Abstract

A REGULATORY ASSESSMENT OF MARKETED NUTRACEUTICAL PREPARATION

Abhishek Mishra*, Neel Kamal Kumar and Nishi Prakash Jain

Abstract

Indian nutraceuticals market is set to grow over fold to 6.1billion dollar by 2020 as consumers become conscious towards health and fitness. Initially India does not had any kind of regulatory guidelines for approval or monitoring of Nutraceuticals1, although Food Safety and Standards Authority of India (FSSAI) has draft a draft regulations shall be taken into consideration for nutraceuticals in India. According to this Nutraceuticals are classified as (a) the vitamins and minerals (b) the Amino acids (c) the Plants or botanicals (d) the substances from animal origin and (e) the nutraceuticals as specified in Schedule IX of these regulations, which may be used in the manufacture of food containing nutraceuticals without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. The objective of this paper is to assessment the regulatory structure and status of regulation of currently issued guidelines for nutraceuticals in India. The survey study was divided in two phases. First phase of study was surveying the awareness and value of nutraceuticals in physicians and the objective of second phase were focused to product and sale of nutraceuticals. This survey focuses on various issues like if very less therapeutic effects produced by nutraceuticals then why they are prescribed with modern medicines. Physicians are interested in quality of these products as good as pharmaceuticals but mute on price matters. Nutraceuticals are available on almost all form of oral pharmaceutical dosage forms and taken by patient as a therapeutic substance.

Keywords: Nutraceuticals, FSSAI (Food Safety and Standards Authority of India), NPPA (National pharmaceutical pricing Authority of India), Regulatory, Assessment.