Bio-entrepreneurs’ bugbear: Regulatory rigmarole

Arun Bhatt
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Abstract

Indian biotech startup sector – a rapidly growing business segment focused on the development of innovative products has the potential to make significant contributions to the country’s economy. Indian bio-entrepreneurs’ optimistic expectation of rapidly moving product development from bench to bedside faces tremendous challenges of the complex Indian regulatory system, which is shaped by a diversity of regulatory authorities, rules, guidelines, and processes. This brief review discusses specific regulatory issues faced by bio-entrepreneurs investing in a variety of innovative products – new drugs, vaccines, medical devices, cell, and gene therapy and suggests approaches which can ease Indian entrepreneur’s endeavors.
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生物企业家的烦恼:繁琐的监管
印度生物技术初创企业部门--一个以开发创新产品为重点的快速增长的企业部门--有可能为印度经济做出重大贡献。印度生物企业家对产品开发迅速从实验室走向临床的乐观期望面临着复杂的印度监管体系的巨大挑战,该体系由多种多样的监管机构、规则、指导方针和程序组成。这篇简短的评论讨论了投资各种创新产品--新药、疫苗、医疗器械、细胞和基因疗法--的生物企业家所面临的具体监管问题,并提出了可减轻印度企业家工作压力的方法。
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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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