弥合差距:印度医疗器械法规的范式转变
Diksha Pundir1, Sukhpreet Kaur2, Rajinder Kaur3
1Department of Laws, Panjab University, Chandigarh, India.
Naunyn-Schmiedeberg's archives of pharmacology
|April 28, 2025
概括
印度的医疗器械市场需要更新的法规. 拟议的2022年法案旨在取代过时的1940年法案,解决约翰逊和约翰逊部植入物问题凸显的患者安全和行业增长挑战.
科学领域:
- 医疗器械监管法规 医疗器械监管法规
- 卫生政策分析 卫生政策分析
- 印度医疗保健市场.
背景情况:
- 由于经济增长和医疗保健需求的不断增长,印度是医疗器械的主要全球市场.
- 现有的监管框架,即1940年的药物和化品法案,对于现代医疗器械来说是不够的.
- 过去的事件,比如约翰逊和约翰逊部植入器丑闻,暴露了患者安全和问责制的关键差距.
研究的目的:
- 批判性地检查1940年药物和化品法案的局限性.
- 分析2022年拟议的药品,医疗器械和化品法案.
- 提供现行和拟议立法的比较法律分析.
主要方法:
- 教义研究方法. 教义研究方法.
- 对1940年"药品和化品法"的批判性审查.
- 1940年法案与2022年法案之间的比较分析,使用约翰逊和约翰逊部植入物案作为参考.
主要成果:
- 1940年"药品和化品法案"没有关于医疗器械定义,监管和安全监督的具体规定.
- "2017年医疗器械规则"是一个临时措施,但需要进行全面的立法更新.
- 拟议的2022年药品,医疗器械和化品法案为医疗器械监管提供了更强大的框架.
结论:
- 印度目前的监管体系不足以确保患者安全,并促进医疗器械领域的可持续增长.
- 拟议的2022年法案是印度医疗器械监管现代化的重要一步.
- 有效实施新立法对于解决监管差距和加强患者保护至关重要.
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