At present, India does not have any kind of regulatory guidelines for approval and monitoring of such products. The official notification of these norms will check counterfeit products and encourage stakeholders to invest in this fast-growing industry.
According to the Food Safety and Standards Authority of India (FSSAI), the draft regulations have been framed for manufacture and sale of -- food or health supplements, nutraceuticals, foods for special dietary uses, foods for special medical purpose, functional foods and novel food. Comments will be accepted during the next 60 days. The norms will come into effect from the ensuing January 1 or July of the year, it said.
As per the norms, FSSAI said, "No person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any food products referred to in these regulations unless they comply with the requirements laid down in these regulations." The formulation of the foods should be based on sound medical or nutritional principles and supported by validated scientific data, wherever required.
FSSAI also said that no hormones or steroids or psychotropic ingredients should be added in these foods. The labels should clearly mention the purpose, the target consumer group and the physiological or disease conditions which they address, apart from the specific labelling requirements as mentioned against each type of food.
The labels, accompanying leaflets/or other labelling and advertising of all types of foods, referred to in these regulations, should provide sufficient information on the nature and purpose of the food as well as detailed instructions and precautions for their use, it said. A food, which has not been particularly modified in any way but is suitable for use in a particular dietary regimen because of its natural composition, should not be designated as "Food Supplements" or "Special Dietary" or "Special Dietetic" or by any other equivalent term, it added.
FSSAI said: "The Food Authority may suspend or restrict the trade of such foods as have been placed in the market that are not clearly distinguishable from foods for normal consumption nor are suitable for their claimed nutritional purpose, or may endanger the human health."
The Food Authority may, at any time, ask a food business operator manufacturing and selling such special types of foods to furnish details regarding the history of use of nutrients added or modified and their safety evaluation, it added. According to Assocham-RNCOS recent paper, nutraceuticals, dietary supplements and functional foods market in India is estimated to grow from the current USD 5.6 billion to USD 12.1 billion in the next five years.