ReviewNaunyn-Schmiedeberg's archives of pharmacology2025
Bridging the gap: a paradigm shift in medical device regulations in India.
Review in Naunyn-Schmiedeberg's archives of pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
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the development of India's medical device industry faces significant challenges, including limited infrastructure, outdated regulatory frameworks, and an inability to support sustainable growth.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.
Indexed as
Identifiers
40293498What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.