Clinical Research Regulation in India and Brazil: An Overview of Current Frameworks and Implementation Gaps
Abstract
Clinical research in emerging economies has expanded significantly over the past two decades, necessitating robust, transparent, and ethical regulatory systems. India and Brazil two major middle-income countries with rapidly growing clinical trial sectors have implemented substantial reforms aimed at strengthening participant protection, streamlining approval pathways, and improving regulatory oversight. This review provides a comparative examination of the current clinical trial regulatory frameworks in India and Brazil, highlighting their legal foundations, governance structures, ethical oversight mechanisms, and operational requirements. In India, the New Drugs and Clinical Trials Rules (NDCTR) 2019 established a consolidated, clearer, and more time-bound regulatory pathway, with mandatory ethics committee registration and enhanced safety reporting obligations. Brazil, through ANVISA regulations and the National Research Ethics Commission (CONEP), has progressively harmonized ethical and scientific review processes, with noteworthy reforms introduced by Law No. 14,874/2024 and updated ANVISA Resolutions. Despite these advances, both countries continue to face implementation gaps, including delays in multicenter trial approvals, variations in ethics committee capacity, limited inspection resources, and challenges in transparency and post-trial access. Comparative analysis reveals opportunities for regulatory convergence, digitalization of review processes, and strengthened collaboration between national authorities to support global clinical research. Addressing these systemic gaps will be essential for building public trust, enhancing research quality, and positioning India and Brazil as reliable hubs for ethical and scientifically sound clinical trials.
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References
https://doi.org/10.4103/picr.PICR_151_19
2. Silva, A. B., & Santos, M. C. Regulatory pathways in Brazil: Opportunities and challenges. Therapeutic Innovation & Regulatory Science [Internet]. 2019[cited 2025 Nov 03]; 53(5):645–653.
https://doi.org/10.1177/2168479018819049
3. Sharma, R., & Bansal, S. Trends in clinical trial approval in India post-2019 reforms. Regulatory Toxicology and Pharmacology [Internet]. 2020[cited 2025 Nov 03]; 119:104837.
https://doi.org/10.1016/j.yrtph.2020.104837
4. Andrade, H. S., & Lima, M. J. Effectiveness of ANVISA reforms. Regulatory Science Insights [Internet]. 2019[cited 2025 Nov 06]; 12(1):45–53.
https://doi.org/10.1177/2381468319861564
5. Patel, P., Cerqueira, D. M., & Santos, G. M. L. Regulatory review timelines for ANVISA. Therapeutic Innovation & Regulatory Science [Internet]. 2020[cited 2025 Nov 06]; 54(6):1428–1435.
https://doi.org/10.1007/s43441-020-00169-5
6. Finkelstein, J., et al. Clinical research infrastructure in Brazil. Brazilian Journal of Medical Research. [Internet]. 2018 [cited 2025 Nov 06];51(2):112–120.
https://doi.org/10.1590/0037-8682-0329-2017
7. Pinto, C. A., & Goyal, R. Clinical trials in India: Regulation and reform. Contemporary Clinical Trials Communications [Internet].2017 [cited 2025 Nov 05]; 6:8–13.
https://doi.org/10.1016/j.conctc.2017.04.001
8. Resende, H., et al. Current landscape of clinical research in Brazil. Ecancermedicalscience [Internet]. 2023 [cited 2025 Nov 05];17:1640.
https://doi.org/10.3332/ecancer.2023.1640
9. Simms, L., et al. ICH-GCP adherence in emerging markets. Global Regulatory Affairs Journal [Internet]. 2022 [cited 2025 Nov 05];14(3):178–188.
https://doi.org/10.1177/00928615221101161
10. Wang, Y., et al. Global challenges in regulatory harmonization. Nature Reviews Drug Discovery [Internet].2020 [cited 2025 Nov 05]; 19(8):495–496.
https://doi.org/10.1038/d41573-020-00083-6
11. Mathur, R. Ethical review of biomedical research in India. Indian Journal of Medical Research [Internet].2018 [cited 2025 Nov 05]; 148(3):235–245.
https://doi.org/10.4103/ijmr.IJMR_500_18
12. Rodrigues, J. F., & Almeida, V. The ethical review system in Brazil. Journal of Bioethics [Internet].2021 [cited 2025 Nov 04];31(2):210–221.
https://doi.org/10.1590/1983-80422021291201
13. Fernandes, M. S., et al. Ethics review delays in Brazil. Clinical Ethics [Internet]. 2020 [cited 2025 Nov 04];15(4):210–219.
https://doi.org/10.1177/1477750920962129
14. Lopes, C. E., et al. Ethics committee performance in Brazil. BMC Medical Ethics [Internet]. 2019 [cited 2025 Nov 04];20:79.
https://doi.org/10.1186/s12910-019-0417-2
15. Chakraborty, S., & Mehta, P. Post-trial access obligations in India. Indian Journal of Medical Ethics [Internet].2021 [cited 2025 Nov 07];6(2):112–118.
https://doi.org/10.20529/IJME.2021.025
16. Perez, M., et al. Ethics review timelines in Latin America. Research Ethics [Internet]. 2020 [cited 2025 Nov 07];16(4):1–16.
https://doi.org/10.1177/1747016120901980
17. Verma, S., & Sen, S. Ethics committee accreditation in India. Bioethics Review [Internet].2021[cited 2025 Nov 07]; 19(3):181–192.
https://doi.org/10.1111/bioe.12888
18. Cunha, L., et al. Compliance with ethics guidelines in Brazil. PLoS ONE [Internet]. 2018[cited 2025 Nov 07];13(9): e0203642.
https://doi.org/10.1371/journal.pone.0203642
19. Singh, H., & Kaur, P. Ethics governance in Indian research institutions. Asian Bioethics Review [Internet]. 2020[cited 2025 Nov 07]; 12(4):345–356.
https://doi.org/10.1007/s41649-020-00139-2
20. Ribeiro, S. R., et al. Ethical compliance in Brazilian biomedical research. Revista Bioética [Internet]. 2020[cited 2025 Nov 07]; 28(2):238–247
https://doi.org/10.1590/1983-80422020282440
21. Sharma, R., & Bansal, S. Impact of NDCT Rules. Regulatory Toxicology and Pharmacology [Internet]. 2020 [cited 2025 Nov 06];119:104837.
https://doi.org/10.1016/j.yrtph.2020.104837
22. Rajan, R., & Chawla, S. Assessment of NDCT implementation. Journal of Regulatory Affairs [Internet].2022 [cited 2025 Nov 06];11(4):213–220.
https://doi.org/10.1016/j.rega.2022.103233
23. Santos, G., et al. Regulatory bottlenecks in Latin America. Pan American Journal of Public Health [Internet]. 2020 [cited 2025 Nov 06];44:e109.
https://doi.org/10.26633/RPSP.2020.109
24. Oliveira, T. P., et al. Trends in Brazilian drug approvals. Frontiers in Pharmacology [Internet]. 2020 [cited 2025 Nov 07];11:1078.
https://doi.org/10.3389/fphar.2020.01078
25. Jena, R., & Prasad, A. India’s trial capacity expansion. Journal of Health Research [Internet].2021[cited 2025 Nov 07]; 35(4):320–331.
https://doi.org/10.1108/JHR-05-2020-0137
26. Costa, L., et al. Harmonization barriers in Latin America. Journal of Global Health [Internet].2022 [cited 2025 Nov 08]; 12:04012.
https://doi.org/10.7189/jogh.12.04012
27. Raj, A., & Thomas, J. Governance of global clinical trials. Clinical Trials [Internet].2023[cited 2025 Nov 08]; 20(2): 123–134.
https://doi.org/10.1177/17407745221149171
28. Ribeiro, D. F., & Silva, R. Ethical review delays. Accountability in Research [Internet].2021[cited 2025 Nov 03]; 28(4):254–268.
https://doi.org/10.1080/08989621.2020.1774372
29. Gupta, Y. K., & Pradhan, A. Injury compensation in India. Drug Safety [Internet].2014[cited 2025 Nov 08]; 37(12):995–1002.
https://doi.org/10.1007/s40264-014-0230-3
30. Banerjee, A. K., et al. Pharmacovigilance system strengthening. International Journal of Risk & Safety in Medicine [Internet].2017[cited 2025 Nov 08]; 29(3–4):125–134.
https://doi.org/10.3233/JRS-170761
31. Aithal, G., & Patel, S. Performance gaps in pharmacovigilance. Drug Safety [Internet].2023[cited 2025 Nov 08]; 46(1):21–33.
https://doi.org/10.1007/s40264-022-01286-y
32. Almeida, G. T., et al. Challenges in pharmacovigilance reporting. Brazilian Journal of Health Research [Internet].2017[cited 2025 Nov 08]; 14(2):65–74.
https://doi.org/10.1590/1413-81232017224.05002016
33. Kalaiselvan, V., et al. PvPI developments. Indian Journal of Pharmacology [Internet].2016[cited 2025 Nov 08]; 48(6):624–628.
https://doi.org/10.4103/0253-7613.194855
34. Mehta, S., & Tiwari, P. Global regulatory dependency pathways. Therapeutic Advances in Drug Safety [Internet].2021[cited 2025 Nov 08];12:1–15.
https://doi.org/10.1177/20420986211011322
35. Souza, V. M., et al. Oversight of clinical data integrity. Journal of Medical Regulation [Internet].2017[cited 2025 Nov 08];103(3):52–60.
https://doi.org/10.30770/2572-1852-103.3.52
36. Das, P., & Bhattacharya, S. Clinical R&D in emerging economies. Journal of Global Health Science [Internet].2022[cited 2025 Nov 08]; 4(1):15–22.
https://doi.org/10.35500/jghs.2022.4.e12
37. Simms, L., et al. ICH-GCP adherence in emerging markets. Global Regulatory Affairs Journal [Internet]. 2022 [cited 2025 Nov 09];14(3):178–188.
https://doi.org/10.1177/00928615221101161
38. Padua, A., et al. Regulatory pathways in Latin America. Journal of Public Health Policy [Internet]. 2020[cited 2025 Nov 09]; 41(4):81–495.
https://doi.org/10.1057/s41271-020-00237-2
39. Davies, R., et al. Digitalization in global trials. Digital Health [Internet]. 2020[cited 2025 Nov 09]; 61–12.
https://doi.org/10.1177/2055207620930959
40. Menon, A., & Jain, P. Digital health regulations in India. Journal of Medical Systems [Internet].2023[cited 2025 Nov 09]; 47:23.
https://doi.org/10.1007/s10916-022-01831-3
41. Costa, J., et al. Brazil’s regulation progress. Revista Panamericana de Salud Pública [Internet]. 2018[cited 2025 Nov 09]; 42:e175.
https://doi.org/10.26633/RPSP.2018.175
42. Kumar, V., & Singh, M. Digital governance in clinical trials. Clinical Trials Communications [Internet]. 2022[cited 2025 Nov 09]; 31:100540.
https://doi.org/10.1016/j.conctc.2022.100540
43. Rodrigues, M., et al. Digital consent adoption. Journal of Medical Internet Research [Internet]. 2021[cited 2025 Nov 09]; 23(8):e28102.
https://doi.org/10.2196/28102
44. Das, S., & Rao, A. Transparency in CTRI reporting. Trials [Internet]. 2019[cited 2025 Nov 09]; 20:448.
https://doi.org/10.1186/s13063-019-3563-7
45. Almeida, R., et al. Patient protection mechanisms in Brazil. Health Research Policy and Systems [Internet]. 2021[cited 2025 Nov 09]; 19:82.
https://doi.org/10.1186/s12961-021-00757-5
46. Davies, R., et al. Digitalization in global clinical trials: Opportunities and challenges. Digital Health [Internet]. 2020 [cited 2025 Nov 09]; 6:1–12.
https://doi.org/10.1177/2055207620930959
47. Menon, A., & Jain, P. Digital health regulations in India: Emerging trends. Journal of Medical Systems [Internet]. 2023 [cited 2025 Nov 08]; 47:23.
https://doi.org/10.1007/s10916-022-01831-3
48. Christian, W., et al. Remote monitoring and decentralized clinical trials: Global regulatory perspectives. Nature Reviews Drug Discovery [Internet]. 2021[cited 2025 Nov 08]; 20(7):558–560.
https://doi.org/10.1038/d41573-021-00072-2
49. Manta, C., et al. E-consent and participant engagement in clinical research. Contemporary Clinical Trials Communications [Internet].2020[cited 2025 Nov 06]; 19:100634.
https://doi.org/10.1016/j.conctc.2020.100634
50. Hurst, S., & Torous, J. Data integrity in digital clinical research: Ensuring ALCOA+ compliance. NPJ Digital Medicine [Internet].2021[cited 2025 Nov 08]; 4:142.
https://doi.org/10.1038/s41746-021-00514-8
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