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Nishith Desai Associates:2026印度基因组学:为精准健康铺路研究报告(中译版)(43页).pdf

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1、 Nishith Desai Associates MUMBAI SILICON VALLEY BENGALURU SINGAPORE NEW DELHI NEW YORK GIFT CITY BOSTONResearchGenomics in IndiaPaving the Way for Precision HealthMarch 2026 Nishith Desai Associates ResearchGenomics in IndiaPaving the Way for Precision Health March 2026DMS Code:149983.1 Nishith Desa

2、i Associates Ranked as the Most Innovative Indian Law Firm in the prestigious FT Innovative Lawyers Asia Pacific Awards for multiple years.Also ranked amongst the Most Innovative Asia Pacific Law Firm in these elite Financial Times Innovation rankings.Genomics in India Paving the Way for Precision H

3、ealth Nishith Desai Associates 2026Provided upon request only DisclaimerThis report is a copyright of Nishith Desai Associates.No reader should act on the basis of any statement contained herein without seeking professional advice.The authors and the firm expressly disclaim all and any liability to

4、any person who has read this report,or otherwise,in respect of anything,and of consequences of anything done,or omitted to be done by any such person in reliance upon the contents of this report.ContactFor any help or assistance please email us on or visit us at .AcknowledgementsNaveli Sharma Naveli

5、 Sharmas practice focuses on advising clients across the healthcare,pharmaceutical,med-tech and life sciences ecosystem on regulatory,compliance and policy-related matters.She regularly works with domestic and international companies on issues relating to drug and medical device regulation,market en

6、try strategies,manufacturing and distribution compliances,and pricing frameworks.Her experience also extends to advising on health-tech,data protection and digital health regulations,including emerging compliance obligations for technology-enabled healthcare platforms.She closely tracks legal and po

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1. **印度基因组市场增长**:预计2033年达18.616亿美元,年复合增长率16.6%;全球市场2030年将达948.6亿美元,年增长率16.5%。 2. **应用领域**:涵盖个性化医疗(如HER2靶向药)、药物基因组学(全球市场2030年将达124亿美元)、基因编辑(如CRISPR治疗镰状细胞病)及法医应用。 3. **法律框架**:缺乏统一立法,依赖《新药与临床试验规则》(基因疗法视为“新药”)、《基因工程生物体规则》及ICMR伦理指南,禁止生殖系基因编辑。 4. **数据保护**:通过《生物技术-PRIDE指南》建立数据分级共享机制,但《数字个人数据保护法》未专门针对遗传数据。 5. **挑战**:数据隐私、知情同意、基因歧视及伦理争议(如“设计婴儿”),需统一立法与政策激励创新。
基因治疗监管? 基因数据隐私? 基因编辑伦理?
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