Menon V. Regulatory gaps in India’s medical device framework: The case of Johnson and Johnson’s faulty hip implants. World J Orthop 2024; 15(12): 1124-1134 [PMID: 39744726 DOI: 10.5312/wjo.v15.i12.1124]
Corresponding Author of This Article
Vidya Menon, LL.M., Research Scholar, Law, Gujarat National Law University, Koba, Gandhinagar, Ahmedabad 382426, Gujarat, India. vidyaphd202055@gnlu.ac.in
Research Domain of This Article
Orthopedics
Article-Type of This Article
Minireviews
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Orthop. Dec 18, 2024; 15(12): 1124-1134 Published online Dec 18, 2024. doi: 10.5312/wjo.v15.i12.1124
Regulatory gaps in India’s medical device framework: The case of Johnson and Johnson’s faulty hip implants
Vidya Menon
Vidya Menon, Law, Gujarat National Law University, Ahmedabad 382426, Gujarat, India
Author contributions: Menon V was responsible for designing the research study and executing all aspects of the research.
Conflict-of-interest statement: Author states that there is no conflict of interest.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Vidya Menon, LL.M., Research Scholar, Law, Gujarat National Law University, Koba, Gandhinagar, Ahmedabad 382426, Gujarat, India. vidyaphd202055@gnlu.ac.in
Received: July 28, 2024 Revised: October 8, 2024 Accepted: November 12, 2024 Published online: December 18, 2024 Processing time: 141 Days and 16.1 Hours
Core Tip
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.
