India’s genetic diversity offers a significant scientific advantage in clinical research, enabling researchers to investigate how diseases develop and how people respond differently to medicines and treatments. By studying diverse population groups, researchers can generate more representative clinical evidence, identify variations in drug safety and effectiveness, and support the development of treatments suited to different patient populations. Dr Seema Pai, president of the Indian Society for Clinical Research (ISCR), said India’s clinical research strengths have traditionally centred on its large population and cost advantages. However, she believes the country’s genetic, ethnic and geographical diversity represents a far greater scientific opportunity. As clinical research increasingly focuses on the relevance of evidence to the populations receiving medicines, India must place diversity at the centre of its clinical research strategy rather than treat it as an additional advantage, she added.
Genetic Diversity Can Improve Drug Safety and Effectiveness
India’s genetic diversity has direct implications for medicine development and patient care. According to Dr Pai, an analysis of 1,029 Indian genomes from the IndiGen dataset identified 134 potentially harmful pharmacogenomic variants affecting 102 pharmacogenes. The researchers also reported significant differences between Indian and global populations in the frequency of clinically actionable pharmacogenomic variants. Pharmacogenomics examines how genetic variations influence an individual’s response to medicines. Therefore, understanding these differences can help researchers assess drug metabolism, safety and effectiveness across population groups.
Dr Pai also highlighted a 2024 study that examined CYP2D6, an important drug-metabolising gene, using whole-genome sequences from 1,518 Indians. The study identified population-specific alleles and differences in variant and phenotype frequencies compared with global populations. These findings reinforce the need to consider genetic diversity when designing clinical studies and evaluating how medicines perform across different populations.
Clinical Trials Must Better Represent India’s Diverse Population
Dr Pai emphasised that researchers should view India’s diversity as more than an advantage for recruiting clinical trial participants. Instead, it offers an opportunity to generate evidence about populations that have historically received insufficient representation in clinical research. International regulatory thinking also reflects this priority. The US Food and Drug Administration’s guidance on Diversity Action Plans highlights the importance of improving the generalisability of clinical evidence to the populations for whom medical products are intended. However, conducting a clinical trial in India does not automatically ensure adequate population representation.
A 2023 analysis published in The Lancet Regional Health – Southeast Asia found that 61.4% of the India-only Phase III trials examined were conducted within a single geographical zone, while only 6.8% covered all six zones. The authors concluded that many of the trials underrepresented India’s diverse ethnic groups. Consequently, researchers need to incorporate geographical and population diversity into clinical trial design from the outset, while maintaining the scientific rigour required by each study protocol.
India’s Clinical Research Framework Continues to Evolve
India’s clinical research ecosystem is also developing through regulatory changes and broader institutional participation. The New Drugs and Clinical Trials Rules, 2019, provide the regulatory framework for new and investigational drugs, clinical trials, bioavailability and bioequivalence studies, and Ethics Committees. Furthermore, a 2026 analysis of 1,385 Phase III trials registered with the Clinical Trials Registry–India (CTRI) between 2007 and June 2025 reported an increase in randomised trials and greater participation by educational and research institutions during the later period studied. These developments create opportunities to strengthen the country’s clinical research capabilities by combining regulatory progress with scientific expertise and more representative study populations.
India Can Strengthen the Quality of Global Clinical Evidence
According to Dr Pai, India’s next priority should be to bring together its investigators, research sites, scientific talent, evolving regulatory framework and population diversity. By designing trials that deliberately account for geographical, ethnic and genetic differences, researchers can improve understanding of how treatments perform across patient groups. Ultimately, India has an opportunity to move beyond its traditional role as a destination for cost-effective clinical research and become a contributor to more comprehensive and generalisable global medical evidence. As reported by harmabiz.com, as Dr Pai emphasised, the country’s ambition should be not merely to participate in global clinical development, but to make global clinical evidence stronger through India’s participation.