Mitigating pharmaceutical supply chain vulnerabilities: A Critical Analysis of Over-Reliance on Asia

Abstract

The global pharmaceutical industry's heavy reliance on Asia and especially on China and India[1]. Both country are main suppliers for active pharmaceutical ingredients (APIs) and finished drug products (FDPs)[2] [3]. During the recent pandemic significant vulnerabilities within the supply chain had come to light[4] [5]. This article delves into the risks like, geopolitical risks[6] [7] [8], natural disasters, and ongoing medicine shortages[9] [10] [11], which all highlight the need to diversify manufacturing sources. I’ll examine potential solutions, such as incentivizing domestic production, fostering international collaborations, and investing in advanced manufacturing technologies. Hopefully my analysis provide a guidance for? a reducing dependence strategy on these nations and creating a more resilient pharmaceutical supply chain.

Introduction

The COVID-19 pandemic has starkly illustrated the fragility of global supply chains, particularly in the pharmaceutical sector[12] [13] [14]. The over-concentration of API[15] and FDP[16] manufacturing in China and India has raised alarms about the potential for disruptions in medicine availability due to geopolitical tensions[17], natural disasters, and other unforeseen events[18] [19] [20].

This paper explores the multifaceted risks associated with this dependence, emphasizing the urgent need for diversification[21] [22] [23]. We investigate the root causes[24] [25] of this concentration, including cost advantages, regulatory environments, and historical factors. Furthermore, what is the impact of recent medicine shortages and the potential consequences of future disruptions[26] [27] [28].

By examining potential solutions like incentivizing domestic production[29] [30] [31], fostering international collaborations[32] [33] [34], and leveraging advanced manufacturing technologies[35] [36], organisations aim to provide a comprehensive framework for mitigating these risks and put forward the importance of a coordinated, global effort to create a more resilient and secure pharmaceutical supply chain.

Geopolitical Risks

The geopolitical landscape poses significant risks to the pharmaceutical supply chain, particularly with the concentration of manufacturing in China and India. Trade disputes[37] [38], political tensions, and even military conflicts[39] [40] can disrupt the flow of APIs and FDPs, leading to shortages and price volatility[41] [42].

For instance, the ongoing trade war between the United States and China[43] [44] [45] has already impacted the pharmaceutical industry, with tariffs and trade restrictions affecting the cost and availability of certain drugs[46]. Similarly, border disputes between China and India have the potential to disrupt manufacturing and transportation, impacting global supply[47] [48].

Natural Disasters

The susceptibility of China and India to natural disasters further exacerbates the vulnerability of the pharmaceutical supply chain. Earthquakes, floods, and other extreme weather events[49] can damage manufacturing facilities, disrupt transportation networks, and lead to widespread shortages[50].

The 2008 Sichuan earthquake in China, for example, caused significant damage to pharmaceutical manufacturing plants, impacting the production of several essential drugs[51]. Similarly, the 2013 floods in Uttarakhand, India[52], disrupted the supply of APIs and intermediates, leading to shortages in various countries.

Recent Medicine Shortages

The COVID-19 pandemic has exposed the fragility of the pharmaceutical supply chain[53] [54], with several countries experiencing shortages of essential medicines[55]. These shortages have been attributed to various factors, including increased demand, panic buying, and disruptions in manufacturing and transportation due to lockdowns and travel restrictions[56] [57].

However, the over-reliance on China and India for (APIs) and (FDPs) has been a significant contributing factor. The pandemic's impact on these countries, including lockdowns and export restrictions, has further highlighted the risks of this dependence[58] [59] [60].

Impact on Global Health

The potential consequences of disruptions in the pharmaceutical supply chain are far-reaching and can have a devastating impact on global health. Shortages of essential medicines can lead to side effects[61], delayed treatments, increased morbidity and mortality, and even the resurgence of previously controlled diseases[62] [63] [64].

For instance, the shortage of antibiotics during the COVID-19 pandemic has raised concerns about the rise of antibiotic resistance[65] [66], which could have severe implications for public health. Similarly, the lack of access to essential medicines for chronic conditions like diabetes [67][68] can lead to complications and increased healthcare costs[69] [70] [71].

Solutions for Diversification

To mitigate the risks associated with over-reliance on certain countries, a multi-pronged approach is required. This can include the following strategies:

1. Incentivizing domestic production: Governments can provide financial incentives, tax breaks, and regulatory support to encourage domestic pharmaceutical manufacturing. This can help create a more diversified and resilient supply chain, reducing dependence on imports[72].
2. Fostering international collaborations: Governments and industry stakeholders can collaborate to establish alternative manufacturing hubs in different regions. This can involve sharing knowledge, technology, and resources to create a more distributed network of production[73] [74].
3. Investing in advanced manufacturing technologies: Advanced manufacturing technologies like continuous manufacturing and 3D printing[75] [76] [77] can revolutionize pharmaceutical production, making it more efficient, flexible, and adaptable to changing demands. Investing in these technologies can help reduce dependence on traditional manufacturing hubs[78] and create a more agile supply chain.
4. Strengthening regulatory oversight: Governments and pharmaceutical sector/industry should work together[79] [80] [81] to establish harmonized regulatory frameworks and quality standards for pharmaceutical manufacturing. This can ensure the safety and efficacy of medicines produced in different countries, building trust and confidence in alternative sources.

Conclusion

The over-reliance on certain areas and/or country for pharmaceutical manufacturing poses significant risks to global health, especially with the knowledge the Covid pandemic has shown us. The geopolitical landscape, natural disasters, and persistent medicine shortages highlight the need for urgent action to diversify and strengthen the supply chain.

By incentivizing domestic production, fostering international collaborations, continue to investing in advanced manufacturing technologies, and work together to strengthen regulatory oversight, we can create a more resilient and secure pharmaceutical supply chain. Let’s work together to aid each other and help keeping essential medicines available to all, regardless of where the patient is located, beliefs and/or comes from.

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Per usual feedback is welcome and hop[e you have a wonderful day.

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[1] Mahajan, A., Sarkar, S., & Chhabra, N. (2021). Discussing India-China relationships with focus on specialty chemicals and pharmaceuticals.?International Journal of Research in Engineering, Science and Management,?4(8), 349-357.

[2] Nagur, M., Kumar, T. M., & Puranik, S. B. (2020). Active pharmaceutical ingredients (api) supply chain in Europe, United States, India, China and Canada.?International Journal of Drug Regulatory Affairs,?8(3), 1-10.

[3] OFFERS, J. API Manufacturing: Facts and Fiction.

[4] Vyas, N., Joshi, A., Malviya, S., & Kharia, A. (2020). Reduced pharma supply chain in covid-19: Measures to reduce india’s reliance for active pharmaceutical ingredients on china and other countries.?Indian Journal of Pharmaceutical Education and Research,?54(4), 835-842.

[5] Francas, D. (2021). Global pharmaceutical supply chains and resilience strategies: overview and implications of the covid-19 pandemic.

[6] Hamilton, D. S. (2022). Enhancing Resilience in Pharmaceuticals Supply Chains.?Transatlantic Leadership Network’s Trade and Technology Working Group.

[7] Zhang, M., & Bjerke, L. (2023). Antibiotics “dumped”: Negotiating pharmaceutical identities, properties, and interests in China–India trade disputes.?Medical Anthropology Quarterly,?37(2), 148-163.

[8] Ray, S. (2021). Global value chains in the pharmaceutical sector.

[9] Miljkovi?, N., Polidori, P., Vinci, D. L., Poje, D. K., Makridaki, D., Kohl, S., & Süle, A. (2024). Results of EAHP’s 2023 shortages survey.?European Journal of Hospital Pharmacy.

[10] Acosta, A., Vanegas, E. P., Rovira, J., Godman, B., & Bochenek, T. (2019). Medicine shortages: gaps between countries and global perspectives.?Frontiers in pharmacology,?10, 451882.

[11] Postma, D. J., Notenboom, K., De Smet, P. A., Leufkens, H. G., & Mantel-Teeuwisse, A. K. (2023). Medicine shortages: impact behind numbers.?Journal of Pharmaceutical Policy and Practice,?16(1), 44.

[12] Oh, M., Dohner, R., & Herr, T. (2020). GLOBAL VALUE CHAINS IN AN ERA OF STRATEGIC UNCERTAINTY: PROSPECTS FOR.

[13] Palit, A. (2022). COVID-19 and Supply Chains: Incentivizing Resilience for Strategic Industries.

[14] Huang, Y. (2020). The Coronavirus Outbreak could disrupt the US drug supply.?Council on Foreign Relations In Brief,?5.

[15] Okeagu, C. N., Reed, D. S., Sun, L., Colontonio, M. M., Rezayev, A., Ghaffar, Y. A., ... & Kaye, A. D. (2021). Principles of supply chain management in the time of crisis.?Best Practice & Research Clinical Anaesthesiology,?35(3), 369-376.

[16] Nagur, M., Kumar, T. M., & Puranik, S. B. (2020). Active pharmaceutical ingredients (api) supply chain in Europe, United States, India, China and Canada.?International Journal of Drug Regulatory Affairs,?8(3), 1-10.

[17] Mohiuddin, A. K. (2023). Escalation of war and conflicts among the COVID-19 pandemic, natural disasters, and economic crises: A global health concern.?American Journal of Biopharmacy and Pharmaceutical Sciences,?3.

[18] Socal, M. P., Ahn, K., Greene, J. A., & Anderson, G. F. (2023). Competition And Vulnerabilities In The Global Supply Chain For US Generic Active Pharmaceutical Ingredients: Study examines the competition and vulnerabilities in the global supply chain for US generic active pharmaceutical ingredients.?Health Affairs,?42(3), 407-415.

[19] Sodhi, M. S., & Tang, C. S. (2021). Supply chain management for extreme conditions: Research opportunities.?Journal of Supply Chain Management,?57(1), 7-16.

[20] Costantino, R. C. (2021). The US medicine chest: Understanding the US pharmaceutical supply chain and the role of the pharmacist.?Journal of the American Pharmacists Association,?61(1), e87-e92.

[21] Bochenek, T., Abilova, V., Alkan, A., Asanin, B., de Miguel Beriain, I., Besovic, Z., ... & Godman, B. (2018). Systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages in 28 European and Western Asian countries.?Frontiers in pharmacology,?8, 942.

[22] Zhu, G., Chou, M. C., & Tsai, C. W. (2020). Lessons learned from the COVID-19 pandemic exposing the shortcomings of current supply chain operations: A long-term prescriptive offering.?Sustainability,?12(14), 5858.

[23] Gereffi, G. (2020). What does the COVID-19 pandemic teach us about global value chains? The case of medical supplies.?Journal of International Business Policy,?3(3), 287-301.

[24] Lee, S. L., O’Connor, T. F., Yang, X., Cruz, C. N., Chatterjee, S., Madurawe, R. D., ... & Woodcock, J. (2015). Modernizing pharmaceutical manufacturing: from batch to continuous production.?Journal of Pharmaceutical Innovation,?10, 191-199.

[25] Fox, E. R., Sweet, B. V., & Jensen, V. (2014, March). Drug shortages: a complex health care crisis. In?Mayo Clinic Proceedings?(Vol. 89, No. 3, pp. 361-373). Elsevier.

[26] Ahlqvist, V., Dube, N., Jahre, M., Lee, J. S., Melaku, T., Moe, A. F., ... & Aardal, C. (2023). Supply chain risk management strategies in normal and abnormal times: policymakers' role in reducing generic medicine shortages.?International Journal of Physical Distribution & Logistics Management,?53(2), 206-230.

[27] Ventola, C. L. (2011). The drug shortage crisis in the United States: causes, impact, and management strategies.?Pharmacy and Therapeutics,?36(11), 740.

[28] Musazzi, U. M., Di Giorgio, D., & Minghetti, P. (2020). New regulatory strategies to manage medicines shortages in Europe.?International journal of pharmaceutics,?579, 119171.

[29] Abbott, F. M., & Reichman, J. H. (2020). Facilitating access to Cross-border supplies of patented pharmaceuticals: the case of the COVID-19 pandemic.?Journal of International Economic Law,?23(3), 535-561.

[30] Cama, J., Leszczynski, R., Tang, P. K., Khalid, A., Lok, V., Dowson, C. G., & Ebata, A. (2021). To push or to pull? In a post-COVID world, supporting and incentivizing antimicrobial drug development must become a governmental priority.?ACS Infectious Diseases,?7(8), 2029-2042.

[31] Ravvin, M. (2008). Incentivizing access and innovation for essential medicines: a survey of the problem and proposed solutions.?Public Health Ethics,?1(2), 110-123.

[32] Breivik, J. H. Medicine shortages–a security question?.

[33] Majeed, A. (2023). UK government must be proactive about drug shortages.?bmj,?383.

[34] Truong, P. H., Rothe, C. C., & Bochenek, T. (2019). Drug shortages and their impact on patients and health care systems—how can systemic and organizational frameworks help to prevent or mitigate them?.?Pharmaceutical Supply Chains-Medicines Shortages, 57-72.

[35] Hall, M. (2019). Stabilizing the drug supply Dec. 31, 2019 Innovations in glass packaging can combat drug shortages by improving quality and increasing efficiency.?Innovations.

[36] Bochenek, T., Abilova, V., Alkan, A., Asanin, B., de Miguel Beriain, I., Besovic, Z., ... & Godman, B. (2018). Systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages in 28 European and Western Asian countries.?Frontiers in pharmacology,?8, 942.

[37] Zhang, M., & Bjerke, L. (2023). Antibiotics “dumped”: Negotiating pharmaceutical identities, properties, and interests in China–India trade disputes.?Medical Anthropology Quarterly,?37(2), 148-163.

[38] Oehler, R. L., & Gompf, S. G. (2020). Shortcomings in the US pharmaceutical supply chain: potential risks associated with international manufacturing and trade-related tariffs.?JAMA,?324(2), 143-144.

[39] Hopewell, K. (2020).?Clash of powers: US-China rivalry in global trade governance. Cambridge University Press.

[40] Sharma, A. (2020). The recent deadly India-China border clash.?New Zealand International Review,?45(5), 4-7.

[41] Mahajan, A., Sarkar, S., & Chhabra, N. (2021). Discussing India-China relationships with focus on specialty chemicals and pharmaceuticals.?International Journal of Research in Engineering, Science and Management,?4(8), 349-357.

[42] Zhang, M., & Bjerke, L. (2023). Antibiotics “dumped”: Negotiating pharmaceutical identities, properties, and interests in China–India trade disputes.?Medical Anthropology Quarterly,?37(2), 148-163.

[43] Ju, J., Ma, H., Wang, Z., & Zhu, X. (2024). Trade wars and industrial policy competitions: Understanding the US-China economic conflicts.?Journal of Monetary Economics,?141, 42-58.

[44] Chen, Y., Zhang, S., & Miao, J. (2023). The negative effects of the US-China trade war on innovation: Evidence from the Chinese ICT industry.?Technovation,?123, 102734.

[45] Benguria, F. (2023). The global impact of the US–China trade war: firm-level evidence.?Review of World Economics,?159(4), 827-851.

[46] Guo, L., Wang, S., & Xu, N. Z. (2023). US economic and trade sanctions against China: A loss-loss confrontation.?Economic and Political Studies,?11(1), 17-44.

[47] Chaturvedi, I., & Kavalakkat, N. (2023). A Case for the Global Governance of AMR by Regulating the Pharmaceutical Supply Chain.?Steering Against Superbugs: The Global Governance of Antimicrobial Resistance, 239.

[48] Lodh, R., & Dey, O. (2023). Trade Implications on Active Pharmaceutical Ingredients (APIS) Due to COVID-19 Pandemic and India China Altercation.?The Journal of Developing Areas,?57(4), 155-174.

[49] China natural disasters cost $3.3 billion in first quarter, government says | Reuters

[50] Natural Disaster Challenges in China: Key Trends and Insights | GFDRR

[51] Ghazi-Tehrani, A. K., & Pontell, H. N. (2022). Domestic, Regional, and Global Consequences. In?Wayward Dragon: White-Collar and Corporate Crime in China?(pp. 141-161). Cham: Springer International Publishing.

[52] Naithaini, Praveen & Rahul, Manmohan. (2016). VIEWING DISASTER MANAGEMENT IN INDIA FROM SUPPLY CHAIN MANAGEMENT PERSPECTIVE.

[53] Zhu, G., Chou, M. C., & Tsai, C. W. (2020). Lessons learned from the COVID-19 pandemic exposing the shortcomings of current supply chain operations: A long-term prescriptive offering.?Sustainability,?12(14), 5858.

[54] Miller, F. A., Young, S. B., Dobrow, M., & Shojania, K. G. (2021). Vulnerability of the medical product supply chain: the wake-up call of COVID-19.?BMJ quality & safety,?30(4), 331-335.

[55] Badreldin, H. A., & Atallah, B. (2021). Global drug shortages due to COVID-19: impact on patient care and mitigation strategies.?Research in Social and Administrative Pharmacy,?17(1), 1946-1949.

[56] Tirivangani, T., Alpo, B., Kibuule, D., Gaeseb, J., & Adenuga, B. A. (2021). Impact of COVID-19 pandemic on pharmaceutical systems and supply chain–a phenomenological study.?Exploratory Research in clinical and social pharmacy,?2, 100037.

[57] Badreldin, H. A., & Atallah, B. (2021). Global drug shortages due to COVID-19: impact on patient care and mitigation strategies.?Research in Social and Administrative Pharmacy,?17(1), 1946-1949.

[58] Lingitz, M., Roth, G. A., & Krenn, C. G. (2020). Dependency and Vulnerability of Intensive Care Medicine in Times of COVID-19 Crisis.

[59] Piatek, O. I., Ning, J. C. M., & Touchette, D. R. (2020). National drug shortages worsen during COVID-19 crisis: proposal for a comprehensive model to monitor and address critical drug shortages.?American Journal of Health-System Pharmacy,?77(21), 1778-1785.

[60] Miller, H. I., & Cohrssen, J. J. (2020). China’s Coronavirus-Induced Paralysis Threatens US Drug Supply Chain.?Missouri Medicine,?117(2), 86.

[61] Bourneau‐Martin, D., Babin, M., Grandvuillemin, A., Mullet, C., Salvo, F., Singier, A., ... & French Network of Regional Pharmacovigilance Centres. (2023). Adverse drug reaction related to drug shortage: a retrospective study on the French National Pharmacovigilance Database.?British Journal of Clinical Pharmacology,?89(3), 1080-1088.

[62] Bubonic plague, cholera and measles are all back. Should we be worried? | BBC Science Focus Magazine

[63] Rabaan, A. A., Abas, A. H., Tallei, T. E., Al‐Zaher, M. A., Al‐Sheef, N. M., Fatimawali, ... & Bin Emran, T. (2023). Monkeypox outbreak 2022: What we know so far and its potential drug targets and management strategies.?Journal of Medical Virology,?95(1), e28306.

[64] Scabies Is Making a Comeback | WIRED

[65] Al Oweidat, K., Toubasi, A. A., Khraisat, F. A., Aldahabi, M. N., Alghrabli, A., Khater, Y., ... & Albtoosh, A. S. (2024). The impact of COVID-19 on antibiotic resistance and clinical outcomes among critically ill patients.?American Journal of Infection Control,?52(5), 546-551.

[66] Langford, B. J., Soucy, J. P. R., Leung, V., So, M., Kwan, A. T., Portnoff, J. S., ... & Daneman, N. (2023). Antibiotic resistance associated with the COVID-19 pandemic: a systematic review and meta-analysis.?Clinical Microbiology and Infection,?29(3), 302-309.

[67] Van Grondelle, S. E., Van Bruggen, S., Rauh, S. P., Van der Zwan, M., Cebrian, A., Seidu, S., ... & Vos, R. C. (2023). The impact of the covid-19 pandemic on diabetes care: the perspective of healthcare providers across Europe.?Primary care diabetes,?17(2), 141-147.

[68] Ramakrishnan, M., Poojari, P. G., Rashid, M., Nair, S., Chandran, V. P., & Thunga, G. (2023). Impact of COVID-19 pandemic on medicine supply chain for patients with chronic diseases: Experiences of the community pharmacists.?Clinical Epidemiology and Global Health,?20, 101243.

[69] Parker, E. D., Lin, J., Mahoney, T., Ume, N., Yang, G., Gabbay, R. A., ... & Bannuru, R. R. (2024). Economic costs of diabetes in the US in 2022.?Diabetes Care,?47(1), 26-43.

[70] Jonsson, B. (1998). The economic impact of diabetes.?Diabetes care,?21(Supplement_3), C7-C10.

[71] Rosella, L. C., Lebenbaum, M., Fitzpatrick, T., O'reilly, D., Wang, J., Booth, G. L., ... & Wodchis, W. P. (2016). Impact of diabetes on healthcare costs in a population‐based cohort: a cost analysis.?Diabetic Medicine,?33(3), 395-403.

[72] Baraldi, E., Ciabuschi, F., & Fratocchi, L. (2022). The pros and cons of reshoring to address the problems of shortages in global pharmaceutical value chains: the case of antibiotics.?Journal of Global Operations and Strategic Sourcing,?16(3), 618-640.

[73] Norberg, J. (2021). Covid 19 and the Danger of Self Sufficiency.?ECIPE Policy Brief,?2, 2021.

[74] Packard, C., & Watson, B. (2020). Resisting Protectionism in the Pharmaceutical Supply Chain.?R Street Policy Study, June,?10.

[75] Mamo, H. B., Adamiak, M., & Kunwar, A. (2023). 3D printed biomedical devices and their applications: A review on state-of-the-art technologies, existing challenges, and future perspectives.?Journal of the mechanical behavior of biomedical materials, 105930.

[76] Datta, S., & Barua, R. (2024). 3D Printing in Modern Healthcare: An Overview of Materials, Methods, Applications, and Challenges.?Emerging Technologies for Health Literacy and Medical Practice, 132-152.

[77] Serrano, D. R., Kara, A., Yuste, I., Luciano, F. C., Ongoren, B., Anaya, B. J., ... & Lalatsa, A. (2023). 3D printing technologies in personalized medicine, nanomedicines, and biopharmaceuticals.?Pharmaceutics,?15(2), 313.

[78] Kumar, A., Kumar, D., Faisal, N., Sharma, A., Kumar Ansu, A., Goyal, A., ... & Kumar, D. (2023). Application of 3D printing technology for medical implants: a state-of-the-art review.?Advances in Materials and Processing Technologies, 1-16.

[79] Mitigating medicines shortages in Europe (europeanpharmaceuticalreview.com)

[80] Addressing critical shortages of medicines in the EU (europa.eu)

[81] Wosińska, M. E., & Frank, R. G. (2023). Federal policies to address persistent generic drug shortages.