Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016

1. Short title and commencement. - (1) These regulations may be called the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. (2) They shall come into force on the date of their publication in the Official Gazette and Food Business Operator shall comply with all the provisions of these regulations by 1st January 2018.

2. Definitions.- In these regulations, unless the context otherwise requires,- (a) “Act” means the Food Safety and Standards Act, 2006 (34 of 2006); (b) “Food Authority” means the Food Safety and Standards Authority of India established under section 4 of the Act; (c) “food for special dietary use” shall have the meaning assigned to it in section 22 of the Act; (d) “food for special medical purpose” means food intended for - (i) particular dietary use specially processed or formulated; (ii) the dietary management of persons and used only under medical advice; (iii) the exclusive or partial feeding of persons with a limited, impaired or disturbed capacity to take, digest, absorb, metabolize or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites; or (iv) other medically determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by food for specific nutritional use, or a combination of them; (e) “food with added prebiotic ingredients” means food that contains added prebiotic ingredients which are non-viable food components that confer health benefits to the consumer by modulation of gut microbiota; (f) “food with added probiotic ingredients” means food with live micro-organisms beneficial to human health, which when ingested in adequate numbers as a single strain or as a combination of cultures, confer one or more specified or demonstrated health benefits in human beings; (g) “functional food” shall have the meaning assigned to it in section 22 of the Act; (h) “health supplements” shall have the meaning assigned to it in section 22 of the Act; (i) “non-food” means an ingredient or a substance which is not a ‘food’ as referred to in clause (j) of section 3 of the Act; (j) “novel food” shall have the meaning assigned to it in section 22 of the Act; (k) “nutraceuticals” shall have the meaning assigned to it in section 22 of the Act; (l) ”nutritional ingredients” means the ingredients specified in Schedules other than the food additives specified in Schedule VA to Schedule VF, packed and made available in a form not for retail-consumer use, but meant for use in formulating a product falling under various categories of these regulations or other categories specified in the Food Safety and Standards (Food Products Standards and Food Additves) Regulations, 2011; (m) “nutrient ingredients” means vitamins, minerals, and amino acids as specified in Schedule I and Schedule II;. (n) “pre-mixes” means a combination of two or more ingredients specified in the Schedules in a specific proportion with or without additives, packed and meant for use in formulating a product falling under any category of these regulations or under the categories specified in the Food Safety and Standards (Food Products Standards and Food Additves) Regulations, 2011; (o) “specialty food containing plant or botanical ingredients” means food which is shown to be containing plant or botanical ingredients with a history of safe usage; and (p) “Schedules” means the Schedules to these regulations. Amendment for insertion of new provision 1[(q) “Sportsperson” means an individual who is involved in various types of sports activities as approved by Sports Authority of India (Ministry of Youth Affairs and Sports, Government of India).] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 2 Version-I (29.09.2021)

3. General requirements.- (1) The articles of food sold in capsule format, hard or soft or vegetarian, shall comply with the general monograph and quality requirements specified for them in Indian Pharmacopoeia: Amendment for substitution of highlighted provision 1[and quality requirements specified for them in Indian Pharmacopoeia, if applicable] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] Provided that the food business operator may use the approved colours and additives permitted in Schedule VF; Provided further that the food business operator may use the natural flavors or nature identical flavours or synthetic flavors in accoradance with the provisions of regulation 3.3.1 of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011. (2) For the purposes of sub-regulation (1) the food business operator may declare the addition of flavour on labels of such products in accoradance with the provisions of Food Safety and Standards (Labelling and Packaging) Regulations, 2011. (3) The tablets, capsules and syrups shall fulfil the general quality requirements and standards as specified in Indian Pharmacopoeia, British Pharmacopoeia or United States Pharmacopoeia. (4) The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, the standards laid down by international food standards body, namely, Codex Alimentarius Commission, shall apply. (5) In case of food products falling under health supplement categories, the individual nutrient content shall not be less than fifteen per cent of the recommended daily allowance where a nutrient content claim is being made: Provided that, if claim of higher nutrient content is made, the nutrient content shall not be less than thirty per cent of the recommended daily allowance. (6) For the articles of food specified in these regulations, the Food Authority may permit the food business operator to add food colours subject to the level restrictions as mentioned in Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011. 3 Version-I (29.09.2021) (7) The articles of food with standard nutrient or nutritionally complete formulation shall consist of a composition delivering the desired level of energy, protein, vitamins and minerals, and other essential nutrients required for respective age group, gender and physiological stage in accordance with the guidelines made by the Indian Council of Medical Research. (8) The purity criteria for the ingredients used in the categories of articles of food covered under these regulations shall be as determined and notified in the official gazette by the Food Authority from time to time. (9) In case such standards are not specified, the purity criteria generally accepted by pharmacopoeias, namely, Indian Pharmacopoeia, Ayurvedic Pharmacopoeia of India, relevant Bureau of Indian Standards Specifications, Quality Standards of Indian Medicinal Plants, Indian Council of Medical Reseach, British Pharmacopoeia, United States Pharmacopoeia, Food Chemical Codex, Joint Food and Agriculture Organization or World Health Organisation Expert Committee on Food Additives or CODEX Alimentarius may be adopted by food Business operators. (10) The food business operator shall intimate the purity criteria adopted for ingredients to the Food Authority including any change when adopted. (11) The tolerance limit for variation in case of articles of food covered in these regulations during analysis of samples of finished products, shall not be more than (-) ten per cent from the declared value of the nutrients or nutritional ingredients on the label . (12) The manufacturing of ingredients and products covered under these regulations shall be carried out in compliance with the established good manufacturing practices. (13) For purposes of these regulations, any of the ingredients specified in Schedule I, Schedule II, Schedule III, Schedule IV, Schedule VI, Schedule VII, and Schedule VIII may be used in food in accordance with the provisions of these regulations, and for the said purpose, may use additives as applicable to categories specified in Schedule VA to Schedule VF. Explanation 1.- For the purposes of these regulations food or ingredients referred to in Food Safety and Standards Regulations, 2011, and for which standards are provided, and the plants and botanicals specified in Schedule IV of these regulations offered in normal or naturally occurring forms shall not constitute a health supplement or nutraceutical, or food for special dietary use or food for special medical purpose. 4 Version-I (29.09.2021) Explanation 2.- Mere food forms such as vegetables, namely, bhindi, karela and other vegetables; cereals, namely, ragi, jowar, millets and other cereals; legumes, namely, rajmah and other legumes; spices, namely, pepper, jeera, turmeric and other spices; fruits, namely, amla, jamun, grapes and other fruits; and other plants or botanicals, minimally processed (cleaned, de-weeded, sorted, dried or powdered), in either as juice or cooked form, shall not constitute ‘health supplement’ or ‘nutraceutical’ or ‘food for special dietary use’ or ‘food for special medical purpose’. Amendment for insertion of new provision 1[Explanation 3: To promote maintenance of health primarily through food formats, as permitted under section 22 of the Act, wherever applicable, tablets, capsules and syrups can also be used as formats for presentation of the products.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (14) The formulation of articles of food shall be based on the principles of sound medicine or nutrition and supported by validated scientific data, wherever required. (15) No hormones or steroids or psychotropic ingredients shall be added in any of the articles of food specified in these regulations. (16) The label on articles of food shall specify the purpose, the target consumer group and the physiological or disease conditions which they address, recommended duration of use, and the specific labelling requirements as mentioned against each type of article of food. (17) The label, accompanying leaflet or other labelling and advertisement of each type of article of food, referred to in these regulations shall provide sufficient information on the nature and purpose of the article of food and detailed instructions and precautions for its use, and the format of information given shall be appropriate for the intended consumer. (18) An article of 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, shall not be designated as ‘health supplement’ or ‘special dietary’ or ‘special dietetic’ or by any other equivalent term, and such food may bear a statement on the label that ‘this food is by its nature X’ (‘X’ refers to the essential distinguishing characteristic as demonstrated by the generally accepted scientific data), provided that the statement does not mislead the consumer. (19) The Food Authority may suspend or restrict sale of such articles of food as have been placed in the market that are not clearly distinguishable from articles of food for normal consumption and are not suitable for their claimed nutritional purpose, or may endanger human health, in accordance with the provisions of the Act. 5 Version-I (29.09.2021) (20) The Food Authority may, at any time, direct a food business operator manufacturing and selling such special type of article of food, to furnish details regarding the history of use of the novel or modified ingredients added and their safety evaluation. (21) The 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 to an article of food or in a food format. Amendment for substitution of highlighted provision 1[(21) The combination of vitamins and minerals, including use of single vitamin and mineral, in dosage formats such as tablets, capsules, syrups, at levels equal to a maximum of one Recommended Dietary Allowances or below shall be covered under these regulations.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (22) The labelling on the article of food shall be in accoradance with the Food Safety and Standards (Packaging and Labelling) Regulations, 2011, and the specific labelling requirements provided in these regulations. (23) The articles of food shall conform to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. (24) 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. (25) Whoever contravenes the provisions of these regulations shall be liable for punishment provided under Chapter IX of the Act. Amendment for insertion of new provision 1[(26) These regulations shall not be applicable to infants up to the age of 24 months. Foods intended for infants up to the age 24 months are specified under the Food safety and Standards (Food for infant nutrition) Regulations, 2020. The products covered under these regulations intended for children 2 to 5 years of age shall only be given under medical advice by any physician or certified dietician or nutritionist. (27) Cereal grains, legumes, fruits and vegetables mentioned in Indian Food Composition Tables published by National Institute of Nutrition, Indian council of Medical Research, and spices included in the list published by the Spices Board of India, may be used either as such or as processed ingredients including extracts, as a supplement or nutraceutical as applicable. However, for claiming specific health benefits prior approval from the Food Authority shall be obtained. 6 Version-I (29.09.2021) (28) Flavours for products covered under these regulations may be used in accordance with the provisions of regulation 3.3.1 of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011. (29) For combining ingredients there shall be a rationale based on available scientific and technical evidence which shall be made available to the Food Authority as and when called for. (30) Any single purified chemical entity listed in these regulations, except extracts of botanicals, which are to be sold as health supplement or nutraceutical or food for special dietary use or food for special medical purpose, as the case may be, is not permitted without prior approval of the Food Authority. (31) Products covered under these regulations may also contain such additional ingredients, other than additives, which are either standardised or permitted for use in preparation of the other standardised foods as specified in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. (32) The food business operator may use water, ethyl alcohol or hydro alcoholic process of extraction for obtaining plants or botanicals extract used in the products covered under these regulations. (33) Food business operator shall seek approval of the claims for the ingredients or products covered under these regulations as per the Food Safety and Standards (Advertising and Claims) Regulations, 2018.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022]

4. Claims. – (1) Every food business operator may make nutritional or health claims in respect of an article of food. (2) For the purposes of sub – regulation (1), a nutritional claim shall consist of the ‘Ingredients (nutrient or nutritional) content’ of an article of food which shall be subject to the nutritional supplement requirements specified in Schedule I,

Schedule II, Schedule III, Schedule IV, and Schedule VI. (3) For the purposes of these regulations, health claim means any representation in respect of an article of food that states, suggests or implies that a relationship exists between the constituent of that nutrient or nutritional, health, and specific disease conditions. (4) The health claim in respect of an article of food consists of the following two essential components, namely:- (i) nutrient or nutritional ingredients; and (ii) health related benefits. 7 Version-I (29.09.2021) (5) The health claim in respect of an article of food may include the following types, but not limited to (i) ingredients (nutrient or nutritional) function claims; (ii) enhanced function claims; 1[(iii) disease risk reduction claims;] [Amendment for omission of this provision w.e.f. 1st April, 2022] (iv) health maintenance claims; (v) immunity claims – increased resistance (excluding vaccines); and (vi) anti-ageing claims. (6) The other claims in an article of food that are not drug claims may be allowed subject to prior approval of the Food Authority. Amendment for substitution of highlighted words 1[Any other claims] th [Amendment in force from 6 September, 2021; FBOs to comply with the provisions by 1st April, 2022] (7) The health claims in respect of an article of food shall be commensurate with the adequate level of documentation and valid proof made available for review by the Food Authority when called for. (8) To claim ingredients, nutrient or nutritional, in respect of an article of food for enhanced function and disease risk reduction, regard shall be had to- (i) claims that led to ingredients (nutrient or nutritional); (ii) available scientific literature including official traditional texts and post market data or consumer studies or cohort or retroactive studies based on eating pattern and health benefits, epidemiological international and national data, and other well documented data; (iii) consensual, congruent and concurrent validity studies; (iv) health promotive and disease risk reduction based on proof from literature and human data of efficacy and safety of the nutrient; (v) not only controlled clinical trials for efficacy and safety data; but also nutraepidemiological data; (vi) qualified structure function claims for specific organ or function which are comprehensible to consumer; (vii) prohibition of implied claims for curing disease or claims of drug like efficacy such as ‘Prevents bone fragility in post menopausal women’; 8 Version-I (29.09.2021) (viii) prohibition of implied cure for disease claims by the name of the product such as cancer cure or through pictures, vignettes or symbols, namely, electrocardiogram tracing, lipid profile; and (ix) for structure-function claims, a case-to-case basis consumer information for specific age or gender or vulnerable population. (9) (i) For the product led claims in respect of an article of food based on human studies with evidence based data, regard shall be had to- (a) valid data and suitable statistical design proving the benefit for disease risk reduction, that is, human intervention studies; (b) ingredient, that is, nutrient or nutritional; (c) the product compatibility for the proposed claim benefit and suitable qualifiers such as heart healthy claim on polyunsaturated fatty acids; (d) the use of word “shown” as depicted in the example below when a single human intervention study shows significant benefit: “Product <Name of the Product> is ‘shown’ to be helping in <keeping your heart healthy> or <heart healthy>: (e) the use of word “Proven" as depicted in the example below when more than one human intervention studies or epidemiological evidence on Indian population have been provided with concurrent validity: “Product <Name of the Product> is ‘proven’ <to make you lose weight>: (ii) For health claims where scientific support does not exist, or if a novel ingredient is to be introduced, there shall be a prior approval of the Authoity which shall be based on adequate scientific evidence. (iii) If the health claims are product led, the food business operator shall notify to the Food Authority before putting the same in the market, by submitting relevant documents along with a copy of the label. 5. General principles for query or challenge.-The food business operator shall- (i) prepare and make available the comprehensive product information, safety and claims support data and shall periodically get it reviewed and scrutinised by a scientist or expert with relevant qualifications and experience; (ii) attach the scientific view of the reviewer on claims and its veracity along with the qualification and experience of the reviewer as an essential part of the document; 9 Version-I (29.09.2021) (iii) clarify, in case of a technical query from the Food Authority or on a public complaint lodged with the Food Authority, and assist the Food Authority to examine or authorise an appropriate expert group to review the case; and (iv) alter or modify or stop claim when directed by the Food Authority which shall be based on the opinion of an expert group. 6. Health supplements.- (1) (i) Health supplements may be used to supplement the normal diet of a person above the age of five years. (ii) the health supplements shall contain concentrated source of one or more nutrients, namely, amino acids, enzymes, minerals, proteins, vitamins, other dietary substances, plants or botanicals, prebiotics, probiotics and substances from animal origin or other similar substances with known and established nutritional or beneficial physiological effect, which are presented as such and are offered alone or in combination, but are not drugs as defined in the clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder. (iii) the health supplements shall be marketed in single use packaging as appropriate to maintain integrity and quality of the product, or in dosage forms namely, capsules, tablets, pills, sachets; jelly or gel, semi-solids and other similar forms or any other forms of liquids and powders designed to be taken in measured unit quantities. (iv) the health supplements shall not include any of the food products or categories of articles of food for which specific standards have been laid down in any other parts of these regulations. (2) (i) The health supplements shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule IV or Schedule VII or Schedule VIII or enzymes only of Schedule VI. Amendment for substitution of highlighted provision 1[(i) The health supplement shall contain singly or in combination with any of the ingredients specified in Schedule I or Schedule II or both. It may also contain singly or in combination with any of the ingredients specified in Schedule IV, Schedule VI (protein and enzymes only), Schedule VII and Schedule VIII.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (ii) The ingredients specified in the Schedules referred to in clause (i) of sub- regulation (2) may be used in manufacturing of health supplements without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. 10 Version-I (29.09.2021) (iii) The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, standards laid down by the international food standards body, namely, Codex Alimentarius Commission shall apply. (iv) The food business operator shall apply to the Food Authority for inclusion of any new nutrient or other substance with a nutritional or physiological function, which has no history of use in India or that without evidence, establishing that the nutrient may result in certain nutritional and physiological benefits with justification for approval. (v) The Food Authority may, after proper scientific evaluation, specify the nutrients approved by it from time to time. (3) (i) The labelling, presentation and advertisement shall not claim that the health supplement has the property of preventing, treating or curing a human disease, or refer to such properties; (ii) The statement by the food business operator relating to the structure or function or the general well being of the body may be allowed by the Food Authority if the statement is supported by the generally accepted scientific data; (iii) Every package of health supplement shall carry the following information on the label, namely.- (a) the words “HEALTH SUPPLEMENT”; (b) the common name of the health supplement, or a description sufficient to indicate the true nature of the health supplement including the common names of the categories of nutrients or substances that characterise the product; (c) a declaration as to the amount of the nutrients or substances with a nutritional or physiological effect present in the product; (d) an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written; (e) the quantity of nutrients, where applicable expressed in terms of percentage of the relevant recommended daily allowances as specified by the Indian Council of Medical Research and bear a warning, “Not to exceed the recommended daily usage”; (f) a statement that the health supplement is not be used as a substitute for a varied diet; 11 Version-I (29.09.2021) (g) a warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and published product or drug interactions, as applicable; and (h) a statement that the product is required to be stored out of reach of children. (4) No food business operator shall use additives for health supplement formulation except those specified in Schedule VA or Schedule VE or Schedule VF. 7. Nutraceuticals.– (1)(i) The nutraceuticals shall provide a physiological benefit and help maintain good health. (ii) A food business operator may extract, isolate and purify nutraceuticals from food or non-food sources, that is preparing amino acids and their derivatives by bacterial fermentation under controlled conditions. (iii) A food business operator may prepare and sell the nutraceuticals in the food- format of granules, powder, tablet, capsule, liquid, jelly or gel, semi-solids and other formats and may be packed in sachet, ampoule, bottle, and in any other format as measured unit quantities except those formats that are meant for parenteral administration. (2) (i) The nutraceuticals shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule IV or Schedule VI or Schedule VII or Schedule VIII. Amendment for substitution of highlighted provision 1[(i) The nutraceutical shall contain ingredients specified in Schedule VI. It may also contain singly or in combination with any of the ingredients specified in Schedule I, Schedule II, Schedule IV, Schedule VII and Schedule VIII.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (ii) A food business operator may use ingredients specified in the Schedules referred to in clause (i) of sub-regulation (2) in manufacturing an article of food containing nutraceuticals without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product; (iii) The quantity of nutrients added where applicable, shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, the standard laid down by international food standards body, namely Codex Alimentarius Commission shall apply; 12 Version-I (29.09.2021) (iv) A nutraceutical which is not provided in these regulations but its safety has been established in India or in any other country, shall be manufactured or sold in India only on prior approval of the Food Authority; (v) For the purposes of clause (iv), a food business operator shall apply to the Food Authority for approval which shall be accompanied by documented history of usage of at least fifteen years in India, or thirty years in the country of origin; (vi) The Food Authority may from time to time specify the nutraceuticals as approved by it after undertaking proper scientific evaluation. (3) (i) No ingredient other than those specified in Schedule VI shall be used as nutraceutical with standardisation to marker compounds specified and at daily usage levels specified therein; (ii) The ingredient for which the standardisation of the marker coumpound has not been specified shall comply with manufacturer specifications or quality requirements and purity criteria as specified in regulation 3; (iii) For the ingredient for which the daily minimum and maximum usage levels have not been specified, the food business operator shall adopt the usage level based on relevant scientific data and retain the documentary evidence of such data; (iv) For the purpose of clause (iii), the food business operator shall submit the documented scientific data to the Food Authority as and when called for; (v) No food business operator shall use the extract of ingredient as nutraceutical other than that specified in Schedule IV; Provided that the ingredient of plant or botanical origin specified in Schedule IV and Schedule VI may be used either in the given form, or their extract, subject to the extractive ratios in relation to the daily usage value. (4) (i) The labelling, presentation and advertisement shall not claim that the nutraceutical has the property of preventing, treating or curing a human disease, or refer to such properties; (ii) The statement by the food business operator relating to the structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data; (iii) Every package of food containing nutraceutical shall carry the following information on the label, namely:- 13 Version-I (29.09.2021) (a) the word “NUTRACEUTICAL”; (b) the common name of the nutraceutical; (c) a declaration as to the amount of each nutraceutical ingredient in the product that either has a nutritional or physiological effect; (d) where it is appropriate, the quantity of nutrient shall be expressed in terms of percentage of the relevant recommended daily allowances as specified by the Indian Council of Medical Research even when the nutrient is present along with a nutraceutical as an adjunct and shall bear an advisory warning ‘not to exceed the stated recommended daily usage’; (e) an advisory warning for ‘recommended usage’ ; (f) an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written; (g) an advisory warning in cases where a danger may exist with excess consumption; (h) an advisory warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable; (i) a statement that the product is required to be stored out of reach of children; (5) No food business operator shall use additives for nutraceutical formulation except those specified in Schedule VA or Schedule VE or Schedule VF. 8. Food for special dietary use, other than infants, and those products intended to be taken under medical advice. – Amendment for substitution of highlighted provision Food for special dietary use, other than infants, and those products intended to be taken under medical advice of physician or certified dietician or nutritionist [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (1) No food business operator shall manufacture, formulate or process an article of food for special dietary use unless- (i) specially processed or formulated to satisfy particular dietary requirements which may exist or arise because of certain physiological or specific health conditions, namely:- (a) low weight, obesity, diabetes, high blood pressure; 14 Version-I (29.09.2021) (b) pregnant and lactating women; 1[****] (c) geriatric population and celiac disease and other health conditions. Amendment for insertion of new provision 1[(d) food for Sportspersons.] th [Amendment in force from 6 September, 2021; FBOs to comply with the provisions by 1st April, 2022] (ii) The food business operator shall clearly indicate on the label whether or not the food for special dietary use is to be taken under medical advice; Amendment for insertion of new provision 1[Provided that food for special dietary use for sportsperson shall only be used under medical advice by physician or certified dietician or nutritionist.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (iii) A food business operator may manufacture or sell an article of food for special dietary use in single use packaging or in dosage form, namely, granules, capsules, tablets, pills, jelly, semi-solid and other similar forms, sachets of powder, or any other similar forms of liquids and powders designed to be taken in measured unit quantities with a nutritional or physiological effect; (iv) A food business operator may formulate an article of food for special dietary use in formats meant for oral feeding through enteral tubes but shall not be used for parenteral use; Amendment for insertion of new provision 1[Provided that food for special dietary use for sportsperson shall only be in formats meant for oral consumption] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (v) An article of food for special dietary use shall not include the normal food which is merely enriched or modified with nutrients and meant for mass consumption, intended for improvement of general health for day to day use and do not claim to be targeted to consumers with specific disease conditions and also not include the article of food intended to replace complete diet covered under food for special medical purpose specified in regulation 9. (2) (i) The articles of food for special dietary use shall contain any of the ingredients specified in Schedules I or Schedule II or Schedule III or Schedule IV or

Schedule VI or Schedule VII or Schedule VIII. 15 Version-I (29.09.2021) Amendment for substitution of highlighted provision 1[(i) The food for special dietary use shall contain singly or in combination of any of the ingredients specified in Schedule I, Schedule II, Schedule IV, Schedule VI, Schedule VII and Schedule VIII.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (ii) A food business operator may use the ingredients specified in the Schedules referred to in clause (i) of sub-regulation (2) in manufacturing food for special dietary use without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. (iii) For any new nutrient, which has no history of use in India or that without a proof establishing that the nutrient may result in certain nutritional and physiological benefits, the food business operator shall apply to the Food Authority with justification for approval, and the Food Authority may, from time to time specify the nutrients approved by it after proper scientific evaluation. (iv) A food business operator may add the quantity of the nutrients at a level higher than the recommended daily allowance, but not exceeding the limits of vitamins and minerals specified in Schedule III. Amendment for substitution of highlighted provision 1[(iv) The food business operator shall add the quantity of the nutrients at levels equal to a maximum of one Recommended Dietary Allowances or below. Provided that product with higher Recommended Dietary Allowances in food format (except tablet, capsule, syrup) may be allowed subject to prior approval of the Food Authority which shall be based on adequate scientific evidence.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (v) (i) The articles of food used as a formula food presented as a replacement for all meals of the daily diet for slimming, weight management and weight control purposes shall comply with the following, namely:- (a) provide energy not less than 800 kcal (3,350 kJ) and not more than 1,200 kcal (5,020 kJ); (b) the individual portions or servings contained in the formula food shall provide approximately one-third or one-fourth of the total energy of the food in the pack depending on whether the recommended number of portions or servings per day is three or four, as the case may be, respectively. (ii) A formula food presented as a replacement for one or more meals of the daily diet shall comply with the following, namely:- 16 Version-I (29.09.2021) (a) provide energy not less than 200 kcal (835 kJ) and not more than 400 kcal (1,670 kJ) per meal; (b) when such products are presented as a replacement for the major part of the diet, the total energy intake shall not exceed 1,200 kcal (5,020 kJ). (iii) Not less than twenty five per cent and not more than fifty per cent of the energy available from the food, when ready-to-serve, shall be derived from its protein content and the total amount of protein shall not exceed 125 g per day. (iv) The quality of protein shall have- (a) the protein digestibility corrected amino acid score of 1.0 known as,the reference protein; (b) the protein digestibility corrected amino acid score where less than 1.0, the minimum level shall be increased to compensate for the lower protein quality; (c) the protein with a protein digestibility corrected amino acid score of 0.8 or more shall be used in a formula food for use in a weight control diet; and (v) For improving the protein quality, the food business operator shall add only L- forms of essential amino acids except for methionine where DL form is allowed. (vi) Not more than thirty per cent of the energy available from fat and not less than three per cent of the energy from linoleic acid in the form of a glyceride. (vii) A formula food represented as a replacement for all meals per day, shall not have less than a hundred per cent of the reccommended daily allowance of vitamins and minerals in the daily intake. (viii) The formula food for special dietary use shall have adequate dietary fiber. Amendment for insertion of new provision 1[(ix) The food for special dietary use as a formula food for replacement of all meals of the daily diet for slimming, weight management and weight control purposes shall not be considered as food for special dietary use for a sportsperson.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (3) (i) No statement or claim shall be made on the label implying prevention, cure or treatment of any specific disease or its diagnosis or otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, unless otherwise approved by the Food Authority; (ii) The statement by the food business operator relating to the structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data; 17 Version-I (29.09.2021) (iii) Every package containing food for special dietary use shall carry the following information on the label, namely:- (a) the words “FOOD FOR SPECIAL DIETARY USE” followed by “Food for……...” (mentioning the particular physiological or health condition)”; (b) a statement “For weight control and management" in close proximity to the name of the articles of food specially prepared for weight management and control; Amendment for insertion of new provision 1[(ba) a statement “FOR SPORTSPERSON ONLY" in close proximity to the name of the articles of food, “Recommended to be used under medical advice by a physician or certified dietician ornutritionist only” and the logo as specified below for the article of food specially prepared for sportsperson. cFSDU "V5~ - FOR - SPORTSPERSONS ] th [Amendment in force from 6 September, 2021; FBOs to comply with the provisions by 1st April, 2022] (c) a statement that the product is not to be used by pregnant, nursing and lactating women or by infants, children, adolescents and elderly, except when medically advised; Amendment for substitution of highlighted provision 1[(c) a statement that the product is not to be used by pregnant, nursing and lactating women or by infants, children under 5 years, adolescents and elderly except when medically advised: Provided that in case of the article of food specially prepared for sportsperson, a statement that the product is not to be used by pregnant, nursing and lactating women or by infants, children under 5 years and elderly.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (d) a statement on the target consumer group, rationale for use of the product and a description of the properties or characteristics that make it useful; (e) if the product has been formulated for a specific age group, a prominent statement to that effect; 18 Version-I (29.09.2021) Amendment for substitution of highlighted provision 1[(e) if the product has been formulated for a specific age group, sports activity as per the approved list of Sports Authority of India (Ministry of Youth Affairs and Sports, Government of India), a prominent statement to that effect;] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (f) a statement specifying the nutrient which is reduced, deleted, increased or otherwise modified, relating to normal requirement, and the rationale for the reduction, deletion, increase or other modification; (g) an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written; (h) a warning in cases where a danger may exist with excess consumption; (i) a warning that the product is not for parenteral use; Amendment for insertion of new provision 1[Provided that a statement ‘for oral consumption only’ for the article of food specially prepared for sportsperson;] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (j) a warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable; (k) the quantity of nutrients expressed in terms of percentage of the recommended daily allowance where it is appropriate; (l) information on osmolality or osmolarity or on acid-base balance where appropriate; and (m) a statement that the product shall be stored out of reach of children. Amendment for insertion of new provision 1[(n) a statement ‘the food is not a sole source of nutrition and shall be consumed in conjunction with a nutritious diet’ for the article of food specially prepared for sportsperson; (o) a statement ‘the food shall be used in conjunction with an appropriate physical training or exercise regime’ for the article of food specially prepared for sportsperson.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (4) No food business operator shall use additives for food for special dietary uses, except those specified in Schedule VB or Schedule VE or Schedule VF. 19 Version-I (29.09.2021) Amendment for insertion of new provision 1[(5) Advertisement of food for special dietary use for general public shall clearly indicate that the product is to be taken under medical advice, wherever applicable. (6) Prohibited substances declared by the World Anti-Doping Agency (WADA) shall not be added in any of the articles of food specified for sport persons. Food business operator must ensure to check the list of prohibited substances which is published annually by the World Anti-Doping Agency and is effective from the January 1 every year.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 9. Food for special medical purpose.- (1) (i) Food for special medical purpose shall include food specially prepared for weight reduction and intended as total replacement of normal diet. (ii) A food business operator may formulate food for special medical purpose in format meant for oral feeding through enteral tubes. (iii) The articles of food for special medical purpose shall not be used for parenteral use. (iv) The articles of food for special medical purpose, other than those intended for infants, may either be nutritionally complete food which, when used in accordance with the manufacturer's instructions, shall constitute the sole source of nourishment for the persons for whom they are intended or nutritionally incomplete food with formulation specific for a disease, disorder or medical condition, but are not suitable to be used as the sole source of nourishment. (v) For the purposes of these regulations, the food for special medical purpose may be classified in to following three categories, namely:- (a) ‘nutritionally complete food with a standard nutrient formulation’, which when used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended; (b) ‘nutritionally complete food with a nutrient-adopted formulation specific for a disease, disorder or medical condition’, which when used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended; and (c) ‘nutritionally incomplete food with a standard formulation or a nutrient- adopted formulation specific for a disease, disorder or medical condition’, which is not suitable to be used as the sole source of nourishment. 20 Version-I (29.09.2021) Note.- the food specified in sub-clauses (b) and (c) of clause (v) may be used as a partial replacement or as a supplement to the person’s diet. (2) (i) Food for special medical purpose shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule III or Schedule IV or Schedule VII or Schedule VIII or enzymes only of Schedule VI . Amendment for substitution of highlighted provision 1[(i) Food for special medical purpose shall contain any of the ingredients specified in

Schedule I, Schedule II, Schedule IV, Schedule VI (enzymes only), Schedule VII and

Schedule VIII.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (ii) A food business operator shall use only the ingredients specified in the Schedules referred to in clause (i) of sub-regulation (2) in manufacturing food for special medical purpose without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. (iii) A food business operator may apply to the Food Authority for any new nutrient, which has no history of use in India or those without proof establishing that the nutrient may result in certain nutritional and physiological benefits with justification for approval and the Food Authority may from time to time specify the nutrients approved by it after proper scientific evaluation. (iv) The articles of food specially prepared for weight reduction and intended as total replacement of complete diet shall, apart from complying with Schedule III, shall also ensure the following, namely:- (a) that a formula food for very low energy diet is prepared according to instructions, with a daily energy intake of 450-800 kcal as the only source of energy; (b) that not less than 50 g protein with a protein digestibility corrected amino acid score of 1 is present in the recommended daily intake of energy, and essential amino acids may be added to improve protein quality only in amounts necessary for this purpose; (c) for the purposes of clause (b) the food business operator shall add only L- forms of essential amino acids except for methionine where DL form is allowed. (d) very low energy diet provides not less than- (I) 3 g of linoleic acid; and (II) 0.5 g α-linolenic acid in the recommended daily intake with the α- linoleic acid and linolenic acid ratio between 1:5 and 1:15; 21 Version-I (29.09.2021) (e) very low energy diet provides not less than 50 g of available carbohydrates in the recommended daily intake of energy; (f) that the formula food for special medical purpose have adequate dietary fiber. (v) In food for special medical purpose, nutrients may be added at levels higher than the recommended daily allowance, but not exceeding the limits of vitamins and minerals as specified in Schedule III. Amendment for substitution of highlighted provision 1[(v) Food business operator shall add the quantity of the nutrients at levels equal to a maximum of one Recommended Dietary Allowances or below. Provided that product other than food specially prepared for weight reduction and intended as total replacement of complete diet with higher RDA in food format (except tablet, capsule, syrup) may be allowed subject to prior approval of the Food Authority which shall be based on adequate scientific evidence.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (3) Every package of food for special medical purpose shall carry the following information on the label, namely:- (a) the words ‘FOOD FOR SPECIAL MEDICAL PURPOSE’ printed in the immediate proximity of the name or brand name of the product; (b) an advisory warning “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” appearing on the label in bold letters in an area separated from other written, printed or graphic information; (c) the statement “For the dietary management of ________” (with the blank to be filled in with the specific disease, disorderor medical conditionfor which the product is intended, and for which it has been shown to be effective) supported by appropriate scientific, and clinical or epidemiological data, and subject to its approval by the Food Authority; (d) a statement ‘NUTRITIONALLY COMPLETE’ if the food is intended to be used as a nutritionally complete food; (e) a statement on the rationale for use of the product by the target consumer group and a description of the properties or characteristics that make it useful; (f) a statement if the product has been formulated for a specific age group; 22 Version-I (29.09.2021) (g) a statement specifying the nutrient which have been reduced, deleted, increased or otherwise modified, relatiing to normal requirements, and the rationale for the reduction, deletion, increase or other modification; (h) the quantity of nutrients expressed in terms of percentages of the recommended daily allowances, where it is appropriate; (i) information on osmolality or osmolarity, Renal Solute Load, Potential Renal Solute Load or acid-base balance, wherever applicable; (j) instructions for appropriate preparation, feeding, use and storage of the product after the opening of the container; (k) a warning that the product is not for parenteral use; and (l) a statement that the product required to be stored out of reach of children. (4) No food business operator shall use additives for food for special medical purpose except those specified in Schedule VC or Schedule VD or Schedule VE or Schedule VF. (5) No food business operator shall advertise the food for special medical purpose for use by general public. 10. Food with added probiotic ingredients. – (1) (i) No food business operator shall use probiotic ingredients in food except the probiotic culture of the microorganisms specified in Schedule VII or those probiotic microorganisms approved by the Food Authority from time to time. Probiotic preparations may contain added prebiotics permitted under these regulations. (ii) The viable number of organisms in food with added probiotic ingredients shall be ≥108 CFU/g: Provided that a lower viable number may be specified with proven studies on -health benefits with those numbers subject to the prior approval of the Food Authority. Amendment for substitution of highlighted provision 1[(ii) The viable number of added probiotic organisms in food shall be ≥108 CFU in the recommended serving size per day;] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (iii) The Food Authority may, from time to time, specify the probiotic microorganisms approved by it after proper scientific evaluation: 23 Version-I (29.09.2021) Provided that the presence of the commonly used starter cultures of lactic acid producing bacteria such as Lactococcus spp., earlier known as Streptococcus spp., Lactobacillus spp. and other such microorganisms used in the preparation of fermented milk (dahi) and related products shall not be considered as probiotics, if the probiotic properties have not been substantiated. Note.- The guidelines issued by the Indain Council of Medical Research and Department of Biotechnology with respect to probiotics provide additional information on their use. (2) (i) The labelling, presentation and advertisement shall not claim that the probiotic food has the property of preventing, treating or curing a human disease, or refer to such properties. (ii) The statement by the food business operator relating to structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data. (iii) Every package of probiotic food shall carry the following information on the label, namely:- (a) the words “PROBIOTIC FOOD”; (b) genus and species including strain designation or culture collection number, where applicable, in brackets where probiotics are mentioned in the list of ingredients; (c) viable numbers at the end of the shelf-life of probiotic strain corresponding to the level at which the efficacy is claimed; (d) the recommended serving size which shall deliver the effective viable dose of probiotics related to health claims and recommended duration of use, proper storage temperature conditions, and time limit for ‘Best Use’ after opening the container; (e) an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written; and (f) a warning or any other precaution to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable. (3) No food business operator shall use additives in probiotic preparations except those specified in Schedule VA to Schedule VF. 11. Food with added prebiotic ingredients.– (1) (i) No food business operator shall use prebiotics in manufacturing food containing prebiotics except those specified in Schedule VIII or those prebiotics approved by the Food Authority from time to time. (ii) The prebiotic component, not an organism, to which the claim of being made, shall be characterised for a given product by providing the source, origin, purity, 24 Version-I (29.09.2021) chemical composition and structure, vehicle, concentration and amount in which it is to be delivered to the host. Amendment for insertion of new provision (iii) Maximum limit for prebiotic per day shall not exceed 40g/2000 kcal for adults. [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (2) (i) The labelling, presentation and advertising shall not claim that the prebiotic has the property of preventing, treating or curing a human disease, or refer to such properties. (ii) The statement by the food business operator relating to structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data. (iii) Every package of food containing prebiotics shall carry the following information on the label, namely:- (a) the words “PREBIOTIC FOOD”; (b) name of prebiotic; (c) the suggested or recommended serving size which shall deliver the effective dose of prebiotic related to the health claim; (d) an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written; (e) a warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable. (3) No food business operator shall use additives in prebiotic preparations except those specified in Schedule VA to Schedule VF. 12. Specialty food containing plant or botanical ingredients with safe history of usage.- (1) (i) A food business operator shall use only plant or botanical ingredients specified in Schedule IV for the preparation of specialty food containing plant or botanical ingredients. (ii) The plant or botanical ingredient which is not specified in these regulations but its safety has been established in India or in any other country, may be 25 Version-I (29.09.2021) manufactured or sold in India only after taking prior approval of the Food Authority. (iii) The application for approval to the Food Authority shall be accompanied by documented history of usage of at least fifteen years in India, or thirty years in the country of origin. (2) The health supplement or nutraceutical or food for special dietary use or food for special medical purpose may contain the ingredient as specified in Schedule IV, formulated either alone or in combination of ingredients or botanicals or their extracts either in unprocessed or in approved processed forms, formulated in a regular or conventional food format such as liquid or syrup, suspension or powder, granule, tablet or capsule or any other format approved by the Food Authority. (3) (i) Every manufacturer or importer shall prepare and maintain a product information file, which shall contain information on the ingredients from

Schedule IV used, finished product quality confirmation, and the test methods to demonstrate the presence of the active ingredient in the food. (ii) The usage level of the specialty food containing plant or botanical ingredients shall not exceed those levels specified in Schedule IV: Provided that the usage level may be distributed or provided, or formulated for delivery in one portion daily, or distributed in more than one portion to be taken in a day. (iii) To use any other plant or botanical ingredient, which is not specified in Schedule IV, the food business operator shall seek prior approval of the Food Authority by submitting- (a) a product information file containing information on the material used; (b) quality confirmation, test methods to demonstrate the presence of the ingredient in the food; (c) relevant published literature providing scientific and technical information of the material or product related to safety and health benefits; and (d) any human intervention study published or conducted, and other relevant information. 26 Version-I (29.09.2021) (iv) The product information file shall be produced for inspection and review by the Food Authority as and when called for. (v) The product information file shall primarily consist of technical and scientific information covering the following, namely:- (a) information on quality of all raw ingredients with official scientific or botanical name; (b) details of formulation or block diagram and brief description of the processing methods or steps adopted; (c) shelf life study data; (d) quality specifications and test methods for analysis of the finished product; (e) safety and pharmacological information, literature base, and additional study, if any conducted; (f) information on human studies, if any; (g) regulatory status in other countries, if any; and (h) any other relevant product information. (4) No food business operator shall use additives for preparation of specialty food containing plant or botanical ingredients except those specified in Schedule VE or Schedule VF. 13. Novel food.– (1)(i) For the purposes of these regulations novel food is a food that- (a) may not have a history of human consumption; or (b) may have any ingredient used in it which or the source from which it is derived, may not have a history of human consumption; or (c) a food or ingredient obtained by new technology with innovative engineering process, where the process may give rise to significant change in the composition or structure or size of the food or food ingredients which may alter the nutritional value, metabolism or level of undesirable substances. (ii) No novel food shall be manufactured or imported for commercial purpose without the prior approval of the Food Authority by filing an application along with all relevant documents and details as specified by the Food Authority from time to time. (2) The labelling of novel food shall be- (i) in accordance with the specific labelling requirements, if any; or 27 Version-I (29.09.2021) (ii) specific to claims relating to the novel product; or (iii) as per the category notified by the Food Authority in the specific regulations. 28 Version-I (29.09.2021) Schedule – I [See regulations 3.(13), 4.(2), 6.(2)(i), 7.(2)(i), 8.(2)(i) and 9.(2)(i)] List of vitamins and minerals and their components S.No. Vitamins and Minerals Components A. Vitamins- 1. Vitamin A (i) Retinol – all trans retinol (ii) Retinyl acetate (iii) Retinyl palmitate 2. Provitamin A (i) Beta-Carotene 3. Vitamin B1 (i) Thiamine chloride hydrochloride (ii) Thiamine mononitrate 4. Vitamin B2 (i) Riboflavin (ii) Riboflavin 5’- phosphate, sodium 5. Vitamin B6 (i) Pyridoxine hydrochloride (ii) Pyridoxal 5’-phosphate 6. Vitamin B12 (i) Cyanocobalamin (ii) Hydroxocobalamin 7. Vitamin C (i) L-ascorbic acid (ii) Sodium-L-ascorbate (iii) Calcium-L-ascorbate (iv) Potassium-L-ascorbate (v) 6-palmitoyl-L-ascorbic acid (vi) Ascorbyl palmitate 8. Vitamin D (i) Vitamin D3 (cholecalciferol) – Animal source (ii) Vitamin D2 (ergocalciferol) – Plant source Amendment for insertion of new provision 1[(iii) Vitamin D3 (cholecalciferol) – Lichen/Algae* (*The species of lichen/algae shall need prior approval of Food Authority)] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 9. Vitamin E (i) D-alpha-tocopherol (ii) DL-alpha-tocopherol (iii) D-alpha-tocopheryl acetate (iv) DL-alpha-tocopheryl acetate 29 Version-I (29.09.2021) S.No. Vitamins and Minerals Components (v) D-alpha-tocopheryl acid succinate (vi) DL-alpha-tocopheryl acid succinate (vii) DL-alpha-tocopheryl polyethylene glesol succinate Amendment for insertion of new provision 1[(viii) Tocotrienols] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 10. Vitamin K1 (i) Phylloquinone (ii) Phytomenadione (2-methyl 3-phytyl-1) (iii) 1,4-napthoquinone (iv) Phytonamidione 11. Vitamin K2 (MK-7) (i) Menaquinone 12. Vitamin K2 (MK-4) (i) Menatetrenone 13. Biotin (i) D-biotin 14. Folic Acid (i) n-pteroyl-l-glutamic acid 15. Niacin (i) Nicotinic acid (ii) Nicotinamide (iii) Nicotinic acid amide 16. Pantothenic acid (i) D-pantothenate, calcium (ii) D-pantothenate, sodium (iii) D-panthenol (iv) DL- pantholnol (v) Sodium-D-pantothenate Note.- Addition of appropriate overages to ensure adequate availability of vitamins in the products shall be permitted based on scientific rationale. However, the maximum proportion of overages shall not exceed as given in the Table ‘C’, below, unless scientifically justified. Labels of such products shall make a declaration of the same as “appropriate overages added” in the composition declaration Panel. B. Minerals (Chemical sources) 1. Calcium (i) Calcium carbonate (ii) Calcium chloride (iii) Calcium salts of citric acid (iv) Calcium gluconate (v) Calcium glycerophosphate (vi) Calcium orthophosphate 30 Version-I (29.09.2021) S.No. Vitamins and Minerals Components (vii) Calcium hydroxide (viii) Calcium oxide (ix) Calcium phosphate, monobasic (x) Calcium phosphate, dibasic (xi) Calcium phosphate, tribasic (xii) Calcium sulphate (xiii) "J Calcium from algal source (Algus calcarius) Amendment for substitution of highlighted provision 1[(xiii) Calcium from algae including red seaweed] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] (xiv) Calcium lactate Amendment for insertion of new provision 1[(xv) natural forms of calcium obtained from corals, shells, pearls, conch, oysters and milk] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 2. Chloride (i) Calcium chloride (ii) Choline chloride (iii) Magnesium chloride (iv) Manganese chloride (v) Potassium chloride (vi) Sodium chloride 3. Chromium (i) Chromium (III) chloride (ii) Chromium (III) sulphate 4. Copper (i) Cupric carbonate (ii) Cupric citrate (iii) Cupric gluconate (iv) Cupric sulphate (v) Copper lysine complex Amendment for insertion of new provision 1[(vi) Copper oxide (copper (II) oxide, cupric oxide and black copper oxide)] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 5. Iodine (i) Sodium iodide 31 Version-I (29.09.2021) S.No. Vitamins and Minerals Components (ii) Sodium iodate (iii) Potassium iodide (iv) Potassium iodate 6. Iron (i) Ferrous succinate (ii) Ferrous citrate (iii) Ferric ammonium citrate (iv) Ferrous gluconate (v) Ferrous fumarate (vi) Ferric sodium di-phosphate (vii) Ferrous lactate (viii) Ferrous sulphate (ix) Ferric di-phosphate (x) Ferric saccharate (xi) Ferrous bis glycinate (xii) Hydrogen reduced iron (xiii) Sodium iron EDTA (xiv) Carbonyl iron (xv) Ferrous orthophosphate (xvi) Ferrous sodium pyrophosphate (xvii) Elemental iron (xviii) Electrolytic iron 7. Magnesium (i) Magnesium aspartate (ii) Magnesium carbonate (iii) Magnesium chloride (iv) Magnesium gluconate (v) Magnesium phosphate dibasic (Magnesium hydrogen phosphate) (vi) Magnesium phosphate tribasic (Trimagnesium phosphate) (vii) Magnesium oxide (viii) Magnesium sulphate 8. Manganese (i) Manganese carbonate (ii) Manganese chloride (iii) Manganese citrate (iv) Magnanese sulphate (v) Magnanese gluconate 32 Version-I (29.09.2021) S.No. Vitamins and Minerals Components (vi) As amino acid chelate 9. Molybdenum (i) Ammonium molybdate (Molybdenum (VI) (ii) Sodium molybdate (Molybdenum (VI) (iii) As amino acid chelate 10. Phosphorous (i) Potassium glycerophosphate (ii) Potassium phosphate, monobasic (iii) Potassium phosphate, dibasic 11. Potassium (i) Potassium bicarbonate (ii) Potassium carbonate (iii) Potassium chloride (iv) Potassium citrate (v) Potassium gluconate (vi) Potassium glycerophosphate (vii) Potassium lactate (viii) Potassium monobasic phosphate (ix) Potassium dibasic phosphate 12. Selenium (i) Sodium selenate (ii) Sodium selenite (iii) Sodium hydrogen selenite (iv) Selenomethionine Amendment for insertion of new provision 1[(v) Selenious acid] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 13. Sodium (i) Sodium bicarbonate (ii) Sodium carbonate (iii) Sodium chloride (iv) Sodium citrate (Trisodium citrate) (v) Sodium gluconate (vi) Sodium lactate (vii) Sodium phosphate monobasic (Sodium dihydrogen phosphate) (viii) Sodium phosphate dibasic (disodium hydrogen phosphate) (ix) Sodium sulphate 14. Zinc (i) Zinc acetate 33 Version-I (29.09.2021) S.No. Vitamins and Minerals Components (ii) Zinc chloride (iii) Zinc citrate (iv) Zinc gluconate (v) Zinc lactate (vi) Zinc oxide (vii) Zinc carbonate (viii) Zinc sulphate 15 Boron (i) Boron proteonate Note- Suitable esters and salts of vitamins and salts and chelates of minerals may be used Amendment for substitution of highlighted provision 1[Suitable esters, derivatives and salts of vitamins and salts and chelates of minerals may be used. Food business operator shall notify in writing to Food Authority, whenever they use such esters, salts, chelates and derivatives. FBOs shall be required to submit additional safety data/information when requested by the Food Authority for such cases.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] Table C. Permissible overages* S.No. Micronutrient Overage (per cent) 1. Vitamin A 30 2. Vitamin C 20 3. Vitamin D 30 4. Vitamin E 10 5. Thiamine (vitamin B1) 25 6. Riboflavin (vitamin B2) 25 7. Niacin (vitamin B3) 10 8. Vitamin B6 25 9. Vitamin B12 25 10. Folic acid 25 11. Pantothenic acid 10 12. Vitamin K1 30 13. Minerals 10 14. Iodine 20 * Overage means the amount of excess nutrients added above label claim during manufacture as a means of maintaining at least the claimed amount of the ingredient(s) for the normal shelf life of the product to compensate for the expected manufacturing / storage loss and to allow for variation in assay performance. Where overages are more than those listed in Schedule I, Table C, the same shall be scientifically substantiated. 34 Version-I (29.09.2021) Schedule – II [See regulations 3.(13), 4.(2), 6.(2)(i), 7.(2)(i), 8.(2)(i) and 9.(2)(i)] List of amino acids and other nutrients A. Essential Amino Acids (i) L-Histidine (xii) L-Aspartic acid (ii) L-Histidine hydrochloride (xiii) L-Argine L-aspartate (iii) L-Isoleucine (xiv) L-Threonine (iv) L-Isoleucine hydrochloride (xv) L- Alanine (v) L-Leucine (xvi) L-Phenylalanine (vi) L-Leucine hydrochloride (xvii) L-Cyststeine hydrochloride (vii) L-Lysine (xviii) L-Tyrosine (viii) L-Lysine hydrochloride (xix) L-Arginine (ix) DL-Methionine (xx) L-Tryptophan (x) L-Cysteine (xxi) L-Valine (xi) L-Cysteine hydrochloride (xxii) L-Arginine hydrochloride B. Non- Essential Amino Acids (i) L-Carnitine (xv) L- Proline (ii) L-Carnitine hydrochloride (xvi) L-Lycine-L-glutamate dihydrate (iii) Carnitine, acetyl-L (xvii) Megnesium L- aspartate (iv) L-Glutamic acid (xviii) Calcium L- glutamate (v) L-Glutamine (xix) Potassium – L- glutamate (vi) Glycine (xx) Carnitine tartrate (vii) L-Hydroxylysine (xxi) Taurine (viii) L-Hydroxyproline (xxii) Choline (ix) L-Lycine acetate (xxiii) Choline chloride (x) N-acetyl-L-cysteine (xxiv) Choline citrate (xi) L- Ornithine (xxv) L-Serine (xii) L-Ornithine mono hydrochloride (xxvi) Tyrosine, acetyl-L (xiii) L-Lycine –L- aspartate (xxvii) Choline hydrogen tartrate (xiv) L-Citruline (xxviii) Myo-inositol C. Nucleotides (i) Adenosine 5-monophosphate (v) Disodium uridine 5-monophosphate (AMP) (ii) Cystidine 5-mono phosphate (vi) Disodium guanosine 5-mono phosphate (CMP) (iii) Guanosine 5-mono phosphate (vii) Disodium ionosine 5-mono phosphate (GMP) (iv) Inosine 5-mono phosphate (IMP) Note.- Suitable esters and salts of amino acids may be used. Amendment for substitution of highlighted provision 1[Suitable esters, derivatives, isomers and salts of amino acids may be used. Food business operator shall notify in writing to Food Authority, whenever they use such esters, salts, isomers and derivatives. Food business operator shall be required to submit additional safety data or information when requested by the Food Authority for such cases.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 35 Version-I (29.09.2021) Schedule – III [See regulations 3.(13), 4.(2), 8.(2)(i), 8.(2)(iv), 9.(2)(i), 9.(2)(iv) and 9.(2)(v)] Values for vitamins, minerals and trace elements allowed to be used in food for special dietary use and food for special medical purpose (other than those intended for use in infant formula) Amendment for substitution of highlighted provision 1[[See regulations 3(13), 4(2) and 9(2)(iv)] Values for vitamins, minerals and trace elements allowed to be used in Food for special medical purpose (other than those intended for use in infant formula)] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 1. Vitamins RDA for Vitamins Vitamins Per 100 kJ Per 100 kcal Minimum Maximum* Minimum Maximum* Vitamin A (µg RE) 8.4 43 35 180 Vitamin D (µg) 0.12 0.65 (0.75)1 0.5 2.5 (3)1 Vitamin K (µg) 0.85 5 3.5 20 Vitamin C (mg) 0.54 5.25 2.25 22 Thiamin (mg) 0.015 0.12 0.06 0.5 Riboflavin (mg) 0.02 0.12 0.08 0.5 Vitamin B6 (mg) 0.02 0.12 0.08 0.5 Niacin (mg NE) 0.22 0.75 0.9 3 Folic acid (µg) 2.5 12.5 10 50 Vitamin B12 (µg) 0.017 0.17 0.07 0.7 Pantothenic acid (mg) 0.035 0.35 0.15 1.5 Biotin (µg) 0.18 1.8 0.75 7.5 0.5/g of 0.5/g of poly polyunsaturated unsaturated fatty acids fatty acids expressed as expressed as Vitamin E (mg α-TE) 0.75 3 linoleic acid but linoleic acid but in no case less in no case less than 0.1 mg per 0.1 mg per 100 100 available kJ available kcal (1): For products intended for children of 1 to 10 years of age; NE – Niacin equivalent; TE – Tocopherol equivalent. * When no upper safe level (maximum permissible level higer than 1 (100 percent ) RDA) 36 Version-I (29.09.2021) has been specified for a particular vitamins and minerals, the content of such nutrient shall not exceed NOAEL (No observed adverse effect level) or one tenth of LOAEL (Lowest observed adverse effect level) 2. Minerals 2 RDA for Minerals Minerals Per 100 kJ Per 100 kcal Minimum Maximum* Minimum Maximum* Sodium (mg) 7.2 42 30 175 Chloride (mg) 7.2 42 30 175 Potassium (mg) 19 70 80 295 Calcium (mg) 8.4 (12)1 42 (60)1 35 (50)1 175 (250)1 Phosphorus (mg) 7.2 19 30 80 Magnesium (mg) 1.8 6 7.5 25 Iron (mg) 0.12 0.5 0.5 2.0 Zinc (mg) 0.12 0.36 0.5 1.5 Copper (µg) 15 125 60 500 Iodine (µg) 1.55 8.4 6.5 35 Selenium (µg) 0.6 2.5 2.5 10 Manganese (mg) 0.012 0.12 0.05 0.5 Chromium (µg) 0.3 3.6 1.25 15 Molybdenum (µg) 0.72 4.3 3.5 18 (1): For products intended for children of 1 to 10 years of age; *When no upper safe level (maximum permissible level higer that 1 (100 per cent) RDA) has been specified for a particular nutrient the content of such nutrient shall not exceed NOAEL (No observed adverse effect level) or one tenth of LOAEL (Lowest observed adverse effect level) 37 Version-I (29.09.2021) Schedule – IV [See regulations 3.(13), 4.(2), 6.(2)(i), 7.(2)(i), 7.(3)(v), 8.(2)(i), 9.(2)(i), 12.(1)(i), 12.(2), 12.(3)(i), 12.(3)(ii) and 12.(3)(iii)] List of plant or botanical ingredients S. No. Botanical name and part used Common Permitted range of usage name for adults per day (given in terms of raw herb/ material) 1. Abelmoschus esculentus (L.) Moench. Fruit/Root Bhindi 5-10 g (as powder) 2. Abies spectabilis (D.Don) / A. pindrow Royle Leaves Talis patra / 2-4 g (as powder) Talis bhed 3. Asculus indica colebs./ A. hippocastanum Fruit /kernel Indian Horse 10-20 g Chestnut/ kanar 4. Abelmoschus moschatus Seed Lata kasturi 3-5 g 5. Abutilon indicum (L.) Sweet ssp. Indicum / A. fruiticosum Seed/Root Atibala 5-10 g (as powder) 6. Acacia arabica Willd. (Now known as Acacia nilotica (L.) Willd. ex Del. ssp. indica (Benth.) Brenan) Gum Babbula 5-10 g Stem bark Babbula 5-10 g 7. Acacia catechu Extract Katha/khair 1-3 g 8. Achyranthes aspera (L.)/ A. bidentala Seed/Plant Chirchida 3-5 g (as powder) 9. Adhatoda zeylanica / A. vasaka Leaf/Root/Flower Adusa/Vasa 5-10 g 10. Aegle marmelos (L.) Corr. Unripe fruit pulp Bael 5-10 g Ripe fruit Bael 50-100 g (as pulp) Leaves/Bark Bael 5 -10 g (as pulp) Pather/Bael chhal 11. Ajuga bracteosa wall Plant Neel Kanthi 2-3 g 12. Alangium salvifolium (L.f.) Wang. ssp. salvifolium Fruit Ankota 10-20 g (as powder ) 13. Albizia lebbeck (L.) Benth/A. Procera/A.odoratissima Flower Siris 3-6 g (as powder) Seed Siris 1-3 g (as powder) 38 Version-I (29.09.2021) Stem bark Siris 3-6 g Leaf Siris 3-6 g (as powder) 14. Alpinia galanga Rhizome Kulanjan 2-4 g 15. Allium cepa L. I 10-20 g Bulb Pyaja 10-20 ml (as juice) Seed Pyaja 1-3 g (as powder) Leaf Pyaja 20-40 g (as vegetable) 16. Allium sativum L. Bulb Lahsuna 3-6 g (Not recommended during pregnancy) Leaf Lahsuna 20-40 g (as vegetable) 17. Allium stracheyi Bakerno Whole plant Farana 2-3 g 18. Alocasia indica Spach (Now known as Alocasia macrorhiza (L.) G. Don) Tuber Mankanda 5-10 g 19. Aloe barbadensis Mill. / A. Ferox / A. vera Leaf Ghikvar 5-10 g Dry leaf juice Elua - 0.5 -1 g Mussabar 20. Althaea officinalis Linn Flower/Root Resh-Khatmi 5-10 g (as powder) 21. Alternanthera sessilis (L.) R. Br. ex DC. Whole plant Gudarisaga 3-5 g (as powder) 22. Amaranthus gangeticus L. (Now known as Amaranthus tricolor L.) / Amaranthus blitum L. Aerial part Lal marsa – 10-20 g (as leafy Sag marsa vegetable) 23. Amaranthus spinosus L. / A. paniculatus L. (A. hybridus L.) Whole plant Chaulai Kateli 20-30 g (as leafy / Jal Chaulai vegetable) 24. Amomum aromaticum Roxb. / A. aromaticum Seed Bangiya Ela 2-4 g (as powder) 25. Amomum subulatum Roxb./ A. aromaticum Fruit Badi Elaichi 1-3 g (as powder) Seed Badi Elaichi 1-2 g (as powder ) 26. Amorphophallus campanulatus (Roxb.) Blume ex Decne Corm Jimikanda 20-50 g (as vegetables) 27. Anacardium occidentale L. Fruit Kernel Kaju 10-20 g 28. Anacyclus pyrethum DC. Root Akarkara 100 - 250 mg (as powder) (Not recommended for children below 5 years) Seed Akarkara 100 - 250 mg (as powder) (Not recommended for children below 5 years) 29. Ananas comosus (L.) Merr. Pineapple 50-100 g (as fruit) 50-100 ml (as juice) (Not recommended during pregnancy) 30. Anethum sowa Roxb. ex Flem. (Now known as Anethum graveolens L.) 39 Version-I (29.09.2021) Fruit Sowa 3-6 g (as powder (fruit)) Leaf Sowa 10-20 g (as powder (leaf)) 31. Angelica glauca Edgew./ Angelica archangelica L. Root and Root stock Chora 1-3 g (as powder) 32. Annona squamosa L./A.reticulata /A. muricata/ A. Cherimola Fruit pulp Shareefa / 20-30 g (as fruit pulp) Shareefa bhed Leaf Shareefa 3-5 g (as powder) (Not recommended for children below 16 years) 33. Apium leptophyllum (Pers.) Muell. / A. Graveolens Linn. Fruit Ajamod / 1-3 g (as powder) Ajmoda bhed 34. Arachis hypogaea L. Seeds Chinia Badam 10-20 g / Mungphali Seed oil Mungaphali 5-10 ml tail 35. Areca catechu L. Seed Supari 1-2 g (as powder) (only to be used after shodhana (purification) ) (Not recommended for children below 5 years) 36. Artemisia absinthium Linn / Whole plant Afsantin / 3-6 g Astimisia / Chauhar / 37. Artocarpus heterophyllus Lam. Ripe / unripe fruit Katahal 20-50 g Seeds Katahal 5-10 g 38. Artocarpus lakoocha Roxb. Ripe Fruit / unripe fruit Badhal 20-30 g Seed Badhal 5-10 g 39. Arnebia nobilis/A. benthamii Root Ratanjot 2-4 g 40. Asparagus adscendens Roxb. Tuberous root Safed musali 3-6 g (as powder) 41. Asparagus officinalis L. Root Shatavar 3-6 g (as powder) bhed Tender Shoots Shatavar 20-50 g bhed 42. Asparagus racemosus Willd. Tuberous root Sitawar 3-6 g (as powder) Tender Shoots Sitawar 20-50 g 43. Asparagus sarmentosus Linn. Tuberous root Badi Shataver 3-6 g (as powder) 44. Avena sativa L. Seed Oat 10-30 g (as powder) 45. Averrhoa carambola L. Fruit Kamarakh 10-20 g 46. Azadirachta indica A. Juss. 40 Version-I (29.09.2021) Leaf Neem 1-3 g (as powder) (Not recommended for males and females planning to conceive) Fruit Neem 1-2 g (as pulp) (Not recommended for males and females planning to conceive) (Not recommended for children below 5 years) Flower Neem 2-4 g (as powder) Root bark Neem 3-6 g (as powder) 47. Bambusa arundinacea (Retz.) Willd. Tender shoots (Young leaf) Bansh 20-30 g (as vegetable) Seed Bansh chaval 20-30 g (as powder) Crystals Bansalochan 0.5-2g (as powder) 48. Bacopa monnieri Whole plant Brahmi 5-10 g (as powder) Extract Brahmigha 1-2 g 49. Basella alba L. Leaf Poyi Saag 20-30 g (as vegetable) 50. Bauhinia variegata L. / Bauhinia purpurea L. / B. tomentosa. Linn Stem bark Kachnar / 3-6 g Sona Flower / Buds Kachnar / 10-20 g (as juice) Sona 51. Benincasa hispida (Thunb.) Cogn. Fruit Petha, Bhatua 30-50 g (as vegetable) 52. Berberis aristata DC./ B. asiatica / B. lycium / B. vulgaris Fruit Daruhaldi 5-10 g (as fruit) Stem extract Rasaunt 0.5-1 g 53. Beta vulgaris L. Tuber Chukandar 10-20 ml (as juice) 54. Boerhaavia diffusa L. (Now known as Boerhaavia repens L. var. diffusa (L.) Hook.f.) / B. verticillata Aerial part Saag itsit 20-30 g (as aerial parts) Root Vishkhaprs 10-15 g (as root) 55. Bombax ceiba L. Stem bark Semal 5-10 g Flower Semal 10-20 ml (as juice) Gum Semal 1-3 g (as powder) Root Semal Musali 5-10 g (as powder) 56. Bombax malabarica / Salmalia malabarica Fruit/Flower/Root Semal/Semar 10-20 g 57. Boswellia serrata Roxb. Oleoresin Salai guggal 2-4 g 58. Borassus flabellifer L. Dried inflorescence Tarkul/Taad 1-3 g (as powder) Seed pulp of unripe fruit Tarkul/Taad 10-30 g Exudate of stem / sap Tarkul/Taad 100-200 ml (as juice) 59. B. verticillata 10-15 g Root 60. Brassica campestris L. (Now known as Brassica rapa L. sp. campestris (L.) Clapham) Seed Sarson 10-20 g (as paste) Seed oil Sarson 10-20 ml 41 Version-I (29.09.2021) Leaf Sarson 10-30 g (as leafy vegetable) 61. Brassica juncea (L.) Czern. Seed Rai 1-2 g Leaf Rai 10-20 g (as leafy vegetable) 62. Brassica nigra (L.) Koch. Seeds Banarasi rai 0.5-1 g 63. Brassica rapa L. Tuber Shalgam 20-40 g Leaf Shalgam 20-30 g (as vegetable) 64. Buchanania lanzan Spreng. Seed Cherounjee 5-10 g (as powder) 65. Butea monosperma Seed/Gum/Root/Bark Dhark 3-6 g 66. Bixa orellana Annato Plant 1-3 g 67. Caesalpinia bonducella (L.) Flem. (Now known as Caesalpinia bonduc (L.) Roxb.) Leaf Karanjuva 2-3 g Seed Karanjuva 2-3 g 68. Cajanus cajan (Linn.)Millsp. Seed Arahar / 30-50 g Tuvar 69. Camellia sinensis Tea leaf / extract Chaya / Tea 1-2 g extract Tea catachins Green tea 0.5-1 g catechins 70. Canavalia ensiformis sensu Baker (Now known as Canavalia gladiata (Jacq.) DC.) Seed Sema 5-10 g 71. Canscora decussata (Roxb.) J.F. and J.H. Schult. Leaf Bangiya 2-4 g (as powder) Sankhapuspi 72. Capparis decidua (Forssk.) Edgew. Fruit Kareer / Dela 10-20 g 73. Capsicum annum L. var. annum Unripe fruit Hari Mircha 1-2 g (Not recommended for children below 5 years) Ripe fruit Lal Mircha 0.5-1.0 g (as powder) (Not recommended for children below 5 years) 74. Capsicum frutescens L. Fruit Simla Mirch 30-50 g (as vegetable) 75. Carica papaya L. Ripe fruit Papita 50-100 g (as ripe fruit ) Unripe fruit Papita 30 -50 g (as unripe fruit) 76. Carissa carandas L. Fruit Karounda 5-10 g 77. Carissa spinarum L. Fruit Karawan 5-10 g 78. Carthamus tinctorius L. Flower Head Barre 2-4 g (as powder) Seed Barre 2-4 g (as powder) Seed oil Barre –tail 5-10 ml 42 Version-I (29.09.2021) 79. Carum carvi L. Fruit Syaha jeera 1-3 g (as powder) 80. Cassia absus L. Seed Chaksu 2-5 g 81. Cassia occidentalis L. Leaf Kasoundi 5-10 g Seed Kasoundi 1-3 g 82. Cassia tora L. Leaf Chakvad / 10-20 g Chakarmard Seed Chakwad 3-5 g (as powder) 83. Cassia fistula Fruit pulp Amaltas 10-20 g (as pulp) Seed Amaltas 2-5 g (as seed) 84. Cassia angustifolia/ C. acutifolia Seed/leaves Sanay / 3-6 g Senna 85. Cedrus deodar Roxb. Seed/Wood/Oil Devdar 5-10 g /2-4 ml 86. Celosia argentea L. var. argentea Seed Surwali / 3-6 g Safed murga 87. Celastrus paniculatus Seed/Oil Malkanguni 5-10 g, (as powder (seed)) 2-4 ml (as oil) 88. Centella asiatica (L.) Urban Leaf/Whole Plant Brahmi 20-30 g (as vegetable) (Galpatri) Extract Brahmi 1-3 g (Galpatri) 89. Centratherum anthelminticum Fruit/Seed Kali-jirii / 3-6 g Van- jirii 90. Chenopodium album L. Whole plant/leaves Bathua 20-30 g (as leafy vegetable) Seed Bathua 2-5 g 91. Chlorophytum borivillianum / C. Musali 5- 10 g arundinaceum/C. tuberosum 92. Cicca acida (L.) Merrill Fruit Harfa rewadi 10-20 g 93. Cicer arietinum L. Tender leaf Chana / 30-50 g (as leafy Kalachana vegetable) Seed Chana / 20-30 g Kalachana 94. Cichorium endivia Seed kasani 5-10g 95. Cinnamomum tamala Nees and Eberm. / C. wightii Leaf Tejapatra 2-3 g 96. Cinnamomum zeylanicum Blume (Now known as Cinnamomum verum J. S. Presl.) Stem bark Dalchini 1-2 g (Ceyloni) (Not recommended during 43 Version-I (29.09.2021) pregnancy) 97. Cissampelos pareria L. var. hirsuta (Buch.-Ham. ex DC.) Forman. Leaf / Plant Padhi 10-20 g (as powder) 98. Cissus quadrangularis L. Aerial part Hadjod 10-20 g (as wet chutney (paste)) Stem Hadjod 3-6 g 99. Citrullus colocynthis (L.) Schard. Fruit Indarun / 0.25-0.5 g (as powder) Indrayan ( Not recommended during pregnancy) 100. Citrullus vulgaris Schrad. ex Eckl.and Zeyh. var. fistulosus (Stocks) Stewart Fruit Tinda 20-40 g (as vegetable) 101. Citrullus lanatus (Thunb.) Matsura and Nakai Fruit pulp Tarbuj 50-100 g Seed Tarbuj 3-6 g Seed oil Tarbuj 1-3 ml 102. Citrus aurantifolia (Christm. and Panz.) Swingle Fruit Nimbu 3-5 ml (as juice) 103. Citrus limon (Linn.)Burm.f. Fruit Jameerinibu 5-10 ml (as juice) 104. Citrus maxima (Burm.)Merr. Fruit Chakotara 5-10 ml (as juice) 30-50 g (as fruit) 105. Citrus medica L.var. medica Fruit Bijoura 5-10 ml (as juice) 106. Citrus reticulata Blanc. Fruit Narangi 30-50 ml (as juice) 107. Citrus sinensis (L.) Osbeck Fruit Mousami 50-100 ml (as juice) 108. Clerodendrum phlomidis Whole plant Arani 10-20 g 109. Clerodendrum serratum Whole plant Bharangi 10-20 g 110. Coccinia grandis (L.) Voigt. / C. indica Leaf Kundru phal 5-10 g / Kuntru shak (Not recommended for children below 5 years) Stem Kundru 3-6 g (as powder) Whole plant Kundru 3-6 g (as powder) 5-10 ml (as juice) Fruit Kundru 20-50 g (as vegetable) 111. Cocos nucifera L. Endosperm Nariyal 10-20 g Water Nariyal jala 100-200 ml Flower Nariyal 5-10 g 112. Cocculus hirsutus (L.) Theob. Leaf Jalajamani 10-20 g 113. Coix lacryma-jobi L. Seed Gargri 10-20 g 114. Coffea arabica Seed/Dry/Green Coffea 3-5 g (Not recommended for children below 5 years) 44 Version-I (29.09.2021) 115. Coleus forskohlii / C.aromaticus Pathachoor, 5-10 g Parn-yavani ( Not recommended for children below 5 years) 116. Colocasia antiquorum Schott. (Now known as Colocasia esculenta (L.) Schott.) Rhizome Arui 20-30 g (as vegetable) (Not recommended for children below 16 years) 117. Commelina bengalensis L. Whole plant Kausar 3-6 g 118. Commiphora wightii Oleoresin Guggal 2-4 g (Not recommended for children below 5 years) 119. Commiphora myrrha Oleoresin Hirabol 2-4 g ( Not recommended for children below 5 years) 120. Convolvulus pluricaulis Whole plant Shankh- 10-20 g pushpi 121. Corchorus acutangulus Lam. (Now known as Corchorus aestuans L.) Aerial part Chench 10-20 ml 122. Corchorus capsularis L. Aerial part Narcha 10-20 ml (as juice) 123. Corchorus olitorius L. Aerial part Palva Saag 10-20 ml (as juice) 124. Cordia dichotoma Forst. f.(Cordia wallichii G.Don) Fruit Lisora 10-20 g 125. Cordia rotthii Roem. and Schult. (Now known as Cordia gharaf (Forssk.) Ehrenb and Asch. Fruit Chhota Lisora 10-20 g 126. Coriandrum sativum L. Fruit Dhaniya 1-3 g (as powder) Aerial part Dhaniya 10-20 ml (as juice) 127. Costus speciosus Kemuk 2-4 g (as powder) (Not recommended for children below 5 years) 128. Crataeva nurvala Fruit/Bark/leaf Varana 10-20 g 129. Crocus sativus L. Style and Stigma Kumkum 25-50 mg (Kesar) (Not recommended for children below 16 years) 130. Cucumis melo L. Fruit Kharbooja 50-100 g Seed Kharbooja 1-3 g (as powder) 131. Cucumis melo L. var. momordica Duthie and Fuller Fruit Phoot 40-50 g (as vegetable) 132. Cucumis melo L. var. utilissimus (Roxb.)Duthie and Fuller Seed Kakri 3-6 g Fruit Kakri 50-100 g (as vegetable) 133. Cucumis sativus L. Seed Khira 3-6 g (as powder) Fruit Khira 50-100 g (as vegetable) 134. Cucurbita maxima Duch. ex Lam. Seed Kashiphal 5 -10 g 45 Version-I (29.09.2021) Fruit Kashiphal 50-100 g (as vegetable) 135. Cucurbita pepo L. Fruit Safed Kaddu 50-100 g (as vegetable) / safed petha Seed Safed petha 5-10 g (as powder) 136. Cuminum cyminum L. Fruit Jeera 1-3 g (as powder) 137. Curculigo orchioides Gaertn. Tuber Kalimushli 3-5 g 138. Curcuma amada Roxb. Rhizome Amahaldi 5-10 g (as fresh ) 2-4 g (as powder) 139. Curcuma angustifolia Root Tavkshir 2-5 g 140. Curcuma longa L. Rhizome Haldi 2-5 g (as powder) Fresh Rhizome Haldi 5-10 ml (as juice) 141. Curcuma zedoaria Roxb. (Now known as Curcuma aromatica Salisb.) Rhizome Kachur 2-5 g (as powder) 142. Cyamopsis tetragonoloba Pod/Seed/Gum Guar, Guar 20-30 g (as powder: gum pod/seed) 5-10 g (as powder: gum) 143. Cymbopogon citratus (DC.) Stapf Whole plant Harichaya 1-3 g 144. Cymbopogon coloratus Stapf Aerial part Manjan pullu 1-3g 145. Cymbopogon jwarankusa (Jones) Schult. Root Lamajjaka 1-3 g 146. Cymbopogon martini (Roxb.)Wats. Whole plant Rosha ghas 1-3 g 147. Cynodon dactylon (L.) Pers. Leaf Duba 3-5 g 148. Cyperus rotundus L. Rhizome Nagarmotha 2-5 g 149. Daucus carota L. Tuberous root Gajar 50-100 g (as vegetable) 50-100 ml (as juice) Seed Gajar 1-2 g (as powder) (Not recommended during pregnancy) 150. Desmodium gangeticum / D. latifolium Whole plant Sarvan 5-10 g 151. Dillenia indica L. Fleshy fresh sepals (Fruit) Chalta 40-50 g (as vegetable) 152. Dioscorea alata L. / D. deltoidea Tuber/Corm Kathalu 10-20 g 153. Dioscorea bulbifera L. Tuber Genthi / 20-30 g (as vegetable) Taradi 5-10 g (as powder) Extract Genthi / 1-2 g (as extract) Taradi 154. Dioscorea esculenta (Lour.) Burkill 46 Version-I (29.09.2021) Tuber Suthani 5-10 g 155. Dioscorea pentaphylla L. Tuber Kantalu 5-10 g 156. Diplezia maxima Tender shoots Lungru 30-50 g 157. Diospyros peregrina Gurke (Now known as Diospyros malabarica (Desr.) Kostel) Ripe fruit Gab 50-100 g Unripe fruit Gab 4-8 g (as powder) 158. Dolichos biflorus L. (Now known as Vigna unguiculata (L.) Walp.) Seed Kulathi 30-50 g 159. Dolichos lablab L. (Now known as Lablab purpureus (L.) Sweet) Seed Sem 20-40 g (as seed) Tender Pod Sem 30-40 g (as vegetable) 160. Echinochloa frumentacea Link Fruit Sanwa 50-100 g 161. Eclipta prostata L. Whole plant Bhangra 3-6 g (as powder) 162. Elettaria cardamomum (L.) Maton Seed Choti elaichi 250-500 mg (as powder) 163. Eleusine coracana (L.) Gaertn. ssp. coracana Caryopsis Madua 20-50 g 164. Emblica officinalis Gaertn. (Now known as Phyllanthus emblica L.) Fruit Anwala / 20-30 g (as fresh fruit) Amla 3-6 g (as powder ) 5-10 ml (as juice) Extract 2-4 g (as extract) 165. Embelia ribes Burm. f. Fruit Bhabhiranga 1-2 g (Not recommended for females planning to conceive) 166. Enicostemma littorale Blume Mamejwa 2-3 g 167. Ephedra gerardiana Wall. Leaves/Whole plant Somlata 2-5g 168. Euphorbia neriifolia/ E. pilosa Stem (tender) after boiling / Leaf Thuhar 10-20 g (as stem) 3-5 g (as leaf) (Not recommended for children below 5 years) 169. Euryale ferox Salisb. Seed Makhana 20-30 g (as seed) 3-5 g (as powder) 170. Evolvulus alsinoides Plant Vishnukranta 10-20 g 171. Fagopyrum esculenttum Moench. Seed Kottu 50-100 g 172. Ferula asafoetida L. Oleo-gum resin Hing 125 mg, Max (as powder) 173. Ficus benghalensis L. Fruit / Shoots Baragad 40-50 g (as fruit)/ 5-10 g (as shoots) 174. Ficus carica L. / F. palmata/ F. lacor Fruit / Leaf Anjeer 20-30 g 175. Ficus glomerata Roxb. (Now known as Ficus racemosa L.) Fruit / Leaf Gular 20-30 g (as vegetable) 47 Version-I (29.09.2021) 176. Ficus hispida L.f. Fruit Kathgulara 10-20 g (Kakodumba) Tender leaf Kathgulara 20-40 ml (as juice) 177. Ficus religiosa L. Fruit Pipal 5-10 g Tender Leaf Pipal 5-10 g 178. Flacourtia jangomas (Lour.)Raeusch syn. F. cataphracta Roxb. ex Willd. Fruit Paniyala 10-20 g 179. Flacourtia ramontchi L’Herit (Now known as Flacourtia indica (Burm.f.) Merr.) Fruit Katai / 5-10 g Kanghu 180. Foeniculum vulgare Mill. Fruit Sounf 5-10 g (as powder) 181. Fumaria vaillantii (Lois.) Hook. f. and Thoms. var. indica Haussk. (Now known as Fumaria indica (Haussk.) Pugsley) Leaves Pittapapda 5-10 g 182. Garcinia indica (Thour.) Choisy / G. cambogia Mature fruit / Butter/ Oil Kokam 10-20 ml (as juice) 5-10 g (as powder) 183. Garcinia pedunculata Roxb. ex Buch.-Ham. Fruit rind Amalbeda 5-10 ml/g (as juice/Powder) 184. Gardenia turgida Roxb. (Now known as Ceriscoides turgida (Roxb.) Tirveng.) Gum Kharahar 1-3 g (as powder) 185. Gisekia pharnaceoides L. Leaf Baluka Saga 5-10 g 186. Glycine max (L.) Merr. Seed Soyabean 20-40 g 187. Glycyrrhiza glabra L. Root and Stolon Mulethi 5-10 g (as powder) 188. Gmelina arborea Roxb. Fruit Gamhari 20-30 g 189. Gmelina asiatica L. Fruit Badhara 20-30 g 190. Gossypium herbaceum Seed/Root Kapas 10-20g 191. Grewia hirsuta Vahl Root Gulsakari 5-10 g 192. Grewia populifolia Vahl (Now known as Grewia tenax (Forssk.) Fiori) Stem bark / Fruit Gangeran 5-10 g (as powder) 193. Grewia tiliaefolia Vahl / G.sclerophylla Fruit Dhamin 20-30 g 194. Gymnema sylvestre Plant Gudmar 5-10 g Extract Gudmar 1-2 g 195. Gynandropsis gynandra (L.) Briq. (Now known as Cleome gynandra L.) Seed Hurhur 1-3 g (as powder) Whole plant Hurhur 10-20 ml (as juice) 196. Habenaria intermedia Root tuber, Rhizome Ridhi 3-5 g 197. Hedychium spicatum Ham ex Smith Rhizome Kapur- 3-5 g 48 Version-I (29.09.2021) Kachari 198. Hemidesmus indicus Root / Stem Anantmula 3-6 g 199. Hibiscus rosa-sinensis L. Flower Gudahal 1-3 g (as powder) (Not recommended during pregnancy) 200. Hibiscus sabdariffa L. Leaf Patawa 5-10 g (as powder) Seed Patawa 1-3 g (as powder) Ripe calyx Patawa 5-10 g (as powder) 201. Hippophae rhamnoides L. / H. salicifolia Fruit / Leaf Amlavetasa 10-20 g Extract Amalvets 1-3 g 202. Hordeum vulgare L. Fruit Jaou 100-200 g (as powder) Whole plant Jaou 10-20 g 203. Hygrophila spinosa Makhana / 20-30 g Tal makhana 204. Hypericum perforatum Leaf Basant 3-6 g Plant extract Basant 1-1.5 g (as extract) 205. Illicium verum Hook. f. Fruit Badiyan 250 - 500 mg As powder - Khatai 206. Inula racemosa. Hook Root Pushkar mool 3- 6 g (as powder) 207. Ipomoea aquatica Forssk. Leaf Kalamisaag 20-30 g 208. Ipomoea batatas (L.) Lam. Tuber Shakarkand 20-30 g 209. Ipomoea digitata auct. non L. (Now known as Ipomoea mauritiana Jacq.) Root/Tuber Bilaikand 3-6 g 210. Juglans regia Linn. Fruit/Leaf/Bark Akhrot 10-20 g 211. Juniperus communis Flower/Leaf Hauber 5-10 g 212. Lagenaria vulgaris Ser. (Now known as Lagenaria siceraria (Mol.) Standl.) Fresh fruit Alabu 100 -150 g (as vegetable) Seed Alabu 1-3 g (as powder) 213. Lagerstroemia indica Leaf Jarul 6 - 12 g (as powder ) Fruit extarct Frash 1-2 g (as extract) 214. Lagerstroemia parviflora Leaf Sidh 6-12 g (as powder) Fruit extract Sidh 1-2 g (as extract) 215. Lens culinaris Medik. Seed Masura 20-40 g (as seed) 216. Lepidium sativum L. Seed Chansur 3-6 g (as powder) (Not recommended during pregnancy) Aerial part Chansur 50-100 g (as vegetable) 49 Version-I (29.09.2021) 217. Leptadenia reticulata (Retz.)W. and A. Leaf Dodisaka 20-30 g (as vegetable) 218. Leucas cephalotus (Koenig ex Roth) Spreng. Leaf Guma 20-30 g 219. Limonia acidissima L. Fruit Kaith 20- 40 g (as fruit) 220. Linum usitatissimum L. Seed Atasi 10-20 g Seed Oil Atasi 10-20 ml 221. Litchi chinensis Sonner Fruit Litchi 50-100 g 222. Luffa acutangula (L.)Roxb. Whole plant Torai 5 -10 g (as powder) Fruit Torai 30-50 g (as vegetable) Seed Torai 1-3 g (as powder) 223. Luffa cylindrica (L.)M. Roem. Fruit Nenua 20-40 g (as vegetable) Seed Nenua 1-3 g (as powder) 224. Lycopersicon esculentum Mill. (Now known as Lycopersicon lycopersicum (L.) Karsten.) Fruit Tamatar 20-40 g (as vegetable) 225. Madhuca indica Gmel.(Now known as Madhuca longifolia (Koen.) Macbride var. latifolia) Flower Mahua 10-15 g (as flower) Fruit Mahua 10-15 g Seed oil Koyna ka tel 2-5 ml 226. Madhuca longifolia (Koenig) Macbride var. longifolia Flower/Fruit Jal mahua 10-15 g 227. Malva sylvestris L. Fruit Gulkhair 5-7 g (as powder) Leaf Gulkhair 3-6 g (as powder) 228. Mangifera indica L. Ripe fruit Aam 50-150 g Unripe fruit pulp Aam 10-30 g Seed Kernel Aam Beej / 1-2 g (as powder) Majja Leaf Aam 3-5 g Extract Amara (ghan) 0.5-1 g 229. Maranta arundinacea L. Rhizome Ararota 10-30 g (as powder) 230. Marsilea minuta L. Leaf Chowpatia 20-30 g (as vegetable) 2-4 g (as powder) Extract Chowpatia 1-2 g (as extract) 231. Mentha spicata L. Mentha arvensis L. / M. aquatica Linn. Aerial part Pudina 5-10 g 232. Mentha piperata L./ Mentha species Peppermint/ 10-30 mg Sat pudina 233. Mesua ferrea Linn. Stemen/Flower Nagkesar 2-5 g 234. Microstylis musifera Ridley Tuber Jivaka 5-10 g 50 Version-I (29.09.2021) 235. Microstylis wallichii Lindl. (Now known as Malaxis acuminate D. Don) Tuber Rishabhka 5-10 g 236. Mimosa pudica Whole plant/Seed Lajwanti 3-6 g 237. Mimusops elengi L. Pericarp Maulsiri 20-40 g Flower Maulsiri 5-10 g Stem bark Maulsiri 3-5 g 238. Mimusops hexandra Roxb. (Now known as Manilkara hexandra (Roxb.) Dub.) Pericarp Khirni 20-40 g 239. Momordica charantia L. Fresh fruit / Seed Karela 30-50 g (as vegetable) 3-5 g (as seed) (Not recommended for females planning to conceive) (Not recommended for children below 5 years) 240. Momordica dioica Roxb. ex Willd. Root Khekhasa 3-6 g (as powder) Fruit Khekhasa 30-50 g 241. Monochoria vaginalis (Burm.f.)Presl. Rhizome Indivara 3-6 g 242. Moringa oleifera Lam. / M.concanensis Nimmo Leaf Sahijan / 10-20 g (as vegetable or Muringya / paste) Lal sehanjan Seed Sahijan / 2-6 g (as vegetable) Muringya Pod Sahijan / 40-80 g Muringya Flower Sahijan / 10-20 g Muringya Stem bark Sahijan / 10-20 g Muringya 2-5 g (as powder) 243. Morus alba L. / M. Indica / M.nigra Fruit / Leaves / Bark / Flower Shahtoot 20-30 g (as fruit) 3-5 g (as leaf ) 244. Moschella esculenta/M. elata Plant Guchhi 10-30 g 245. Mucuna pruriens (L.) DC. Root Kawach 10-20 g Pod Kawach 20-30 g (as vegetable) Seed Kawach 5-10 g 246. Murraya koenigii (L.) Spreng. / M. exotica Linn (kamini) Leaf / Fruit Kadhipatta 5-10 g 247. Musa paradisiaca L. Flower Kela 20-30 g Fresh shoot Kela 20-50 g 10-20 ml (as juice) Ripe Fruit Kela 100-200 g Unripe Fruit Kela 50-100 g 248. Myrica esculenta Buch. Ham. / M. nagi Hook Fruit Kaiphal 5-10 g Stem bark Kaiphal 2-3 g 51 Version-I (29.09.2021) 249. Myristica fragrans Houtt. Seed Jaiphala 0.25- 1.0 g (Caution: excessive use may cause giddiness) Aril Javitri 0.25 -1 g (as powder) 250. Myristica malabarica Lam. Seed Jangali 0.5 -2 g Jayaphala Aril Jangali javitri 0.25 -1 g 251. Nardostachys jatamansi Jatamansi 2-5 g 252. Nasturtium officinale/ N. aquaticum Water-cress 20-40 g 253. Nelumbo nucifera Gaertn. Flower Kamal 3-6 g (as powder) Rhizome Bhen 30-50 g Stalk Murar 30-50 g (as powder) Seed Kamalgatta 3-6 g (as powder) 254. Nymphaea alba Linn/ N. rubra/ N. stellate Rhizome/ Seed/ Flower Kamlini 10-20 g 3-6 g (as flower) 255. Nigella sativa L. Seed Kalaunji 5-10 g (Not recommended during pregnancy) 256. Nyctanthes arbortristis L. Flower Harshringara 1-2 g Leaf Harshringara 1-3 g 257. Nymphaea rubra Roxb. ex Salisb Flower Lal Kumud 3-6 g (as powder) 258. Nymphaea stellata Willd. Flower Neelofer 3-6 g (as powder) 259. Ocimum basilicum L. Leaf (Bhavari 3-6 ml (as juice) Tulsi) 1-3 g (as powder) Niajboo Seed Tulasi 125-250 mg (Jangali) 260. Ocimum gratissimum L. Leaf Ram Tulasi 2-4 g (as powder) (Mumbai) 261. Ocimum sanctum L. (Now known as Ocimum tenuiflorum L.) Leaf Tulasi 2-5 g Seed Tulasi 1-2 g 262. Olea europaea Seed/Oil Jaitun/Tail 10-20 g/ml 263. Onosma bracteatum Whole plant/Leaf Gaujvan 5-10 g 264. Onosma hispidum Root Ratanjol 3-5 g 265. Operculina turpethum Root/seed Nishoth 3-5 g (Not recommended for children below 5 years) 266. Opuntia vulgaris / O. dillenii Fruits Nagphani 10-20 g 267. Orchis latifolia L. (Now known as Dactylorhiza hategeria (D. Don) Soo) 52 Version-I (29.09.2021) Tuber Salampanja 5-10 g (as powder) 268. Origanum majorana L. Leaf Marubaka 5-10 drops (as juice) 269. Oroxylum indicum Bark/Seed Shyonok 5-10 g 270. Oryza sativa L. Seed Chawal - shali 100-200 g (as powder) 271. Oxalis corniculata L. Leaf Tinpatia 5-10 ml (as juice) 272. Pandanus odoratissimus L.f. Oil / Flower Kewada 2-5 drops /2-5 g 273. Panicum miliaceum L. Seed Cheen 50-100 g 274. Papaver somniferum L. Seed Postadana 2-5 g (as powder) 275. Parmelia perlata Whole plant Chharila 3-5 g 276. Paspalum scrobiculatum L. Seed/Caryopsis Kodo 50-100 g 277. Paspalum scrobiculatum Fruit/Seed Kodon 30-500 g 278. Pedalium murex Bada gokharu 5-10 g 279. Pennisetum typhoideum L. C. Rich. (Now known as Pennisetum americanum (L.) K. Schum.) Seed Bajra 20-40 g 280. Peucedanum graveolens (L.) Benth. and Hook.f Seed Shepu 1-3 g 281. Phaseolus aconitifolius Jacq. (Now known as Vigna aconitifolia (Jacq.) Marechal) Seed Moth 20-50 g 282. Phaseolus aureus Roxb. (Now known as Vigna radiata (L.) Wilczek var. radiata) Seed Jangali 20-50 g moong 283. Phaseolus lunatus L. Pod Sem 25-50 g (as pulse) 284. Phaseolus mungo L. (Now known as Vigna mungo (L.) Hepper) Seed Urad - 20-50 g (as pulse) 285. Phaseolus radiatus L. / P. trilobus sensu Seed Moong 50-100 g (as pulse) 286. Phaseolus vulgaris L. Pod Lobia 10-20 g (as pulse) 287. Phoenix dactilifera L. Fruit Chuhara / 20-50 g Khajur 288. Phoenix sylvestris (L.) Roxb. / P. acaulis Fruit Khajoor 20-50 g Nira (Sap) Khajoor 30-50 ml (as fresh juice) 289. Phyllanthus amarus / P. urinaria Plant Tamlaki 5-10 g (as plant) Extract Tamlaki 1-2 g (as extract) 290. Physalis alkekengi L. Fruit Kaknaj 5-10 g 291. Physalis minima L. 53 Version-I (29.09.2021) Fruit Papoto 10-20 g 292. Physalis peruviana L. Fruit Rasbhari 10-20 g 293. Pimpinella anisum L. Fruit Anisoon 1-3 g 294. Pinus excelsa Fruit /Oil Kail 5-10 g/1-2 ml (Not recommended for children below 5 years) 295. Pinus gerardiana Wall. Endosperm Chilgoja 5-10 g 296. Pinus roxburghii Fruit /Oil Chiia 5-10 g / 1-2 ml (Not recommended for children below 5 years) 297. Piper betle L. Leaf Pana 2-5 g (Not recommended below the age of 5 years) 298. Piper chaba Hunter (non Blume) (Now known as Piper retrofractum Vahl) Leaf Chabh 1-3 g (as powder) 299. Piper cubeba L.f. Fruit Kabab chini 1-3 g (as powder) 300. Piper longum L. Fruit Pipar 0.5-2 g (as powder) (Not recommended for prolonged use) 301. Piper nigrum L. Fruit Kali Maricha 0.5-2 g 302. Pistacia integerrima Stewart (Now known as Pistacia chinensis Bunge ssp. Integerrima (Stewart) Rech.f. Gall Kakadasingi 1-2 g 303. Pistacia vera L. Seed Pista 5-10 g 304. Pisum sativum L. Seed Matar 50-150 g (as vegetable) 305. Plantago ovata Forssk. Seed / Husk Isabgol 5-10 g (as vegetable) 306. Polygonatum cirrhifolium (Wall.) Royle Rhizome Meda 5-10 g 307. Polygonatum verticillatum (L.) All. Rhizome Mahameda 5-10 g 308. Portulaca oleracea L. Aerial part Kulpha - sag 20-30 g (as vegetable) 309. Portulaca quadrifida L. Aerial part Nonia - sag 20-30 g 310. Premna integrifolia / P. latifolia Whole plant / Bark Agnimanth 5-10g 311. Prunus amygdalus Baill. var. dulchin Kernel Badama 10-20 g Seed oil Badama ka 3-5 ml tel 312. Prunus armeniaca L. Pericarp Khumani 10-20 g Kernel Khumani 3-5 g 54 Version-I (29.09.2021) Seed oil Khumani 3-5 ml 313. Prunus cerasoides Wood/Flower Padamkasht 5-10 g / Pajja 314. Prunus persica (L.) Batsch. Pericarp Adu 10-20 g 315. Psidium guajava L. Fruit Amruda 20-50 g (as fresh fruit) Leaf Amruda 3-5 g 316. Pterocarpus marsupium Ht. Wood Vijaysar 5-10 g 317. Pterocarpus santalinus Ht Wood Lal chandan 5-10 g 318. Pueraria tuberosa (Roxb. ex Willd.) DC. Tuber Patal Kohda 10-20 g 319. Punica granatum L. Seed Anar 20-50 g (as seed) Fruit rind Anar 5-10 g (as fruit rind) 320. Putranjiva roxburghii Fruit Jiya-pota 3-6 g (Not recommended for children below 5 years) 321. Pyrus communis L. Fruit Nashpaati 50-100 g 322. Pyrus malus L. (Now known as Malus pumila Mill.) Fruit Seb 100-200 g 20-40 ml (as juice) 323. Raphanus sativus L. Root Muli 20-50 g Leaf Muli 20-50 g Seed Muli 125-250 mg 324. Reinwardtia indica Whole plant/leaf/ Basanti 5-10 g (as powder) extract 0.5-1 g (as extract) 325. Rhododendron arboreum Sm. / R. companulatum / R. lepidotum Wall Flower Buransa 20-30 g (as flower) Extract Buransa 2-3 g (as extract) 326. Rheum emodi Wall. ex Meissn. / R. officinale Leaf Revand chini 0.5-1 g 327. Rhus parviflora Roxb. ex DC. Fruit Samakdana 30-75 g 328. Ricinus communis Seed/Root/Leaf Erand 5-10 g (Not recommended for children below 5 years) 329. Rosa alba L. Flower Safed gulab 10-20 g 330. Rosa centifolia L. Flower Gulab 10-20 g (as flower) Oil Gulab 2-5 drop (as oil) 331. Rosa damascena Mill. Flower/oil Gulab Fasali 10-20 g / 2-5 drops 332. Roscoea procera Wall. Root tuber Kandamula 5-10 g (as powder) 55 Version-I (29.09.2021) 333. Rubia cordifolia Root/Stem Manjeeth 3-6 g 334. Rumex vesicarius L. Leaf Ambat 10-20 g chukka 335. Rumex nepalensis / R.maritimus / Shak/Fafru 20-40 g R.acetosella (Not recommended for children below 5 years) 336. Saccharum officinarum L. Stem / Juice /Root / Decoction Ganna 100-200 ml (as juice) (Not recommended for diabetics) Sugar Chini / 50-100 g Shakkar (Not recommended for diabetics) Jaggery Gud 50-100 g (Not recommended for diabetics) 337. Salacia chinensis L. / Salacia oblonga Wall. ex Wight and Arn / Salacia reticulata Wight / S. roxburghii / S. macrosperma Root Saptrangi 5-10 g Stem extract Saptrangi 0.5-1 g 338. Salvadora persica/ S. oleoides Fruit/Leaf Peelu / Bada 5-10 g pelu 339. Santalum album L. Oil Chandan ka 3-5 drops (as oil) tel Hard wood 1-2 g (as hard wood) 340. Saraca asoca Bark/Leaf Ashok 5-10 g (Not recommended for children below 5 years) 341. Saussurea lappa Root/Rhizome Kuth 3-5 g (Not recommended for children below 5 years) 342. Scindapsus officinalis Stem Gaj pippali 3-5 g 343. Scirpus kysoor Roxb. (Now known as Scirpus grossus (L.f.) Palla) Rhizome Kasheru 20-50 g (as vegetable) 344. Selinum tenuifolium / S.vaginatum Rhizome /Root Bhootkesi 3-5 g 345. Sesamum indicum L. (Now known as Sesamum orientale L.) Seed Tila 10-20 g Oil Tila 5-10 ml 346. Sesbania grandiflora (L.) Poir. Flower Agathi 10-20 g (as vegetable) Leaf Agathi 10-20 g 347. Setaria italica (L.) P. Beauv. Seed Kangu 10-50 g 348. Sida cordifolia L. / S. rhombifolis Linn/ S. acuta Whole plant / Extract Bariyara 10-30 g Seed Bariyara 3-5 g 349. Solanum indicum / S.surattense / S.torvum Whole plant Kantkari 5-10 g Fruit extract Kateli 1-2 g (as extract) 56 Version-I (29.09.2021) 350. Solanum melongena L. Fruit Baigan 50-100 g 351. Solanum nigrum L. Leaf / Plant Choti Makoy 30-60 g 352. Sorghum vulgare Pers. Seed Jwara 50-100 g 353. Sphaeranthus indicus Flower Gorakmundi 5-10 g 354. Spinacia oleracea L. Leaf Palak 50-100 g 355. Spondias mangifera Willd. (Now known as Spondias pinnata (L.f.) Kurz.) Fruit / Leaf Ambada 20-50 g 1-3 g (as powder) 356. Strychnos potatorum L. Seed Nirmali 5-10 g (as powder) 357. Swertia chirayita / S.ciliata / S.angustifolia Whole plant Chiraita 3-5 g (as whole plant) Extract Chiraita 0.5-1 g (as extract) 358. Symplocos racemosa Bark/Leaf Lodhar 3-5 g 359. Syzygium aromaticum (L.)Merr. and L.Perry Flower bud Laung 0.5-1 g 360. Syzygium cuminii (L.) Skeels Pericarp and mesocarp Jamun 10-50 g Seed Jamun 5-10 g 361. Tacca aspera Roxb. Tuber Bhevara ke 20-50 g kand 362. Tamarindus indica L. Fruit pulp Imali 5-10 g (Not recommended during skin ailments) Seed Imali 5-10 g 363. Tephrosia purpurea Whole plant Sarponkha 5-10 g 364. Teramnus labialis (L.f.) Spreng. Whole plant Mashaparni 20-50 g 365. Terminalia arjuna Bark/Leaf/Fruit Arjun 5-10 g Extract Arjun 0.5 -1 g (as extract) 366. Terminalia belerica (Gaertn.) Roxb. Fruit pericarp Bahera 3-5 g (as fruit pericarp) Extract Bahera 0.5-1 g (as extract) 367. Terminalia catappa L. Kernel Desi badama 10-20 g 368. Terminalia chebula Retz. Fruit pericarp Harad 3-5 g (as powder) Extract Harar 0.5-1 g (as extract) 369. Terminalia tomentosa Stem/Bark/Leaf Jarandrum / 5-10 g Asan 370. Thymus serpyllum auct. non L. (Now known as Thymus linearis Benth.) Leaf Ban ajwain 1-3 g (as powder) 57 Version-I (29.09.2021) 371. Trachyspermum ammi (L.) Sprague Seed Ajwain 1-3 g (as powder) Leaf Ajwain 10-20 g 372. Trapa bispinosa Roxb. (Now known as Trapa natans L. var. bispinosa (Roxb.) Makino) Endosperm / Fruit Singhada 30-60 g 373. Trianthema portulacastrum L. Whole plant Swet 10-20 g I punarnava 374. Tribulus terrestris Fruit/Whole plant Gokhru 5-10 g 375. Tricholepis glaberrima Plant Brahm dandi 3-6 g 376. Trichosanthes anguina L. Fruit Chichinda 30-60 g 377. Trichosanthes dioica Roxb. Fruit/ Leaf Parawal 30-60 g 378. Trigonella foenum-graceum L. Seed Methi 5-10 g Leaf Methi 50-100 g 379. Triticum aestivum L. Seed Gehun 50-100 g Tender shoot/spout Ankurita 10-50 g Gehu 380. Typhonium trilobatum (L.) Schott. Tuber Konchu 20-50 g 381. Tinospora cardifolia Miers. (menispermaceae) Syn. T. glabra (n. Burm) Roots/stem 5-10 g (as powder) 10-20 ml (as decoction) 400 mg, Max (as sattva) Extract 1-2 g 382. Urtica parviflora / U. dioica Tender Leaf Bicchubuti 10-20 g 383. Uraria picta Whole plant Pithvin 5-10 g 384. Valeriana jatamansi Jones / V. wallichii Rhizome Tagar 1-3 g (as powder) 385. Vetiveria zizanioides Whole plant Khas 10-20 g 386. Vigna trilobata (L.) Verdc. Whole plant Mugvan 20-50 g 387. Viola odorata / V. pilosa / V. sylvestris Whole plant/Flower Vanksha 3-5 g (Not recommended for children below 5 years) 388. Vitex agnus-castus Linn. Seed / Leaf Renuka beej / 3-6 g Sage (Not recommended for children below 5 years) 389. Vitex negundo / V. trifolia Fruit/Seed/Leaves Nirgundi 3-5 g 390. Vitis vinifera L. Fruit Munakka 10-30 g Seed / Fruit skin Munakka 1-3 g 58 Version-I (29.09.2021) 391. Wedelia calendulacea (L.) Less. (Now known as Wedelia chinensis (Osbeck) Mer.) Leaf Pila bhagra 5-10 g (as powder) 392. Withania coagulans (Stocks) Dunal Fruit Paneer Doda 5-10 g 393. Withania somnifera (L.) Dunal. Root Asgandh 3-6 g (as powder) Extract Asgandh 0.5-1 g (as extract) 394. Woodfordia fruticosa Flower Dhay ke 5-10g phool 395. Wrightia tinctoria / W.tomentosa Bark/Leaf/Seed Meetha kutaj 5-10 g 396. Zanthoxylum alatum Roxb. (Now known as Zanthoxylum armatum DC.) Seed / Stem bark Timura 1-3 g 397. Zea mays L. Seed Makka 20-100 g Anthers Makka 5-10 g 398. Zingiber officinale Rosc. Rhizome Adrakh 5-10 g (Not recommended during hypertension and bleeding disorders) 399. Zizyphus jujuba Lam. Pericarp Ber 10-50 g 400. Zizyphus nummularia (Burm.f.)W. and A. Pericarp Jangali Ber / 15-30 g Jhar ber Note 1.- Ingredients listed in the above Schedule shall be used after due processing or in their extract forms subject to permissible usage range given in the last column of the Table. Offering these ingredients, either alone or in combinations as such or minimally processed (cleaned, de-weeded, sorted, dried or powdered) is/are not permitted. Note 2.- The ingredients listed above shall comply with Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. Note 3.- Permitted range of usage for children between 5-16 years is ½ of the permitted range of usage for adults. Note 4.- Permitted range of usage for children between 1-5 years is ¼ of the permitted range of usage for adults. 59 Version-I (29.09.2021) Amendment for substitution of Schedule IV 1[Schedule – IV [See regulations 3.(13), 4.(2), 6.(2)(i), 7.(2)(i), 7.(3)(v), 8.(2)(i), 9.(2)(i), 12.(1)(i), 12.(2), 12.(3)(i), 12.(3)(ii) and 12.(3)(iii)] List of plant or botanical ingredients S.No. Botanical name and part used Official and common names, Permitted range of usage for adults per day (given in terms of raw herb/ material) 1. Abelmoschus esculentus (L.) Moench. Fruit/Root Bhindi 5-10 g (as powder) 2. Abies spectabilis (D.Don) / A. pindrow Royle / Abies webbiana Lindl (syn) Leaf/ Fruit Talis patra / Talis bhed 2-3 g (as powder) 3. Asculus indica colebr./ A. hippocastanum Fruit /Kernel Ban-khoda / Indian Horse 3 – 5 g (as powder) Chestnut Extract 300 – 500 mg 4. Abelmoschus moschatus / Hibiscus abelmoschus (syn) Seed Lata kasturi 1-2 g 5. Abutilon indicum (L.) Sweet ssp. indicum / A. fruiticosum Seed/Root / Stem Atibala / kanghibala 3 – 4 g (as powder) 6. Acacia arabica Willd. (Now known as Acacia nilotica (L.) Willd. ex Del. ssp. indica (Benth.) Brenan Gum Babbul 1-3 g Bark 5-10 g 7. Acacia catechu Extract / heartwood Khadir/ Katha/khair 1-3 g 8. Acacia leucophloea Willd/A. farnesiana (syn) Bark/Leaf Airmed/Trimed 3-5 g 60 Version-I (29.09.2021) Seed/Gum 2-3 g 9. Achillea millefolium Linn. / A. Lanulosa Nutt. (syn) Leaf Gandana/Biranjaasif 2-3 g (as powder) 10. Achyranthes aspera (L.)/ A. bidentala Seed/Plant Apamarga / Chirchida 5-8 g (as powder) 11. Acorus calamus Linn. Leaf Vachha/Waj/Vacha 60-125 mg (as powder) 12. Adhatoda zeylanica / A. vasaka Stem/ Leaf /Root/ Flower Vasa / Adusa 5-10 g 13. Aegle marmelos (L.) Corr. Unripe fruit pulp Bilwa / Bael 5-10 g (as pulp) Ripe fruit pulp 30-50 g (as pulp) Leaf/Bark Bael Pather/ Bael chhal 3-6 g (as powder) 14. Ajuga bracteosa Wall. Plant Neel Kanthi 0.5 – 1 g 15. Alangium salvifolium (L.f.) Wang. ssp. salvifolium / A. lamarckii (syn) Fruit Ankota 2-6 g (as powder) 16. Albizia lebbeck (L.) Benth/A. procera/A. odoratissima Flower/ Stem bark / Leaf Shireesh / Siris 3-6 g (as powder) Seed Siris 1-3 g (as powder) 17. Alpinia galanga Rhizome Kulanjan 1-3 g (as powder) 18. Allium cepa L. Bulb Plandu / Pyaj 10-20 ml (as juice) Seed Pyaj 1-3 g (as powder) Leaf 20-40 g (as fresh) 61 Version-I (29.09.2021) 19. Allium sativum L. Bulb Rason/ Lahsun 1-3 g (Not recommended during pregnancy) Leaf Lahsun 10-20 g (as fresh) 20. Allium stracheyi Bakerno Whole plant Farran 2-3 g 21. Alocasia indica Spach (Now known as A. macrorhiza (L.) G. Don) Tuber Mankand / Kasnalu 5-10 g 22. Aloe barbadensis Mill. / A. Ferox / A. vera / A. indica Leaf Kumari / Ghikvar / Ghrit 5-10 g (as pulp) kumari Dried Pulp Elua -mussabar / kanyasar 0.5 – 1 g 23. Althaea officinalis Linn. Flower/Root Khatmi / Resha-khatmi 3-6 g (as powder) 24. Alternanthera sessilis (L.) R. Br. ex DC. Whole plant Matsyakshi / Gudarisaga 2-3 g (as powder) 25. Amaranthus gangeticus L. (Now known as A. tricolor L.) / A. blitum L. Aerial part Maaraish / Lal marsa -sag / 10-20 g (as fresh) marsa 26. Amaranthus spinosus L. / A. paniculatus L. (A. hybridus L.) Whole plant Tanduliya / Chaulai Kateli / 20-30 g (as fresh) Jal Chaulai 27. Amomum subulatum Roxb./ A. aromaticum Roxb. Fruit Sthula- elaa / Badi Elaichi 1-3 g (as powder) Seed Badi Elaichi 1-2 g (as powder ) 28. Amorphophallus campanulatus (Roxb.) Blume ex Decne. Corm Suran / Jimikand 20-50 g (as fresh) 29. Anacardium occidentale L. 62 Version-I (29.09.2021) Fruit kernel Kaju / Cashew nut 10-20 g 30. Anacyclus pyrethrum DC. Root/ Seed Akarkar 100 - 250 mg (as powder) (Not recommended for children below 5 years) 31. Ananas comosus (L.) Merr. Fruit Ananas / Pineapple 50-100 g (as fresh) 50-100 ml (as juice) (Not recommended during pregnancy) 32. Andrographis paniculata Whole plant Kalmegh / Bhuunimba 1-3 g (as powder) Extract 125 - 250 mg 33. Anethum sowa Roxb. ex Flem. (Now known as A. graveolens L.) Fruit Shataahvaa / Shatapushpa/ 3-6 g (as powder ) Sowa / Indian dill seed Leaf Sowa 10-20 g (as fresh) 34. Angelica glauca Edgew./ A. archangelica L. / A. himalaica Krishna. & Badhwar. Root / Root stock Chandeo / Choraka / Chora 2-4 g (as powder) 35. Annona squamosa L (Sitaphal)./A. reticulata (Ramphal)/A. muricata (Laxmanphal)/ A. cherimola (Hanuman phal) Fruit pulp Shareefa 20-30 g Leaf 3-5 g (as powder) (Not recommended for children below 16 years) 36. Apium leptophyllum (Pers.) Muell. / A. graveolens Linn. 63 Version-I (29.09.2021) Fruit Ajamod / Ajmoda bhed / 1-3 g (as powder) celery 37. Arachis hypogaea L. Seeds (kernel) Mungphali / peanut / 20-30 g ground nut / sing dana Seed oil Mungaphali tail 5-10 ml 38. Argyreia speciosa Sweet / A. nervosa (syn) Root Vridharuka / Bridhara 3-5 g Seed 1-2 g 39. Armoracia lapathifolia Gilib / A .rusticana Gaertn. (syn) Leaf Horse radish 2 -5 g 40. Artemisia absinthium Linn / A.vulgaris / A. officinalis Linn / A. maritima / A. dracunculus / A. annua Whole plant Damanak / Afsantin / 1-2 g Chauhar / 41. Artocarpus heterophyllus Lam. (Jackfruit) Ripe / unripe fruit Katahal 20-50 g Seeds 5-10 g 42. Artocarpus lakoocha Roxb. Ripe fruit / Unripe fruit Lakuch / Badhal 20-30 g Seed Badhal / Dhehu 5-10 g 43. Arnebia nobilis/A. benthamii Root Ratanjot 2-4 g 44. Asparagus adscendens Roxb. Tuberous root Musali / Safed musali 3-6 g (as powder) 45. Asparagus officinalis L. Root Shatavari bhed 3-6 g (as powder) Tender Shoots 20-50 g 46. Asparagus racemosus Willd. 64 Version-I (29.09.2021) Tuberous root Shatawar 3-6 g (as powder) Tender Shoots 20-50 g 47. Asparagus sarmentosus Linn. Tuberous root Badi shatawar 3-6 g (as powder) 48. Astragalus gummifer Labill. Gum Kateeva gond (gum)/ 3-5 g Tragacanth gum 49. Avena sativa L. Seed Oat 10-30 g (as powder) 50. Averrhoa carambola L. Fruit Karmarang / Kamarakh 10-20 g 51. Azadirachta indica A. Juss. Leaf Nimba / Neem / Margosa 1-3 g (as powder) tree (Not recommended for males and females planning to conceive) Fruit Neem 1-2 g (as pulp) (Not recommended for males and females planning to conceive) (Not recommended for children below 5 years) Flower 2-4 g (as powder) Bark / Root bark 3-6 g (as powder) 52. Bambusa arundinacea (Retz.) Willd. / B. bambos Linn. (syn) Tender shoots (Young leaf) Bansh 20-30 g (as fresh) Seed Bansh chaval 20-30 g (as powder) Crystals Bansalochan 0.5-2 g (as powder) 53. Bacopa monnieri 65 Version-I (29.09.2021) Whole plant Brahmi 5-10 g (as fresh) Extract Brahmi ghan 0.5 – 1 g 54. Basella alba L. Leaf Poyi saag 20-30 g (as fresh) 55. Bauhinia variegata L. / B. purpureaL. / B. tomentosa. Linn / B. racemosa / B. malabarica. Roxb. Bark Kachnar 1-3 g Flower / Buds Kachnar / Kurvindar / 10-20 ml (as juice) Kovindar Extract 0.5 – 1 g 56. Benincasa hispida (Thunb.) Cogn. Fruit Kushmanda / Petha / Bhatua 30-50 g (as fresh) Seed 5-10 g 57. Berberis aristata DC./B. asiatica / B. lycium / B. vulgaris Fruit / Leaf / Root / Stem Daruhaldi / kashmall 5-10 g Root extract/ Stem extract Rasaunt 0.5-1 g 58. Bergenia linguts Wall / B.ciliatasyn. / Saxifraga lingulata Wall. Root/ Leaf Pashanbhed / Pathar Chatta 10-20 g (for decoction) 3-6 g (as powder) 59. Beta vulgaris L. Tuber Palanki / Chukandar 10-20 ml (as juice) 60. Blepharis edulis Pers. / B. linariaefolis Root Uttangan/ Karmavridhi 5-10 g (for decoction) Seed 3-6 g 61. Boerhavia diffusa L. (Now known as B. repens L. var. diffusa (L.) Hook.f.) / B. Verticillata Aerial part Punarnava / Itsit 20-30 g (for decoction) 1-3 g (as powder) 66 Version-I (29.09.2021) Root Bishkhapra 10-15 g (for decoction) 1-3 g (as powder) 62. Bombax malabarica / Salmalia malabarica / B. ceiba L. Bark Shalmali / Semal / Semal 5-10 g Musali Flower 10-20 ml (as juice) 2-5 g (as powder) Gum/Root 1-3 g (as powder) 63. Boswellia serrata Roxb. Oleoresin Shallaki / Kunduru / Salai 1-3 g guggal 64. Borassus flabellifer L. Dried inflorescence Tarkul/Taad / Taadi 1-3 g (as powder) Seed pulp of unripe fruit 10-30 g Exudate of stem / sap 100-200 ml (as juice) 65. Brassica campestris L. (Now known as B. rapa L. ssp. campestris (L.) Clapham) Seed Sarshap/ 10-20 g (as paste) Seed oil Sarson 10-20 ml Leaf 10-30 g (as fresh) 66. Brassica juncea (L.) Czern./B. nigra Linn. Seed Rajikaa / Rai / Raai 1-2 g Leaf Rai 10-20 g (as fresh) 67. Brassica rapa L. Tuber Shalgam / 20-40 g Leaf Shaljam 20-30 g (as fresh) 68. Buchanania lanzan Spreng. Seed Priyala / Chirounji 5-10 g (as powder) 69. Butea monosperma Taub / B. frondosa 67 Version-I (29.09.2021) Seed Palash / Dhark 1–3g Gum 0.5-1.5 g Root/Bark 5-10 g (for decoction) 70. Bixa orellana Linn. Seed Sindhuri / Annato Plant 1-3 g 71. Caesalpinia bonducella (L.) Flem. (Now known as C. bonduc (L.) Roxb. C.crista) Leaf /Bark / Seed Putikaranj / Karanjuva / 2-3 g Latakaranja 72. Cajanus cajan (Linn.) Millsp. Seed Adaki / Arahar / Tuvar ki 20-30 g daal 73. Camellia sinensis Tea leaf Chai patti Upto 10 g per day dried or processed leaf as infusion Extract Tea extract 0.5 – 2 g Tea catachins Green tea catechins 0.3-0.7 g 74. Canavalia ensiformis sensu Baker (Now known as C. gladiata (Jacq.) DC.) Fresh pod Sem 30-50 g Seed 5-10 g 75. Canscora decussata (Roxb.) J.F. and J.H. Schult. Leaf Bangiya / Sankhapusphi 2-4 g (as powder) 76. Capparis decidua (Forssk.) Edgew./ C. aphylla Edgew (syn) Fruit Kareer / Dela 10-20 g 77. Capparis seppiara Linn. / C. spinosa Linn. Root / Plant Himsraa/ Kakadaani 5 – 10 g (as powder / for decoction) 78. Capsicum annum L. var. annum 68 Version-I (29.09.2021) Unripe fruit Hari Mirch 1-5 g (Not recommended for children below 5 years) Ripe fruit Lal Mirch 0.5-1 g (as powder) (Not recommended for children below 5 years) 79. Capsicum frutescens L. Fruit Simla mirch 30-50 g (as fresh) 80. Carica papaya L. Ripe fruit Erand karkaki / Papita 50-100 g Unripe fruit Papita 30 -50 g (Not recommended during pregnancy) Leaf/Juice 5 – 10 g/ml (for decoction) (Not recommended during pregnancy) 81. Carissa carandas L. / C. spinarum L. Fruit Karmard / Karounda 10 – 20 g Bark Garnaa 10-20 g (for decoction) 82. Carthamus tinctorius L. Flower / Leaf / Seed Kusumbh / Barre 2-4 g (as powder) Seed oil Barre –tail 5-10 ml 83. Carum carvi L. Fruit Krishna jeerak/ Syaha /kala 1-3 g (as powder) jeera 84. Cassia absus L. Seed Chakshushya / Chaksu 2-5 g 85. Cassia occidentalis L. 69 Version-I (29.09.2021) Leaf Kasmard / Kasoundi 5-10 g Seed / Fruit 1-3 g 86. Cassia tora L. / C. alata L. Leaf/Juice Chakarmard / Chakwad 10-20 g/ml Seed 3-5 g (as powder) 87. Cassia fistula Linn. Fruit / Tender fruit Aaragavadh / Amaltas 10-20 g (as pulp) Seed / Bark Amaltas 2-5 g (as powder) 88. Cassia angustifolia/ C. acutifolia / C. senna L Seed/Leaf Swarnapatri / Sanay / Senna 0.5 – 2 g (as powder) Extract 125 – 250 mg 89. Cedrus deodar Roxb. Seed/Wood/Bark Devdaru / Devdar 3-6 g (as powder) Oil 2-4 ml 90. Celosia argentea L. var. argentea Seed Shitivaaraka / Surwali / 3-6 g Safed murga 91. Celastrus paniculatus Seed Jyothishmati / Malkanguni 2 – 3 g (as powder) Oil 1-2 ml 92. Celastrus paniculata willd. Seed Jyothishmati / Maalkangni 3-5g Seed oil 5 - 15 drops Leaf 3-5 g (as powder) 93. Centella asiatica (L.) Urban 70 Version-I (29.09.2021) Whole Plant Mandukaparni / Brahmi 20-30 g (as fresh) (Galpatri) / Manduki Leaf 3-5 g (as powder) Extract Brahmi 0.5 – 1 g 94. Centratherum anthelminticum Fruit/Seed Aranya jeerak/ Kali-jeeri / 1–3g Van- jeeri 95. Chenopodium album L. Whole plant/Leaf Vasthuka/ Bathua 20-30 g (as fresh) Seed Bathua 2-5 g 96. Chlorophytum borivillianum / C. arundinaceum/ C. tuberosum Root Musali safed / Musali 3 – 6 g (as powder) 97. Cicca acida (L.) Merrill Fruit Harfa rewadi 10-20 g 98. Cicer arietinum L. Tender leaf Chanak / Chana / Kalachana 30-50 g (as fresh) Seed Chana / Kalachana 20-30 g 99. Cichorium endivia Seed/Root Kasani/Chicory 5-10 g 100. Cinnamomum tamala Nees/ Eberm. / C. wightii Leaf Tamalpatra/ Tejapatra 2-3 g 101. Cinnamomum zeylanicum Blume (Now known as C. verum J. S. Presl.)/ C. cassia (syn) / C. aromaticum Bark Twak / Dalchini (Ceyloni) 1-2 g (Not recommended during pregnancy) 102. Cissampelos pareria L. var. hirsuta (Buch. Ham. ex DC.) Forman. Leaf / Whole Plant/ Root Patha/ Padhi 3 – 6 g (as powder) 71 Version-I (29.09.2021) 103. Cissus quadrangularis L. Aerial part Astisamhara / Hadjod 20-30 g (as fresh) Stem Hadjod 3-6 g Extract 0.5 – 1 g 104. Citrullus colocynthis (L.) Schard. Fruit / Root / Leaf Indarvaruni / Indarun / 0.25-0.5 g (as Indrayan powder) (Not recommended during pregnancy) 105. Citrullus vulgaris Schrad. ex Eckl.and Zeyh. var. fistulosus (Stocks) Stewart Fruit Tinda 20-40 g (as fresh) 106. Citrullus lanatus (Thunb.) Matsura and Nakai Fruit Tarbuj 50-100 g (as pulp) Seed 3-6 g Seed oil 1-3 ml 107. Citrus aurantifolia (Christm. and Panz.) Swingle / C. medica / C. acida. Roxb. Fruit / Leaf / Root Nimbuca / Nimbu 3-5 ml (as juice) 108. Citrus limon (Linn.) Burm.f. Fruit / Leaf / Root Jambeer / Jameerinibu 5-10 ml (as juice) 109. Citrus maxima (Burm.)Merr./ C.grandis L Fruit / Leaf Chakotara / 30-50 g (as fresh) Sadaphala 5-10 ml (as juice) 110. Citrus medica L.var.medica Fruit Turanuj / Bijoura 5-10 ml (as juice) 111. Citrus reticulata Blanc. Fruit / Leaf Narangi / Santra 30-50 ml (as juice) 112. Citrus sinensis (L.) Osbeck Fruit / Leaf Mousami 50-100 ml (as juice) 113. Clerodendron infortunatum 72 Version-I (29.09.2021) Whole plant Bhandiri / Bhaandi / 10 – 20 ml (as juice) Bhatechh 114. Clerodendrum phlomidis Whole plant Arani / Laghuagnimandh 10-20 g (for decoction) 3-5 g (as powder) 115. Clerodendrum serratum Whole plant Bharangi 3-6 g (as powder) 116. Clitoria ternatea Linn. Root/Seed Girikarnika / Aparajita 1-3 g Leaf 2-5 g (as powder) 117. Coccinia grandis (L.) Voigt. / C. indica / C. cardifolia (syn) Leaf Bimbi/ Kundru phal / 5-10 g Kuntru shak (Not recommended for children below 5 years) Stem Kundru 3-6 g (as powder) Whole plant Kundru 3-6 g (as powder) 5-10 ml (as juice) Fruit Kundru 20-50 g (as fresh) 118. Cocos nucifera L. Endosperm Nariyal 10-20 g Water Nariyal jala 100-200 ml Flower Nariyal 5-10 g Shell / Fibre / Whole fruit Ash 125 – 250 mg 119. Cocculus hirsutus (L.) Theob. Leaf / Whole plant Chilihintha / Jalajamani 10-20 g (for decoction) 2 – 4 g (as powder) 120. Coix lacryma-jobi L. 73 Version-I (29.09.2021) Seed Millet/ Gavedhukaa/ Gargari 10-20 g 121. Coffea arabica / C. robusta Seed (Dry/Green) Kaaphi / Kahava / Coffee 3-5 g (Not recommended for children below 5 years) 122. Coleus forskohlii / C. aromaticus / C. barbatus (syn) Root / Leaf / Whole plant Gandiva / Pathachoor / 3-5 g (as powder) Parn-yavani ( Not recommended for children below 5 years) 123. Coleus vettiveroides K.C. Jacob. Stem / Leaf / Root Hrivera / Baalatka 3-5 g (as powder) 124. Coleticum luteum Baker Corm Suranjan / Suranjan-kadvi 0.5 - 1 g (Not recommended in children below 5 years and pregnant mothers) 125. Colocasia antiquorum Schott. (Now known as C. esculenta (L.) Schott.) Rhizome Pindalaka/ Arvi/ 20-30 g (as fresh) Aaluki (Not recommended for children below 16 years) 126. Commelina bengalensis L. Whole plant Karnsphota / karnmorata / 3-6 g Kausar 127. Commiphora wightii Oleoresin Guggal 2-4 g (Not recommended for children below 5 years) 128. Commiphora myrrha Oleoresin Hirabol 2-4 g 74 Version-I (29.09.2021) ( Not recommended for children below 5 years) 129. Convolvulus pluricaulis / Evolvus alsinoides Whole plant (with white or Shankh-pushpi / 10-20 g (for bluish flowers) decoction) Vishnukranta 130. Convolvulus turpethum / Iporius turpethum Root / Seed Sygma-kali nishoth / Safed 2-4 g (as powder) Nishoth 131. Coptis teeta Wall. / C. chinensis syn Whole plant Mamira / Tiktamoola 1-3 g ( as powder) 132. Corchorus acutangulus Lam. (Now known as C. aestuans L.) / C. capasularis L / C. olitorius L Aerial part Chunchu / kaala / shaak / 10-20 ml (as juice) palva saag / Chench 133. Cordia dichotoma Forst. f. (C. wallichii G.Don) Fruit Shlashmotaka / Lisora / 10-20 g gondra 134. Cordia rotthii Roem. and Schult. (Now known as C. gharaf (Forssk.) Ehrenb and Asch. Fruit Chhota Lisora / Lasudi 10-20 g 135. Coriandrum sativum L. Fruit / Seed Dhanyaka / Dhaniya 1-3 g (as powder) Aerial part / Fresh leaf Dhaniya 10-20 ml (as juice) 136. Costus speciosus / C. koeniga (syn) Rhizome / Root Kebuka / Kemuk 2-4 g (as powder) (Not recommended for children below 5 years) 137. Crataeva nurvala Buch- ham / C. megna DC Fruit/Bark/Leaf Varun / Barana 10-20 g (for decoction) 138. Crocus sativus L. 75 Version-I (29.09.2021) Style/ Stigma Kumkum 25-50 mg (Kesar) (Not recommended for children below 16 years) 139. Cucumis melo L. / C. melo L. var. momordica Duthie and Fuller / C. melo L. var. utilissimus (Roxb.) Duthie and Fuller Fruit Kharbooja 50-100 g Seed 1-3 g (as powder) 140. Cucumis sativus L. Seed Tripasha / Khira/cucumber 3-6 g (as powder) Fruit Khira 50-100 g (as fresh) 141. Cucurbita maxima Duch. ex Lam. Seed Peetkushmand/ Kashiphal/ 5 -10 g kaddu Fruit Kashiphal 50-100 g (as fresh) 142. Cucurbita pepo L. Fruit Kushmand / Safed Kaddu / 50-100 g (as fresh) safed petha Seed Safed petha 5-10 g (as powder) 143. Cuminum cyminum L. Fruit Jeerak / Jeera / safed 1-3 g (as powder) 144. Curculigo orchioides Gaertn. Tuber Talmuli / 3-5 Kalimushli g 145. Curcuma amada Roxb. Rhizome Aamra haridra / Ambaahaldi 5-10 g (as fresh ) 2-4 g (as powder) 146. Curcuma angustifolia Root Tavakasheer/ Tavkshir / 2-5 g Tikhur 76 Version-I (29.09.2021) 147. Curcuma longa L. Rhizome Haldi 1-3 g (as powder) Fresh Rhizome / Leaf 5-10 ml (as juice) 148. Curcuma zedoaria Roxb. (Now known as C. aromatica Salisb.) Rhizome Karchura / Kachur 1-3 g (as powder) 149. Cyamopsis tetragonoloba Pod/Seed Gaurphali /Guar / Guar gum 20-30 g (as powder) Gum 5-10 g (as powder) 150. Cymbopogon citratus(DC.) Stapf / C. coloratusStapf / C. jwarankusa (Jones) Schult / C. martini (Roxb.)Wats Whole plant Lamajjaka / Harichaya / 1-3 g (as infusion) Rosha Ghas / lemon grass 151. Cynodon dactylon (L.) Pers. Leaf / Whole plant Durva / Duba 3-5 g 152. Cyperus rotundus L. / C. seariosus R. Br Rhizome Mushtaka / Nagarmotha / 2-5 g Bhadramushtaka 153. Daucus carota L. Tuberous root Gajar 50-100 g (as fresh) 50-100 ml (as juice) Seed 1-2 g (as powder) (Not recommended during pregnancy) 154. Desmodium gangeticum / D. latifolium Whole plant / Root Shaalparnii / Sarvan 5-10 g (for decoction) 2-5 g (as powder) 155. Dillenia indica L. Fleshy fresh sepals / Bark / Bhavya /Chalta 10-20 g (for Leaf decoction) 77 Version-I (29.09.2021) Fruit 40-50 g (as fresh) 156. Dioscorea alata L. / D. deltoidea Tuber / Aerial bulbs Kathalu / 10-20 g Extract Shingali 0.5-1 g 157. Dioscorea bulbifera L. Tuber /Aerial bulbs Varahikand / Genthi / Taradi 20-30 g (as fresh) 5-10 g (as powder) Extract 0.5-1 g 158. Dioscorea esculenta (Lour.) Burkill / D. pentaphyla L Tuber Madhvaluk / Suthani 5-10 g 159. Diplezia maxima Tender shoots Lungru 30-50 g Root 5 – 10 g 160. Diospyros peregrina Gurke (Now known as D. malabarica (Desr.) Kostel) Ripe fruit Tinduka / Tendu / 20-30 g Gab Unripe fruit Gab 4-8 g (as powder) Bark / Leaf / Seed 3-5 g (as powder) 161. Dluchea lameolata C.B. Clarke Aerial parts / Leaf Razana / Vaaya-surai 5-10 g (as powder) 162. Dolichos biflorus L. (Now known as Vigna unguiculata (L.) Walp.) Seed Kulath / Kulathi 20-30 g Gontha 163. Dolichos lablab L. (Now known as Lablab purpureus (L.) Sweet) Seed Nishpaav/ Sem/ 20-40 g (as seed) Semphali Tender Pod Sem 30-40 g (as fresh) 78 Version-I (29.09.2021) 164. Echinochloa frumentacea Link / Panicum frumentacea (syn) Fruit Sanwa / Shyamaka 30-50 g 165. Eclipta prostata L. / E. alba (syn) Whole plant Bhringaraj/ Bhangra 3-6 g (as powder) 166. Elettaria cardamomum (L.) Maton Seed Elaa/ Sukshma elaa/ Chhoti 250-500 mg (as elaichi powder) 167. Eleusine coracana (L.) Gaertn. ssp. coracana (Finger millet) Seed Madhuli / Madua / Ragi 20-50 g 168. Elsholtzia cristata Willd. / E. ciliate (syn) Leaf Ajogandha 5-10 ml (as juice) Seed 2-3 g 169. Emblica officinalis Gaertn. (Now known as Phyllanthus emblica L.) Fruit Amalaki/ Anwala / Amla 20-30 g (as fresh) 3-6 g (as powder ) 5-10 ml (as juice) Extract 1-3 g 170. Embelia ribes Burm. f. Fruit Vidanga / Vai-vidanga / 1-2 g Bhabhiranga (Not recommended for females planning to conceive) 171. Embelica tsjeriam -cotton A.DC / E. robusta (syn) Fruit Vidanga (bhed) / Bai-vidang 5-10 g (as powder) (bhed) 172. Enicostemma littorale Blume Whole plant Maamajaka / Mamejwa / 2-3 g Naai Extract 0.5 – 1 g 173. Ephedra gerardiana Wall. 79 Version-I (29.09.2021) Leaf/Whole plant Somlata / 2-3 g (as powder) Som / Somvalli 174. Euphorbia hidra Linn. / E. thymifolis Linn. Whole plant Dugdhika / Dudhi 3-5 g (as powder) 175. Euphorbia neriifolia/ E. pilosa / E. royalana / E. dracunculoides Stem (tender) after boiling Snuhi / 10-20 g (as fresh) Thuhar / Sehund 3-5 g (as fresh) Leaf (Not recommended for children below 5 years and pregnant women) 20 – 30 mg Latex 176. Euryale ferox Salisb. Seed Makhana / 20-30 g (as seed) Fox-nut 3-5 g (as powder) 177. Fagopyrum esculentum Moench. / F. tataricum Gaertn. / F. essence Seed Kuttu 30 -50 g 178. Ferula asafoetida L. / Syn. F. foetida Regal/ F. narthex. Boiss Oleo-gum resin Hingu / 60- 125 mg (as powder) Hing / Heeng 179. Ficus benghalensis L. Fruit Vatt / Nyagrodha / Baragad 40-50 g Shoot / Bark / Aerial root 5-10 g (for decoction) 2-5 g (as powder) 180. Ficus carica L. / F. palmata 80 Version-I (29.09.2021) Fruit Anjeer / fig / phalguni / 20-30 g Indian fig Leaf / Bark 3 – 5 g (as powder) 181. Ficus glomerata Roxb. (Now known as F. racemosa L.) Fruit / Leaf Udumbara / Gular 20-30 g (as fresh) Bark 3 – 5 g (as powder) 182. Ficus hispida L.f. Fruit Kathgulara / Kakodumba 10-20 g Bark 3 – 5 g (as powder) Tender leaf Kathgulara 20-40 ml (as juice) 183. Ficus locar Buch. Ham / F. infectoria Fruit / Stem / Bark / Leaf Plaksha / Pakad 5-10 g 184. Ficus religiosa L. Fruit / Tender Leaf Aswath /Pipal / Peepal 5-10 g Bark 3 – 5 g (as powder) 185. Flacourtia ramontchi L’ Herit (Now known as F. indica (Burm.f.) Merr.) / F. jangomas (Lour.) Raeusch Fruit Vikantaka / Katai / Kanghu 5-10 g /Surva vruksha 186. Foeniculum vulgare Mill. Fruit Mishraya / Sounf / Fennel 3-6 g (as powder) seed Leaf 20-30 g (as fresh) 187. Fumaria vaillantii (Lois.) Hook. f. and Thoms. var. indica Haussk. (Now known as F. indica (Haussk.) Pugsley) / F. parviflora (syn) Whole plant Parpat / 1-3 g (as powder) 81 Version-I (29.09.2021) Pittapapda 188. Garcinia indica (Thour.) Choisy / G. cambogia Mature fruit Vrukshamala / Kokam 10-20 ml (as juice) 5-10 g (as powder) Butter/ Oil 3-5 g/ml Extract 1–2g 189. Garcinia pedunculata Roxb. ex Buch-Ham. Fruit rind Vatasamla / Amalbeda 5-10 ml/g (as juice/powder) 190. Gardenia gummifera Linn. F Gum Naadihingu / Dikkamaali 250 – 500 mg 191. Gardenia turgida Roxb. (Now known as Ceriscoides turgida (Roxb.) Tirveng.) Gum Kharahara /Mahapindi / 1-3 g (as powder) Kharahatta 192. Gentiana kurroo Royle. Rhizome / Root Trayamana / Trayanta 1–3g 193. Gisekia pharnaceoides L. Leaf Elavallukavari / Baluka Saga 5-10 g 194. Glycine max (L.) Merr. Seed Soya / Soyabean 20-40 g Soya proteins 10-20 g 195. Glycyrrhiza glabra L. Root / Stolon Madhuyasti / Yashtimadhu / 5-10 g (as powder) Mulethi / liquorice 196. Gloriosa superba Linn. Root / Tubers Langali / Kalihari 125 – 250 mg (not indicated in children and lactating mothers) 197. Gmelina arborea Roxb. / Premna arborea Roth (syn) 82 Version-I (29.09.2021) Fruit Gambhari / Gamhari / 20-30 g Kaashmari Stem /Bark / Leaf 3 – 5 g (as powder) 198. Gmelina asiatica L. Fruit Gopabhadra, Badhara 20-30 g Stem / Bark / Leaf 1 – 3 g ( as powder) 199. Gossypium herbaceum / G. arboreum L. Seed Karpasi/ Kapas/ 10-20 g Root Cotton 3 – 6 g (as powder) 200. Grewia hirsuta Vahl Root / Stem Nagabala / Gulsakari 5-10 g (as powder) Fruit 3- 5 g 201. Grewia populifolia Vahl (Now known as G. tenax (Forssk.) Fiori) Bark / Fruit Gangeru / Gangeran 5-10 g (as powder) 202. Grewia tiliaefolia Vahl / G. sclerophylla / G. optiva Fruit Dhanvana / Dhamin 20-30 g Bark 3 – 5 g powder 203. Gymnema sylvestre B. Br. Plant Meshashrungi / Gudmar / 5-10 g (for decoction) Madhunashini 3-5 g (as powder) Extract Gudmar 0.5-1 g 204. Gynandropsis gynandra (L.) Briq. (Now known as Cleome gynandra L.) / G. pentaphyla DC Seed Ajagandha / Hurhur 1-3 g (as powder) Whole plant Hurhur 10-20 ml (as juice) 205. Habenaria intermedia / H. acuminata THW /H. edgeworthi Root tuber / Rhizome Vruddhi / Ridhi 3-5 g 206. Hedychium spicatum Ham ex Smith / H. album 83 Version-I (29.09.2021) Rhizome Shatti / Kapur-Kachari 3-5 g 207. Helicteres isora Linn. Pod (fruit) / Bark / Leaf Avartani / Avartaki / 3-6 g (as powder) Marodphali 208. Heliotropium indicum Linn. Whole plant Hastishundi / Vrisehikaali 3-6 g (as powder) 209. Hemidesmus indicus syn. Periploca indicus L. Root / Stem Anantmula 3-6 g 210. Hibiscus rosasinensis L. Flower Japakusum/ Gudahal 1-3 g (as powder) (Not recommended during pregnancy) 211. Hibiscus sabdariffa L. Leaf Abaasthaki/Patawa 5-10 g (as powder) Seed Patawa 1-3 g (as powder) Ripe calyx 5-10 g (as powder) 212. Hippophae rhamnoides L. / H. salicifolia Fruit / Leaf Amlavetasa / Leh-beri/ 10-20 g Chharma/ Sea buck thorn Extract Amalvets 0.5-2 g 213. Hordeum vulgare L. Seed Yava/Jau 30-50 g Aerial parts (processed)/Ash 2-5 g 214. Hygrophila spinose / H. auriculata syn. / H. schull (ham) Seed Kokilaksha/ Ikshura / Tal 3–6g makhana Whole plant 1 – 3 g (as ash) 215. Hypericum perforatum Leaf / Whole plant Basant 3-6 g 84 Version-I (29.09.2021) Plant extract 0.5-1 g 216. Hyssopus officinalis Linn. Whole plant Zuufea dayaa-kunji 3-5 g 217. Illicium verum Hook. f. Fruit Badiyan Khatai /Aniseed star 250 - 500 mg (as powder) 218. Inula racemosa. Hook / I. roylanna non- DC (syn) Root Pushkar mool / 1-3 g (as powder) Pokhar mool 219. Ipomoea aquatica Forssk. / I. raptans por (syn) Leaf Kalambi / Kalamisaag 20-30 g 220. Ipomoea batatas (L.) Lam. Tuber Shakarkandi / Mukhaalwka / 20-30 g Sweet potato 221. Ipomoea digitata auct. non L. (Now known as I. mauritiana Jacq.) Root/Tuber Kasheer – vidhara / 3-6 g Vidarikand Seed 1-2 g 222. Ipomia nil Linn. / Convolvulus nil Linn. / Convolvulus biobatus (syn) Seed Shankhini / Krishanbeej / 3-5 g (Not Kaaladana recommended in children below 5 years and pregnant women) 223. Juglans regia Linn. / J. cineraria L. Fruit/Endosperm Akshod / Akhrot / Walnut 10-20 g Leaf/Bark 3-5 g 224. Juniperus communis Flower/Leaf Hapusha / Hauber 2–6g 225. Jusmin auriculata Vahl. / J. humile Linn. Leaf / Flower Yuthika / Juhil / Swarn- 3-5 g 85 Version-I (29.09.2021) yuthika (swarnjati) 226. Jusmn officinale Linn. / J. grandiflorum Leaf / Flower Jaati / Chameli / Jasmin 3-5 g 227. Kaempferin galanga Linn. Rhizome Sugandhvacha / 500mg – 1 g Chandevmula 228. Kigelia pinnata Jaeg. DC . Fruit Balam kheera 20-30 g Stem / Bark 3-6 g 229. Lagenaria vulgaris Ser. (Now known as L. siceraria (Mol.) Standl.) Fresh fruit Katutumbi / Tumbini 10-20 g Seed Alabu 1-3 g (as powder) 230. Lagerstroemia indica / L. parviflora Leaf Jarul 6 - 12 g (as powder ) Extract Frash/ Faransh 1-2 g 231. Lens culinaris Medik. Seed Masura 20-40 g 232. Lepidium sativum L. Seed Chandershoola / Chansur / 3-6 g (as powder) Halon / Garden cress (Not recommended during pregnancy) Aerial part Chansur 30-50 g (as fresh) 233. Leptadenia reticulata (Retz.)W. and A. Leaf/ Aerial part Jeevanti/ Dodisaka/ 20-30 g (as fresh) Hemavati 5-10 g (for decoction) Root / Whole plant 3-5 g (as powder) 234. Leucas cephalotus (Koenig ex Roth) Spreng./ L. aspera Leaf Drona pushpi / Guma 20-30 g (as fresh) 3-5 g (as powder) 86 Version-I (29.09.2021) 235. Limonia acidissima L. Fruit Kapittha / Kainth / Wood 20- 40 g (as fruit) apple 1-3 g Leaf/Bark extract 236. Linum usitatissimum L. Seed Alasi / Atasi/ 10-20 g linseed/flaxseed Seed oil Atasi ka tail 10-20 ml 237. Litchi chinensis Sonner Fruit Litchi 30-50 g 238. Luffa acutangula (L.) Roxb. Whole plant Katu koshatakri / Torai / 5 -10 g (as powder) dhartorai / ridged gourd Fruit Torai 30-50 g (as fresh) Seed 1-3 g (as powder) 239. Luffa cylindrica (L.)M. Roem. / L. echinata (devdali) Fruit Dhaamargava /Nenua / 20-40 g (as fresh) Rajkoshataki Seed Nenua 1-3 g (as powder) 240. Lycopersicon esculentum Mill. (Now known as L. lycopersicum (L.) Karsten.) Fruit Tamatar/ tomato 20-40 g (as fresh) 241. Madhuca indica Gmel.(Now known as M. longifolia (Koen.) Macbride var. / M. longifolia (Koenig) Macbride var. latifolia) Flower Madhuca / Mahua / jal 10-15 g (as flower) mahua Fruit Mahua 10-15 g Seed oil Koyna ka tail 2-5 ml 87 Version-I (29.09.2021) 242. Malva sylvestris L. / M. rotundifolia Fruit Suvarchala / Khubharaji / 5-7 g (as powder) Gulkhair Leaf Gulkhair 3-6 g (as powder) 243. Mangifera indica L. Ripe fruit Aamar / Aam 50-150 g Unripe fruit pulp Aam 10-30 g Seed kernel Aam Beej / Majja 1-2 g (as powder) Leaf / Bark Aam 3-5 g Extract of leaf Amara (ghan) 0.5-1 g 244. Maranta arundinacea L. Rhizome Kookaineer (Sidha)/ 10-30 g (as powder) Ararota/ Arrow-root 245. Marrubium vulgare Linn. Whole plant Fasaasiyum 3-5 g (as powder) 246. Marsilea minuta L. Leaf / Whole plant Sunishannak/ Chowpatia 10-20 g (as fresh) 2-4 g (as powder) Extract Chowpatia 0.5-1 g 247. Mentha spicata L. / M. arvensis L. / M. aquatica Linn./ M. suaveolans Aerial part Putina/ Pudina 3-5 g 248. Mentha piperata L./ Mentha spp. Leaf Peppermint / Sat pudina 2-5 g (as fresh) 1-2 g (as dry) Distilled oil/Extract 10-30 mg 249. Mesua ferrea Linn. Stemen/Flower bud Nagkesar 1-3 g 250. Microstylis musifera Ridley Tuber Jivaka 3-5 g 88 Version-I (29.09.2021) 251. Microstylis wallichii Lindl. (Now known as Malaxis acuminate D. Don) Tuber Rishabhka 5-10 g 252. Mimosa pudica Whole plant/Seed Lajjalu / Lajwanti 3-6 g 253. Mimusops elengi L. Pericarp Bakula / Maulsiri 20-40 g Flower Maulsiri 5-10 g Bark 3-5 g 254. Mimusops hexandra Roxb. (Now known as Manilkara hexandra (Roxb.) Dub.) Pericarp Khirni 20-40 g 255. Momordica charantia L. Fresh fruit / seed Karabelwa / Karela 30-50 g (as fresh) 3-5 g (as seed) Dried fruit / seed 0.5-1 g Extract (Not recommended for females planning to conceive and children below 5 years) 256. Momordica dioica Roxb. ex Willd. Root Karkotaka / Khekhasa/ 3-6 g (as powder) Karkoda Fruit Khekhasa 30-50 g 257. Monochoria vaginalis (Burm.f.)Presl. Rhizome Indivara 3-6 g 258. Moringa oleifera Lam. / M. concanensis Nimmo Leaf Shiguru/ Sahijan / Muringya 10-20 g (as fresh or paste) 2-5 g (as 89 Version-I (29.09.2021) / Lal sehanjan powder) Seed Sahijan / Muringya 2-6 g (as fresh) Pod 40-80 g (as fresh) 2-5 g (as powder) Flower 10-20 g (as fresh) Extract of Bark/ Leaf/Fruit 0.5-1 g 259. Morus alba L. / M. Indica / M. nigra Fruit Shahtoot / Toot 20-30 g Tender leaf / Bark / Flower 3-5 g 260. Morchella esculenta/M. elata Fruiting body Guchhi 10-20 g 261. Mucuna pruriens (L.) DC. / M. prurita Honk. Root Atma Gupta / Kapikachhu / 10-20 g (for Kawach/ Concha decoction after processing) Pod Kawach 20-30 g (as fresh after processing) Seed 3-6 g Extract 0.5-1 g 262. Murraya koenigii (L.) Spreng. / M. exotica Linn (Kamini) Leaf / Fruit Kaidarya /meetha neem/ 5-10 g Kadhipatta 263. Musa paradisiaca L. Flower Kadali / Kela / banana / 20-30 g plantain Fresh shoot Kela 20-50 g 10-20 ml (as juice) Ripe Fruit 30-50 g Unripe Fruit 10-20 g 90 Version-I (29.09.2021) 264. Myrica esculenta Buch. Ham. / M. nagi Hook Fruit Kataphala / Kaiphal 5-10 g Bark Kaiphal 2-3 g 265. Myristica fragrans Houtt. Seed (kernel) Jatiphala / Jaiphala / 0.25- 1.0 g Jatipatra (Caution: excessive use may cause giddiness) Aril (outer part of fruit) Javitri 0.25 -1 g (as powder) 266. Myristica malabarica Lam. Seed Pashika / Pashupati / Jangali 0.5 -2 g Jayaphala Aril Jangali javitri 0.25 -1 g 267. Nardostachys jatamansi DC / N. grandiflora Stem/Aerial parts Jatamansi / mansi 2-5 g Extract 0.25-0.50 g 268. Nasturtium officinale/ N. aquaticum Leaf Chhu-nalli / Water-cress / 10-20 g Piriya - haalim 269. Nelumbo nucifera Gaertn. Flower Kamal / Padam 3-6 g (as powder) Rhizome Bhen / Bhain 30-50 g (as fresh) Stalk Murar / Kamalgatta 30-50 g (as fresh) Seed kamalbeej 3-6 g (as powder) 270. Nymphaea alba Linn/ N. rubra/ N. stellate Rhizome/ Seed Kumud – utpala / Kamlini/ 10-20 g Nilofer /Shavet/ rakta / neel kamal 91 Version-I (29.09.2021) Flower 3-6 g 271. Nigella sativa L. Seed Kalaunji / Kaala jaaji 1-3 g(Not recommended during pregnancy) 272. Nilgirianthus ciliatus (Nees) / Strobilanthes ciliatus (syn) Fruit Sehachara 3-5 g (as powder) 273. Nyctanthes arbortristis L. Flower Parijat / Shephaali/ 1-2 g Harshringara Leaf / Seed Harshringara 1-3 g 274. Ocimum basilicum L. / O. pilosum Wild. Leaf Barbari /Bhavari Tulsi/ 3-6 ml (as juice) Niajboo 1-3 g (as powder) Seed 125-250 mg Extract 0.25-0.50 g 275. Ocimum gratissimum L. Leaf / Seed Vriddha tulasi / Ram Tulasi 1-3 g (as powder) Extract 0.25-0.50 g 276. Ocimum sanctum L. (Now known as Ocimum tenuiflorum L.) Leaf Tulasi / Surasa / vrinda 2-5 g Seed Tulasi 1-2 g Extract 0.25-0.50 g 277. Olea europaea Seed Zaitoon / Jaitun 10-20 g Oil 10 – 20 ml Leaf 3-5 g (as powder) 278. Onosma bracteatum Whole plant/Leaf Gojihraa /Gaozabaan 5-10 g 92 Version-I (29.09.2021) 279. Onosma hispidum/ O. echioides Linn. Root Ratanjot 3-5 g 280. Operculina turpethum / Ipomea turpethum (syn) Root/Seed Trivrat / 1-3 g Nishoth (Not recommended for children below 5 years) 281. Ophiocordyceps sinensis / O. indica D.Don Whole plant Keetjaadi 20-60 mg 282. Opuntia vulgaris / O. dillenii Ripe fruit Nagphani / 10-20 g (as fresh) Chhiter thohar 283. Orchis latifolia L. (Now known as Dactylorhiza hategeria (D. Don) Soo) Tuber Mynjataka / 3-5 g (as powder) Salampanja / Salam-mishu 284. Origanum majorana L. / Majorana hostensis (syn) Leaf Marubaka / 5-10 drops (as juice) Marnaa 285. Oroxylum indicum Bark/Seed Shyonok /Sonapatha / 5-10 g (for decoction) Talvarphali /Tataplang 3-5 g (as powder) 286. Oryza sativa L. Seed Shali-tandul / 50-100 g Root stock Chawal - shali 10-20 g (for decoction) 287. Oxalis corniculata L. Leaf Changeri / Chukraa / 5-10 ml (as juice) 93 Version-I (29.09.2021) Tinpatia 288. Paederia foetida Linn. Whole Plant Prasarini / Gandh Prasarini 5-10 g (for decoction) 289. Panax pseudo ginseng Wall / P. quinquefolium Linn. / P. schinseg Knees. Root Laxmana 1-3 g (as powder) 290. Pandanus odoratissimus L.f. / P. facicularis Linn. Oil Kethaki / Koedaa/ 2-5 drops Kewada Flower 2-5 g 291. Panicum miliaceum L. (Millet) Seed (grains) Chinast /Cheenaa 50-100 g 292. Papaver somniferum L. Seed Posta-daana / 1-2 g (if taken regularly) Khas-Khas 2-5 g (as powder – occasionally) 293. Parmelia perlata (Huds) Ach. Whole plant Lichen / Shaileya / 3-5 g Shailpushp / Chhareela 294. Paspalum scrobiculatum L. (Kodo millet) Seed Kodrava /Kodon/ 50-100 g Kodo 295. Pedalium murex Linn. Fruit Brihat Gokshura 5 – 10 g (for decoction) Bada gokharu 3-5 g (as powder) 296. Pennisetum typhoideum L. C. Rich. (Now known as P. americanum (L.) K. Schum.) 94 Version-I (29.09.2021) (Millet) Seed Bajra 20-40 g 297. Peucedanum graveolens (L.) Benth. and Hook.f Seed Shepu 1-3 g 298. Phaseolus aconitifolius Jacq. (Now known as Vigna aconitifolia (Jacq.) Marechal) Seed Makushtha / 20-50 g Whole plant Moth -dal 3 – 6 g (as powder) 299. Phaseolus aureus Roxb. (Now known as Vigna radiata (L.) Wilczek var. radiata) Seed Jangali moong 20-50 g Whole plant 3 – 6 g (as powder) 300. Phaseolus lunatus L. Pod Sem 25-50 g (as pulse) 301. Phaseolus mungo L. (Now known as Vigna mungo (L.) Hepper) Seed Masha / 20-50 g (as pulse) Urad - kale 302. Phaseolus radiatus L. / P. trilobus Sensu. Seed Mudga / 50-100 g (as pulse) Mudgaparni / Moong 303. Phaseolus vulgaris L. / P. namus Linn. Pod / Seed Lobia /Rajma / 10-20 g (as pulse) Kidney bean 304. Phoenix dactilifera L. Fruit Kharjuura /Khajur / 20-30 g Chuhara 305. Phoenix sylvestris (L.) Roxb. / P. acaulis Fruit Kharjuura/Khajoor –jungli 20-30 g Nira (Sap) Khajoor 30-50 ml (as fresh 95 Version-I (29.09.2021) juice) 306. Phyllanthus amarus / P. urinaria / P. fraternus Webster Plant Tamlaki /Bhumyamalaki/ 5-10 g Bhui - amla Extract Tamlaki 0.5-1 g 307. Physalis alkekengi L. Fruit Raajabutraka /Winter cherry 5-10 g /Kaknaj 308. Physalis minima L. Fruit Tankaari /Papoto 10-20 g 309. Physalis peruviana L. Fruit Parpoti (var) / 10-20 g Rasbhari 310. Picorhiza kurroa Royle Ex. Benth / P. scrophularii flora Root Katuk / Kutaki / Kulaki 1-3 g (as powder) (Bheda) Extract 125-250 mg 311. Pimpinella anisum L. Fruit Anisoon / 1-3 g Aniseed Oil 0.5 - 1 ml 312. Pinus excelsa / P. wallichiana (syn) Fruit Kail / 5-10 g Oil Saral (var) 1-2 ml Bark 2–3g (Not recommended for children below 5 years) 313. Pinus gerardiana Wall. Endosperm Nikochaka / 10-20 g 96 Version-I (29.09.2021) Oil Chilgoja / 1- 2 ml Bark Neerachail 2 -3 g 314. Pinus roxburghii /P. longifolia Roxb Fruit / Saral / 10-20 g Oleoresin Cheer / 1-2 g Oil Cheel 1-2 ml (Not recommended for children below 5 years) 315. Piper betle L. Leaf Tambula / 2-5 g Pana-patta / (Not recommended for children below 5 Paan years) 316. Piper chaba Hunter (non Blume) (Now known as P.r retrofractum Vahl)/ P. officinarum Leaf Chabya / 1-3 g (as powder) Chabh / Chavika 317. Piper cubeba L.f. Fruit Kankola / 1-3 g (as powder) Kabab chini 318. Piper longum L. / P. retrofractum Linn. Fruit Pippaali / 0.5-2 g (as powder) Long pepper / (Not recommended for prolonged use) Magha 319. Piper nigrum L. Fruit Maricha / 0.5-2 g Kali Maricha/ Black pepper 320. Pistacia integerrima Stewart (Now known as P. chinensis Bunge ssp. integerrima 97 Version-I (29.09.2021) (Stewart) Rech.f. Gall Karkatasharingi / 1-2 g Kakadasingi / kakdain 321. Pistacia lentiscum Linn. Gum-Resin Mastagi / Roomi-mastagi 2-3 g 322. Pistacia vera L. Seed endosperm Mukuulaka / 5-10 g Pista 323. Pisum sativum L. Seed and pod Matar 30-50 g (as fresh) 324. Plantago ovata Forssk. / P. major Linn. / P. lanceolata Linn. Seed Isabgol 5-10 g Husk 5 – 10 g 325. Plumbago zeylanica Linn. / P. indica Root Chitraka / Chitra-sfed / Lal- 1-2 g (as powder) pushp after purification (Not recommended for children below 5 years and pregnant women) 326. Podophyllum hexandrum Poyle. / P.emodii Wall. (syn) Fruit / Rhizome / Root Ban-kakadi / Giriparpat 125-250 mg (Not recommended for children below 5 years and pregnant women) 327. Pongania pinnorta Pierre. / P. glabra syn Seed Karanj 1-3 g (as powder) Leaf/ Stem/ Bark 3-5 g Oil 1-2ml 328. Polygonatum cirrhifolium (Wall.) Royle Rhizome Meda 5-10 g 98 Version-I (29.09.2021) 329. Polygonatum verticillatum (L.) All. Rhizome Mahameda 5-10 g 330. Portulaca oleracea L. / P. quadrifida L. Aerial part Kulpha - sag / 20-30 g (as fresh) Nonia - sag 331. Premna integrifolia / P. latifolia / P. tomentosa Whole plant / Bark / Leaf Agnimanth 5-10 g (as powder) 332. Prosopis spicegera Linn. / P.cineriaria Druce/ P. stephanianna (syn) Pods Shami / Khekjjadii Pods 20-30 g ( as fresh) Leaf / Bark /Flower 3-6 g (as powder) 333. Prunus amygdalus Baill. var. dulchin Fruit seed Vaataama / 10-20 g Badam Seed oil Badam ka tail 3 - 5 ml 334. Prunus armeniaca L. Pericarp Khumani / 10-20 g Aaluka / Apricot Kernel Khumani 3-5 g Seed oil 3-5 ml 335. Prunus cerasoides D. Dons / P. puddum Roxb. (syn) Wood Padmaka / 1-3 g (as powder) Padamkasht / Pajja/ Wild Himalaya cherry Flower 1 -2 g 336. Prunus domestika Linn. / P. communis Huds. Fruit Aarak/ Aaluuchar / 5-10 g (as dried fruit) Aaluubhukaara 99 Version-I (29.09.2021) Seed Oil 2-3 ml 200 mg , Max (not recommended for Stem extract usage beyond 30 days.) 337. Prunus persica (L.) Batsch. / P. vulgaris Nutt. Pericarp / Fruit Aarun / 10-20 g Adu/ Aaluka/ Aru-adu 338. Psidium guajava L. Fruit Peruka / 20-50 g Peru/ Amruda Leaf Amruda 3-5 g 339. Pterocarpus marsupium Roxb. Heart wood Asana / 5-10 g Vijaysar / Extract Beejaka - beeja 0.5-1 g 340. Pterocarpus santalinus Linn. Heart wood Rakt Chandan/ 5-10 g Lal chandan 341. Pterospermum cerifolium Willd. Flower Muchukund 3-6 g Leaf 5-10 g 342. Pueraria tuberosa (Roxb. ex Willd.) DC. Tuber Vidaari / 10-20 g Patal Kohda / Bhumi-kushmand / Lasood 100 Version-I (29.09.2021) 343. Punica granatum L. Seed Dadima/ 20-50 g Dadaka/ Anar Fruit rind Anar 5-10 g Leaf 5 -10 g (for decoction) 344. Putranjiva roxburghii Fruit seed kernel Putrajivak / 3-6 g Jiya-pota (Not recommended for children below 5 years) 345. Pyrus communis L. Fruit Nashpaati / 50-100 g Seed Babbughosha 1–3g Leaf 1-5 g (for decoction) 346. Pyrus malus L. (Now known as Malus pumila Mill.) Fruit Seb 100-200 g 20-40 ml (as juice) 347. Ranunculus scleratus Linn. Whole plant /Root Kaandir / Jal dhaniya 1-3 g (as powder) 348. Raphanus sativus L. Root / Leaf Muulika / 20-50 g (as fresh) Muli Seed 125-250 mg 349. Reinwardtia indica Whole plant/Leaf Basanti 5-10 g (as powder) Extract 0.5-1 g 350. Rhododendron arboreum Sm. / R. companulatum / R. lepidotum Wall. Flower Rodo / 10-20 g 101 Version-I (29.09.2021) Burans / Baraha Extract Burans 1-2 g 351. Rheum emodi Wall. ex Meissn. / R. officinale Leaf Revand chini / 0.5-1 g Root / Stem Peatmuli 1–2g 352. Rhus parviflora Roxb. ex DC. / R. coriaria Linn. Fruit Tinda / 30-75 g Samakdana 353. Ricinus communis Seed/ Root Erand / 5-10 g Leaf Arand / 5-10 ml (as juice) Oil Castor seed 1-5 ml (as laxative occassionally) (Not recommended for children below 5 years) 354. Rosa alba L. / R. centifolia L. / R. damascena Mill. Flower Gulab / Taaruni 10-20 g Oil (distilled) 2 – 5 drops 355. Roscoea procera Wall. Root tuber Kakoli /Kandamula / 5-10 g (as powder) Ksheerakakoli 356. Rubia cordifolia Root/Stem Manjishta /Manjeeth 1-2 g 357. Rumex vesicarius L. / R. nepalensis / R. maritimus / R. acetosella Leaf Ambat chukka / Chukra 10-20 g (Not recommended for children below 5 102 Version-I (29.09.2021) years) 358. Saccharum Munja Roxb. / S. spontaneum Linn. Root Shara-munja / Kaasha 10-20 g (for decoction) 6-10 g (as powder) 359. Saccharum officinarum L. Stem - Juice Iiksashu/ 100-200 ml (as juice) Ganna Root 5-15 g (for decoction) (Not recommended for diabetics) Sugar Chini / Shakkar 15-30 g (Not recommended for diabetics) Jaggery Gud 15-30 g (Not recommended for diabetics) 360. Salacia chinensis L. / Salacia oblonga Wall. ex Wight and Arn / Salacia reticulata Wight. / S. roxburghii / S. macrosperma Root /Stem Saptachakra /Saptrangi / 5-10 g (for decoction) Suvarnamula /Anakoranti ke mula Extract of root or stem Saptrangi 0.5-1 g 361. Salix alba Linn./S. babylonica/ S. capra/ S. frag. Lis / S. tetraspermi Leaf / Bark / Root Jalavetas / vetas / Bed- 10-20 g (for Mushak decoction) 3-6 g (as powder) 362. Salvadora persica/ S. oleoides Fruit/Leaf Peelu / Bada pelu 5-10 g 363. Salvia aegiptica Linn. / S. moorcrafliana / S. officinalis Seed Tukhm-malanga / sage 1-2 g 103 Version-I (29.09.2021) 3-5 g (as leaf powder) Plant 364. Santalum album L. Oil Chandan ka tail 3-5 drops Hard wood 1-2 g (as powder) 365. Saraca asoca Roxb. / S. indica Bark/Leaf Ashok 5-10 g (Not recommended for children below 5 years) 366. Saussurea lappa (Deeni) / S. costus Root/Rhizome Kushta / 3-5 g Kuth (Not recommended for children below 5 years) Oil 5-10 drops 367. Scindapsus officinalis (Schoft) Stem Gajapipplai/Gaj pippali / 3-5 g Gaj krishna 368. Scirpus kysoor Roxb. (Now known as S. grossus (L.f.) Palla) / S. tuberosus Desf. Rhizome Kasheruk /Kasheru / 20-50 g (as fresh) Tuber Rajkasheruka 369. Selinum tenuifolium / S. vaginatum / S. Monnieri Linn. Rhizome /Root Murra-Maangi / 1-3 g Bhuutakoshi 370. Semicarpus anacardium Linn. Fruits / Nuts Bhallataka / Bhallava Detoxified fruit 1-2 g in milk confection (Not recommdeded for children beow 5 years and pregnant 104 Version-I (29.09.2021) women) 371. Sesamum indicum L. (Now known as S. orientale L.) Seed Tila /Sesame /Gingelly 10-20 g Oil Tila 5-10 ml Whole plant 2-3 g (as ash) 372. Sesbania grandiflora (L.) Poir. / S. susben Linn. Flower Agasthya /Jayanti / 10-20 g (as fresh) Agathi /Jait Leaf Agathi 10-20 g 373. Setaria italica (L.) P. Beauv. (Millet) Seed Kanguni / 10-50 g Kangu 374. Shoria robusta Gaertn. Raisin Saala / Shaala 1-3 g Fruit / Bark /Wood 3-5 g (as powder) Oil 1-3 ml 375. Sida cordifolia L. / S. rhombifolis Linn./ S. acuta / S. spinose/ S. veronica folia Whole plant Balla / 10-20 g (for decoction) Mahaballa /Nagaballa / Rajaballa /Bariyara 1-2 g Extract Seed Bariyara 1-2 g 376. Sisimbrium rio Linn./S. losetii Linn. Seed Khuub Kalan 1-3 g Plant 3-6 g (as powder) 377. Smilax china Linn./S. glabra Roxb./ S. lanceifolia Roxb. 105 Version-I (29.09.2021) Tuber Chobachini / Deepanter 60-125 mg (as Vaacha powder) 378. Solanum indicum / S. surattense / S. torvum / S. trilobetum Linn. Whole plant/ Root / Fruit Bruhati / 5-10 g (for decoction) Kantkari-shavet Extract Kateli 0.5-1 g 379. Solanum nigrum L. Whole Plant Kakamachi / 10-20 g Chhoti Makoy / Mako 380. Sorghum vulgare Pers. (Millet) Seed Jwara / 50-100 g Yaava - naal 381. Sphaeranthus indicus Flower Mundi / 5-10 g Mundika / Gorakmundi 382. Spinacia oleracea L. Leaf Palak / Spinach 30 -50 g 383. Spondias mangifera Willd. (Now known as S. pinnata (L.f.) Kurz.) Fruit Aamrataka / 20-30 g Ambada / Leaf / Bark Kapitania 5-10 g (for decoction) 1-3 g (as powder) 384. Stephania glabra Miers. Tuber / Rhizome / Leaf Raaja paatha / Kitha-kanehar 1-3 g (as powder) 385. Strychnos potatorum L. Seed Kataki / 1-3 g (as powder) Nirmali 106 Version-I (29.09.2021) 386. Swertia chirayita / S. ciliata / S. angustifolia Whole plant Kiratik /Cheretta / 3-5 g Bhuunimba /Chiraita Extract Chiraita 0.5-1 g 387. Symplocos racemose Roxb. / S. paniculata Thunb. Bark/Leaf Lodhara / 3-5 g Lodhera - pathani 388. Syzygium aromaticum (L.)Merr. and L.Perry Flower bud Lavanga /Laung 0.5-1 g 389. Syzygium cuminii (L.) Skeels Pericarp and mesocarp Jambu /Jamun 10-50 g Seed Jamun 3-5 g 390. Tacca aspera Roxb. Tuber Bhevara ke kand 20-30 g 391. Tamarindus indica L. / T. officinalis Hk (syn) Fruit pulp Amlika /Chincha / 2-5 g Imali /Tamarind (Not recommended during skin ailments) Seed Imali 5-10 g 392. Taraxacum officinale Leaf /Whole Plant Dugdh - pheni / Dudhi / 1-2g (as powder) Dandelion 393. Taxus baccata Leaf Talis patra/ Sthavneyak / 1-3 g (as powder) Thunera / Birmi Bark 3-5 g (as powder) 394. Tecomella undulata Seem. Bark Rohitaka / Roheda 15-30 g (for decoction) 3-6 g (as powder) 395. Tephrosia purpurea 107 Version-I (29.09.2021) Whole plant Sarponkha 5-10 g (for decoction) 3-5 g (as powder) 396. Teramnus labialis (L.f.) Spreng. Whole plant Mashaparni 10-20 g (for decoction) 397. Terminalia arjuna Roxb. Bark/Leaf/Fruit Arjun /Parth 1-5 g Extract Arjun 0.5 -1 g 398. Terminalia belerica (Gaertn.) Roxb. Fruit pericarp Bibitaki 3-5 g Bahera Extract Bahera 0.5-1 g 399. Terminalia catappa L. Kernel Jungali badaama / Desi 10-20 g badama 400. Terminalia chebula Retz. Fruit pericarp Haritaki /Harad / 3-5 g (as powder) Shiva Extract Harar 0.5-1 g 401. Terminalia tomentosa Wight. and Arn. Stem/Bark/Leaf Asana / 5-10 g (for decoction) Jarandrum / Asan 3-5 g (as powder) 402. Tetragonia expansa/ T. tetragonoides Pall. Shoots / Seed / Root / Flower Van-paalak 20-50 g (as fresh) 5-10 g (as powder) 403. Thalictrum foliolosum DC. Plant / Root Peetranga / Mamirii 1-2 g (as powder) 404. Thespesia populnea soland. Stem / Bark Paarisha / kapitana / 10-20 g (for Paarish-pippala decoction) 108 Version-I (29.09.2021) 3-6 g (as powder) 405. Thymus serpyllum auct. non L. (Now known as T. linearis Benth.) / T. vulgaris Leaf Banya-ajwain / 1-3 g (as powder) Ban ajwain 406. Tilia cordata Linn. / T. Vulgaris Flower Telia 2-5 g (as powder) 407. Trachyspermum ammi (L.) Sprague Seed Yavani /Ajwain / 1-3 g (as powder) Desi ajwain Leaf Ajwain 3 -5 g Oil 5-10 drop 408. Trapa bispinosa Roxb. (Now known as T. natans L. var. bispinosa (Roxb.) Makino) Endosperm / Fruit Shrungataka / 30-60 g Singhada / Sigadu 409. Trianthema portulacastrum L. Whole plant Varsha vhun / 1-3 g Vishakhaparna 410. Tribulus terrestris Linn. Fruit/Whole plant Gokhru / 2-4 g (as powder) Gokshura 5-10 g (for decoction) 411. Tricholepis glaberrima DC. Plant Brahmadandi /Brahm dandi 3-6 g 412. Trichosanthes anguina L. Fruit Dadhipushpi /Chichinda 30-60 g 413. Trichosanthes dioica Roxb. Fruit/ Leaf Patola /Parawal 10-20 g 109 Version-I (29.09.2021) 414. Trigonella foenum-graceum L. Seed Methika / 1-2 g (soaked in water or germinated Methi or roasted) Leaf Methi 50-100 g (as fresh) 415. Triticum aestivum L. Seed Gehun 50-100 g Tender shoot/spout Ankurita Gehu 10-30 g 416. Typhonium trilobatum (L.) Schott. Tuber Karu karunai / 20-50 g Konchu 417. Tinospora cardifolia Miers. (menispermaceae) syn. T. glabra (n. Burm) / T. crispa Linn. Roots/Stem Guduchi / 5-10 g (as powder) Amrita-valli / 10-20 ml (for decoction) Giloya / 0.5-1 g Max (as Giloy sattva) Extract 0.5-1 g 418. Trichosanthes bracteata Lam. / T. palmata Roxb. (syn) Root / Fruit Inder Vaaruni / Vishaalaa 0.5-1 g (as powder) (Not recommended for children below 5 years and pregnant women) 419. Urtica parviflora / U. dioica Tender Leaf Vrishchhiya – shaakiar / 10-20 g (for decoction) Bicchubuti 420. Uraria picta / U. crinita Desv / U. pililifera Linn. Whole plant Prishnaparni 5-10 g (for decoction) Pithvin 3-5 g (as powder) 421. Urginea indica Roxb. Kunth / Drimia indica Roxb. (syn) 110 Version-I (29.09.2021) Bulb / Root / Leaf Van palandu / jangali piyaz / 125-250 mg kolakand (Not recommended for children below 5 years and pregnant women) 422. Valeriana jatamansi Jones / V. wallichii Rhizome Sugandh –baalaa / 1-3 g (as powder) Tagar 423. Veronika officinalis / V. teres Wall. Whole plant / Leaf pamukha 0.25 – 1 g 424. Vetiveria zizanioides Whole plant Ushira / 5 - 10 g (for decoction) Khas / Vetiver 425. Vigna trilobata (L.) Verdc. Whole plant Mudadaparni / 2-4 g (as powder) Mugvan 426. Viola odorata / V. pilosa / V. sylvestris Whole plant Banafsha / 3-5 g Flower Vanksha 1-2 g 427. Vitex agnus-castus Linn. Seed Renuka beej / Sage 1-2 g Leaf 1-3 g (Not recommended for children below 5 years) 428. Vitex negundo / V. trifolia Fruit/Seed/Leaf Nirgundi /Sambhaalu 1-3 g 111 Version-I (29.09.2021) 429. Vitis vinifera L. Fruit dry Draksha /Munakka 5-10 g Seed / Fruit skin Munakka 1-3 g 430. Wedelia calendulacea (L.) Less. (Now known as W. chinensis (Osbeck) Mer.)/ W. biflora DC. Leaf Peet-bhringraja/ 5-10 g (for decoction) Pila bhagra 1-3 g (as powder) 431. Withania coagulans (Stocks) Dunal Fruit Desi – asgandh / 3-10 g Paneer doda 432. Withania somnifera (L.) Dunal. Root Ashwagandha /Asgandh / 3-6 g (as powder) Nagauri / asgandha Extract Asgandh 0.5-1 g 433. Woodfordia fruticosa Flower Dhataki pushp /Dhay ke 3-5 g phool 434. Wrightia tinctoria / W. tomentosa Bark/Leaf Svet kutaj / 3- 5 g Meetha kutaj / Inderyava Seed 1-3 g 435. Zanthoxylum alatum Roxb. (Now known as Zanthoxylum armatum DC.) Seed / Bark Timura /Tejovati /Tis-mira 1-3 g 436. Zea mays L. Seed Makka 20-50 g Anthers / Corn silk 3-5 g 437. Zingiber officinale Rosc. 112 Version-I (29.09.2021) Rhizome Adrakh /Shunti 5-10 g (as fresh) 1-3 g ( as dried) 0.1 – 1 g (Not recommended during hypertension and bleeding Extract disorders) 438. Zizyphus jujuba Lam. Pericarp Unnaba / unnab ber 10-50 g (as fresh) 10-20 g (as powder) 439. Zizyphus nummularia (Burm.f.) W. and A. / Z. oenoplia / Z. xylopyra Willd. Pericarp Jangali Ber / Jhar ber 15-30 g (as fresh fruit) Leaf 3-6 g (as powder) Note 1.- Ingredients listed in the above Schedule shall be used after due processing or in their extract forms subject to permissible usage range given in the last column of the Table. Offering these ingredients, either alone or in combinations as such or minimally processed (cleaned, de-weeded, sorted, dried or powdered) is/are not permitted. Note 2.- Adequate scientific rationale, either based on rationale as enshrined in the Authoritative texts, or as demonstrated in published scientific literature shall be applied for manufacturing foods as supplements/nutraceuticals while using ingredients listed in the Schedule IV of said regulations. In case of use of more than one ingredient listed in the above Schedule in a formulation, adjustment may be permitted by way of reduction or alteration within the permissible usage range (given in the last column of the Table) based on similar scientific rationale subject to that such a use provides a safe formulation. Ingredients, if used in extracts form, as permitted in these regulations, proportion of which shall be based on extractive values as applicable. FBO’s shall provide the rationale as part of the application or when demanded by the Authority. Note 3.- The ingredients listed above shall comply with Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. Note 4.- Permitted range of usage for children between 5-16 years is ½ of the permitted range of usage for adults. 113 Version-I (29.09.2021) Note 5.- Permitted range of usage for children between 2-5 years is ¼ of the permitted range of usage for adults.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] Schedule – VA [See regulations 3.(13), 6.(4), 7.(5), 10.(3) and 11.(3)] List of food additives for health supplements, nutraceuticals and food with added probiotics and prebiotics S. No. INS No. Food Additive or Group Maximum permitted level 1. 950 Acesulfame potassium 2,000 mg/kg 2. 304, 305 Ascorbyl Esters 500 mg/kg 3. 951 Aspartame 5,500 mg/kg 4. 962 Aspartame-Acesulfame salt 2,000 mg/kg 5. 901 Beeswax GMP 6. 210, 211, 212, 213 Benzoates 2,000 mg/kg 7. 133 Brilliant blue FCF 300 mg/kg 8. 320 Butylated hydroxyanisole (BHA) 400 mg/kg 9. 321 Butylated hydroxytoluene (BHT) 400 mg/kg 10. 902 Candelilla wax GMP 11. 150c Caramel III – Ammonia caramel 20,000 mg/kg 12. 150d Caramel IV – Sulfite ammonia 20,000 mg/kg caramel 13. 903 Carnauba wax 5,000 mg/kg 14. 160a(ii) beta-Carotenes (vegetable) 600 mg/kg 15. 160a(i), (iii), 160e, Carotenoids 300 mg/kg 160f 16. 1503 Castor oil 1,000 mg/kg 17. 141(i),(ii) Chlorophylls and Chlorophyllins, 500 mg/kg Copper Complexes 18. 472e Diacetyltartaric and fatty acid 5,000 mg/kg esters of glycerol 19. 385, 386 Ethylene diamine tetra acetates 150 mg/kg 20. 143 Fast green FCF 600 mg/kg 21. 163(ii) Grape skin extract 500 mg/kg 114 Version-I (29.09.2021) S. No. INS No. Food Additive or Group Maximum permitted level 22. 132 Indigotine (Indigo carmine) 300 mg/kg 23. 961 Neotame 90 mg/kg 24. 338, 339(i)-(iii), Phosphates 2,200 mg/kg 340(i)-(iii), 341(i)- (iii), 342(i),(ii), 343(i)-(iii), 450(i)-(iii),(v)-(vii), 451(i),(ii), 452(i)-(v), 542 25. 1203 Polyvinyl alcohol 45,000 mg/kg 26. 900a Polydimethylsiloxane 50 mg/kg 27. 1521 Polyethylene Glycol 70,000 mg/kg 28. 432-436 Polysorbates 25,000 mg/kg 29. 1201 Polyvinylpyrrolidone GMP 30. 124 Ponceau 4R (Cochineal red A) 300 mg/kg 31. 310 Propyl gallate 400 mg/kg 32. 101(i)-(iii) Riboflavins 300 mg/kg 33. 954(i)-(iv) Saccharins 1,200 mg/kg 34. 904 Shellac, Bleached GMP 35. 200-203 Sorbates 2,000 mg/kg 36. 960 Steviol Glycosides 2,500 mg/kg 37. 955 Sucralose 2,400 mg/kg (Trichlorogalactosucrose) 38. 474 Sucroglycerides 2,500 mg/kg 39. 110 Sunset yellow FCF 300 mg/kg Amendment for insertion of new provision 1[40. 172(i), 172(ii), Iron oxides 7,500 mg/kg (For 172(iii) use in surface treatment only)] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 115 Version-I (29.09.2021) Schedule – VB [See regulations 3.(13), 8.(4), 10.(3) and 11.(3)] List of food additives for foods for special dietary use and food with added probiotics and prebiotics S. No. INS No. Food Additive or Group Maximum permitted Level 1. 950 Acesulfame potassium 450 mg/kg 2. 956 Alitame 300 mg/kg 3. 304, 305 Ascorbyl Esters 500 mg/kg 4. 951 Aspartame 1,000 mg/kg 5. 962 Aspartame-acesulfame salt 450 mg/kg 6. 210, 211, 212, 213 Benzoates 2,000 mg/kg 7. 133 Brilliant blue FCF 300 mg/kg 8. 150c Caramel III – Ammonia caramel 20,000 mg/kg 9. 150d Caramel IV - Sulfite ammonia caramel 20,000 mg/kg 10. 160a(ii) Beta-Carotenes (vegetable) 600 mg/kg 11. 160a(i), (iii), 160e, Carotenoids 300 mg/kg 160f 12. 472e Diacetyltartaric and fatty acid esters of 5,000 mg/kg glycerol 13. 163(ii) Grape skin extract 250 mg/kg 14. 132 Indigotine (Indigo carmine) 300 mg/kg 15. 961 Neotame 65 mg/kg 16. 338, 339(i)-(iii), Phosphates 2,200 mg/kg 340(i)-(iii), 341(i)- (iii), 342(i),(ii), 343(i)-(iii), 450(i)-(iii),(v)-(vii), 451(i),(ii),452(i)-(v), 542 17. 900a Polydimethylsiloxane 50 mg/kg 18. 124 Ponceau 4R (Cochineal red A) 300 mg/kg 19. 101(i)-(iii) Riboflavins 300 mg/kg 20. 954(i)-(iv) Saccharins 200 mg/kg 21. 200-203 Sorbates 1,500 mg/kg 22. 960 Steviol glycosides 660 mg/kg 23. 955 Sucralose (Trichlorogalactosucrose) 400 mg/kg 24. 110 Sunset yellow FCF 300 mg/kg 116 Version-I (29.09.2021) Schedule – VC [See regulations 3.(13), 9.(4), 10.(3) and 11.(3)] List of food Additives for foods for special medical purpose (other than those products intended for foods for infants) and food with added probiotics and prebiotics S. No. INS No. Food Additive or Group Maximum Permitted Level 1. 950 Acesulfame potassium 500 mg/kg 2. 951 Aspartame 1,000 mg/kg 3. 962 Aspartame-acesulfame salt 500 mg/kg 4. 210 - 213 Benzoates 1,500 mg/kg 5. 133 Brilliant blue FCF 50 mg/kg 6. 150c Caramel III – Ammonia caramel 20,000 mg/kg 7. 150d Caramel IV - Sulfite Ammonia 20,000 mg/kg caramel 8. 160a(ii) beta-Carotenes (vegetable) 600 mg/kg 9. 160a(i), (iii), 160e, 160f Carotenoids 50 mg/kg 10. 472e Diacetyltartaric and fatty acid 5,000 mg/kg esters of glycerol 11. 163(ii) Grape skin extract 250 mg/kg 12. 132 Indigotine (Indigo carmine) 50 mg/kg 13. 961 Neotame 33 mg/kg 14. 338, 339(i)-(iii), 340 (i)-(iii), Phosphates 2,200 mg/kg 341(i)-(iii), 342 (i),(ii), 343(i), (iii), 450 (i)-(iii), (v)-(vii), 451(i), (ii), 452(i)-(v), 542 15. 900a Polydimethylsiloxane 50 mg/kg 16. 432 - 436 Polysorbates 1,000 mg/kg 17. 124 Ponceau 4R (Cochineal red A) 50 mg/kg 18. 477 Propylene glycol esters of fatty 5,000 mg/kg acids 19. 101(i)-iii) Riboflavins 300 mg/kg 20. 954 (i)-(iv) Saccharins 200 mg/kg 21. 200-203 Sorbates 1,500 mg/kg 22. 960 Steviol glycosides 350 mg/kg 23. 955 Sucralose 400 mg/kg (Trichlorogalactosucrose) 24. 474 Sucroglycerides 5,000 mg/kg 25. 110 Sunset yellow FCF 50 mg/kg 117 Version-I (29.09.2021) Schedule – VD [See regulations 3.(13), 9.(4), 10.(3) and 11.(3)] List of food additives for foods for special medical purpose (other than those intended for infant foods); formula for slimming purpose and weight reduction and food with added probiotics and prebiotics S. No. INS No. Food Additive or Group Maximum permitted Level 1. 950 Acesulfame potassium 450 mg/kg 2. 304, 305 Ascorbyl Esters 500 mg/kg 3. 951 Aspartame 800 mg/kg 4. 962 Aspartame-acesulfame salt 450 mg/kg 5. 210 - 213 Benzoates 1,500 mg/kg 6. 133 Brilliant blue FCF 50 mg/kg 7. 150c Caramel III – Ammonia caramel 20,000 mg/kg 8. 150d Caramel IV - Sulfite Ammonia 20,000 mg/kg caramel 9. 160a(ii) Beta-Carotenes (vegetable) 600 mg/kg 10. 160a(i), (iii), 160e, 160f Carotenoids 50 mg/kg 11. 472e Diacetyltartaric and fatty acid 5,000 mg/kg esters of glycerol 12. 163(ii) Grape skin extract 250 mg/kg 13. 132 Indigotine (Indigo carmine) 50 mg/kg 14. 961 Neotame 33 mg/kg 15. 338, 339(i)-(iii), 340(i)-(iii), Phosphates 2,200 mg/kg 341(i)-(iii), 342(i),(ii), 343(i)-(iii), 450 (i)-(iii),(v)-(vii), 451(i),(ii), 452(i)-(v), 542 16. 900a Polydimethylsiloxane 50 mg/kg 17. 432 - 436 Polysorbates 1,000 mg/kg 18. 124 Ponceau 4R (Cochineal red A) 50 mg/kg 19. 477 Propylene glycol esters of fatty 5,000 mg/kg acids 20. 101(i)-iii) Riboflavins 300 mg/kg 21. 954 (i)-(iv) Saccharins 300 mg/kg 22. 200-203 Sorbates 1,500 mg/kg 23. 960 Steviol Glycosides 270 mg/kg 24. 955 Sucralose 320 mg/kg (Trichlorogalactosucrose) 25. 474 Sucroglycerides 5,000 mg/kg 26. 110 Sunset yellow FCF 50 mg/kg 118 Version-I (29.09.2021) Schedule – VE [See regulations 3.(13), 6.(4), 7.(5), 8.(4), 9.(4), 10.(3), 11.(3) and 12.(4) ] List of food additives to be used (at GMP levels) for- (I) Nutraceuticals, (II) Foods for special dietary use other than foods for infants, (III) Foods for special medical purpose, (IV) Foods with added probiotic ingredients and prebiotic ingredients, (V) Specialty foods containing plant or botanical ingredients, and (VI) Health supplements S. No. INS No. Additive Functional Class 1. 260 Acetic acid, glacial Acidity regulator, Preservative 2. 472a Acetic and fatty acid esters of Emulsifier, Sequestrant, Stabilizer glycerol 3. 1422 Acetylated distarch adipate Emulsifier, Stabilizer, Thickener 4. 1417 Acetylated distarch phosphate Emulsifier, Stabilizer, Thickener 5. 1451 Acetylated oxidized starch Emulsifier, Stabilizer, Thickener 6. 1401 Acid treated starch Emulsifier, Stabilizer, Thickener 7. 406 Agar Bulking agent, Carrier, Emulsifier, Gelling agent, Glazing agent, Humectant, Stabilizer, Thickener 8. 400 Alginic acid Bulking agent, Carrier, Emulsifier, Foaming agent, Gelling agent, Glazing agent, Humectant, Sequestrant, Stabilizer, Thickener 9. 1402 Alkaline treated starch Emulsifier, Stabilizer, Thickener 10. 1100 (i) alpha-Amylase from Flour treatment agent Aspergillus oryzae 11. 1100 (vi) Carbohydrase from Bacillus Flour treatment agent licheniformis 12. 1100 (iv) alpha-Amylase from Bacillus Flour treatment agent megaterium expressed in Bacillus subtilis 13. 1100 (ii) alpha-Amylase from Bacillus Flour treatment agent stearothermophilus 14. 1100 (v) alpha-Amylase from Bacillus Flour treatment agent stearothermophilus expressed in Bacillus subtilis 15. 1100 (iii) alpha-Amylase from Bacillus Flour treatment agent subtilis 16. 264 Ammonium acetate Acidity regulator 17. 403 Ammonium alginate Bulking agent, Carrier, Emulsifier, Foaming agent, Gelling agent, Glazing agent, Humectant, Sequestrant, Stabilizer, Thickener 119 Version-I (29.09.2021) S. No. INS No. Additive Functional Class 18. 503(i) Ammonium carbonate Acidity regulator, Raising agent 19. 510 Ammonium chloride Flour treatment agent 20. 503(ii) Ammonium hydrogen Acidity regulator, Raising agent carbonate 21. 527 Ammonium hydroxide Acidity regulator 22. 328 Ammonium lactate Acidity regulator, Flour treatment agent 23. 300 Ascorbic acid, L. Acidity regulator, Anti-oxidant, Flour treatment agent 24. 162 Beet red Colour 25. 1403 Bleached starch Emulsifier, Stabilizer, Thickener 26. 1101(iii) Bromelain Flavour enhancer, Flour treatment agent, Stabilizer 27. 629 Calcium 5'-guanylate Flavour enhancer 28. 633 Calcium 5'-inosinate Flavour enhancer 29. 634 Calcium 5'-ribonucleotides Flavour enhancer 30. 263 Calcium acetate Acidity regulator, Preservative, Stabilizer 31. 404 Calcium alginate Anti-foaming agent, Bulking agent, Carrier, Foaming agent, Gelling agent, Glazing agent, Humectant, Sequestrant, Stabilizer 32. 302 Calcium ascorbate Anti-oxidant 33. 170(i) Calcium carbonate Acidity regulator, Anti-caking agent, Carrier, Firming agent, Flour treatment agent, Stabilizer 34. 509 Calcium chloride Firming agent, Stabilizer, Thickener 35. 623 Calcium di-L-glutamate Flavour enhancer 36. 578 Calcium gluconate Acidity regulator, Firming agent, Sequestrant 37. 526 Calcium hydroxide Acidity regulator, Firming agent 38. 327 Calcium lactate Acidity regulator, Flour treatment agent 39. 352(ii) Calcium malate, DL- Acidity regulator 40. 529 Calcium oxide Acidity regulator, Flour treatment agent 41. 282 Calcium propionate Preservative 42. 552 Calcium silicate Stabilizer 43. 516 Calcium sulfate Firming agent, Flour treatment agent, Sequestrant, Stabilizer 44. 150a Caramel I – plain caramel Colour 45. 290 Carbon dioxide Carbonating agent, Packaging gas, Preservative, Propellant 120 Version-I (29.09.2021) S. No. INS No. Additive Functional Class 46. 410 Carob bean gum Emulsifier, Stabilizer, Thickener 47. 407 Carrageenan Bulking agent, Carrier, Emulsifier, Gelling agent, Glazing agent, Humectant, Stabilizer, Thickener 48. 427 Cassia gum Emulsifier, Gelling agent, Stabilizer, Thickener 49. 140 Chlorophylls Colour 50. 1001 Choline salts and esters Emulsifier 51. 330 Citric acid Acidity regulator, Anti-oxidant, Sequestrant 52. 472c Citric and fatty acid esters of Anti-oxidant, Emulsifier, Flour glycerol treatment agent, Sequestrant, Stabilizer 53. 466 Cross carmellose sodium Binder, Thickening agent, Disintegrant 54. 468 Cross-linked sodium Stabilizer, Thickener carboxymethyl cellulose (Crosslinked- cellulose gum) 55. 424 Curdlan Firming agent, Gelling agent, Stabilizer, Thickener 56. 457 Cyclodextrin, alpha- Stabilizer, Thickener 57. 458 Cyclodextrin, gamma- Stabilizer, Thickener 58. 1504 (i) Cyclotetraglucose Carrier, Glazing agent 59. 1504 (ii) Cyclotetraglucose syrup Carrier 60. 1400 Dextrins, roasted starch Emulsifier, Stabilizer, Thickener 61. 628 Dipotassium 5'-guanylate Flavour enhancer 62. 627 Disodium 5'-guanylate Flavour enhancer 63. 631 Disodium 5'-inosinate Flavour enhancer 64. 635 Disodium 5'-ribonucleotides Flavour enhancer 65. 1412 Distarch phosphate Emulsifier, Stabilizer, Thickener 66. 315 Erythorbic Acid (Isoascorbic Anti-oxidant acid) 67. 968 Erythritol Flavour enhancer, Humectant, Sweetener 68. 462 Ethyl cellulose Bulking agent, Carrier, Glazing agent, Thickener 69. 467 Ethyl hydroxyethyl cellulose Emulsifier, Stabilizer, Thickener 70. 297 Fumaric acid Acidity regulator 71. 418 Gellan gum Stabilizer, Thickener 72. 575 Glucono delta-lactone Acidity regulator, Raising agent, Stabilizer 73. 1102 Glucose oxidase Anti-oxidant 74. 620 Glutamic acid, L(+)- Flavour enhancer 75. 422 Glycerol Humectant, Thickener 121 Version-I (29.09.2021) S. No. INS No. Additive Functional Class 76. 626 Guanylic acid, 5'- Flavour enhancer 77. 412 Guar gum Emulsifier, Stabilizer, Thickener 78. 414 Gum arabic (Acacia gum) Bulking agent, Carrier, Emulsifier, Glazing agent, Stabilizer, Thickener 79. 507 Hydrochloric acid Acidity regulator 80. 463 Hydroxypropyl cellulose Bulking agent, Emulsifier, Foaming agent, Glazing agent, Stabilizer, Thickener 81. 1442 Hydroxypropyl distarch Emulsifier, Stabilizer, Thickener phosphate 82. 464 Hydroxypropyl methyl Emulsifier, Glazing agent, Stabilizer, cellulose Thickener 83. 1440 Hydroxypropyl starch Emulsifier, Stabilizer, Thickener 84. 630 Inosinic acid, 5' Flavour enhancer 85. 953 Isomalt (Hydrogenated Anti-caking agent, Bulking agent, isomaltulose) Glazing agent, Sweetener 86. 416 Karaya gum Emulsifier, Stabilizer, Thickener 87. 425 Konjac flour Carrier, Emulsifier, Gelling agent, Glazing agent, Humectant, Stabilizer, Thickener 88. 270 Lactic acid, L-, D- and DL- Acidity regulator 89. 472b Lactic and fatty acid esters of Emulsifier, Sequestrant, Stabilizer glycerol 90. 966 Lactitol Emulsifier, Sequestrant, Stabilizer 91. 322(i) Lecithin (and its salts and Anti-oxidant, Emulsifier esters from soya or other sources) 92. 1104 Lipases Stabilizer 93. 160d(iii) Lycopene, Blakeslea trispora Colour 94. 160d(i) Lycopene, synthetic Colour 95. 160d (ii) Lycopene, tomato Colour 96. 504(i) Magnesium carbonate Acidity regulator, Anti-caking agent, Colour retention agent 97. 511 Magnesium chloride Colour retention agent, Firming agent, Preservative 98. 625 Magnesium di-L-glutamate Flavour enhancer 99. 580 Magnesium gluconate Acidity regulator, Firming agent, Flavour enhancer 100. 528 Magnesium hydroxide Acidity regulator, Colour retention agent 101. 504(ii) Magnesium hydroxide Acidity regulator, Anti-caking agent, carbonate Carrier, Colour retention agent 102. 329 Magnesium lactate, DL- Acidity regulator, Flour treatment 122 Version-I (29.09.2021) S. No. INS No. Additive Functional Class agent 103. 530 Magnesium oxide Anti-caking agent 104. 553(i) Magnesium silicate, synthetic Anti-caking agent 105. 518 Magnesium sulfate Firming agent, Flavour enhancer 106. 296 Malic acid, DL- Acidity regulator 107. 965(i) Maltitol Bulking agent, Emulsifier, Humectant, Stabilizer, Sweetener 108. 965(ii) Maltitol syrup Bulking agent, Emulsifier, Humectant, Stabilizer, Sweetener 109. 421 Mannitol Anti-caking agent, Bulking agent, Humectant, Stabilizer, Sweetener 110. 461 Methyl cellulose Bulking agent, Glazing agent, Humectant, Stabilizer, Thickener 111. 465 Methyl ethyl cellulose Emulsifier, Gelling agent, Stabilizer, Thickener 112. 460(i) Microcrystalline cellulose Anti-caking agent, Bulking agent, (Cellulose gel) Carrier, Emulsifier, Foaming agent, Glazing agent, Stabilizer, Thickener 113. 471 Mono and di-glycerides of Anti-foaming agent, Emulsifier, fatty acids Stabilizer 114. 624 Monoammonium L-glutamate Flavour enhancer 115. 622 Monopotassium L-glutamate Flavour enhancer 116. 621 Monosodium L-glutamate Flavour enhancer 117. 1410 Monostarch phosphate Emulsifier, Stabilizer, Thickener 118. 941 Nitrogen Packaging gas, Propellant 119. 942 Nitrous oxide Anti-oxidant, Foaming agent, Packaging gas, Propellant 120. 1404 Oxidized starch Emulsifier, Stabilizer, Thickener 121. 1101(ii) Papain Flavour enhancer 122. 440 Pectins Emulsifier, Gelling agent, Stabilizer, Thickener 123. 1413 Phosphated distarch Emulsifier, Stabilizer, Thickener phosphate 124. 1200 Polydextroses Bulking agent, Glazing agent, Humectant, Stabilizer, Thickener 125. 964 Polyglycitol syrup Sweetener 126. 1202 Poly vinyl pyrrolidone, Colour retention agent, Stabilizer insoluble, including cross povidone 127. 632 Potassium 5’-inosinate Flavour enhancer 128. 261 Potassium acetates Acidity regulator, Stabilizer 129. 402 Potassium alginate Bulking agent, Carrier, Emulsifier, Foaming agent, Gelling agent, Glazing agent, Humectant, Sequestrant, 123 Version-I (29.09.2021) S. No. INS No. Additive Functional Class Stabilizer, Thickener 130. 303 Potassium ascorbate Anti-oxidant 131. 501(i) Potassium carbonate Acidity regulator, Stabilizer 132. 508 Potassium chloride Flavour enhancer, Gelling agent, Stabilizer, Thickener 133. 332(i) Potassium dihydrogen citrate Acidity regulator, Sequestrant, Stabilizer 134. 577 Potassium gluconate Acidity regulator, Stabilizer 135. 501(ii) Potassium hydrogen Acidity regulator, Raising agent, carbonate Stabilizer 136. 351(i) Potassium hydrogen malate Acidity regulator 137. 515 (ii) Potassium hydrogen sulfate Acidity regulator 138. 525 Potassium hydroxide Acidity regulator 139. 326 Potassium lactate Acidity regulator, Anti-oxidant 140. 351(ii) Potassium malate Acidity regulator 141. 283 Potassium propionate Preservative 142. 515(i) Potassium sulfate Acidity regulator 143. 460(ii) Powdered cellulose Anti-caking agent, Bulking agent, Carrier, Emulsifier, Foaming agent, Glazing agent, Stabilizer, Thickener 144. 407a Processed eucheuma seaweed Bulking agent, Carrier, Emulsifier, Gelling agent, Glazing agent, Humectant, Stabilizer,Thickener 145. 944 Propane Propellant 146. 280 Propionic acid Preservative 147. 1101(i) Protease Flavour enhancer, Flour treatment agent, 1999 Glazing agent, Stabilizer 148. 1204 Pullulan Glazing agent, Thickener 149. 470(i) Salts of myristic, palmitic and Anti-caking agent, Emulsifier, Stabilizer stearic acids with ammonia, calcium, potassium and sodium 150. 470(ii) Salts of oleic acid with calcium, Anti-caking agent, Emulsifier, Stabilizer potassium and sodium 151. 551 Silicon dioxide, amorphous Anti-caking agent, Anti-foaming agent, Carrier 152. 262(i) Sodium acetate Acidity regulator, Preservative, Sequestrant 153. 401 Sodium alginate Bulking agent, Carrier, Emulsifier, Foaming agent, Gelling agent, Glazing agent, Humectant, Sequestrant, Stabilizer, Thickener 124 Version-I (29.09.2021) S. No. INS No. Additive Functional Class 154. 301 Sodium ascorbate Anti-oxidant 155. 500(i) Sodium carbonate Acidity regulator, Anticaking agent, Raising agent 156. 466 Sodium carboxymethyl Bulking agent, Emulsifier, Firming cellulose (Cellulose gum) agent, Gelling agent, Glazing agent, Humectant, Stabilizer, Thickener 157. 469 Sodium carboxymethyl Stabilizer, Thickener cellulose, enzymatically hydrolysed (Cellulose gum, enzymatically hydrolyzed) 158. 331(i) Sodium dihydrogen citrate Acidity regulator, Emulsifier, Sequestrant, Thickener 159. 350(ii) Sodium DL-malate Acidity regulator, Humectant 160. 316 Sodium erythorbate (Sodium Anti-oxidant isoascorbate) 161. 365 Sodium fumarates Acidity regulator 162. 576 Sodium gluconate Sequestrant, Stabilizer, Thickener 163. 500(ii) Sodium hydrogen carbonate Acidity regulator, Anti-caking agent, Raising agent 164. 350(i) Sodium hydrogen DL-malate Acidity regulator, Humectant 165. 514(ii) Sodium hydrogen sulfate Acidity regulator 166. 524 Sodium hydroxide Acidity regulator 167. 325 Sodium lactate Acidity regulator, Anti-oxidant, Bulking agent, Humectant, Thickener 168. 281 Sodium propionate Preservative 169. 500(iii) Sodium sesquicarbonate Acidity regulator, Anti-caking agent, Raising agent 170. - Sodium starch glycolate Binder, Thickening agent, Disintegrant 171. 514(i) Sodium sulfate Acidity regulator 172. 420(i) Sorbitol Bulking agent, Humectant, Sequestrant, Stabilizer, Sweetener 173. 420(ii) Sorbitol syrup Bulking agent, Humectant, Sequestrant, Stabilizer, Sweetener 174. 1420 Starch acetate Emulsifier, Stabilizer, Thickener 175. 1450 Starch sodium octenyl Emulsifier, Stabilizer, Thickener succinate 176. 1405 Starches, enzyme treated Emulsifier, Stabilizer, Thickener 177. 473a Sucrose Oligoesters, Type I Emulsifier, Stabilizer and Type II 178. 553(iii) Talc Anti-caking agent, Glazing agent, Thickener 179. 417 Tara gum Gelling agent, Stabilizer, Thickener 180. 957 Thaumatin Flavour enhancer, Sweetener 125 Version-I (29.09.2021) S. No. INS No. Additive Functional Class 181. 171 Titanium dioxide Colour 182. 413 Tragacanth gum Emulsifier, Stabilizer, Thickener 183. 1518 Triacetin Carrier, Emulsifier, Humectant 184. 380 Triammonium citrate Acidity regulator 185. 333(iii) Tricalcium citrate Acidity regulator, Firming agent, Sequestrant, Stabilizer 186. 332(ii) Tripotassium citrate Acidity regulator, Sequestrant, Stabilizer 187. 331(iii) Trisodium citrate Acidity regulator, Emulsifier, Sequestrant, Stabilizer 188. 415 Xanthan gum Emulsifier, Gelling agent, Stabilizer, Thickener 189. 967 Xylitol Emulsifier, Humectant, Stabilizer, Thickener 126 Version-I (29.09.2021) Schedule VF [See regulations 3.(1), 3.(13), 6.(4), 7.(5), 8.(4), 9.(4), 10.(3), 11.(3) and 12.(4)] List of food additives to be used in formats such as tablets, capsules and syrups (I) Nutraceuticals, (II) Foods for special dietary uses other than foods for infants, (III) Foods for special medical purpose, (IV) Foods with added probiotic ingredients and prebiotic ingredients, (V) Speciality foods containing plant or botanical ingredients, and (VI) Health supplements S.No. Additive (Pharmaceutical Functionality Maximum Permitted Aid) Level 1. Acacia gum Binding agent GMP 2. Acetone Solvent for coating GMP (does not remain in the tablet and residual levels to be as per IP) 3. Ascorbic acid and its esters Antioxidant 0.5% and salts 4. Benzoic acid and its salts Preservative 0.5% 5. BHA Antioxidant 0.5% 6. BHT Antioxidant 0.5% 7. Bronopol Preservative 0.5% 8. Calcium carbonate Diluent, Dissintegrant GMP 9. Calcium stearate Lubricant 1% 10. Carboxymethylcellulose Binding agent 5-15% Calcium 11. Carrageenan gum Binding agent 2% 12. Cellulose acetate phthalate Coating agent 2% 13. Citric acid Disintegrant 2% 14. Citric and fatty acid esters of Stabilizer 2% glycerol 15. Copovidone Binding agent 2-5% 16. Corn oil Vehicle GMP 17. Corn starch Diluent, Binding agent, GMP Dissintegrant 18. Cross carmellose sodium Disintegrant 2%J Amendment for substitution of highlighted provision 1[0.5 to 5 %] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 127 Version-I (29.09.2021) 19. Cyclodextrin Diluent GMP 20. Dextrose Diluent GMP 21. Dicalcium phosphate Diluent GMP 22. Ethyl acetate Solvent for coating GMP (does not remain in the tablet and residual levels to be as per IP) 23. Ethyl alcohol Solvent for coating GMP (does not remain in the tablet and residual levels to be as per IP) 24. Ethyl cellulose Coating agent, GMP Ingredient of capsule shells 25. Fructose Diluent GMP 26. Gelatin Binding agent, GMP Ingredient of capsule shells 27. Glycerin Vehicle, Humectant for GMP capsule shells 28. Guar gum Binding agent GMP 29. Hydrogenated castor oil Lubricant 2% 30. Hydrogenated vegetable oil Lubricant 1% 31. Hydroxy propyl Coating agent, GMP methylcellulose Ingredient of capsule shells 32. Isomalt Soluble fiber 15% 33. Kaolin Diluent GMP 34. Lactitol Diluent 200 mgper capsule 35. Lactose Diluent GMP 36. Lecithin and its salts/esters Emulsifier, Stabilizer GMP from soya or other sources 37. Light magnesium carbonate Anticaking agent 0.5% 38. Light magnesium oxide Anticaking agent 0.5% 39. Liquid glucose Binding agent GMP 40. Magnesium carbonate Adsorbant 0.3% 41. Magnesium stearate Antisticking agent, 2% Glidant 42. Maize Starch Diluent, Binding agent, GMP Dissintegrant 43. Maltitol Sweetener, Diluent GMP 44. Maltodextrin Diluent GMP 45. Maltose Diluent GMP 46. Manitol Diluent, Sweetner GMP 47. Methyl paraben and its salts Preservative 0.2% 48. Microcrystalline cellulose Diluent GMP 49. 1[Natural and synthetic colors Coloring agents Limits as per FSSR] I as per FSSR I I [Amendment for omission of this provision w.e.f. 1st April, 2022] I I 128 Version-I (29.09.2021) 50. Peanut oil Vehicle GMP 51. Pectin Binding agent GMP 52. PEG 4000 Diluent for direct GMP compression tablets 53. Colors permitted under Rule Coloring agents GMP 127 of Drugs & Cosmetics Rules including lake colours 54. Poly ethylene glycol (PEG) Vehicle, Humectant for GMP capsule shells 55. Povidone Binding agent 5% 56. Propyl paraben and its salts Preservative 0.02% 57. Propylene glycol Vehicle, Humectant for GMP capsule shells 58. Purified Talc Glidant, Dusting 2% powder for coating 59. Saff flower oil Vehicle GMP 60. Sodium alginate Binding agent 5% 61. Sodium starch glycolate Disintegrant, Binder, 2% Thickening agent 62. Sorbitan crystalline Diluent 15% 63. Sorbitan oleate esters Solubalizers 0.5% (Tweens) 64. Sorbitol liquid Vehicle, Humectant for GMP capsule shells 65. Starch, pregelatinized Disintegrant 1% 66. Stearic acid Antisticking agent, 2% Glidant 67. Sucrose Diluent, Coating agent GMP 68. Sunflower oil Vehicle GMP 69. TBHQ Antioxidant 0.5% 70. Tocoferol and its esters Antioxidant 0.5% 71. Tragacanth gum Binding agent GMP 72. Tribasic calcium phosphate Diluent, anticaking GMP agent 73. Tricalcium phosphate Diluent GMP 74. Vegetable oils Vehicle GMP 75. Xanthan gum Binding agent GMP 76. Xylitol Diluent, Sweetner GMP 77. Zinc stearate Lubricant 0.5-1.5% Amendment for insertion of new provision 1[78. Glycerol palmito stearate - GMP 79. Medium chain triglyceride - GMP 80. Glycerylbehenate - GMP 81. Triethyl citrate - GMP 129 Version-I (29.09.2021) 82. Methacrylate copolymers - GMP 83. Propane 1, 2 diol alginate (INS - 1200mg/kg 405) 84. Isopropyl alcohol Solvent for coating GMP 85. Dichloromethane Solvent for coating GMP 86. Potassium chloride Gelling agent GMP] th [Amendment in force from 6 September, 2021; FBOs to comply with the provisions by 1st April, 2022] Schedule –VI [See regulations 3.(13), 4.(2), 6.(2)(i), 7.(2)(i), 7.(3)(i), 7.(3)(v), 8.(2)(i) and 9.(2)(i)] List of ingredients as nutraceuticals PART A S. No. Nutraceutical Common Purity Criteria Permitted ingredients name Range 1. Astaxanthin - Astaxanthin content 4 mg/day, Max (from Haematococus pluvalis), powder or oleoresin 2. Boswellia serrate - gum Salai guggul / Total boswelic acids or 11- 250 - 1,500 mg resin extract Kundru keto-beta boswelic acids extract/day content 3. Caffiene Caffiene Per cent caffiene Within levels specified in FSS Regulations 4. Chromium picolinate/ - Chromium picolinate/ 200 - 400 mcg / nicotinate nicotinate content day 5. Cimicifuga racemosa (or Black cohosh Total triterpene glycosides 40 - 200 mg Actaea racemosa). (minimum 0.4%), calculated as /day, Max Extracted from rhizomes 23-epi-26-deoxyactein). and roots 6. Citrus Bioflavonoids Citrus Bioflavinoids and total 150 - 600 mg / (Citrus x paradisi, Citrus polyphenol content day, Max reticulata x maxima, C. x sinensis and Citrus limon) 7. CoQ10 from non GM Co enzyme Ubiqinone and ubiqinol content 100-1,000 mg / source Q10 day, Max 8. Echinacea (E. angustifolia, Echinacea Alkamides (0.25 mg/ml) and 900 mg / day, E. purpurea, and E. cichoric acid (2.5 mg/ml), if the Max pallida) Liquid/powder extract used is in liquid form. extract In case of Hydroethanolic Echinacea extract is in a powdered form computation may be done proportionately to the weight/weight dry powder extract based on liquid 130 Version-I (29.09.2021) PART A S. No. Nutraceutical Common Purity Criteria Permitted ingredients name Range extract used to obtain a dry powder format. 9. Ginkgo biloba extract Ginkgo biloba Ginkgo flavone glycosides and 120-240 mg/ obtained from dried leaves extract Ginkgolides (diterpene day, Max of Ginkgo (Ginkgo biloba. lactones). Total flavonoids L.). content (20.2 to 27% calculated as flavanol glycosides and tested for total terpene lactones (5.4% to 12.0%). Presence of Ginkgolides A, B, C needs to be tested qualitatively. 10. Glucosamine Glucosamine Glucosamine content 1,500-3,000 hydrochloride mg/day, Max 11. Glucosamine sulphate Glucosamine Glucosamine content 2,500-5,000 mg/day, Max 12. Gymnema sylvestre Gudmar Gymnemic acid content 500-1,500mg / extract powder extract day, Max 13. Lactase (β- - Enzyme activity 3,000 – 9,000 IU galactosidase)* (or FCC units) / day, Max 14. Panax ginseng ( Ginseng Ginsenoside content ranging 90 - 400 mg /day, Syn;Korean Ginseng) extract from 0.7 to 3%. Max extract - (obtained from 0.6 to 2.0 gm of Ginseng root, (Panaxginseng.C A. Meyer, Araliaceae) 15. Phycocynin from Spirulina Spirulina Protein: 50-70 %; 50 – 250 mg plantesis (Aethrospira Carbohydrates: 20-40%; /day, Max plantesis) Dried powder Minerals (Ash): 5.0 – 15%; Moisture: 3.0 – 6.0 % 16. Piper nigrum / Piper Peeper / Piperine content 15 mg/day of longum extract Pippali piperine, Max(Duration of use: maximum 30 days) 17. Quercetin obtained from - Quercetin content 100 mg / day, extracts of citrus fruits Max and other vegetables 18. Schizandra berry extract Five-flavor Schizandrin berries 1 – 3 g / day, Max berry containing 2.5-3.0% schizandrin 19. Scutellaria bicalensis Skullcap Aq. Extract of Scutellaria 250 – 1,000 mg/ bicalensis standardized to day, Max bicallin content (NLT 50%) 20. Selenium Yeast - Selenium content and number 2 mg/day of of yeast counts (Cfu/g) selenium, Max 21. Siberian ginseng- Ginseng Releutherosides content 100 – 450 mg / obtained from 0.6 to 2.0 extract day, Max gm of Ginseng 131 Version-I (29.09.2021) PART A S. No. Nutraceutical Common Purity Criteria Permitted ingredients name Range root (Acanthopanax senticosus, belonging to panax type, C A. Meyer, Araliaceae) 22. Silybum marianum Milk Thistle Standardized extract – silimarin 250 - 1,000 mg/ extract (silymarin content day extract) 23. Spirulina (algae) from Spirulina (Protein (min.) - 55%, 500 - 3,000 mg / Spirulina platensis carbohydrates (max.)-30%, fats day (Arthrospira platensis) (lipid) – not more than 10%, minerals (ash)-5-10%, moisture- 3-6% (also fatty acid profile to be mentioned on the package) 24. Vaccinium myrstillus Bilberry Anthocyanin content 50 - 600 mg / extract extract day, Max Part B S.No. Nutraceuticals / Ingredients Common name. 1. (+) Hydroxycitric acid Allium sativum – bulbs dried powder / extract powder 2. standardized Garlic 3. Aloe vera – juice /concentrate /powder of sap /gel Indian aloe, Ghrit kumari 4. Alpha amylase* - 5. Alpha mangostin - 6. Alpha-galactosidase* - 7. Alpha-lipoic acid - 8. Amaranthus tricolor – leaf powder / extract - 9. Amylase* - 10. Amyloglucosidase* - 11. Anethum graveolens L. - seeds and oil Dill 12. Anthocyanin - 13. Arabinogalactan - 14. Arachidonic acid - 15. Asparagus densiflorus - extract Asparagus 16. Bacopa monnieri - leaf extract Brahmi 17. Barley seed powder Barley 18. Berberis vulgaris – stem/root extract Berberry Beta carotene – standardized soft concentrate / emulsified 19. concentrate / powder - 20. Beta ecdysterone - 21. Beta glucans - 22. Beta vulgaris – root extract Beet 132 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Common name. 23. Beta sitosterol - 24. Betula platyphylla - bark extract Birch 25. Biota orientalis - seed powder Biota 26. Black /green tea extract, standardized powder - 27. Borago officinalis - oil Borage 28. Campestanol - 29. Campesterol - 30. Capsicum annum - extract / standardized to capsicin content Cayenne pepper 31. Caricus papaya – leaf extract Papaya 32. Carotenoids (natural mixed, including from algal sources) - 33. Casein and caseinates 34. Caulophyllum thalictroides - root extract Blue cohosh 35. Cellulase* - 36. Centella asiatica – leaf/aerial parts standardized extract Mandukparni / Gotu Kola 37. Matricaria chamomilla (Matricaria recutita) – aerial parts extract Chamomile 38. Chlorella platensis – dried powder Green algae 39. Chlorogenic acids and caffeic acid - 40. Chondroitin sulphate Chondroitin 41. Cichorium intybus – roasted root powder Chicory 42. Cinnamomum verum – bark powder / extract Cinnamon 43. Citrulline - 44. Citrus aurantium – peel extract / bioflavonoids standardized Bitter orange 45. Citrus naringenin - 46. Citrus naringinine - 47. Clove powder Lavang 48. Cnicus benedictus – aerial parts extract / root extract Blessed thistle 49. Cocoa (chocolate) bean - extract - 50. Coccinia grandis (L.) Voigt - extract Ivy gourd 51. Collagen hydrolysed - 52. Conjugated linoleic acid concentrate - 53. Crustacean shells - 54. Cuminum cyminum L – oil / extract Cumin 55. Curcuma longa – rhizome powder / extract standardized Turmeric 56. Curcuminoids – soft extract / powder and curcumin complex - 57. Cyperus rotandus - extract Nirgundi 58. Dehydroepiandrosterone (DHEA) and 7-Keto DHEA 59. Diastase* - 60. D-Pinitol - Edible legumes (seed powder), legume proteins (protein 61. isolates/ concentrates/ hydrolysates) - 133 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Common name. 62. Ellagic acid - 63. Emblica officinalis – dried fruit extract / spray dried pulp powder Indian gooseberry/ amla 64. Eriocitrin (from citrus fruit) - 65. Evening primrose oil - 66. Fagopyrum esculentum - seed Buckwheat 67. Fish oil - 68. Foeniculum vulgare - fruit - oil / extract Fennel 69. Freeze-dried banana powder - 70. Galactomannan - 71. Gallic acid - 72. Gamma-linoleic acid (GLA ) - 73. Gamma-oryzanol - 74. Garcinia gummi-gatti and Garcinia cambogia – fruit rind extract Kokum / Brindall Berry / standardized to hydroxyl citric acid, powder) Malabar tamarind 75. Garcinia mangostana – seed extract standardized Mangosteen 76. Glucoamylase* - 77. Glucomannan - 78. Glycyrrhiza glabra - extract Licorice 79. Grape seed extract - Green coffee seed extract standardized, including decaffeinated 80. coffee bean powder/extract - 81. Grifola frondosa – standardized extract Maitake mushroom Guar gum and gum arabic and its derivatives as a source of fibers; 82. and fibers from other food sources 83. Hemicellulase* - 84. Hesperidin - High oleic sun flower oil and other vegetable oils with high oleic 85. content - 86. Hippophaerh amnoides – fruit dried powder / extract / juice Sea buckthorn 87. Humulus lupulus L – powder / extract Hops 88. Hydrolysed whey peptide Whey 89. Hypericum perforatum – aerial parts standardized extract St. Johns Wort 90. Inula racemosa - root extract Pushkarmoola 91. Invertase* - 92. Isoflavones (genistein, daidzein) - 93. Kelp (brown algae) - 94. Krill oil - standardized for DHA / EPA - 95. Lactalbumin - 96. Lactoferrin - 97. Lactoperoxidase* - 98. Lagerstroemia speciosa L (leaf extract) Banaba 134 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Common name. 99. Lecithins - 100. Lignans - 101. Linum usitatissimum - seed powder and oil Flaxseed 102. Lipase* - 103. Lutein - 104. Lutein/zeaxanthin complex - 105. Lycopene - Lycium eleagnus - fruit - dried powder / concentrate 106. standardized Goji berry (wolfberry) 107. Maltase* - 108. Medicago sativa extract Alfalfa 109. Medium chain triglycerides - 110. Menyanth estrifoliata - Leaf powder Buckbean / bogbean 111. Millets and their powder - 112. Momordica charantia - fruit / seed extract Bitter melon (bitter gourd) 113. Monodora myristica (Gaertn.) Dunal – oil / extract Nutmeg 114. Morinda citrifolia extract Noni 115. Moringa oleifera leaf / pods / seed extract powder Moringa / drum stick 116. Mulberry tea – leaf / fruit extract Mulberry 117. Myrica cerifera – bark extract Bayberry 118. Myristica fragrans Mace 119. N-Acetyl D-glucosamine - 120. Nasturtium officinale - extract Watercress 121. Nattokinase enzyme (as Soy Bean Fibrinase) - Ocimum tenuiflorum /Ocimum sanctum – aerial parts / seed 122. extract Basil /tulasi Omega-3 fatty acids (docosahexaenoic acid - ‎eicosapentaenoic 123. acid - ‎alpha - linolenic acid) - 124. Omega-6-fatty acids (linoleic acid, arachidonic acid and - conjugated linoleic acid) 125. Oyster shell powder - 126. Pancreatin* - 127. Pancrelipase* - 128. Papain* - 129. Passiflora foetida - extract Passion flower 130. Arachis hypogaea - (roasted) powder Pea nut 131. Pectin - 132. Pepsin* - 133. Phellodendron amurense leaf oil Phellodendron 134. Phosphatides /Phospholipids - 135. Phyllanthus amarus - extract Bhuiamalaki 135 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Common name. 136. Phytase* - 137. Picrorhiza (Picrorhiza kurroa) - extract Kurchi 138. Pimento officinalis L. - extract/powder Allspice 139. Pinus gerardiana - bark extract Pine nut 140. Piper longum - extract Long pepper (pippali) 141. Piper nigram - green extract Green pepper 142. Piper nigrum– powder / standardized extract Black pepper 143. Policosanol - 144. Protease* - 145. Prunus serotina - extract Black cherry 146. Psyllium (Ispaghula) - seed husk Isaphgul 147. Pumpkin seed oil /meal - 148. Punica granatum – fruit /seed /skin extract /powder Pomegranate / dadima 149. Raphanus sativus var. niger - root powder/ extract Black radish 150. Red wine - extract /concentrate - 151. Red yeast rice - 152. Resveratrol - 153. Rhododendron arboretum - juice/extract Rhododendron 154. Rice bran - 155. Rice bran arabinoxylan compound - 156. Rose hips - 157. Rosmarinus officinalis – leaves/ needles extract /oil Rosemary 158. Royal Jelly - 159. Rutin from fruit peels - 160. Salvia officinalis – leaf extract Sage Elderberry/ Black 161. Sambucus nigra - extract elderberry 162. Shark cartilage /squalene oil - 163. Shiitake mushroom - extract - 164. Solanum lycopersicum – fruit powder/ extract Tomato 165. Soy sprouts – dried powder - 166. Soya protein isolate/ edible legume seed protein isolate - 167. Spearmint – leaf and distillate - 168. Stanols and sterols including cholesterols - 169. Tagetes sp. – petals oleo resin / extract Marigold 170. Tea catechins (epigallo catechin gallate, epicatechin, catechin - gallates) 171. Terminalia arjuna - bark /leaf extract (standardized extract) Arjuna 172. Terminalia bellerica - fruit extract Myrobalan / Baheda 173. Terminalia chebulia - fruit extract Myrobalan / Harad 174. Theaflavin - 136 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Common name. 175. Theanine - 176. Theobromine -- 177. Tocopherols - 178. Trigonella-foenum-graecum – seeds extract Fenugreek 179. Triticum sativum - bran Wheat 180. Trypsin* - 181. Vaccinium corymbosum - fruit - dried powder / concentrate Blueberry standardized 182. Vaccinium oxycoccos - fruit - dried powder / concentrate Cranberry standardized 183. Vitis alba and Vitis vinifera - fruit - dried powder / concentrate Blue grapes standardized 184. Wheat germ - 185. Zeaxanthin (max. 4 mg/day) - 186. Zingiber officinale - rhizome standardized extracts Ginger 187. α-galactosidase* - Note.- *Enzymes- The enzymes listed in this schedule are primarily used as processing aids, but also may be used in nutraceutical products. Amendment for substitution of Schedule VI 1[Schedule –VI [See regulations 3.(13), 4.(2), 6.(2)(i), 7.(2)(i), 7.(3)(i), 7.(3)(v), 8.(2)(i) and 9.(2)(i)] List of ingredients as nutraceuticals PART A S. No. Nutraceutical Official / Purity Criteria Permitted Ingredients Common Range name (1) (2) (3) (4) (5) 1. American ginseng Ginseng American ginseng extract 90 - 400 mg (Panax quinquefolius extract (containing NLT 10% of total /day, Max L.) (American). ginsenosides on dried basis). 2. Astaxanthin - Astaxanthin content 2 - 12 mg/day, (from Haematococcus Max pluvalis), powder or oleoresin 3. Beta Alanine - - 4 - 6 g / day, Max (not more than 4 weeks at a 137 Version-I (29.09.2021) PART A S. No. Nutraceutical Official / Purity Criteria Permitted Ingredients Common Range name (1) (2) (3) (4) (5) stretch) 4. Betaine (N,N,N,- - - 600 - 650 mg trimethylglycine) /day, Max 5. Boswellia serrata - Salai guggul / Total boswelic acids or 11- 250 - 1,500 mg gum resin extract Kundru keto-beta boswelic acids extract/day, content Max 6. Caffeine Caffeine Caffeine Per cent 3 mg/kg b/w per day, subject to a maximum limit of 300mg per day and not more than 200mg in a single dose (only for adults and not recommended for pregnant and lactating women). 7. Calcium hydroxyl - CaHMB content 3 - 6 g / day, methyl butyrate Max (CaHMB) (Not recommended for use by pregnant women and lactating mothers) 8. Chlorella vulgaris – Green algae / 1 – 4 g/day, dried powder Shaiwal Max 9. Chromium picolinate/ - Chromium picolinate/ 200 - 400 mcg / nicotinate nicotinate content day, Max 10. Cimicifuga racemosa Black cohosh Total triterpene glycosides 40 - 200 mg (or Actaea racemosa). (minimum 0.4%), /day, Max Extracted from calculated as 23-epi-26- rhizomes and roots deoxyactein). 11. Citrus bioflavonoids Citrus / Bioflavinoids and total 150 - 600 mg / 138 Version-I (29.09.2021) PART A S. No. Nutraceutical Official / Purity Criteria Permitted Ingredients Common Range name (1) (2) (3) (4) (5) (Citrus paradisi, C. Jambir polyphenol content day, Max reticulate, C.maxima, C. sinensis and Citrus limon) 12. CoQ10 from non GM Co enzyme Ubiqinone and ubiqinol 60 -300 mg / source and Ubiquinol Q10 content day, Max acetate 13. Colostrum - - Bovine colostrum spray dried powder at usage level of 15g per day (containing 3g of IgG) or 3g per day (containing 0.3g IgG) without any efficacy claims. 14. Creatine (source- - - 3 g / day, Max Creatine monohydrate, (for adults Creatine hydrochloride only) and Creatine nitrate) 15. Cryptoxanthin / - - 3 mg / day, Max Mesoxanthin 16. Echinacea (E. Echinacea Alkamides (0.25 mg/ml) 900 mg / day, angustifolia, E. and cichoric acid (2.5 Max purpurea, and E. mg/ml), if the extract used pallida) Liquid/powder is in liquid form. In case of extract Hydroethanolic Echinacea extract is in a powdered form computation may be done proportionately to the weight/weight dry powder extract based on liquid extract used to obtain a dry powder format. 17. Ginkgo biloba extract Ginkgo biloba Ginkgo flavone glycosides 120-240 mg/ obtained from dried extract and Ginkgolides (diterpene day, Max 139 Version-I (29.09.2021) PART A S. No. Nutraceutical Official / Purity Criteria Permitted Ingredients Common Range name (1) (2) (3) (4) (5) leaves of Ginkgo lactones). Total flavonoids (Ginkgo biloba. L.). content (20.2 to 27% calculated as flavanol glycosides and tested for total terpene lactones (5.4% to 12.0%). Presence of Ginkgolides A, B, C needs to be tested qualitatively. 18. Glucosamine Glucosamine Glucosamine content 1,500-3,000 hydrochloride mg/day, Max 19. Glucosamine sulphate Glucosamine Glucosamine content 2,500-5,000 mg/day, Max 20. Glutathione / S-acetyl 50 - 600 mg / - - glutathione day, Max 21. Gymnema sylvestre Madhunashin Gymnemic acid content 500-1,500 mg / extract powder i, Gudmar day, Max (extract) 22. Lactase (β- - Enzyme activity 3,000 – 9,000 galactosidase)* IU (or FCC units) / day, Max 23. L-carnosine - - 130 - 600 mg / day, Max 24. L- theanine Chai suksham 50- 200 satva mg/day, Max 25. Melatonin - - 2 – 10 mg / day, Max 26. Methyl sulfonyl - - 1000 - 3000 mg methane / day, Max (Not recommended for use by pregnant women and lactating mothers) 27. Panax ginseng ( Ginseng Ginsenoside content 90 - 400 mg Syn;Korean Ginseng) extract ranging from 3 - 10 % and /day, Max 140 Version-I (29.09.2021) PART A S. No. Nutraceutical Official / Purity Criteria Permitted Ingredients Common Range name (1) (2) (3) (4) (5) extract - (obtained adjusted to potency basis from 0.6 to 2.0 g of 3% total ginsenoside Ginseng root, (Panax content ginseng.C A. Meyer, Araliaceae) 28. Phycocyanin from Spirulina Protein: 50-70 %; 50 – 250 mg Spirulina plantesis Carbohydrates: 20-40%; /day, Max (Aethrospira Minerals (Ash): 5.0 – 15%; plantesis) Dried Moisture: 3.0 – 6.0 % powder 29. Piper nigrum / Piper Pippali/ Piperine content 15 mg/day of longum extract Pepper piperine, Max (Duration of use: maximum 30 days) 30. Quercetin obtained - Quercetin content 100 mg / day, from extracts of citrus Max fruits, vegetables and other plant sources. 31. Schizandra berry Five-flavor Schizandrin berries 1 – 3 g / day, extract berry containing 2.5-3.0% Max schizandrin 32. Scutellaria bicalensis Patwar topi, Aq. extract standardized 250 – 1,000 Skullcap to bicallin content 30 - mg/ day, Max 50 % and adjusted to potency basis 50 % bicallin content 33. Selenium Yeast - Selenium content and 2 mg/day of number of yeast counts selenium, Max (Cfu/g) 34. Siberian ginseng- Ginseng Eleutherosides content 100 – 450 mg / obtained from 0.6 to extract day, Max 2.0 g of Ginseng root (Acanthopanax senticosus, belonging to panax type, C A. Meyer, Araliaceae) 35. Silybum marianum Milk Thistle Standardized extract – 250 - 1,000 extract (silymarin silimarin content mg/ day, Max 141 Version-I (29.09.2021) PART A S. No. Nutraceutical Official / Purity Criteria Permitted Ingredients Common Range name (1) (2) (3) (4) (5) extract) 36. Spirulina (algae) from Shaiwal/ (Protein (min.) - 55%, 500 - 3,000 mg (Spirulina platensis, carbohydrates (max.)-30%, / day, Max Spirulina fats (lipid) – not more than Arthrospira platensis) 10%, minerals (ash)-5-10%, moisture- 3-6% (also fatty acid profile to be mentioned on the package) 37. Undenatured type II - - 40 mg/day, Max collagen 38. Vaccinium myrstillus Bilberry Anthocyanin content 50 - 600 mg / extract extract day, Max 39. Zeaxanthin - - 4 mg/day, Max 40. Camellia sinensis-Black Chai & tea - 0.5 g - 2 g/day, /green tea extract, extract Max standardized powder 41. Camellia sinensis-Tea Chai satva - 0.7 g/day, Max” catechins (epigallo catechin gallate, epicatechin, catechin gallates) Part B S.No. Nutraceuticals / Ingredients Official and Common names. (1) (2) (3) 1. (+) Hydroxycitric acid - 2. Albizia lebbeck - extract Shireesh Allium sativum – bulbs dried standardized powder / 3. extract Rason/ Lashun/Garlic 4. Aloe vera – juice /concentrate /powder of sap /gel Ghrit Kumari /Indian aloe 5. Alpha amylase* - 6. Alpha mangostin - 7. Alpha-galactosidase* - 8. Alpha-lipoic acid - 142 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Official and Common names. (1) (2) (3) 9. Amaranthus tricolor – leaf powder / extract Marisha-Rakt Extract 10. Amylase* - 11. Amyloglucosidase* - 12. Anethum graveolens L. - seeds and oil Shatahva/ Sowa /Soa /Dill 13. Anthocyanin - 14. Arabinogalactan - 15. Arachidonic acid - 16. Asparagus densiflorus - extract Asparagus / Shatavari 17. Bacopa monnieri - leaf extract Brahmi 18. Barley seed powder Yava /Barley 19. Bauhinia variegata - extract Kachnar Berberis vulgaris/ B. aristata/B.asiatica – stem/root 20. extract Berberry / Daru haridra Beta carotene – standardized soft concentrate / 21. emulsified concentrate / powder - 22. Beta ecdysterone - 23. β-glucans - 24. Beta vulgaris – root extract Palanki/Beet 25. β-sitosterol - 26. Betula platyphylla/B.utilis - bark extract Bhojapatra/Birch 27. Biota orientalis - seed powder Biota 28. Borago officinalis - oil Borage 29. Campestanol - 30. Campesterol - 31. Capsicum annum - extract / standardized to capsicin Lanka/Cayenne pepper / Lal content mirchi Caricus papaya – leaf extract Papaya / Papeeta, Erand- 32. karkati Carotenoids (natural mixed, including from algal 33. sources) - 34. Casein and caseinates - 35. Caulophyllum thalictroides - root extract Blue cohosh 36. Cellulase* - 37. Centella asiatica – leaf/aerial parts standardized extract Mandukparni / Gotu Kola 143 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Official and Common names. (1) (2) (3) 38. Matricaria chamomilla (Matricaria recutita) – aerial Chamomile parts extract 39. Malpighia emarginata (Cherry acerola) Acerola 40. Chlorogenic acids - 41. Caffeic acid 42. Chondroitin sulphate Chondroitin 43. Cichorium intybus – roasted root powder Kasani/ Chicory 44. Cinnamomum verum – bark powder / extract Tvak bhed/Cinnamon 45. Citrulline/ L-citrulline DL-malate (2:1) - Citrus aurantium – peel extract / bioflavonoids 46. standardized Bitter orange 47. Citrus naringenin - 48. D-Mannose - 49. Syzygum aromaticum- Clove powder & oil Lavang tail 50. Cnicus benedictus – aerial parts extract / root extract Blessed thistle 51. Theobroma cacao-Cocoa (chocolate) bean - extract - 52. Coccinia grandis (L.) Voigt - extract Bimbi/Kunduru/ Ivy gourd 53. Collagen and its hydrolysed peptides and chelates - 54. Conjugated linoleic acid concentrate - 55. Crataeva nurvala - extract Varun 56. Crustacean shells - 57. Cuminum cyminum L – oil / extract Jeerak/Safed Jeera/Cumin Curcuma longa – rhizome powder / extract 58. standardized Haridra/Haldi/Turmeric Curcuminoids – soft extract / powder and curcumin 59. complex - 60. Cyperus rotundus - extract Mustak/Nagar motha 61. Diastase* - 62. D-Pinitol - 63. Dioscorea bulbifera - extract Varahi kand 64. Protein isolates/concentrates/hydrolysates - 65. Ellagic acid - 66. Emblica officinalis – dried fruit extract / spray dried Indian gooseberry/ amlaki pulp powder 144 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Official and Common names. (1) (2) (3) 67. Eriocitrin (from citrus fruit) - 68. Oenothera biennis- Evening primrose oil - 69. Fagopyrum esculentum - seed Buckwheat 70. Fish oil - 71. Foeniculum vulgare - fruit - oil / extract Fennel / Saunf 72. Freeze-dried banana powder - 73. Galactomannan - 74. Gallic acid - 75. Gamma-linoleic acid (GLA ) - 76. Gamma-oryzanol - 77. Garcinia gummi-gutta and Garcinia cambogia/G.indica – Kokum / Vrikshamalak / fruit rind extract standardized to hydroxyl citric acid, Malabar tamarind powder) 78. Garcinia mangostana – seed extract standardized Mangosteen 79. Glucoamylase* - 80. Glucomannan - Madhuyashti/Licorice / 81. Glycyrrhiza glabra - extract Mulethi 82. Grape seed extract - Coffea arabica, C. robusta- Green coffee seed extract 83. standardized, including decaffeinated coffee bean powder/extract Kaphi 84. Grifola frondosa – standardized extract Maitake mushroom Guar gum and gum arabic and its derivatives as a source of fibers; Maltodextrin/Resistant maltodextrin/ Limit 85. Dextrin; chia seed fiber and fibers from other food sources - 86. Hemicellulase* - 87. Hesperidin - High oleic sun flower oil and other vegetable oils with 88. high oleic content - Hippophae rhamnoides – leaf/fruit dried 89. powder/extract / juice Amalvetas /Sea buckthorn / 90. Humulus lupulus L – powder / extract Phaph/Hops 91. Hyaluronic acid and its salts - 145 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Official and Common names. (1) (2) (3) 92. Hydrolysed whey peptide Whey Hypericum perforatum – aerial parts standardized 93. extract Basant/St. Johns Wort 94. Inula racemosa - root extract Pushkarmoola extract 95. Invertase* - 96. Isoflavones (genistein, daidzein) - 97. Kelp (brown algae) - 98. Krill oil - standardized for DHA / EPA - 99. Lactalbumin - 100. Lactoferrin - 101. Lactoperoxidase* - 102. Lagerstroemia speciosa L (leaf extract) Jarul/Banaba 103. Lecithins - 104. Lignans - 105. Linum usitatissimum - seed powder and oil Atasi/Alasi/Flaxseed 106. Lipase* - 107. Lutein - 108. Lutein/zeaxanthin complex - 109. Lycopene - Lycium barbarum/ Lycium europaeum/ Lycium 110. ruthenicum fruit - dried powder/concentrate standardized Goji berry (wolfberry) 111. Maltase* - 112. Mangifera indica – mangiferine, leaf extract - 113. Medicago sativa extract Ashar-bala/Alfalfa 114. Medium chain triglycerides - 115. Menyanthes trifoliata - Leaf powder Buckbean / bogbean 116. Millets and their powder - 117. Momordica charantia - fruit / seed extract Karvalli/Kodon,/bitter gourd/, Karela 118. Monodora myristica (Gaertn.) Dunal – oil / extract Nutmeg 119. Morinda citrifolia extract Akshiki/Noni 120. Moringa oleifera leaf / pods / seed extract powder Shigru/Moringa / drum stick 121. Morus alba- Mulberry tea– leaf / fruit extract Toot/Mulberry 146 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Official and Common names. (1) (2) (3) 122. Myrica cerifera/M. nagi – bark extract Katphala/Bayberry 123. Myristica fragrans Houtt. Jatipatri/Mace/ Javitri 124. N-Acetyl d-glucosamine - 125. Nardostachys jatamansi - extract Jatamansi 126. Nasturtium officinale - extract Chhu nail/Watercress 127. Nattokinase enzyme (as Soy bean Fibrinase) - Ocimum tenuiflorum /Ocimum sanctum – aerial parts / Surasa/ 128. seed extract Basil /Tulasi Omega-3 fatty acids (docosahexaenoic acid - 129. ‎eicosapentaenoic acid‎-‎‎alpha - linolenic acid) - 130. Omega-6-fatty acids (linoleic acid, arachidonic acid and - conjugated linoleic acid) 131. Oyster shell powder Shukti/Seep 132. Pancreatin* - 133. Pancrelipase* - 134. Papain* - 135. Passiflora foetida - extract Passion flower 136. Arachis hypogaea - (roasted) powder Mandapi/Pea nut/ Munghphali 137. Pectin - 138. Pepsin* - 139. Perna canaliculus (Green lipped mussel / Mussel Oil) - 140. Phellodendron amurense leaf oil Phellodendron 141. Phosphatides /Phospholipids - 142. Phyllanthus amarus - extract Tamalaki/ Bhuiamalaki 143. Phytase* - 144. Picrorhiza kurroa-Picrorhiza - extract Katuka/Kutaki 145. Pimento officinalis L. - extract/powder Allspice 146. Pinus gerardiana - bark extract Nikochak/Pine nut 147. Piper longum - extract Pippali/ Magha/Long pepper 148. Piper nigram - green extract Green pepper, Krishan Marich Krishan Marich/ Marich/ Black 149. Piper nigrum– powder / standardized extract pepper 150. Policosanol - 151. Protease* - 147 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Official and Common names. (1) (2) (3) 152. Prunus serotina - extract Black cherry 153. Plantago ovata (major) –Psyllium (Isaphula)- seed husk Isaphgul-Ashabgol 154. Cucurbita pepo, C. maxima- Pumpkin seed oil /meal Kaddu beej tail Punica granatum – fruit /seed /skin extract /leaf 155. /powder Dadima/Pomegranate 156. Raphanus sativus var. niger - root powder/ extract Mulika/ Muli /Black radish 157. Red wine - extract /concentrate - 158. Red yeast rice - 159. Resveratrol - 160. Rhododendron arboreum/R. campanulata - juice/extract Buras/Rhododendron 161. Rice bran - 162. Rice bran arabinoxylan compound - 163. Rose hips - 164. Rosmarinus officinalis – leaves/ needles extract /oil Rosemary 165. Royal Jelly - 166. Rutin from fruit peels - 167. Salvia officinalis – leaf extract Renuka Leaf Extract/Sage 168. Sambucus nigra - extract Khaman Kabir /Elderberry/ Black elderberry 169. Shark cartilage /squalene oil - 170. Shiitake mushroom - extract - Solanum lycopersicum/ S. esculentum – fruit powder/ 171. extract Tamatar/Tomato 172. Soy sprouts – dried powder - 173. Soya protein isolate/ edible legume seed protein isolate - 174. Spearmint – leaf and distillate - 175. Sterols/Stanols including their esters - 176. Tagetes sp. – petals oleo resin / extract Marigold 177. Terminalia arjuna - bark /leaf extract (standardized Arjuna extract extract) 178. Terminalia bellerica - fruit extract Bibhitak/Baheda/Myrobalan 179. Terminalia chebulia - fruit extract Haritaki / Harad/Myrobalan 180. Theaflavin Chai sukshara satva 181. Theobromine - 148 Version-I (29.09.2021) Part B S.No. Nutraceuticals / Ingredients Official and Common names. (1) (2) (3) 182. Tocopherols - 183. Trigonella-foenum-graecum – seeds extract Methika/Methi/Fenugreek 184. Triticum sativum - bran Godhum/Wheat/Gehu 185. Trypsin* - 186. Vaccinium corymbosum - fruit - dried powder / Blueberry concentrate standardized 187. Vaccinium oxycoccos/Vaccinium macrocarpon - fruit - Cranberry dried powder / concentrate standardized 188. Valeriana wallichii - extract Tagar 189. Vitis alba and Vitis vinifera - fruit - dried powder / concentrate standardized Draksha/ Munakka/Blue grapes 190. Wheat germ - 191. Zingiber officinale - rhizome standardized extracts Shunti/Ginger 192. Mucopolysaccharides Note 1.- *Enzymes- The enzymes listed in this schedule are primarily used as processing aids, but also may be used in nutraceutical products. Note 2.-The sources for ingredients listed under Schedule-VI shall only be from those listed/specified under Food Safety and Standrds Regulations. The chemically synthesized nutraceutical ingredients shall only be used with prior approval of the Food Authority.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 149 Version-I (29.09.2021) Schedule –VII [See regulations 3.(13), 6.(2)(i), 7.(2)(i), 8.(2)(i), 9.(2)(i) and 10.(1)(i)] List of strains as probiotics (live micro-organisms) S. No. Name of the Microorganism 1. Lactobacillus acidophilus 2. Lactobacillus plantarum 3. Lactobacillus reuteri 4. Lactobacillus rhamnosus 5. Lactobacillus salivarius 6. Lactobacillus casei 7. Lactobasillus brevis 8. Lactobacillus johnsonii 9. Lactobacillus delbrueckii sub- sp. bulgaricus 10. Bacillus coagulans 11. Lactobacillus fermentum 12. Lactobacillus caucasicus 13. Lactobacillus helveticus 14. Lactobacillus lactis 15. Lactobacillus amylovorus 16. Lactobacillus gallinarum 17. Lactobacillus delbrueckii 18. Bifidobacterium bifidum 19. Bifidobacterium lactis 20. Bifidobacterium breve 21. Bifidobacterium longum 22. Bifidbacterium animalis 23. Bifidobacterium infantis 24. Streptococcus thermophilus 25. Saccharomyces boulardii 26. Saccharomyces cerevisiae 27. Lactobacillus paracasei 28. Lactobacillus gasseri Note.- (1) These organisms may be used either singly or in combination but shall be declared on the label with full information and has to be Non-GMO. (2) The Food Authority may add any new strain of microorganism, possessing probiotic properties, after proper scientific evaluation, and include in this Schedule. 150 Version-I (29.09.2021) Amendment for substitution of Schedule VII 1[Schedule –VII [See regulations 3.(13), 6.(2)(i), 7.(2)(i), 8.(2)(i), 9.(2)(i) and 10.(1)(i)] List of probiotic (live) micro-organisms S.No. Name of the Microorganism (1) (2) 1. Lactobacillus acidophilus 2. Lactiplantibacillus plantarum 3. Limosilactobacillus reuteri 4. Lacticaseibacillus rhamnosus 5. Ligilactobacillus salivarius 6. Lacticaseibacillus casei 7. Levilactobacillus brevis 8. Lactobacillus johnsonii 9. Lactobacillus delbrueckii sub- sp. bulgaricus 10. Bacillus coagulans 11. Limosilactobacillus fermentum 12. Lactobacillus caucasicus 13. Lactobacillus helveticus 14. Lactobacillus lactis 15. Lactobacillus amylovorus 16. Lactobacillus gallinarum 17. Lactobacillus delbrueckii (Lactobacillus delbrueckii subsp. delbrueckii) 18. Bifidobacterium bifidum 19. Bifidobacterium lactis (Bifidobacterium animalis subsp. lactis) 20. Bifidobacterium breve 21. Bifidobacterium longum (Bifidobacterium longum subsp. longum) 22. Bifidobacterium animalis (Bifidobacterium animalis subsp. animalis) 23. Bifidobacterium infantis (Bifidobacterium longum subsp. infantis) 24. Streptococcus thermophilus (Streptococcus salivarius subsp. thermophilus) 25. Saccharomyces boulardii (Saccharomyces cerevisiae subsp. boulardii) 26. Saccharomyces cerevisiae (Saccharomyces cerevisiae subsp. cerevisiae) 27. Lacticaseibacillus paracasei 28. Lactobacillus gasseri 29. Bacillus clausii 30. Established probiotic strains of Bacillus subtilis Note.- (1) These organisms may be used either singly or in combination but shall be declared on the label with full information and has to be Non-GMO. (2) The Food Authority may add any new strain of microorganism, possessing probiotic properties, after proper scientific evaluation, and include in this Schedule.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 151 Version-I (29.09.2021) Schedule – VIII [See regulations 3.(13), 6.(2)(i), 7.(2)(i), 8.(2)(i), 9.(2)(i) and 11.(1)(i)] List of prebiotic compounds S. No. Prebiotic Compounds 1. Polydextrose • 2. 1[2. Soybean oligosaccharidesI Amendment for substitution of highlighted provision Soya poly-saccharides and soya oligosaccharides] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] 3. Isomalto-oligosaccharides 4. Fructo-oligosaccharides 5. Gluco-oligosaccharides 6. Xylo-oligosaccharides 7. Inulin 8. Isomaltulose 9. Gentio-ologsaccharides 10. Lactulose 11. Lactoferrin 12. Sugar alcohols such as lactitol, sorbitol, maltitol, inositol, isomalt 13. Galacto-oligosaccharides Amendment for insertion of new provision 1[14. Partially Hydrolyzed Guar Gum (Guar gum derivative) 15. Pectin 16. Resistant dextrin] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] Note.- The Food Authority may add any new specific prebiotic after proper scientific evaluation and include in this Schedule. 152 Version-I (29.09.2021) Amendment for insertion of new provision 1[Schedule IX Standards for ingredients (1) Psyllium (Isabgol) husk: (i) Psyllium (Isabgol) husk means product manufactured from dry seed coats of Plantago ovate Forsk. (Fam. Plantaginaceae) obtained by crushing the clean seeds and separating the husks by winnowing. (ii) The product shall be white or translucent, odourless, thin boat shaped structures, 2 to 3 mm long and 0.5 to 1 mm wide. The taste shall be bland and mucilaginous. It should not give any gritty feeling during sensorial (organoleptic) evaluation. (iii) It shall be free from insect infestation, fungal contamination and fermented, musty or other odours. It shall also be free from any added additives, colours, flavours and harmful foreign materials. (iv) The product shall conform to the following requirements: S. No. Characteristics Requirements (1) (2) (3) (i) Moisture, per cent by mass Not more than 11.5 (ii) Total ash (on dry basis), per cent by mass Not more than 4.0 (iii) Acid Insoluble Ash (on dry basis), per cent by Not more than 0.45 mass (iv) Swell Volume, ml/gram Not less than 40 (v) Organic extraneous matter*, per cent by Not more than 2 mass *Organic extraneous matter includes broken or entire embryo, fragments of endosperm or capsular wall of fruits belonging to isabgol crop.] [Amendment in force from 6th September, 2021; FBOs to comply with the provisions by 1st April, 2022] Note. - The principal regulations were published in the Gazette of India, Extraordinary vide notification number No. 1-4/ Nutraceutical/ FSSAI-2013, dated the 23rd December, 2016 and subsequently amended vide notification numbers: 1. Stds./03/Notification (Nutra)/FSSAI – 2017, dated 6th September, 2021. 153 Version-I (29.09.2021)