5 Citations (Scopus)


The rapid growth of the Muslim population in Indonesia has led to a corresponding increase in the demand for halal medicines and medication. To ensure the halal status of medicines, Indonesia has adopted a regulatory framework for halal certification and labeling for all products marketed in the country. The new framework makes halal certification mandatory for all food, beverage, medicines, cosmetics, chemicals (used for human consumption), sold in Indonesia by October 2019. However the implementation of the new framework faces complex challenges that call for innovative solutions. Apart from basic inconsistencies in the law, there are no clear regulations for implementation. More importantly, most medicines marketed in the country are patented imports and 95% of Indonesian raw pharmaceutical ingredients are imported from different doubtful halal sources. This situation makes it difficult to audit the halal status of medicines even when patent holders manufacture the medicines in Indonesia. Furthermore, for halal certification, Indonesia will need well-regulated and transparent harmonized accreditation procedures that meet global standards that patent holders can comply with. . As a member of the WTO, Indonesia is bound by the Technical Barriers to Trade (TBT) Agreement that prohibit any trade barriers that might be presented by halal certification. With only a few months left for the pharmaceutical industry to meet the October 2019 deadline, there is an urgent need for Indonesia to look at innovative ways to implement halal medicines certification effectively and efficiently. The paper critically evaluates the systemic challenges that face halal certification for patented medicines and recommends the use of digital technology as a remedy. The paper argues that the use of Online Single Submission and BlockChain technology may be the panacea for the pains of halal certification in Indonesia.

Original languageEnglish
Pages (from-to)210-217
Number of pages8
JournalSystematic Reviews in Pharmacy
Issue number12
Publication statusPublished - 2020


  • Digital technology
  • Halal certification
  • Indonesia
  • Patented medicines


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