Topic explainer | How should Chinese pharmaceutical enterprises respond to Indonesia''s mandatory Halal certification rules?

Under Indonesia''s Halal Product Assurance (JPH) law, products circulating and traded within Indonesia must pass Halal certification. Especially for the pharmaceutical industry and drugs, mandatory Halal certification is stipulated by Presidential Regulation No. 6 of 2023: all drugs, biological products, and medical devices circulating and traded within Indonesia must pass Halal certification and carry an Indonesian BPJPH certificate.

Thus, like food and beverages, Halal certification for the pharmaceutical industry is also very urgent. Under Islamic law, consuming Halal medicine is an obligation for Halal-observing people.

According to Indonesia''s Law No. 33 of 2014, Halal certification for the pharmaceutical industry will be carried out in phases. Government Regulation No. 39 of 2021 stipulates in detail the phases of Halal drug certification, specifically as follows:

1. Traditional medicines and health products must obtain Halal certification during the period from October 17, 2021 to October 17, 2026;

2. Over-the-counter drugs and limited over-the-counter drugs must obtain Halal certification during the period from October 17, 2021 to October 17, 2029;

3. Prescription drugs other than psychotropic drugs must obtain Halal certification during the period from October 17, 2021 to October 17, 2034;

4. From 2021 to 2034, biological products including vaccines are regulated by presidential regulation.

Data from Indonesia''s LPH LPPOM show that since 2017, the number of pharmaceutical companies applying for Halal certification has shown a year-on-year increasing trend, but relative to Indonesia''s huge market demand, there are still very few drug raw-material suppliers with Halal certification. Of the 10 drug active ingredients with the largest local demand in Indonesia, only four drugs can be produced domestically. According to Indonesia''s Deputy Minister of Health, 90% of Indonesia''s pharmaceutical raw materials still need to be obtained from abroad through imports.

This is good news for Chinese pharmaceutical enterprises. Not just end-drug manufacturing enterprises, but suppliers of drug raw materials, auxiliary materials, and even those providing drug packaging materials - as long as their export markets cover Indonesia, the relevant enterprises should keep Indonesia''s policy time nodes in mind and use this window period to complete the Halal certification of their own products

in preparation.

If your enterprise feels overwhelmed when facing Indonesia''s cumbersome Halal certification process, feel free to contact SINOQUAL at any time. Our professional certification team will provide you with comprehensive and detailed certification guidance, assist you in establishing a Halal management system, and smoothly obtain Indonesia''s BPJPH Halal certification!

FAQ

What does Indonesia stipulate for mandatory Halal certification of drugs?
Under Indonesia''s Presidential Regulation No. 6 of 2023, all drugs, biological products, and medical devices circulating and traded within Indonesia must pass Halal certification and carry a BPJPH certificate. Under Law No. 33 of 2014, Halal certification for the pharmaceutical industry is carried out in phases.
What are the phased time nodes for Indonesia''s drug Halal certification?
Per Government Regulation No. 39 of 2021: (1) traditional medicines and health products must be certified during October 17, 2021 to October 17, 2026; (2) over-the-counter and limited over-the-counter drugs during 2021 to October 17, 2029; (3) prescription drugs other than psychotropic drugs during 2021 to October 17, 2034; (4) from 2021-2034, biological products including vaccines are regulated by presidential regulation.
Is Indonesia''s drug Halal certification an opportunity for Chinese pharmaceutical enterprises?
It is positive. Although the number of pharmaceutical companies in Indonesia applying for Halal certification is increasing year by year, there are still very few drug raw-material suppliers with Halal certification - of the 10 drug active ingredients with the largest demand in Indonesia, only 4 can be produced domestically, and about 90% of pharmaceutical raw materials depend on imports. Whether end-drug, raw and auxiliary material, or drug packaging material suppliers, as long as their export markets cover Indonesia, they should seize the window period to complete Halal certification preparation.