Abstract

CURRENT REGULATORY REQUIREMENTS FOR REGISTRATION OF NUTRACEUTICALS IN INDIA AND JAPAN

Komal Nawale*, Dr. A. G. Namdeo and Deepak Gaware

ABSTRACT

Nutraceuticals, defineds any food or part of food which provides health benefits including prevention or treatment of disease, have emerged as a necessity for consumers in developed and developing countries. By changing their lifestyle and related diseases, and the functional ingredients such as vitamins, minerals, amino acids, fatty acids and probiotics are part of this category. The nutraceuticals are used for human consumption and regulatory authorities are worked on their quality and safety. As nutraceutical products are reaching from one country to another country, they maintaining their safety and quality standards as per various regulatory regulatory guidelines set by the respective governments become important; which can be an important for the industry growth. In today‟s lifestyle the food and food habits are changed so they affect on healthy body and mind. Hence in this case if “food be your medicine” then it would be great to achieve a healthy body and mind. This review shows Nutraceutical regulation set out in India by Food Safety Standard Authority of India and in Japan by food for special dietary use. It mainly focuses on the comparison of nutraceutical regulatory framework and approval process in India and Japan, with harmonised technical requirements for registration of nutraceutical product in both markets. This article is based on the complete legal requirements that are necessary for the countries that want to register a nutraceutical foods or drug product in India and Japan.

Keywords: Nutraceuticals, FSSAI( Food Safety Standard Authority Of India), FOSHU (Food For Specialised Health Uses) Dietery Supplements, Health food, Health claims and label claims.