Pundir Diksha, Kaur Sukhpreet, Kaur Rajinder, Baldi Ashish
Department of Laws, Panjab University, Chandigarh, India.
Dasmesh College of Pharmacy, Faridkot, Punjab, India.
Naunyn Schmiedebergs Arch Pharmacol. 2025 Apr 28. doi: 10.1007/s00210-025-04197-6.
India is among the top 20 international markets for medical devices. With increasing economic growth, rising life expectancy, and rapid technological advancements, the healthcare needs of the population have surged. This is particularly evident with the rise in chronic diseases, growing healthcare awareness, and the growing demand for personalized care and treatment. Medical devices, which encompass a wide range of machines, instruments, apparatus, and even software, play a vital role in diagnosing, treating, preventing, monitoring, and providing palliative care for various health conditions. Examples include X-ray machines, pacemakers, hip implants, ultrasound machines, glucose metres, prosthetics, and defibrillators. These devices are indispensable in the healthcare continuum across India. However, the development of India's medical device industry faces significant challenges, including limited infrastructure, outdated regulatory frameworks, and an inability to support sustainable growth. The Johnson & Johnson hip implant scandal highlighted the gaps in the existing regulatory system. The current Drugs and Cosmetics Act of 1940 (DCA, 1940) is inadequate in defining medical devices, regulating their import and manufacture, ensuring patient safety, managing adverse event reporting, and holding medical device companies accountable. To address these issues, the Medical Device Rules was introduced by the Government of India in 2017 (MDR, 2017). However, there has been a long-standing need for a more comprehensive legislative framework specifically for medical devices. To this end, the new Drugs, Medical Devices, and Cosmetics Bill of 2022 was proposed to substitute the outdated 1940 Act. This doctrinal research critically examines the shortcomings of the current DCA,1940 vis-à-vis the case study of Johnson & Johnson hip implant issue and provides a comparative analysis of this Act with the newly proposed Drugs, Medical Devices, and Cosmetics Bill of 2022.
印度是医疗设备的前20大国际市场之一。随着经济增长、预期寿命的提高和技术的快速进步，民众的医疗保健需求激增。这在慢性病的增加、医疗保健意识的提高以及对个性化护理和治疗需求的增长中尤为明显。医疗设备涵盖了广泛的机器、仪器、设备甚至软件，在诊断、治疗、预防、监测以及为各种健康状况提供姑息治疗方面发挥着至关重要的作用。例如X光机、心脏起搏器、髋关节植入物、超声波机器、血糖仪、假肢和除颤器。这些设备在印度的整个医疗保健连续过程中不可或缺。然而，印度医疗设备行业的发展面临重大挑战，包括基础设施有限、监管框架过时以及无法支持可持续增长。强生髋关节植入物丑闻凸显了现有监管体系的漏洞。现行的1940年《药品和化妆品法案》（DCA，1940）在定义医疗设备、监管其进口和制造、确保患者安全、管理不良事件报告以及追究医疗设备公司责任方面存在不足。为解决这些问题，印度政府于2017年出台了《医疗设备规则》（MDR，2017）。然而，长期以来一直需要一个专门针对医疗设备的更全面的立法框架。为此，2022年提出了新的《药品、医疗设备和化妆品法案》以取代过时的1940年法案。本理论研究通过强生髋关节植入物问题的案例研究，批判性地审视了现行1940年DCA的缺点，并将该法案与新提出的2022年《药品、医疗设备和化妆品法案》进行了比较分析。
