“Regulatory Challenges For The Development Of Probiotics As Foods And Drugs And Cmc (Chemistry Manufacturing And Control) Considerations For Probiotics”

Abstract

The purpose of this study is to elucidate the importance of probiotics, regulatory challenges that are faced in developing probiotics as foods and drugs and as well as the Chemistry, Manufacturing and control (CMC)considerations for probiotics. Probiotics are friendly live microorganisms (in most cases, bacteria) that are similar to the beneficial microorganisms found in the human gut and, when consumed, have the potential to improve or maintain the intestinal microbial flora of consumers, thereby benefiting their health. The utilization of probiotics has been in existence for a very long time. Lactobacilli, bifidobacterial, and lactococciare are the examples of probiotics have long been assumed to be safe whereas the most important determinant for probiotics selection is human health safety. Probiotics can be consumed by consumers largely in the form of food and dietary supplements. They are also even available in the form of tablets, capsules and powders and in some other forms as well, yet, their claims of health advantages could put the conventional distinction between food and medicine in jeopardy. The position of the regulatory environment for probiotics within the existing categories has become hazy and quite unclear as a result of the introduction of numerous probiotic products into the global market