Abstract

A BRIEF REVIEW ON INTELLECTUAL PROPERTY RIGHTS

Dr. D. Nagarjuna Reddy*, Dr. K. Nageswara Rao, Dr. D. Raghava and P. Gayatri

ABSTRACT

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 text examines the drug clearance system in numerous nations, including the US and India. A drug product need to be tested for safety and efficacy in human beings before it may be certified for import or production of a new medicinal drug. A corporation's regulatory affairs branch is essential in adhering to the legal guidelines, regulations, and requirements installed via many countries' regulatory businesses. The purpose of this article is to evaluate the drug approval techniques inside the united states of America, India, and all data on drug patents granted inside the preceding years and the present day year.

Keywords: Intellectual Property Rights, Licensing, Regulations, Marketing.