Division of Basic Medical Sciences, Indian Council of Medical Research Hqrs, New Delhi, India.
Biological Sciences Division, Indian Council of Medical Research - National Institute of Occupational Health, Ahmedabad, Gujarat, India.
Adv Exp Med Biol. 2023;1430:135-154. doi: 10.1007/978-3-031-34567-8_8.
The understanding of disease biology and advances in cellular and molecular biology platforms have ushered in a new era of cell and gene based therapeutic products. The US-FDA refers to this category of products as Cellular and Gene Therapy Products (CGTPs), while the European Medicines Agency, Europe, refers to them as Advanced Therapy Medicinal Products (ATMPs). The research and development (R&D) and final commercialization of these products have thus picked up pace, especially in the last decade. This emerging scenario necessitates framing regulations and guidelines that take into consideration the unique biological nature of these products. Regulators and government agencies of different countries across the globe have come up with regulations and guidance documents to guide, monitor, and regulate the research and development in this field. India, given its powerful resources of skilled scientific manpower and infrastructure, is also contributing to development of these innovative therapeutic products. Keeping in line with the international counterparts, the Indian regulators and government agencies have developed regulations and guidelines for stakeholders. This chapter summarizes the regulatory landscape for research and development of CGTP in India. It provides an overview of the government agencies and committees overseeing this field and their roles that a stakeholder working in this field needs to have knowledge of. Furthermore, the chapter outlines the salient features of rules, regulations, and guidelines relevant to CGTP, the approval process, the current approved products in Indian market, and finally, the challenges and way forward for CGTP in India.
疾病生物学的理解和细胞及分子生物学平台的进步开创了细胞和基因治疗产品的新时代。美国食品和药物管理局（US-FDA）将这类产品称为细胞和基因治疗产品（CGTPs），而欧洲药品管理局（EMA）则将其称为先进治疗药物产品（ATMPs）。因此，这些产品的研发和最终商业化步伐加快，尤其是在过去十年中。这种新兴情况需要制定监管法规和指南，考虑到这些产品的独特生物学性质。全球不同国家的监管机构和政府机构已经制定了法规和指导文件，以指导、监测和监管该领域的研究和开发。印度凭借其强大的熟练科学人力和基础设施资源，也在为这些创新治疗产品的开发做出贡献。与国际同行保持一致，印度监管机构和政府机构也为利益相关者制定了法规和指南。本章总结了印度 CGTP 研发的监管格局。它概述了监督该领域的政府机构和委员会及其各自的作用，从事该领域工作的利益相关者需要了解这些作用。此外，本章还概述了与 CGTP 相关的规则、法规和指南、审批程序、印度市场已批准的现有产品的显著特点，最后探讨了 CGTP 在印度面临的挑战和未来发展方向。
