Abstract

This paper provides a comparative analysis of the legal and ethical frameworks governing gene editing and patenting in India and the European Union (EU). Both regions welcome advancements in gene editing but impose stringent restrictions to maintain ethical compliance and public safety. The Indian Patent Act, with Sections 3(b), 3(c), and 3(j), and the EU's morality and ordre public doctrines limit the patentability of genetic modifications. While India permits gene editing in plant biotechnology, biomedical research faces tighter regulations under the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT). Similarly, the EU's regulatory bodies maintain strict oversight to prevent unethical practices. This paper discusses the evolving guidelines, including India's 2020 draft by DBT and CDSCO, and the EU's established frameworks, highlighting their approaches to balancing innovation and ethical integrity. By comparing these regulations, the paper elucidates how both regions navigate the complexities of gene editing to foster advancements while safeguarding societal values.

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