中印假劣药违法行为监管对比  

Comparison of supervision on illegal behaviors of fake and inferior drugs between China and India

作　　者：肖妍 XIAO Yan(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药学研究》2023年第12期1051-1056,共6页Journal of Pharmaceutical Research

摘　　要：目的对比中印两国假劣药违法行为监管现状,研究各自内在成因,为加强我国药品监管提供借鉴和思路。方法采用文献研究法与比较研究法,将中印两国假劣药违法行为监管现状进行对比,分析两国假劣药品违法行为产生的原因,结合两国目前的药品监管现状,分析存在的不足、两国监管法律法规及法律概念的差异,针对性地提出适合我国国情的关于药品监管制度的政策建议。结果中国和印度同属于发展中国家,都是医药大国,但是在假劣药违法行为的监管上各有经验与不足。结论总体看来,我国对于药品违法行为的惩治虽有进步,但仍然需要结合国情进行更深刻的制度改革。应取消劣药概念,严密法网;强化监管力度和技术支撑力量;加强法规宣传并提高政策执行力;引导医药产业技术升级,进一步加强药品监管的有效性。Objective To compare the current situation of the supervision of counterfeit and inferior drugs in China and India,study their internal causes,and provide reference and ideas for strengthening the drug supervision in China.Methods By using the literature research method and comparative research method,this paper compares the current situation of the supervision of counterfeit and shoddy drugs in China and India,analyzes the causes of the illegal behaviors of counterfeit and shoddy drugs in the two countries,analyzes the existing shortcomings,the differences between the regulatory laws and regulations and legal concepts of the two countries,and puts forward targeted policy suggestions on the drug regulatory system suitable for China′s national conditions.Results China and India are both developing countries and major pharmaceutical countries,but each has its own experience and shortcomings in regulating the illegal behavior of counterfeit and substandard drugs.Conclusion Generally speaking,although China has made progress in punishing drug violations,it still needs to carry out more profound system reform in combination with the national conditions.The concept of inferior drugs should be abolished and the legal net should be tightened;Strengthen supervision and technical support;Strengthen the publicity of laws and regulations and improve the implementation of policies;We will guide the technological upgrading of the pharmaceutical industry and further strengthen the effectiveness of drug regulation.

关 键 词：中国 印度 假劣药 药品违法行为 药品管理法 

分 类 号：R95[医药卫生—药学]