Meshram, N., S. Harane, V. Kale, D. Biyani, and M. J. Umekar. “Regulatory Overview on New Drugs and Clinical Trials Rules, 2019”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 1, Mar. 2023, pp. 31-42, doi:10.22270/ijdra.v11i1.578.