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Original Research Indonesian Journal of Health Administration

(Jurnal Administrasi Kesehatan Indonesia)


p-ISSN 2303-3592, e-ISSN 2540-9301
10.20473/jaki.v11i2.2023.196-211

CHALLENGES AND POLICY SUPPORTS IN INDONESIAN


PHARMACEUTICAL RAW MATERIALS INDUSTRY

Tantangan dan Dukungan Kebijakan Industri Bahan Baku Obat di Indonesia

*Erwan Hermawan1, Nur Anis Hadiyati2, Adiarso Adiarso1, Ermawan Darma Setiyadi1, Siti Zunuraen3,
Dudi Hidayat2, Anwar Wahyudi4, Hartini Ahadiyatur Ru’yi5
1
Research Center for Process and Manufacturing Industry Technology - National Research and Innovation
Agency, Serpong, Indonesia
2Directorate of Research, Technology, and Innovation Policy Formulation – National Research and Innovation

Agency, Jakarta, Indonesia


3
Research Center for Marine and Land Bioindustry - National Research and Innovation Agency, Pemenang,
Indonesia
4Ministry of Health Republic of Indonesia, Jakarta, Indonesia
5Directorate of Research and Innovation Infrastructure Partnership, National Research and Innovation Agency,

Jakarta, Indonesia
Correspondence*:
Address: PUSPIPTEK, Jl. Raya Puspitek, Muncul, Kota Tangerang Selatan, Indonesia | e-mail: erwa005@brin.go.id

Abstract
Background: Indonesian pharmaceutical industry is experiencing many challenges, spesficically their raw materials mostly are
imported products. Several factors that cause the pharmaceutical raw materials industry to be challenging are lack of mastery of
technology, lack of government support, low budget for R&D, high costs of development and time consuming, and low innovation
incentives.
Aims: The aim of this study is to conduct a study on the strategies for developing the pharmaceutical raw material industry in
Indonesia
Methods: This study employed a qualitative method, the data triangulation gathered from interviews and discussions with several
industries and institutions. The study was conducted for six months in 2022.
Results: The policies that require to be implemented in order to make the pharmaceutical raw materials industry thrive are (i) the
presence of a clear grand strategy, (ii) determining the priority of pharmaceutical raw materials based on industrial needs, (iii)
protecting domestic products, (iv) increasing health spending, (v) strengthening basic chemical product, and (vi) increasing the
budget for R&D.
Conclusion: Some policies that can be enhanced include providing incentives and policies that favor the local pharmaceutical
raw material industry, ranging from regulated prices, put an end to dependence on imported products, tax incentives, domestic
products protection through import tariff policies, energy subsidies, technology transfers, et cetera.

Keywords: pharmaceutical raw materials, policy, pharmaceutical

Abstrak
Latar Belakang: Industri bahan baku farmasi di Indonesia mengalami banyak permasalahan, terutama ketergantungan terhadap
produk impor. Beberapa faktor yang menyebabkan industri bahan baku obat memiliki tantangan tersendiri seperti kurangnya
penguasaan teknologi, dukungan pemerintah, anggaran riset rendah, tingginya biaya pengembangan bahan baku, dan insentif
untuk inovasi masih rendah.
Tujuan: Tujuan dilakukan kajian ini adalah untuk menentukan kebijakan strategi pengembangan industri bahan baku obat
Indonesia.
Metode: Studi ini menggunakan metode kualitatif, data triangulasi diperoleh dari proses interview dan diskusi dengan beberapa
institusi dan industri. Penelitian ini dilakukan selama enam bulan di tahun 2022.
Hasil: Kebijakan yang perlu ditingkatkan mulai dari (i) adanya grand strategy yang jelas, (ii) menentukan prioritas bahan baku
obat berdasarkan kebutuhan industri, (iii) melindungi produk domestik, (iv) meningkatkan health spending, (v) penguatan industri
kimia dasar, dan (vi) meningkatkan anggaran untuk R&D.
Kesimpulan: Beberapa kebijakan yang dapat ditingkatkan mulai dari pemberian insentif terhadap industri bahan baku obat mulai
dari penetapan harga, berhenti ketergantungan terhadap produk impor, insentif pajak, perlindungan produk domestik melalui
kebijakan tarif impor, subsidi energi, transfer teknologi, dll.

Kata kunci: bahan baku obat, kebijakan, farmasi

Indonesian Journal of Health Administration (Jurnal Administrasi Kesehatan Indonesia)


p-ISSN 2303-3592, e-ISSN 2540-9301, Volume 11 No.2 2023, DOI: 10.20473/jaki.v11i2.2023.196-211
Received: 2023-05-10, Revised: 2023-08-21, Accepted: 2023-10-04, Published: 2023-11-08.
Published by Universitas Airlangga in collaboration with Perhimpunan Sarjana dan Profesional Kesehatan Masyarakat Indonesia (Persakmi).
Copyright (c) 2023 Erwan Hermawan, Nur Anis Hadayati, Adiarso Adiarso, Ermawan Darma Setiyadi, Siti Zunuraen, Dudi Hidayat, Anwar Wahyudi, Hartini Ahadiyatur
Ru’yi. This is an Open Access (OA) article under the CC BY-SA 4.0 International License (https://creativecommons.org/licenses/by-sa/4.0/).
How to cite:
Hermawan, E., Hadiyati, N.A., Adiarso, A. Setiyadi, E.D., Zunuraen, S., Hidayat, D., Wahyudi, A., and Ru’yi, H.A. (2023) “Challenges and Policy Supports in
Indonesian Pharmaceutical Raw Materials Industry”, Indonesian Journal of Health Administration, 11(2), pp. 196-211. doi: 10.20473/jaki.v11i2.2023.196-211.

Hermawan, Hadiyati, Adiarso, Setiyadi,


Challenges and Policy... 196 Zunuraen, Hidayat, Wahyudi, Ru’yi
Original Research Indonesian Journal of Health Administration
(Jurnal Administrasi Kesehatan Indonesia)
p-ISSN 2303-3592, e-ISSN 2540-9301
10.20473/jaki.v11i2.2023.196-211

Introduction (2020), several factors that cause


challenges in the pharmaceutical raw
The COVID-19 pandemic gives us material industry are lack of technology
many lessons. Several sectors expertise, lack of government support, low
experienced a decline in their business, but budget for R&D, high cost of development
the pharmaceutical industry still survive and and time-consuming in the R&D process,
has grown significantly (Esparcia and and low innovation incentives. An
López, 2022; Lim and Rokhim, 2021). appropriate development strategy is
Furthermore, Indonesian pharmaceutical needed to overcome these problems so the
sector has experienced rapid growth since Indonesian pharmaceutical raw material
the implementation of the Indonesian industry can develop or sustain. Although
National Health Insurance (JKN) program there have been studies on the appropriate
in 2014 (Theodore et al., 2022). In 2019, drug development policies in Indonesia
the number of people participating in this (Siagian et al., 2020) and the impact of drug
program reached 215 million or 83% of the pricing in Indonesia (Anggriani et al., 2020),
total population. Meanwhile, JKN has these studies have yet to discuss the
gained 86.7% of the total population strategy for developing pharmaceutical raw
(Anggriani et al., 2020; Binekasri, 2022). It materials in Indonesia. From those studies,
indicates that the pharmaceutical industry it needs to map the current situation in
will develop even more rapidly in line with Indonesia based on challenge and policy
the massive rise of JKN program. aspects. So, this study aims to map the
Strategic planning to strengthen the problems in the pharmaceutical raw
national pharmaceutical industry is needed material industry and to formulate policy
to improve the resilience of the national recommendations.
drug supply in the JKN program. However,
the reality is that the pharmaceutical Method
industry in Indonesia still needs to be more
sustainable. The number of industries This study employed a qualitative
continues to increase; in 2021, there were method. To obtain policy recommendation
241 pharmaceutical companies (Ministry of and information about the current condition
Industry Republic of Indonesia, 2021; of the pharmaceutical industry, interviews
Ministry of Investment Republic of and discussions were conducted with
Indonesia, 2022). Based on National several industries and institutions. The
Agency of Drug and Food Control (2022), study was conducted for four months in
86% of pharmaceutical company were 2022-2024. The institutions involved in this
concentrated on the finished chemical study were several related ministries
products, and only 2.9% focused on raw (Ministry of Health, National Agency of
material medicine. Raw material or Active Drug and Food Control, Ministry of Industry,
Pharmaceutical Ingredients (API) are Coordinating Ministry for Economic Affairs),
primary active ingredients that elicit Indonesia’s state-owned enterprise (PT.
pharmacological responses. The Kimia Farma Sungwun Pharmacopia), and
dependence of the pharmaceutical industry experts from the University of Indonesia
on imported pharmaceutical raw materials and Bandung Institute of Technology.
reaches 90% (Ministry of Health Republic Figure 1 shows the research
of Indonesia, 2022; The Jakarta Post, flowchart. The data triangulation was
2022). As such, Indonesia is vulnerable to gathered from discussion and literature
external disturbances if the government study. We invite and discuss with each of
does not obtain a supply of raw materials. the six stakeholders related to the
As we can see now, Indonesia's pharmaceutical industry issues to
pharmaceutical raw material rely heavily on understand the current situation and policy
imported products. implementation. In regulator, several
Based on previous research by Lim questions were inquired, such as the
and Rokhim (2021) and Siagian et al. current policy to support pharmaceutical
raw material industry, pharmaceutical raw

Hermawan, Hadiyati, Adiarso, Setiyadi,


Challenges and Policy... 197 Zunuraen, Hidayat, Wahyudi, Ru’yi
Original Research Indonesian Journal of Health Administration
(Jurnal Administrasi Kesehatan Indonesia)
p-ISSN 2303-3592, e-ISSN 2540-9301
10.20473/jaki.v11i2.2023.196-211

material roadmap, and overview of current API products to become raw materials in
challenge. The information from industry medicine. Their pharmaceutical industry is
are needed to explore their current projected to grow 12% annually and
business, policy needed for industry, and surpass USD 6 billion in 2019 – 2025
obstacle in their business. The information (Castle, 2022). While China is the highest
from college is gathered to give us the producer and exporter of more than 1500
perspective from academician in describing API products. The total market size
the problem based on a public policy accounts for up to one-third of the global
approach. API production (Liu, 2021). Now, China is
A literature study was carried out to the second largest pharmaceutical market
gain information from several countries in the world behind the US (Kanavos et al.,
such as China, Bangladesh, India, and 2019). In India, the pharmaceutical industry
United States (US). We propose these is expected to grow up to USD 130 billion in
countries because they mostly rely on 2030. Different from China, India could
pharmaceutical sector, high market share produce API products at lower cost while
of pharmaceutical product, has succeeded maintaining quality (Neshith Desai
in developing pharmaceutical sector, and Associates, 2023). Although the US API
has increased trend in pharmaceutical products supplied mostly from China and
sector. These countries can be called the India, the US is widely recognized as a
developed hi-tech in pharmaceutical generic medicine producer (Sardella,
sectors. Bangladesh has made a strong 2023). As much as 64% of sales of new
baseline and is moving towards self- medicine during 2016-2021 was originated
sufficiency for pharmaceutical sector. from US (EFPIA, 2022).
Bangladesh succeeds in manufacturing

Mapping Indonesia current status of


pharmaceutical raw material
industry

Data Triangulation

Benchmarking Criteria
Finding situation
• The country mostly rely on
pharmaceutical sector
• High market share of pharmaceutical
Interview/sharing
product
knowledge
• Has succeed in developing
pharmaceutical sector
• Has increase trend in pharmaceutical
sector
• Ministry of Industry • University of Indonesia • PT. Kimia Farma
• Ministry of Health • Bandung Institute of Sungwun Pharmacopia
• Coordinating Ministry for Technology
Economic Affairs Countries with the most
• Research Center for developed hi-tech in
Medicines and Traditional pharmaceutical sector
Medicines
• National Agency of Drug
and Food Control
• China,
Bangladesh,
US, India

Policy overview

Policy
Recommendation

Figure 1. Research flowchart

Hermawan, Hadiyati, Adiarso, Setiyadi,


Challenges and Policy... 198 Zunuraen, Hidayat, Wahyudi, Ru’yi
Original Research Indonesian Journal of Health Administration
(Jurnal Administrasi Kesehatan Indonesia)
p-ISSN 2303-3592, e-ISSN 2540-9301
10.20473/jaki.v11i2.2023.196-211

Result and Discussion to maintain the R&D ecosystem so that


research and development activities can
Current Status of Indonesian run according to what has been planned on
Pharmaceutical Raw Material the roadmap. Third, the Ministry of Health
Based on the Indonesia National also facilitates the transfer of technology
Agency of Drug and Food Control (BPOM), change sources to optimize domestic
in 2022, 143 pharmaceutical companies potential.
already had Good Manufacturing Practice Other policies protect local industries
(GMP) certificates. Most of these through Presidential Decree No. 12/2021;
companies produced medicinal products. the government requires local content on
Meanwhile, only nine companies produce domestic products to be at least 40%.
pharmaceutical raw materials or 3.7% of Furthermore, the pharmaceutical raw
the total companies. Based on the material industry is regulated through the
distribution of industries, several industries Minister of Industry No. 16/2020, where the
are concentrated in western Indonesia composition of local content for raw
(Warsito, 2022). The pharmaceutical raw materials is 50%, R&D 30%, production
material industry only exists in Lampung, processes 15%, and packaging processes
West Java, and East Java provinces. Most 5%. These policies are issued to encourage
of the pharmaceutical raw materials are the growth of the domestic drug raw
supplied from imported products. As of May material industry and will impact the
2022, imports of auxiliary raw materials, resilience of the Indonesian pharmaceutical
which included chemicals, reached 78% industry.
(Ministry of Trade Republic of Indonesia, The government also provides
2022). The five main pharmaceutical raw incentives for priority sector industries. In
materials imported in 2021 reached USD Presidential Regulation No. 10/2021, two
147,917,018 (IDR 2.1 trillion) (BPS, 2022). incentives can be used for priority sectors:
The Ministry of Health reported that fiscal and non-fiscal. In addition, through
the API molecule that has the highest value the Ministry of Finance, the government
in Indonesia is clopidogrel, with a total sales also issued Minister of Finance Regulation
value of IDR 4.52 trillion, followed by No. 130/2020 regarding tax reduction
paracetamol with IDR 4.48 trillion (Ministry (Coordinating Ministry for Maritime Affairs
of Health Republic of Indonesia, 2022). and Investment, 2021). Incentives related
Further, it is also reported that from the 20 to COVID-19 are also provided based on
main molecules of drugs, Indonesia can the Ministry of Finance Regulation No.
produce only three molecules: clopidogrel, 9/2021, where the government bears
paracetamol, and atorvastatin (Ministry of income tax. Tax reductions can also be
Health Republic of Indonesia, 2022). made through Ministry of Finance
Regulation No. 153/2020, which states that
Current Policy for Supporting industries that carry out R&D activities
Pharmaceutical Raw Material Industry could receive a tax deduction of up to 300%
Through the Ministry of Health, the of the total cost.
government continues to encourage the
development of drug molecules that are Lesson Learned from Pharmaceutical
widely used in terms of volume and value. Industry Success Story: China,
The raw medicinal roadmap made until Bangladesh, and India
2024 includes the development of six drug Table 1 illustrates the differences in
molecules (candesartan and bisoprolol in policies implemented in China, India, and
2022, amlodipine and lansoprazole in 2023, Bangladesh. India has been successful in
and cefixime and ceftriaxone in 2024). The developing the local pharmaceutical
Ministry of Health has several policies to industry. The Indian government provides a
support this; first, developed a mid-term small portion of the budget for health care.
roadmap to determine the main molecules Additionally, the Indian government has a
to be developed in the next few years. role in encouraging the local
Second, it is necessary to have a task force manufacturing.

Hermawan, Hadiyati, Adiarso, Setiyadi,


Challenges and Policy... 199 Zunuraen, Hidayat, Wahyudi, Ru’yi
Original Research Indonesian Journal of Health Administration
(Jurnal Administrasi Kesehatan Indonesia)
p-ISSN 2303-3592, e-ISSN 2540-9301
10.20473/jaki.v11i2.2023.196-211

Hermawan, Hadiyati, Adiarso, Setiyadi,


Challenges and Policy... 200 Zunuraen, Hidayat, Wahyudi, Ru’yi
Original Research Indonesian Journal of Health Administration
(Jurnal Administrasi Kesehatan Indonesia)
p-ISSN 2303-3592, e-ISSN 2540-9301
10.20473/jaki.v11i2.2023.196-211

Hermawan, Hadiyati, Adiarso, Setiyadi,


Challenges and Policy... 201 Zunuraen, Hidayat, Wahyudi, Ru’yi
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(Jurnal Administrasi Kesehatan Indonesia)
p-ISSN 2303-3592, e-ISSN 2540-9301
10.20473/jaki.v11i2.2023.196-211

India has started the development of to producing finished pharmaceutical


the pharmaceutical raw materials industry products (FFPs). China focuses on FFPs
since 1970. The government mandates the because FFPs have a higher level of
development of API products with schemes profitability (Fang, 2017; World Health
of 100% domestic company ownership, Organization, 2017). In addition, China
foreign investors partially owning the tends to maximize domestic use by limiting
company, and 100% owned by foreign pharmaceutical industry investment to a
investors (World Health Organization, maximum foreign shareholding of 49%.
2017). The pharmaceutical policy in
Apart from India, Bangladesh also developed countries, such as the US, has a
has an excellent pharmaceutical industry massive concern for the health sector. In
structure. Bangladesh has a similar vision 2001, the US experienced an anthrax virus
as India; they are not dependent on attack, considered as bioterrorism. The US
imported API products. Currently, the then needed the antibiotic ciprofloxacin
Bangladesh drug market is divided into two: more broadly to deal with bioterrorist
generic, with a share of about 92% of the attacks. The US government provides a
total local production and 8% of patents, 50% discount on antibiotics to enable
Local companies meet 97% of national access to people at a low price. The
demand, while imports meet the remaining government can procure and produce
3%. Bangladesh has produced 19 API drugs at low prices (Kesselheim et al.,
products (Sampath, 2019). 2019; Morgan and Sterling, 2019). In 2001,
Bangladesh also provides many the US spent USD 6 billion in response to
incentives for domestic pharmaceutical raw bioterrorism attacks, showing the public
material industries, ranging from lower health system improvement. An excellent
export levies for the pharmaceutical raw public health education program, good
material industry, tax breaks, technology clinicians, epidemiological skills, and
transfer, and a "block list" system. adequate health infrastructure become the
Bangladesh has a good development plan instruments for anticipating outbreaks.
for the drug industry. The technology Further, they can also minimize casualties
transfer process is carried out properly so and the broader economic impact (Franz,
the local pharmaceutical industry can 2009).
develop rapidly. An exciting policy is the
application of a "block list" system. In this Challenges in Developing
system, imports of raw materials must go Pharmaceutical Raw Material Industry
through the approval of the Directorate in Indonesia
General of Drug Administration (DGDA) The challenge of the Indonesian
(United Nations, 2012). This system pharmaceutical raw material industry is low
provides information regarding health expenditure. One indicator related to
pharmaceutical production plans so that economic growth is healthcare expenditure
the supply of pharmaceutical raw materials (Yang et al., 2021). Based on several
will be recorded and well-known. studies, healthcare expenditure and
China is one of the countries with a economic growth have a relationship (
rapidly growing pharmaceutical industry Chaabouni and Saidi, 2017; Raghupathi
(Peña et al., 2021). China has a different and Raghupathi, 2020). The increase in
strategy from India and Bangladesh. China healthcare expenditure indicates increased
is a densely populated country, so the economic growth. Figure 2 shows the plot
strategy to encourage its pharmaceutical between health expenditure per capita and
industry is to mass-produce low-level GDP. Indonesia is included in the top 20
generic drugs and API products (Ni et al., countries with the largest GDP in the world.
2017). China has 6,807 pharmaceutical However, Indonesia's health expenditure
companies that produce 2.000 API per capita is very low, which is only 3.1% of
products with an annual capacity of 2 the total GDP. Indonesia's health
million tons. China's current strategy is to expenditure per capita value is still below
start shifting from producing API products other ASEAN countries, such as Malaysia

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Challenges and Policy... 202 Zunuraen, Hidayat, Wahyudi, Ru’yi
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(Jurnal Administrasi Kesehatan Indonesia)
p-ISSN 2303-3592, e-ISSN 2540-9301
10.20473/jaki.v11i2.2023.196-211

(USD 361), Vietnam (USD 36), Singapore (Schuhmacher et al., 2021). The R&D
(USD 1,804), and Thailand (USD 111) budget is an important element for
(Suwantika et al., 2020). Health developing the pharmaceutical raw
expenditure is still considered a luxury item, material in terms of competitiveness,
so people tend to be low in spending their technology, efficiency, new products, and
income on health needs (Shaikh and services (Rahman and Howlader, 2022).
Gandjour, 2019). The pharmaceutical sector relies heavily on
Another challenge is R&D activities. innovations to produce new molecules
The financial burden incurred from R&D will (Schuhmacher et al., 2021). The
not necessarily produce products that can established companies will allocate around
be directly sold to the public. This event is 40-50% of their revenue on R&D activities
often interpreted as a "valley of death", (Rahman and Howlader, 2022). In
where it takes a high cost to develop drug Indonesia, one of the state-owned
molecules with a development period of 15- companies with a large pharmaceutical
20 years and a failure rate of up to 95% market share, PT. Kimia Farma, issued a
(Gamo et al., 2017; Scherer, 2014). budget of USD 2 million or 0.2% of total
Industries with a low market share will sales in 2021 for R&D (Ayubi, 2022; Kimia
undoubtedly find it difficult to carry out the Farma, 2021).
R&D process with high-cost requirements Prices of local products tend to be
and the uncertainty of the developed less competitive compared to imported
product. Due to the high cost and products. On the other hand, the price gap
uncertainty, pharmaceutical companies in of imported pharmaceutical raw materials
countries such as India tend to develop and varies widely. For example, clopidogrel's
manufacture drug molecules that have lowest price is USD 150 per kg, while the
been proven to be mass-produced and highest is USD 1,392 per kg. The price of
sold. However, the pharmaceutical industry local clopidogrel is around USD 210 per kg,
relies heavily on innovation to produce
high-value new molecular entities (NMEs)

10.000,0 50 countries with highest GDP


Switzerland US
9.000,0 Norway
20 countries with highest GDP
Health Expenditure per capita (USD)

8.000,0
Denmark
7.000,0
Australia
Sweden
6.000,0
Finland Ireland France Germany
5.000,0 Netherlands Canada United Kingdom

4.000,0 Belgium Japan


New Zealand
Spain
3.000,0 Israel
Italy
Singapore Average world health
2.000,0 PortugalSaudi Arabia expenditure per capita
Czech Mexico Korea, Rep.
Brazil (USD 1.300)
1.000,0 Turkey Russian Federation
India
Indonesia
China
-
- 500,00 1.000,00 1.500,00 2.000,00 2.500,00 3.000,00 3.500,00 4.000,00 4.500,00 5.000,00
GDP (USD Billion)

Source: World Bank (2022)


Figure 2. Mapping of health expenditure in 50 countries with highest GDP– reprocessed data

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Challenges and Policy... 203 Zunuraen, Hidayat, Wahyudi, Ru’yi
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(Jurnal Administrasi Kesehatan Indonesia)
p-ISSN 2303-3592, e-ISSN 2540-9301
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but the price of imported clopidogrel is still factor that should be stated. This priority is
lower than local products (Ministry of a part of the consensus as previously
Industry Republic of Indonesia, 2022). stated. As we learn from Bangladesh, in
Similarly, amoxycillin made in a small 1982, they had 150 essential drugs, but in
laboratory plant in Indonesia has an 2016 there were 285 drugs became the
estimated price of USD 30-50, which is priority (Murshid and Haque, 2019).
higher than amoxycillin imported from India At this time, Indonesia has ten drug
and China with a price of USD 20 (Agency priorities based on the highest value in the
for the Assessment and Application of local economy. This should be compared
Technology, 2020). with the technology availability and the
basic chemical that already produced in
Discussion and Policy Support Indonesia by local industry. This priority will
keep our strategy on track. After
Based on interviewing experts and formulating priority drug molecules, further
benchmarking several countries such as research must be in line with the priority of
India, Bangladesh, and China, there are developing these molecules. It must be
several important lessons learned in clear, understood, and approved by all
formulating recommendations for stakeholders.
developing the pharmaceutical raw
material industry in Indonesia, which are as Market protection of local drug prices
follows: Market protection is the main strategy
used to maintain the viability of indigenous
Indonesia still needs to have a clear enterprises, as we can learn from India and
and integrated grand strategy for Bangladesh. According to Ederington and
developing pharmaceutical raw McCalman (2011) and Melitz (2005),
material protecting the infant industry from foreign
The appropriate policy framework still products is vital to close the technology gap
needs to be formulated based on Table 1. with such items. The imposition of import
It is obvious that several Ministries or taxes and quotas, along with production
agencies organizing the implementation of subsidies, can provide protection.
policies in Indonesia often have different However, this support is only temporary
policy philosophies, occasionally reflecting because the infant industry will eventually
their individual sectoral egos. According to mature. As a result, it is exceedingly
Nugroho (2015), policymaking does not challenging for the infant industry to
only look at the problems faced, but it is compete with established rivals. According
also necessary to determine the expected to the learning curve principle, in this
ideal conditions as a milestone in instance, the unit cost will fall as output
describing the policy planning that will be rises (Qiu et al., 2019).
pursued (Nugroho, 2015). Handing over to Policies such as price control, tax
the market to produce pharmaceutical raw incentives, import duties, etc., should be
materials is impossible because it is less implemented. As the country with the
profitable for the private sector. In this world's largest economy, The US also
situation, the government has to take a applies a policy of protecting local products.
major role in fixing the market and giving In 2018, the US imposed an import tariff of
direction to the stakeholders (Mazzucato, 12%. This policy aimed to preserve the
2017). intermediate products of local traders
(Barattieri and Cacciotore, 2023).
The research goals for pharmaceutical Consequently, the import tariffs in the US
raw materials should be aligned with could reduce imported products, especially
the national demand those imported from China, and increase
To achieve national resilience in exports to non-Chinese countries (Cheng
health care, the government must ensure et al., 2021).
the availability of pharmaceutical raw The current approach of the
materials at all times. Priority is an essential government entails the implementation of a

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local content policy for pharmaceutical


products as a means to protect the market Strengthening basic chemical industry
for indigenous pharmaceutical raw The basic chemical industry is a part
material. In accordance with the Ministry of of the upstream sector of the
Health's 2020-2024 Action Plan, it is pharmaceutical industry. For example,
projected that by the year 2024, the local petrochemical products, benzene and
content of the top 10 medicines listed in the propylene, are processed into para-
National Formulary (FORMAS) will surpass aminophenol (PAF) as a raw material for
the threshold of 50% (Ministry of Health pharmaceutical products such as
Republic of Indonesia, 2020). In pricing paracetamol. Currently the government
mechanism, the government use e- through Ministry of Industrial is developing
catalogues which is facilitated by the Medicine Industrial Area in Batang. This
National Public Procurement Agency, action will accelerate the industry because
wherein the necessary pharmaceuticals the area will also integrate among
are subjected to auctions and negotiations pharmaceutical supply chain. Another
to secure the most favorable rates (Winda, action is a paracetamol factory with a
2018). 3,800-ton annual capacity was built in
partnership between Kimia Farma and
Increase health expenditure to boost up Pertamina. The existing local content policy
local market industry is deemed suitable for fostering growth in
The low health expenditure in the pharmaceutical raw material business.
Indonesia is the main issue that causes However, it is important to note that the
typically low common market share in absence of incentives may hinder the
Indonesia. The large population of industry's progress and expansion. Policy
Indonesia makes the increase in health support was also issued by Ministry of
expenditure an important variable in Finance, tax holiday and allowance
increasing the local market. The growth of provided to help industry growth. Another
pharmaceutical market will help reducing policy needs such us ease of licensing,
the marginal costs, which will impact certificate issuance, and support finished
strengthening competitiveness. Health good development. The incentive policy will
expenditure is a crucial factor; higher health enhance the economic viability of
expenditure will boost economic pharmaceutical raw material manufacturing
performance by increasing human capital facilities.
productivity (Raghupathi and Raghupathi,
2020). Increased health expenditure can be Increase R&D budget allocation
done through public education, improving The intensity of pharmaceutical R&D,
health insurance performance, and so on. especially for pharmaceutical raw
One of the contributing factors to the materials, must be increased. In addition,
limited allocation of funds towards the budget for R&D also needs to be
healthcare is the presence of low income improved. Countries with leading industries
levels (Raghupathi, 2020). According to a in R&D activities (pharmaceutical,
study conducted by (Ke et al., 2011), there engineering, and biotech) tend to be more
is a positive correlation between the intense in carrying out R&D. In contrast,
utilization of health insurance mechanisms countries with industries that mostly
and the levels of health expenditure in depend on natural resources, tourism,
various nations, as indicated by the finance, and transportation tend to have
research conducted by the World Health lower R&D activities (Sandra, 2021). The
Organization (WHO). Hence, enhancing industrial structure in Indonesia is
the efficacy of Indonesia Social Health characterized by a relatively low-intensity
Insurance (BPJS) services holds significant R&D activity. The solution to this issue
importance in promoting individuals' should be found in the mid-term plan
inclination towards seeking medical
treatment when afflicted with illness.

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Figure 3. Summary policy recommendations that can be taken as an effort to grow the
domestic drug raw material industry (author’s concept)

(Figure 3). The mid-term strategy could be products, tax incentives, domestic
a form of improving research collaboration protection products through import tariff
between institutions. By improving R&D policies, energy subsidies, to technology
intensities, firm innovation will emerge. One transfers. Several policies carried out by
indicator that a company is considered to the government to encourage the national
be innovative is if the ratio between R&D pharmaceutical raw material industry are
spending and revenue is above 3% (Park the synchronization between the
et al., 2021). government and stakeholders that have an
interest in the pharmaceutical raw material
Conclusion industry, determining pharmaceutical raw
material research priorities following
The pharmaceutical industry has a industry needs, protecting the local market,
vital role in supporting the Indonesian increasing health expenditure,
economy. To support the current policy, strengthening basic chemical industry, and
there are several barriers that need to be increasing the budget for R&D.
addressed, starting from Indonesia's low
health expenditure, low budget allocation Abbreviation
for R&D activities, and price competition
against imported pharmaceutical raw GDP: Gross Domestic Product;
material products. Based on benchmarks RIPIN: National Industrial Development
from several countries that have been at Master Plan; JKN: Jaminan Kesehatan
the forefront in developing their Nasional; GMP: Good Manufacturing
pharmaceutical raw material industries, Practice; API: Active Pharmaceutical
such as India, Bangladesh, and China, of Ingredients; DGDA: Directorate General of
course, providing many incentives and Drug Administration; FFPs: finished
policies favor the local drug raw material pharmaceutical products; PAF: para-
companies, ranging from regulated prices, aminophenol; NMEs: new molecular
stopping dependence on imported entities.

Hermawan, Hadiyati, Adiarso, Setiyadi,


Challenges and Policy... 206 Zunuraen, Hidayat, Wahyudi, Ru’yi
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Declaration Biopharmaceutical Industry


Innovation. Information Technology &
Ethics Approval and Consent Participant Innovation Foundation. Available at:
This study has been approved by the https://itif.org/publications/2020/09/0
National Research and Innovation Agency 8/impact-chinas-policies-global-
(BRIN). This research does not display biopharmaceutical-industry-
data that is confidential. Most of the data innovation/ (Accessed: 5 November
obtained is general information and is 2023).
contained in the literature. Ayubi, S. (2022) ‘The Role of SOE
Healthcare Holding Company in
Conflict of Interest Indonesia Healthcare Ecosystem’.
The authors state that there were no Barattieri, A. and Cacciatore, M. (2023)
substantial conflicting financial, ‘Self-Harming Trade Policy?
professional, or personal interests that Protectionism and Production
could have influenced the performance Networks’, American Economic
Journal: Macroeconomics, 15(2), pp.
Availability of Data and Materials 97–128. Available at:
The data used to support the findings of this https://doi.org/10.1257/mac.2019044
study are included within the article. 5.
Binekasri, R. (2022) ‘86,7% of Indonesian
Authors’ Contribution Population has Already join JKN
EH conceptualized, analyzed and wrote the Program’. Available at:
study, EDS and NAH analyzed the result, https://www.cnbcindonesia.com/mar
AA and DH reviewed the manuscript, SZ ket/20220630130849-17-
collected the data, AW review policy 351778/867-penduduk-ri-sudah-jadi-
recommendation, and HAR review country peserta-jkn (Accessed: 9 May 2022).
benchmarking and wrote the study. BPS (2022) Indonesian GDP 2021. Badan
Pusat Statistik. Available at:
Funding https://www.bps.go.id/indicator/11/10
This study was financially supported by the 6/2/-seri-2010-distribusi-pdb-
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