PRECISION MEDICINE IN INDIA: REGULATORY LANDSCAPE, CHALLENGES, AND PATHWAYS FORWARD

Precision medicine is redefining modern healthcare by customizing treatment strategies based on an individual’s genetic profile, environmental exposures, and lifestyle factors. In India, interest in personalized therapies is rapidly growing, driven by advancements in genomics, pharmacogenomics, and artificial intelligence. Despite this momentum, the country’s regulatory ecosystem remains nascent and fragmented when compared to global benchmarks, posing significant barriers to the safe, effective, and equitable integration of precision medicine. This review critically examines India’s current regulatory frameworks, with a focus
on the Central Drugs Standard Control Organisation (CDSCO), and evaluates existing policiesrelated to genetic testing, companion diagnostics, and targeted therapies. While milestones such as the approval of trastuzumab for HER2-positive breast cancer mark progress, regulatory gaps persist particularly in areas like next-generation sequencing (NGS), AI-based diagnostics, and gene therapies. The Digital Personal Data Protection Act (DPDPA, 2023) represents an important step toward safeguarding genetic data; however, it leaves key issues related to privacy, consent, and data ownership unresolved. A comparative analysis with established
regulatory models in the United States (FDA), European Union (EMA), and China (NMPA) underscores the absence of harmonized guidelines in India, particularly concerning biomarker validation and advanced diagnostics. Additionally, ethical challenges such as informed consent, genetic discrimination, and disparities in access especially in rural and underserved areas highlight the pressing need for a cohesive, forward-looking regulatory strategy. The paper
argues for an integrated framework that promotes innovation while ensuring patient safety, data security, and equitable access to the benefits of precision medicine in India’s diverse healthcare landscape.

Keywords: Precision medicine, pharmacogenomics, genetic testing, regulatory framework, India, HER2.