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