A nutraceutical is a food or food related component that intends for health benefits even in treatment and prevention of aliments. Many people rely on dietary supplements as alternative therapy that are medicinal herbs and nutraceuticals. There is rising demand for nutraceuticals worldwide. The annual growth of nutraceuticals was found to be 25% in India which is similar to the developed country Japan. In this view, many new companies have begun manufacturing nutraceuticals in India.
The pharmaceutical companies and FMCG (fast moving consumer goods) suppliers placed a key role in the success of Indian nutraceuticals market. The Indian nutraceuticals market is divided into functional foods and beverages and dietary supplements. Over 64% of nutraceuticals market in India is occupied with vitamin and mineral supplements. The Indian nutraceuticals market which has grown from $1 billion in 2008 to $1.8 billion in 2013, has crossed $2 billion in 2014 and is expected to top $4 billion by 2018.
Nutraceuticals are considered as foods by the FSS Act, 2006, Rules and Regulations, 2011. The Food Safety and Standards Authority of India (FSSAI) has issued regulations with respect to licensing and registration of food business, manufacturing, packing and labelling, food product standard and so on.
In FSSA in India (FSSAI) has defined regulatory guidelines for approval of nutraceuticals in the Indian market. This Act consists of 21 chapters and in that the 4th Article that means 22 of the Act says about nutraceuticals, dietary supplements and various functional foods, and these products can be produced/manufactured, marketed that means sold or distributed that means import can be done by any of the company.
In the Nutraceuticals Regulations, 2016, under the ‘General Requirements,’ the FSSAI has stated that (21) mere combination of vitamins and minerals formulated in tablets, capsules, syrup formats shall not be covered in any of the categories of these regulations except when vitamins and minerals are added.
FSS Regulations, 2011, issued guidance for licensing and registration of food businesses; packaging and labelling; food product standards and food additives; prohibition and restriction on sales; contaminants, toxins and residues; laboratory and sampling analysis. FSS issued regulations for food or health supplements, nutraceuticals, foods for special dietary uses, foods for special medical purpose, functional foods, and novel food in 2015.
The following information shall be included in any claimed novel foods – (a) chemical composition of the engineered food; (b) surface modification/ surface chemistry; (c) primary particle size; (d) solubility; (e) digestibility; (f) amount of nanomaterial if any in the food product; (g) specific claim, if applicable.
Nutraceuticals shall contain any of the ingredients specified in Food Act
Vitamins and minerals
Essential amino acids and other nutrients
List of plants and botanical ingredients
List of ingredients as nutraceuticals
List of strains as probiotics
List of prebiotic compounds