation of halal certification in Indonesia is entering a new phase. After the first stage, halal certification was intensified for food and beverage products, as well as slaughtering services. Currently, the phasing of the halal obligations of the drug industry has begun. This is in accordance with Government Regulation (PP) Number 39 of 2021 concerning Implementation of the Halal Product Guarantee Field. The phasing of the drug industry's halal obligations begins on October 17, 2021 - October 17, 2034 with the following category stages:

• Traditional medicine, quasi-medicine, and health supplements (until 17 October 2026)
• OTC drugs and limited over-the-counter drugs (until 17 October 2029)
• Strong drugs are exempt from psychotropics (until October 17, 2034)

Purpose of Phasing Drug Industry Halal Certificate

Every regulation that is made, of course, has a basis for its purpose, as well as regulations for the halal certification of the drug industry. Quoting from the Minister of Religion, this stage has the aim that the obligation of halal certification for products as stipulated in regulations, is carried out properly and avoids potential difficulties, especially for business actors in maintaining the continuity and development of their business.

Furthermore, medicines or pharmaceutical products that must fulfill the Hala certification obligation are contained in RI Presidential Regulation (Perpres) Number 6 of 2023 concerning Halal Certification of Medicines, Biological Products and Medical Devices. In the Presidential Decree in Article 2 paragraph 1 it is explained that drugs, biological products and medical devices that enter, circulate and trade in Indonesian territory must be halal certified.

Then in Article 2 paragraph 2 it is explained about the scope of drugs that must be halal, namely medicinal ingredients, over-the-counter drugs, limited over-the-counter drugs, hard drugs, traditional medicines, health supplements, and quasi-drugs. Meanwhile for the scope of biological products, it is explained in Article 2 paragraph 4. The scope of biological products that must be certified are enzymes, monoclonal antibodies, hormones, stem cells, gene therapy, vaccines, blood products, recombinant DNA products, and immunosera.

Meanwhile, the scope for medical devices that must be halal certified is contained in Article 2 paragraph 5 covering in vitro reagents and calibrators, software, materials and materials used singly or in combination, to prevent fertilization, disinfection of medical devices, and in utro testing of specimens. from the human body, and may contain drugs that do not reach the main action on the human body through pharmacological, immunological, or metabolic processes to be able to help the desired function or work.

Article 2 paragraph 6 explains that the Medical Devices as referred to in paragraphs (1) and (5) are only for those originating from animals and/or containing animal elements.

Success Tips for Drug Industry Halal Certificate

With the mandatory halal certification for the pharmaceutical industry, IHATEC as a halal training and consulting service institution would like to share a few tips for successful halal certification for you business actors in the pharmaceutical industry.

First, you need to understand what the requirements for halal certification are. Then, secondly, you have to prepare documents, such as Business Identification Number (NIB), application letter, product list, list of ingredients, product processing process, and the Halal Product Assurance System (SJPH) manual. The third tip, prepare locations, places, tools that comply with halal requirements, maintain sanitation and hygiene. Fourth, don't forget to prepare halal supervisors, a competent halal management team, and also apply SJPH consistently and continuously.

In the process towards halal certification, Halal personnel need not worry because IHATEC is ready to assist the halal certification process with special training programs including preparing competent halal human resources based on SKKNI.

9 August 2023. Article By: