Regulation of CRISPR-Mediated Genome Editing in Humans: An Indian Perspective

Abstract

November 2025 marked seven years since a Chinese biophysicist declared having used the controversial CRISPR technology to produce the world’s first genome-edited baby. Much before this unprecedented application of CRISPR, the scientific community has been rallying for an international moratorium on heritable genome editing in humans. Although global consensus makes room for uninheritable gene therapies, but the regulatory approvals for CRISPR-mediated gene therapies have only just begun to be considered. What lies ahead is an uphill battle for responsible and uniform policymaking, as well as public acceptance of novel gene-editing techniques in the backdrop of localized social, political, and religious affiliations. This paper aims to analyze several legal frameworks governing the use of CRISPR technology in humans, with a particular focus on Indian biotechnology regulations. It further identifies crucial shortcomings in the existing biomedical policies and carves a pathway for better regulation and widespread acceptance towards this groundbreaking technology.