CRISPR Technology in Drug Development: Ethical and Regulatory Challenges

Prof.(Dr.) Arpit Jain
K L E F Deemed To Be University
Vaddeswaram, Andhra Pradesh 522302, India

dr.jainarpit@gmail.com

Abstract

CRISPR-Cas systems have rapidly transformed the landscape of genetic engineering, offering unprecedented precision and versatility in editing genomes. This manuscript explores the integration of CRISPR technology into drug development with a particular focus on the ethical and regulatory challenges that accompany its clinical application. Drawing upon literature published up to 2017, the review discusses the potential of CRISPR to revolutionize therapeutics, while highlighting concerns related to off-target effects, gene drives, patient safety, and social equity. The analysis is structured around a systematic literature review, followed by a methodological discussion on criteria for evaluating research outputs and regulatory frameworks. The manuscript concludes by emphasizing the need for robust ethical oversight and comprehensive regulatory policies to ensure that CRISPR-driven innovations in drug development are safe, effective, and socially responsible.

Keywords

CRISPR, gene editing, drug development, ethical challenges, regulatory frameworks, off-target effects, patient safety, biotechnology

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