Nutraceutical Regulations in the Indian Market and Comparison with the United States and Europe (PDF)

Document from the year 2022 in the subject Pharmacology, Andhra University, course: PHARMACEUTICAL REGULATORY AFFAIRS, language: English, abstract: A product that combines pharmaceutical efficacy and food safety is called as a Nutraceutical. It is used to describe foods that have therapeutic or nutritional properties. They have the capacity to attract a lot of customers due to the potential quality of health benefits supplied to the human body. A brief explanation of how these products are regulated in India, along with the schedules, registration process, method of preparation, labelling, claims, and its advantages are clearly explained in this article. A comparison table is prepared comparing various parameters like definition, scope, forms, fees etc. for India, United States, and European Union.

Traditional foods and herbal extracts have been acknowledged as an essential component of the holistic effort to attain total well-being and health throughout history, particularly in the ancient Ayurveda system of medicine in India but also in traditional Chinese, Roman, and Greek medicine. "Let food be thy medicine and medicine be thy food" as Hippocrates (460-377 BC), the well-known father of modern medicine, declared, to emphasize the correlation between suitable foods for nutrition and their therapeutic effects. The guiding principle was "Focus on prevention". Theophrastus (370-285 BC), Cato (234-149 BC), Pliny the Elder (23-79 AD), and Galan (131-201 AD) all issued statements warning against the adulteration of food products at that time. Since 2000 BC, Schwan has used microorganisms (fungi or yeast) 1837 to produce products through the alcoholic fermentation process. Funk (1884-1967), the father of vitamin therapy, started a new investigation on vitamins and identified them as nutritional required components for the survival of good health. Dr. Stephen L. De Felice, the chairman and founder of the innovation of medicine, coined the word "nutraceuticals." in 1989 by the combination of two words "nutrition" and "pharmaceutical". Essentially, this is a marketing tool.