Regulatory affairs (RA) play crucial roles in the pharmaceutical industry because they are concerned with the lifecycle of healthcare products, they offer strategic, tactical, and operational direction, and they support working within the law to hasten the development and delivery of safe and effective healthcare products to people all over the world. The purpose of regulatory affairs is to create and implement a regulatory strategy to guarantee that the combined efforts of the drug development team result in a product that is acceptable to international regulators while also standing out from the competition. Microorganisms play a vital role in every field of drug such as production of antibiotics, antifungal, anticancer, vitamins, vaccines and enzymes etc. These are some examples where microbial products are widely used. In the present work we will discuss various aspects where microorganisms widely used in production of drug and their regulations in US and India.