How to Start a dietary supplement business in India

1. +91 7672005050, +91-11-28081765 contact@cliniexperts.com How to Start a dietary supplement business in India Summary: In this article, we will discuss in brief about the dietary supplement products requirements for its business in India. Difference Between Food Supplement and Drugs In the market, a large number of products containing a large number of vitamins and minerals are sold in the name of food or health supplements. Meanwhile many multivitamin tablets containing other nutrients are sold by obtaining the required nutritional supplement license from the drug authorities. Therefore, without proper categorization, the manufacturer of health supplement product can fall under the risk of prosecution. So, the food supplement product was properly defined to eradicate the confusion. It can be defined as a foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition or specific diseases and disorders and which are presented as such, wherein the composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist, and may contain one or more of the following ingredients, namely plants or botanicals or their parts in the form of powder, concentrate or extract; minerals or vitamins or proteins or metals or their and what are the

2. +91 7672005050, +91-11-28081765 contact@cliniexperts.com compounds or amino acids (in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits); substances from animal origin; a dietary substance for use by human beings to supplement the diet by increasing the total dietary intake. The food supplements may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and are meant for oral administration. The Food supplement does not include a drug as defined in clause (b) and ayurvedic, siddha and unani drugs as defined in clauses (a) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made thereunder; does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the regulations made under this Act; does not include a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) and rules made thereunder and substances listed in Schedules E and EI of the Drugs and Cosmetics Rules, 1945. What is your business model? For starting a food/nutritional/dietary business, you are first required to register your business and then decide about the structure of the business as well as the sales model. A dietary supplement license has to be obtained from FSSAI pertaining to the product. According supplement

3. +91 7672005050, +91-11-28081765 contact@cliniexperts.com to the structure you select, it is determined how your profit will be taxed by the government and the kind of legal protections you have. Some of the reliable options are a sole proprietorship, LLC, and Partnership. Depending on your business model it will be determined whether or not you require a license. If you are going to make your own supplements with own nutritional formulas then you will require a nutraceutical FSSAI Central License. On the other hand, you have an option to go through a supplement manufacturer and get your private label through them. Thus eliminating the need to obtain nutraceutical compliance from FSSAI. What are the FSSAI Guidelines for food supplements business? It is important for all food supplement business operators to follow the nutraceutical compliance guidelines as set by FSSAI for marketing of food/dietary supplement products. These guidelines have been set keeping in mind the health issues of the public and the avoidance of inferior food supplements. Some of the guidelines are: ●Such foods should be produced and manufactured in form of capsules, tablets, syrups etc. ●These items must fulfil all the standards of quality as mentioned. ●The formulation of this food articles should be based on proper nutrition and medicinal principles. ●It should not contain any hormones, steroids or psychotropic ingredients. ●The number of nutrients should not exceed RDA or recommended daily allowance limits.

4. +91 7672005050, +91-11-28081765 contact@cliniexperts.com ●The additives and colours used should also be within permitted limits. Labelling Supplements. The labelling of the nutritional supplements has certain requirements. If you are thinking of starting a food supplement business in India then you must have a firm knowledge of the labelling requirements before applying for a dietary supplement license. Like proper specification of the purpose of the product, consumer group, disease or the physiological condition as specified by the food group, using directions. All the required information should be given on the label about the purpose, precautions and usage directions. A food product that has not undergone any modification and can be used as per a specific dietary regimen for its regular composition is not considered as a nutritional supplement. While introducing the food supplement in the market for the use of public, the label should contain a statement that will clearly define the nature of the food and should not in any way mislead the buyer. compliance with fssai shall be maintained under all circumstances to avoid any penalties. . Requirement for Food/Nutritional These nutraceutical

5. +91 7672005050, +91-11-28081765 contact@cliniexperts.com Author Bio: The author is a nutritionist with years of experience and knowledge in nutritional products and their marketing.