Article 6

Alarms during the pandemic and beyond (1/3)

Fluctuations in the pharmaceutical supply chain can lead to access and safety concerns.

Disruptions in supply chains due to restricting exports and imports
There is a global reliance on all components of the supply chain. While the advantages of globalization may include lower costs, it poses a challenge in situations of natural disasters or where countries may limit or restrict imports and exports due to pandemics – as we have seen with India and China.(1-3)
 
With an estimated 20% of the world’s generic drug supply being manufactured in India, India’s decision to restrict 26 pharmaceutical ingredients and medications (accounts for 10% of its exports) last month led to significant concerns and questions regarding the impact of such a decision on the global supply chain.(2-5)  India relies on China for almost 70% of its active pharmaceutical ingredients and has been impacted by China’s decisions and efforts to control the pandemic.(1-5) The global supply chain depends significantly on both India and China. While such decisions are made in order to prevent drug shortages within the country, the potential impact on the global supply chain is worth noting. Although we may see a relaxing of restrictions on exporting and importing of certain medications over time,(6) the existence of these restrictions as options (now or in the future) makes the supply chain susceptible to potential disruptions. This reality has triggered individuals to question whether manufacturers should start focusing their efforts locally – this includes obtaining active ingredients and transferring their production efforts locally rather than globally.  This necessitates not only the option of increasing the number of manufacturers locally but an overhaul of the geographical location component of the supply chain (raw materials and finished medications).(1)
 
Emergence of more unregulated supply chains
As suppliers and manufacturers rapidly change due to closures, new and existing restrictions, and shortages begin to impact access, we have and will continue to see an emergence of unregulated supply chains.  When shortages and restrictions occur,  we are left with a limited number of sources and concerns of quality, reliability, and safety linger.(1,7) The United States Pharmacopeia (USP), stresses the need for strong regulatory and quality assurance oversight and provides quality standards and resources for COVID-19.(1)
 
Introduction of adulterated and falsified medications to the supply chain
The current vulnerable environment and the introduction of these unregulated supply chains become breeding grounds for the introduction of adulterated and falsified medications. More considerable attention and caution is advised when evaluating the source, quality, and safety of the raw materials and finished products.(7-8) Within the United States, the FDA has created a website for individuals to report medications that falsely claim to prevent or treat COVID-19.(8)

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Previous Article # 5
Understanding the Global Medication Supply Chain

Article # 7: 
Alarms during the pandemic and beyond – Part II of III

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Information is constantly evolving in the healthcare space. Responsible effort was made to provide accurate information from reliable sources at the time of publication. Information provided in the articles and website is done so in good faith; however, no liabilities for the information (such as errors or omission) exist. The reader should make their own assessment and determination of how they will use the information provided. The author and publisher provide no guarantees of any specific outcome or consequence as a result of utilizing recommendations or information offered in this article. Readers are advised to continuously check the latest updates, practices and guidelines.

1.  United States Pharmacopeia (USP). COVID-19: addressing the global health crisis. https://www.usp.org/covid-19.
2. European Pharmaceutical Review. COVID-19 update: coronavirus and the pharmaceutical supply chain. https://www.europeanpharmaceuticalreview.com/article/116145/covid-19-update-coronavirus-and-the-pharmaceutical-supply-chain/
3. Nawrat A. Covid-19 pandemic: knock-on effects for pharma supply chains. Pharmaceutical Technology. April 8, 2020. https://www.pharmaceutical-technology.com/features/covid-19-pharma-supply-chains/
4. Mike Moloney – Premier, Inc. Statement on the Indian Government’s Restrictions on Exports. March 3, 2020. https://www.premierinc.com/newsroom/policy/premier-inc-statement-on-the-indian-governments-restrictions-on-exports-of-drugs-and-active-pharmaceutical-ingredients
5. Thomas C. Dasgupta N. Global supplier India curbs drug exports as coronavirus fears grow. Reuters. https://www.reuters.com/article/us-health-coronavirus-india/global-supplier-india-curbs-drug-exports-as-coronavirus-fears-grow-idUSKBN20Q0ZZ
6. Roy R. India Again Allows Export of Antimalarial Drug Touted for Coronavirus. The Wallstreet Journal. https://www.wsj.com/articles/india-again-allows-export-of-antimalarial-drug-touted-for-coronavirus-11586257292
7. Newton PN, Bond KC, 53 signatories from 20 countries. COVID-19 and risks to the supply and quality of tests, drugs, and vaccines. Lancet Glob Health. 2020 Apr 9. pii: S2214-109X(20)30136-4. doi: 10.1016/S2214-109X(20)30136-4.
8. United States Food and Drug Administration. Fraudulent Coronavirus Disease 2019 (COVID-19) Products. https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products