Is drug development in India is responsive to disease burden: A descriptive study

Abstract Objective: The aim of this study was to investigate the association between approved drugs and disease burden in India and to assess the need to address the unmet healthcare needs of the public. Materials and Methods: This descriptive study was conducted using two sets of data. The data on new drug approvals from January 2020 to August 2024 were downloaded from the Central Drugs Standard Control Organization website in India, and data on disease burden (mortality and disability) from 2017 to 2021 were downloaded from the World Health Organization website. The relationship between drug approval and disease burden was assessed using descriptive analysis. Results: From 2020 to 2024, a total of 126 new drugs were approved; of these 29.36% were approved for the leading causes of mortality and morbidity. Ischemic heart disease, chronic obstructive pulmonary disease, diabetes, diarrheal diseases, lower respiratory tract infection, and tuberculosis were among the leading causes of mortality and morbidity. A total of 19 (15%) drugs were approved for infectious diseases, including 9 (7%) for COVID-19. Other drugs approved included only 9 (7%) for cardiovascular disease, 8 (6%) for diabetes, and 1 (0.7%) for anemia. Conclusion: Our study found that although new drug development in India is increasingly focused on addressing the country’s evolving disease burden of noncommunicable diseases and infectious diseases, a lower proportion of new drugs is being approved for the leading cause of morbidity and mortality. There is a need to intensify research output, as significant potential exists for improvement in drug development in India to address this issue.