Bridging the gap: a paradigm shift in medical device regulations in India.

Abstract

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the development of India's medical device industry faces significant challenges, including limited infrastructure, outdated regulatory frameworks, and an inability to support sustainable growth.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 To this end, the new Drugs, Medical Devices, and Cosmetics Bill of 2022 was proposed to substitute the outdated 1940 Act.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.