Local Content Certificate for Pharmaceutical Products in Indonesia

How to Obtain Local Content Certificate for Pharmaceutical Products in Indonesia

  • InCorp Editorial Team
  • 1 August 2023
  • 5 minute reading time

The global pharmaceutical sector has been a focal point in the coronavirus crisis since it played a critical role in the development of the COVID-19 vaccine. Moreover, an economy cannot function and flourish without being backed by physically fit individuals. Hence Indonesia pharmaceutical industry assumes prime significance.

The Indonesian government is inclined to see the national pharmaceutical sector expand because it has remained heavily reliant on raw material imports, putting significant strain on the country’s trade balance, current account balance, and rupiah exchange rate. In its bid to increase domestic production in the pharmaceutical industry, the government has pivoted towards global investment.

Moreover, a rising number of Indonesians are devoting more of their disposable income to healthcare, the country’s reliance on imported raw materials is only going to expand if the domestic raw material output is not boosted.

Why Foreign Investors Should consider Investing in Indonesia’s Pharmaceutical Industry?

Opportunities in Pharmaceutical Raw Products Business

According to the Indonesian Ministry of Health, there are 241 drug manufacturing businesses, 17 pharmaceutical raw drug industries, 132 traditional medicine industries, and 18 natural product extract industries in Indonesia as of 2021.

The Indonesian pharmaceutical industry, for example, accounts for 27% of the whole ASEAN pharmaceutical industry. The majority of these businesses are involved in the formulation or production of pharmaceuticals, however, for ascertaining raw materials Indonesia continues to be heavily reliant on imports from other countries. Consequently, investing in pharmaceutical raw materials in Indonesia presents a lot of lucrative prospects.

Improved Business Licensing Process

The government has decided to speed up the licensing procedure for medical equipment suppliers to assist Indonesia in combating the COVID-19 pandemic. By using the Indonesian Investment Coordinating Board (BKPM)’s Online Single Submission (OSS) and maximizing monitoring through the BKPM Investment Control and Command Center (Pusat Kopi BKPM), the license may now be obtained in less than 24 hours.

Open to 100% Foreign Ownership

To lessen its reliance on imported pharmaceutical raw materials, the Indonesian government permitted foreign investors to own 100% of their investment in its pharmaceutical industry. According to the Positive Investment List, the following are some of the pharmaceutical-related company operations that are available for 100% ownership:

KBLI Number Business Activities
21011 Pharmaceutical Material
21011A Pharmaceutical Raw Material and Its derivative products
21011B Biotech-based Pharmaceutical Raw Material
21011C Blood-based Pharmaceutical Raw Material

How to Calculate Local Content for Pharmaceutical Products in Indonesia

MOI Regulation No.16 of 2020 outlines the components of the local content level for pharmaceutical finished goods and raw materials, as well as the mechanism for calculating it. It also lays out the steps for obtaining a certificate indicating the level of local content in pharmaceutical products.

Local Content Calculation for Pharmaceutical Products in Indonesia


When evaluating the local content level of local pharmaceutical manufacturing operations, the following are the key elements to consider:

  1. the employees’ nationalities
  2. the manufacturing plants’ ownership
  3. utilization of locally sourced materials


The local content of pharmaceutical products is calculated using four factors such as raw materials, research and development, manufacturing process, and packaging.

For the computation of total local content, each component is further divided down into sub-components with varying weight values, as follows:

No. Component Sub-Component
Description Weight Description Weight
1 Raw Materials Content 50% Active Pharmaceutical Ingredients (“API”) 65%
Additional Ingredients 35%
2 Research and Development 30% Development of New Drugs 25%
Clinical Trial 30%
Formulation 35%
Bioavailability (“BA”) / Bioequivalence (“BE”) 10%
3 Production Process 15% Compounding 60%
Dosage Forming 40%
4 Packaging Process 5% Batch Release 50%
Primary Packaging 40%
Secondary Packaging 10%

Issuance of Local Content Certificate

The Ministry Of Industry (MOI) has the right to provide a local content certificate for pharmaceutical products, according to MOI Reg. 16/2020. The relevant pharmaceutical manufacturing company (“PMC”) will first determine the local content level manually. The PMC may submit an application to the Directorate General of Chemical, Pharmaceutical, and Textile Industry (“Directorate General”), through the MOI’s Public Services Unit (“PSU”), for verification of the local content calculation, including the following documents:

  1. Industrial Business License;
  2. Company profile, organizational structure, and production data;
  3. PMC’s self-assessment of the local content level;
  4. Certificate of Production from the Ministry of Health; and
  5. A yearly production and marketing realization report presented to the Food and Drugs Supervisory Agency.

Within one business day of the PMC submitting the necessary papers, the PSU will check that they are complete and shall transmit the application to the Directorate General. Within five business days of receiving the application from the PSU, the Directorate General will issue a letter approving the computation of the local content level if there are no issues with the application.

When the PMC receives the permission letter, it must forward it to an independent assessor authorized by the MOI to validate the local content estimate. The independent assessor will notify the Center for the Utilization of Domestic Products, which will provide the local content certificate within five working days if the verification result matches the PMC’s computation. The certificate for local content is valid for two years.

Get in Touch with Us

While making an investment in Indonesia’s pharmaceuticals industry, Incorp will provide you with a seamless company registration experience. Our license specialists can assist you in a hassle-free acquisition of business licenses.

Moreover, Incorp’s can assist you in your product registration service in Indonesia. Furthermore, Incorp provides tax and accounting services and can act as your HR entity to carry out HR and recruitment services to help cut overhead costs of setting up a department.

Pandu Biasramadhan

Senior Consulting Manager at InCorp Indonesia

An expert for more than 10 years, Pandu Biasramadhan, has an extensive background in providing top-quality and comprehensive business solutions for enterprises in Indonesia and managing regional partnership channels across Southeast Asia.

Get in touch with us.

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Disclaimer: The information is provided by PT. Cekindo Business International (“InCorp Indonesia/ we”) for general purpose only and we make no representations or warranties of any kind.

We do not act as an authorized government or non-government provider for official documents and services, which is issued by the Government of the Republic of Indonesia or its appointed officials.

We do not promote any official government document or services of the Government of the Republic of Indonesia, including but not limited to, business identifiers, health and welfare assistance programs and benefits, unclaimed tax rebate, electronic travel visa and authorization, passports in this website.

Frequent Asked Questions

You can transfer the license as long as your current local distributor agrees to change the product license holder. The procedure will be different for each product category. We can only recommend you try to prevent these issues by setting cooperation with a trustworthy partner from the beginning

Before you can distribute your products in Indonesia, you will have to register your product with the BPOM (National Agency of Food and Drugs) and MoH (Ministry of Health). Only an Indonesian legal entity can register the product. If you decide to distribute your product via a local distributor, they will register the product under their entity in Indonesia and become the product license holder. Cekindo can act as your local distributor and register the product under its name.