Last Updated on March 20, 2022 by The Health Master
US Pharmacopeia report finds high reliance on Indian manufacturers for APIs
The United States Pharmacopeia (USP) has launched a Medicine Supply Vulnerability Insights Series to identify and highlight weaknesses in the global active pharmaceutical ingredients (API) supply chain.
The USP’s insights are sourced from its global medicine supply map, which makes use of more than 40 external datasets and 250 million data points to quantify risk and resilience in the upstream pharmaceutical supply chain.
On average, it takes a pharmaceutical company at least ten years to bring a new medicine through the complete drug development process. This long journey involves five key stages, moving from initial discovery and development to preclinical and clinical research.
A non-profit scientific organization, the USP develops and sets standards in compounding, biologics, pharmaceutical manufacturing, and other fields across the US.
These are followed by regulatory review – typically the most complex and difficult portion of the process, whereby a New Drug Application (NDA) is filed – and FDA post-market safety monitoring.
The manufacturer’s work doesn’t stop there, however. Now, they must find ways to maximise the value of the product across its roughly 20-year lifecycle.
The first findings published by the USP highlight the US’ reliance on large Indian manufacturers for APIs.
Over 80% of all APIs for essential medicines used in the US have no domestic manufacturing source, with the US relying heavily on API manufacturing sites in India and China for crucial ingredients.
According to the USP, of the 342 manufacturing facilities worldwide with more than 10 active US-approved API products, more than half are based in India. Of those with more than 30 active US-approved API products, India accounts for 65%.
US pharma: a fragile supply chain
The US’ reliance on overseas API manufacturers means its supplies of essential medicines – from antibiotics to painkillers – are precarious.
A study published last year by the Center for Analytics and Business Insights (CABI) at Washington University’s Olin Business School revealed that less than 5% of large-scale API manufacturing sites are in the US.
The lack of API manufacturing presence in the US is largely due to “the ‘race to the bottom’ on pricing against global players, lower input costs, and lesser regulatory burdens” in overseas facilities, the report found.
Anthony Sardella, a senior research advisor at CABI, previously told Pharmaceutical Technology that the US must build a diverse supply chain to secure its access to APIs.
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“It’s not all about moving everything to the United States with new technology, but also diversifying and partnering with other countries that could be producers,” he said.Data, insights, and analysis delivered to you.
“Having a more balanced, resilient, diversified supply chain is a very important aspect for building resilience for the US supply chain and decreasing our vulnerabilities.”
According to an analysis of FDA data last year, manufacturing delays accounted for 11% of all drug shortages in the US. Ingredient shortages were behind around 5% of the drugs reported to be in short supply.
The Medicine Supply Vulnerability Insights Series will examine the global distribution of APIs and risks associated with specific drug classes to identify potential supply chain vulnerabilities that could impact the availability of critical medicines, the USP said in a statement.
The organization’s Medicine Supply Map will also be discussed in upcoming USP Convention meetings, where members will identify specific solutions for improving supply chain resilience, develop recommendations to ensure facilities are prepared to meet demand, and build on collaboration between supply chain partners such as governments and manufacturers.
USP CEO Ronald Piervincenzi said: “USP’s Medicine Supply Map is an innovative early warning system to help identify ingredient and finished product at risk of shortage so providers, manufacturers and governments can take actions to help prevent the shortage from occurring.”
“Without visibility into the medicine supply chain, preparing for the next crisis is not possible.”
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