Abstract

CURRENT REGULATORY REQUIREMENTS FOR NUTRACEUTICALS IN INDIA AS PER CDSCO IN COMPARISON WITH TANZANIA

Ashok Kumar P.*, Harshitha A. H., G. Deepika, Ramya A. and Thanushree H. N.

ABSTRACT

"Nutraceuticals" are the combination of Nutrition and pharmaceutical. The term Nutraceutical was given by Dr. Stephen in 1989. A dietary supplement is a product taken by oral cavity that contains a dietary ingredient (Vitamins, Minerals, Herbs, Amino acids etc.) Numerous definitions and nomenclature for dietary supplements exist worldwide. In India Food Safety and Standards authority (FSSA), defines Nutraceuticals as "foods for special dietary uses or functional foods or health supplements". In Tanzania; Tanzania food and drug authority regulation (TFDA), defines Nutraceuticals as “food supplement product”. Every country has their own guidelines, regulatory requirements which deal with regulatory registration procedures of Nutraceuticals. In order to enter the Indian Nutraceutical market, some of the very important areas of focus include product evaluation, actual product analysis, procuring licenses and developing India specific health and label claims.

Keywords: Nutraceuticals, FSSAI (Food Safety and Standard Authority of India, TFDA (Tanzania Food and Drug Authority Regulation).