India's and Brazil's pharmaceutical sovereignty: Challenges and strategies for Active Pharmaceutical Ingredient (API) manufacturing independence
- Pharmacy & Pharmacology International Journal
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Renan Marcel Bonilha Dezena,<sup>1</sup> Marco Aurelio Martins Cordeiro,<sup>2</sup> Felipe Augusto Nery Nambu,<sup>3</sup> Bruno Gomes,<sup>2</sup> Airton Gonçalves Salles Junior<sup>4</sup>
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Abstract
The globalization of pharmaceutical supply chains has significantly improved access to affordable medicines worldwide. However, the concentration of active pharmaceutical ingredient (API) manufacturing in a limited number of countries has created strategic vulnerabilities for national health systems. Recent global disruptions, particularly the COVID-19 pandemic, exposed weaknesses in pharmaceutical supply chains and renewed interest in pharmaceutical sovereignty and local manufacturing capacity. This review examines the challenges and policy responses related to API manufacturing independence in India and Brazil, focusing on essential medicines. India has established itself as one of the world’s largest suppliers of generic medicines, yet approximately 65–70% of its API requirements are met through imports, largely from China.1 Brazil faces similar challenges, characterized by technological dependence, limited domestic API production, and reliance on imported pharmaceutical inputs.2 Economic, technological, regulatory, and geopolitical factors influencing API manufacturing resilience are discussed, together with policy strategies aimed at strengthening domestic pharmaceutical industries and improving health security.
Keywords
active pharmaceutical ingredients, pharmaceutical sovereignty, essential medicines, India, Brazil, pharmaceutical manufacturing, health security
