The critical need to include India in global infectious disease trials

Since 2016, the number of clinical trials registered in the World Health Organization-International Clinical Trials Registry Platform has been steadily increasing. The number of clinical trials registered between 2018 and 2022 is 39 765 for BRICS countries. Though India’s contribution increased from 33% to 40% in the interim, the number of infectious disease trials registered in India is low (325) compared to the number of oncology clinical trials (1936) [1]. The number of phase 3 registrational antibacterial clinical trials conducted in India is also low (Table 1). This poses a serious public health challenge given the infectious disease burden in India[2].Table 1: Recent major antibiotic clinical trials, sponsor name, regulatory approval status, infection type and presence of Indian cities.Moreover, the cost of clinical development of antibacterial agents is increasing with more challenges of funding. The majority of anti-infective pharmaceutical innovation is driven mainly by small and medium-sized companies, with limited contributions from large firms, leaving a significant gap in funding for antibacterial development that underscores the need for federal support. Furthermore, though the cost of conducting clinical trials in India is 40%-70% less than in the United States of America and the European Union, in comparison to the United States of Food and Drug Administration and the European Medicines Agency, there is a relative drug lag of 43.2, 25.6, and 30.3 months, respectively, for drug approval by the Central Drugs Standard Control Organization of India[3]. To encourage clinical trials in India, the Indian Council of Medical Research has launched a nationwide Indian Clinical Trial and Education Network to provide more sophisticated sites for conducting clinical trials along with world-class phase 1 clinical sites to cater for the need of early-phase clinical trials. As part of combating antimicrobial resistance in Asia, including India, ADVANcing Clinical Evidence in Infectious Diseases, is a network of around 30 hospitals in Asia collaborating to conduct high-quality clinical trials in infectious diseases to improve the lives of seriously ill patients with infections caused by antimicrobial resistance[4]. Moreover, in India, along with international collaborators, the Clinical Research Network for Drug-Resistant Infections has been established to conduct high-quality clinical research, with harmonizing efforts to reduce antimicrobial resistance and to improve patient outcomes. By doing so, it will allow early access to medicines at lower costs for any unmet medical need and meet the United States of Food and Drug Administration requirements on diversity and inclusion of underrepresented populations or countries in clinical trials, including infectious disease trials. In conclusion, all facts delineate the need for the inclusion of India in future clinical trials of infectious disease for faster access to effective new medicines. Moreover, it is not just about access to new drugs; conducting trials in India would ensure the safety and efficacy of new drugs in the Indian population. There is an urgent need to further facilitate the dialogue between the regulatory authorities of developed nations (i.e., the US) and India. Conflict of interest statement The author declares that there is no conflict of interest. Funding The authors received no extramural funding for the study. Publisher’s note The Publisher of the Journal remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Edited by Zhang Q, Lei Y, Pan Y