ABSTRACT A regulatory process of drug approval is very important in ensuring that new pharmaceutical products are safe, effective and produced without quality standards. In this review, the approval procedures in India, The US and Canada are compared. This also involves an organized evaluation that is supported by scientists. The three systems aim to safeguard the well-being of the masses by ensuring that medicines reach the patients only when they are well characterized, evidence based, and of the highest quality, irrespective of the system structure, documentation requirements, reviewing period and the regulatory authority roles. This comparative study outlines similarities and specific regulatory aspects to define Indian, U.S., and Canadian drug-approval process. Keywords: Drug approval process, Regulatory affairs, Pharmaceutical regulations, New drug approval, CDSCO, USFDA, Health Canada, Clinical trials, Regulatory authority, Drug safety and efficacy.