Ethical and Regulatory Challenges in Implementing Personalized Medicine in India: Role of Artificial Intelligence in Overcoming Ethical Challenges

Personalized medicine or precision medicine is a holistic approach to combat with patient's disease through their individual characteristics. This includes genetic makeup, lifestyle, and environmental influences. In addition to this, personalized medicine offers several advantages such as saving time, being cost-effective, and improving patient compliance. Looking at these benefits, researchers have explored personalized medicines in several diseases such as cardiovascular disease, neurodegenerative disease, and cancer. Furthermore, to ensure safety, efficacy, and quality of therapeutic treatments, regulatory guidelines are essential for evolving technologies and advancement in the field of personalized medicine. Various regulatory authorities play an important role in the regulation of personalized medicine in India, including CDSCO, ICMR, DBT, and PCI. Regulation of these guidelines ensures the protection of patients' safety by developing new treatments that require robust testing and clinical trials to assure the effectiveness and identify potential risks. The present review covers a brief introduction on personalized medicine and its history, the need for personalized medicines, tools used in personalized medicine, the importance of regulatory guidelines, Regulatory bodies in India, Challenges in personalized medicine, role of AI in overcoming obstacles in the path of personalized medicines, possible solutions, and future aspects.