Author byline as per print journal: Takanao Hashimoto1, PhD; Akihiko Ozaki2, MD, PhD; Hiroaki Saito3, MD; Erika Yamashita4; Tetsuya Tanimoto5, MD; Mihajlo Jakovljevic6,7,8, MD, PhD

Abstract:
This paper examines the repercussions of recent quality and regulatory crises in Japan’s generic pharmaceutical sector, focusing on incidents involving Sawai Group Holdings (Sawai GHD) and other manufacturers. It provides a comprehensive analysis of the consequences stemming from lapses in good manufacturing practice (GMP) compliance, particularly highlighted by the case of teprenone capsules 50 mg ‘Sawai’ where stability monitoring was found deficient. These lapses have impacted manufacturers like Sawai GHD, leading to the resignation of their head of quality assurance. Additionally, these issues have caused significant healthcare disruptions due to forced drug recalls and substitutions, further strained by existing drug shortages.

The study highlights the broader context of Japan’s pharmaceutical landscape, including government policies aimed at boosting generic drug use to mitigate healthcare expenses in one of the world’s most aged societies. Despite these efforts, the study illustrates that intense price competition and regulatory pressures have led to financial strains and a focus on cost-cutting measures, often at the expense of product quality and supply stability. The repercussions have been profound, leading to public and professional distrust in generics, which has been exacerbated by a series of controversies, such as the contamination incident involving Kobayashi Kabo Co, Ltd in 2021.

Drawing on comparisons with global trends, comparisons with global trends, particularly the German market, the study argues for the need to reassess Japan’s healthcare policies, advocate for sustainable pricing models, and emphasize rigorous quality oversight to restore confidence in the generic drug sector. It calls for strategic reforms to reconcile cost containment with quality and supply chain stability, ensuring the pharmaceutical industry can meet both domestic and international healthcare demands effectively.

Submitted: 25 February 2024; Revised: 8 August 2024; Accepted: 9 August 2024; Published online first: 23 August 2024

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.