A novel drug's development necessitates extensive study in chemistry, production, controls, preclinical science, and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing and labelling of pharmaceutical products. This article examines the drug clearance procedure in various nations, including the United States and India. A drug product must be examined for safety and efficacy in people before it can be licensed for import or production of a new medicine. A company's regulatory affairs department is critical in adhering to the laws, regulations, and standards established by many countries' regulatory agencies. The purpose of this article is to compare the drug approval processes in the United States, India, and all data on drug patents granted in the previous years and the current year.
Lakshmi Priya Manda (Sat,) studied this question.