Regulatory gaps in India’s medical device framework: The case of Johnson and Johnson’s faulty hip implants

Abstract

The Johnson and Johnson faulty hip implant case represents one of the most significant crises in medical device history, impacting nearly 93000 patients worldwide. In response to alarming failure rates and a global recall in August 2010, countries such as Australia, the United States, and the United Kingdom quickly implemented revision surgeries and reimbursement programs to protect patient safety. In stark contrast, India's response was alarmingly delayed; defective implants continued to be sold even after the global recall. By the time the import license was revoked, and the Central Drugs Standard Control Organization issued a recall notice, these implants had already been involved in 4700 surgeries across India. This paper explores the systemic weaknesses in India’s medical device regulatory framework that contributed to this delayed action, resulting in many patients suffering from serious health complications. It highlights deficiencies in monitoring and reporting mechanisms, inadequate regulatory oversight, and insufficient approval processes. Furthermore, the inability to trace affected patients and provide necessary compensation underscores significant gaps in regulation. Although subsequent legislative reforms were introduced, this paper argues that substantial loopholes remain, posing risks for future incidents. Thus, urgent, comprehensive, and enforceable regulatory measures are needed to increase patient safety.

Keywords: Johnson & Johnson faulty hip implants; DePuy articular surface replacement hip implants; Medical devices rules 2017; Materiovigilance program of India; Medical device adverse events; Indian medical device regulatory regime

Core Tip: This study provides a comprehensive examination of regulatory inadequacies within India’s medical device sector, focusing exclusively on the Johnson & Johnson hip implant case. It identifies critical deficiencies in the existing legislative framework, insufficient postmarket surveillance, and a lack of effective accountability mechanisms, all of which pose substantial risks to patient safety. The findings underscore the urgent need for systematic reforms, including the implementation of mandatory clinical investigations, the establishment of centralized patient registries, and enhanced collaboration with international regulatory authorities. Addressing these regulatory gaps is imperative for safeguarding public health and restoring confidence in the medical device industry.