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首页> 外文期刊>Journal of Pharmacy and Bioallied Sciences >Clinical research regulation in India-history, development, initiatives, challenges and controversies: Still long way to go
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Clinical research regulation in India-history, development, initiatives, challenges and controversies: Still long way to go

机译：印度的临床研究法规-历史，发展，倡议，挑战和争议：任重道远

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The Central Drugs Standard Control Organisation and its chairman Drug Controller general of India are bequeathed to protect the citizens from the marketing of unsafe medication. The startling findings, of the 59threport of the Parliamentary Standing Committee on Health and Family Welfare, have uncovered the lax standards followed by the regulatory authorities in India. The growing clinical research after the product patents rights for the pharmaceutical industries as per the trade related aspects of intellectual property rights agreement and adverse drug reaction monitoring of the marketed drugs have raised many ethical and regulatory issues regarding the promotion of new drugs in Indian markets. Many controversial group of medicines; unauthorised and irrational FDCs not relevant to India's medical needs, are available which are not sold in any of the countries with matured regulatory bodies. It becomes vital to understand the history, growth and evolution of the regulatory aspects of drugs which are handled by multiple Ministries and Departments of the Government of India. Although amendment to Schedule Y, registration of Contract Research Organisations, registration of Clinical Trials, Speeding up review process, Pharmacovigilance (PhV) programme for India and Inspection of clinical trial sites have been started by the various regulatory agencies. However due to casual approach in marketing approval for sale of the drugs, the unethical steps taken by some pharmaceutical companies and medical practitioners has reiterated the need to get appropriate understanding of present regulation of drugs and clinical research especially regarding the practical rules and regulations.KEY WORDS: CDSCO, clinical research, drug and cosmetic act, drug and cosmetic rule, drug regulation
机译：中央药品标准控制组织及其印度药品总局局长被遗赠来保护公民免受不安全药物的营销。议会卫生与家庭福利常务委员会第59次报告的惊人发现揭露了印度监管机构遵循的宽松标准。根据知识产权协议中与贸易相关的方面以及对上市药物的不良药物反应监测，制药行业获得产品专利权之后的临床研究不断增多，这引发了许多在印度市场上推广新药物的道德和监管问题。许多有争议的药品;与印度的医疗需求无关的未经授权和不合理的FDC可供使用，在任何具有成熟监管机构的国家中都不出售。了解由印度政府多个部委处理的药品监管方面的历史，增长和发展至关重要。尽管已对附表Y进行了修订，但各个监管机构已经启动了合同研究组织的注册，临床试验的注册，加快审查流程，印度的药物警戒（PhV）计划和临床试验地点的检查。但是，由于在销售药品的销售许可中采取了随意的方法，一些制药公司和从业人员采取了不道德的措施，重申需要对当前的药品法规和临床研究，尤其是在有关实际法规方面进行适当的了解。词：CDSCO，临床研究，药物和化妆品行为，药物和化妆品规则，药物法规

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