GUIDELINE FOR REGULATING

HEALTH SUPPLEMENTS

Registration Division
Drug Regulatory Authority
Royal Government of Bhutan

1st Edition, 2018

Page 1 of 28
 Contents
Introduction……………………………………………………………………………………………………………………….3

Scope…………………………………………………………………………………………………………………………………4

References………………………………………………………………………………………………………………………..5

Definition of terminologies………………………………………………………………………………………………..6

Principles for regulation of health supplements……………………………………………………………..7-8

Process Flowchart……………………………………………………………………………………………………………..9

Procedure for application……………………………………………………………………………………………....10

Evidence to susbtantiate claims………………………………………………………………..……………….11-12

Labelling requirements…………………………………………………………………………………………………..13

Tables …………………………………………………………………………………………………......................16-26

Application Form……………………………………………………………………………………………………………27

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Introduction
Health Supplements are known by various terminologies in different countries. They
are often referred to as dietary supplements, nutrition supplements, complementary
medicines etc. in different National Regulatory Authorities. In this Guideline, the term
Health Supplement is used as a generic term inclusive of all the terminologies
outlined above.

Due to increased trend of manufacturers venturing into the Health Supplement

market, there is unprecedented promotion and public interest in the use of such
products. Bhutan Medicines Board, taking note of such developments and
challenges in monitoring consumers’ safety, instructed Drug Regulatory Authority
(DRA) to regulate this category of product. Accordingly, Food and Drug Interface
committee (FDIC) was also formed comprising of representatives from Bhutan
Agriculture and Food Authority (BAFRA), Office of Consumers Protection, Ministry
of Health, Jigme Dorji Wangchuck National Referral Hospital and Bhutan Standards
Bureau to provide technical guidance to DRA.

The “Guideline for regulating Health Supplements” is formulated to assist the

applicants in preparation of the dossier for listing with DRA and to serve as guidance
document to the FDIC or DRA Regulatory officials for regulating Health
Supplements.

This Guideline is broadly based on ASEAN Guidelines for regulation of Health

Supplements. Certain annexures of the ASEAN Guidelines are identically adopted.
Adoption of ASEAN Guidelines for regulation of Health Supplements was endorsed
during the 17th Bhutan Medicine’s Board Meeting. For the purpose of clarity, this
guideline contains both the regulatory requirements and procedures for listing of the
Health Supplements.

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1. Scope
1.1 This Guideline shall apply to all categories of Health Supplements as follows:
i. Products containing vitamins, amino acids and minerals (natural & synthetic)
within the prescribed limits as per table 3.
ii. Substances derived from natural sources, including animal and plant
materials in the form of extracts, concentrates and isolates.
iii. Foods with claims for general wellbeing.
iv. Health Supplements may be presented in dosage forms such as capsules,
tablets, powders etc.

1.2 However, this Guideline shall not apply to any of the following:
i. Product used as an essential ingredient of a meal or a diet.
ii. Product containing ingredients which are listed in the negative list of
substances for Health Supplements under table 1.
iii. Product intended for use in prohibited disease/conditions under table 2
iv. Injectable or sterile preparation
v. Any material in its crude form
vi. Vitamin and Mineral supplements intended for children below 12 years of
age.
vii. Products used in alternative system of medicine such as Homeopathy,
Ayurveda, Unani and Siddha system of Indian Medicine.

Page 4 of 28
2. References
i. Annex I – ASEAN Guiding Principles for Inclusion into or Exclusion from the
Negative List of Substances for Traditional Medicines and Health
Supplements;
ii. Annex II – ASEAN Guiding Principles for the Use of Additives and Excipients
in Traditional Medicines and Health Supplements;
iii. Annex III – ASEAN Guidelines on Limits of Contaminants for Traditional
Medicines and Health Supplements;
iv. Annex IV – ASEAN Guidelines for Minimizing the Risk of Transmission of
Transmissible Spongiform Encephalopathies in Traditional Medicines and
Health Supplements;
v. Annex V – ASEAN Guidelines on Stability and Shelf-Life of Traditional
Medicines and Health Supplements;
vi. Annex VI – ASEAN Guiding Principles on Safety Substantiation for Traditional
Medicines and Health Supplements;
vii. Annex VII – ASEAN Guidelines on Claims and Claims Substantiation for
Traditional Medicines and Health Supplements;
viii. Annex VIII – ASEAN Guidelines on Good Manufacturing Practice for
Traditional Medicines and Health Supplements; and
ix. Annex IX – ASEAN Guidelines on Labeling Requirements for Traditional
Medicines and Health Supplements.
x. Food Safety and Standards (Health Supplements, nutraceuticals, food for
special dietary use, food for special medical purpose, functional food and
novel food), Regulations 2016, Food Safety & Standards Authority of India.
xi. Health Supplements Guidelines, Revised August 2017, Health Sciences
Authority, Singapore.

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3. Definition of Terminologies
3.1 Adverse Drug Reaction (ADR): means any noxious, undesired, or unintended
response to a drug which occurs at therapeutic dose.
3.2 Authority: refers to Drug Regulatory Authority.
3.3 Assessment: refers to the evaluation of the application/label submitted by the
applicant using prescribed set of criteria.
3.4 Health Supplements: Health supplement refers to a product that is used to
supplement a diet, with benefits beyond those of normal food, and or to support
or maintain the healthy functions of the human body.
3.5 Licensed Pharmacy: refers to a pharmacy which is authorized to sell medicinal
product by the Authority.
3.6 Listing: refers to formal regulatory approval for a Health Supplement product by
inclusion into a predefined list of allied products.
3.7 Market Authorization Holder: refers to firm in whose name the product is
listed/licensed.
3.8 Product: refers to Health Supplement products
3.9 Recommended Daily Allowance (RDA) value: refers to the amount of an
essential nutrient, as a vitamin or mineral, adequate to meet the average daily
nutritional needs of most healthy persons according to age group and sex.
3.10 Listing Certificate: refers to document issued by the Authority in a prescribed
format after the completion of assessment.
3.11 Technical Authorization for sale & distribution: refers to the authorization
issued to a local firm to deal in selling and distribution of medicinal product.

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4 PRINCIPLES FOR REGULATING HEALTH SUPPLEMENTS

4.1 All products such as dietary supplements, food supplements, nutrition

supplements, nutraceuticals or complementary medicines shall be known as
“Health Supplements” if it falls under the definition of Health Supplements.

4.2 Claims on products shall be consistent with the definition of Health Supplement
and it must not be advertised or promoted for any specific medicinal purpose,
i.e. treatment or prevention, implied or otherwise, of any disease or disorder.

4.3 Health Supplements shall be categorized into three into three categories based
on the product label/manual; Category (i) Nutrient/General Claim, Category, (ii)
Functional and Category and (iii) Disease Risk Reduction.

4.4 Health Supplements shall be regulated in line with the principle of “Risk based
approach” and documentation requirement for listing shall be tagged with the
category of the product it has been assigned to it.

4.5 Regulatory approval for listing Health Supplement under category-II (functional
products) & III (disease risk reduction products) shall be granted only to a
registered firm holding Technical Authorization for sale & distribution of Medicinal
Product issued by the Authority and the concerned product manufacturers.

4.6 All categories of Health Supplements shall require listing and Import
Authorization from DRA.

An application for listing of Health Supplement shall be rejected on the following

grounds:

i. If the product label contains ingredients included in the table 1 of this guideline.
ii. If the product label contains indication in prohibited disease/conditions as table
2 of this guideline.
iii. If the applicant fails to submit evidence to substantiate claims within 6 months
from the date of application.

4.7 The Regulatory Approval shall be issued within 30 working days excluding the
period when the application is kept on hold pending clarification or submission

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 evidence to substantiate claims/indication/intended use. In such case, the party
shall be informed.

4.8 Applicants shall be informed after assessment of the evidence to substantiate

claims has been completed. If the application is successful, the product shall be
listed under respective category in a prescribed format.

4.9 The application for listing must be accompanied by the application fee of Nu.500
(Five hundred only).

4.10 The sale & distribution of category-I & II products shall not be restricted to
licensed pharmacy; only the sale of products classified as category-III shall be
restricted only through a licensed Pharmacy under the supervision of a
competent person.

4.11 The Importer shall be responsible for ensuring safety, quality & effectiveness,
of the product and timely removal/recall from the Bhutanese market in case of
product recalls.

4.12 The Market Authorization Holders shall notify the Authority in case of any
change on the label including indication/intended use and should strictly sell or
distribute as per the categorization granted in listing certificate.

4.14 Any adverse reaction or side effects related to the use of the health
supplements shall be reported using the prescribed Adverse Events Form to DRA.

4.1 5 Only the Board shall approve the advertisement of any product as per section
27 of the Act and hence approval shall be sought for advertisement of these
products.

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 5. Process Flow for listing of Health Supplement

Enquiry on product registration/listing

Refer Bhutan Yes Is the

Medicine Rules Medicine?
e and Regulation
t
a
c No

i
n
Is the
u Listing not required: No
product
m
(Eg: Food/
FDI?
Cosmetics)
m
o
C

Yes

Application for listing DRA-P-D1-72

No Is evidence
satisfactory?

Yes

Nutrient/general Functional Claim Disease Risk

Claim Product Product Reduction product

Page 9 of 28
6. Procedure for application

6.1 Application form

The application for listing of Health Supplement shall be made to DRA using the
application form (Annexure 1 of this guideline) with the following documents:

i. Letter of authorization
ii. Product Profile
iii. Evidence to substantiate claims
iv. Original product label/sample

6.2 Letter of authorization

The Letter of Authorization from the manufacturer/dealer should contain following

information:

i. Include list of product authorized by the manufacturer or the dealer.

ii. The approval from principle manufacturer should be reflected on the
authorization if the letter of authorization is issued by dealer or regional
offices.

6.3 Product Profile

The product profile should provide following information on the finished product:

i. Name/Brand name
ii. Dosage Form
iii. Strength of the product
iv. List of all ingredients in the dosage form and their amount on a per unit basis
v. Description of the organoleptic characteristics of the product; including size,
shape, superficial markings for identification purposes, color, odor, taste,
consistency, type of tablet or capsules etc.
vi. Commercial presentation of packaging and pack size in terms of
quantity/weight/volume etc.
vii. Intended use for the product with a description of how to use it.

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6.4 Evidence to substantiate claims

A product can make three types of claims as follows:

6.4.1 Nutritional/General Claims

i. A statement on product label that describes the amount of a nutrient or a
dietary substance in a product.
ii. Such claims are permitted only when the relevant vitamin and mineral used
in the product amounts to >30% of the RDA value. If the amount of the nutrient
is less than 30% of the RDA, the amount may be declared on the labelling but
the said nutrient must not be emphasized on the labelling.
iii. Comparative nutrient claims which uses words like ‘better than’, ‘richer than’,
or Equivalent to etc. are not permitted.

6.4.2 Functional Claims

i. Relate to a positive contribution to health or to the improvement of a function
or to modifying or preserving health in the context of total diet on normal
functions or biological activities of the body.
ii. Maintains or enhances structure or function of the body, excluding disease
related claims.
iii. The dealer must provide with the text of the claim to the authority when
required to do so. This product is not intended to diagnose, treat, cure, or
prevent any disease.

6.4.3 Disease Risk Reduction Claims

i. Significantly altering or reducing a risk factor of a disease or health related
condition.
ii. Helps to reduce risk of osteoporosis by strengthening bone, helps to reduce
risk of dyslipidemia.

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6.5 Evidence to Substantiate Claims.

In general, claims should not be false, misleading or imply to treat or cure any disease
or condition. All claims mentioned on product label / product manual must be
substantiated with evidence. The evidence must be specific to claims as mentioned
on product label and should not contain other unnecessary information.

6.5.1 Category I: Products with nutritional/ general claim

i. Any Authoritative reference texts: reference textbooks, pharmacopoeia,
scientific journals -Scientific opinion from scientific organizations or
regulatory authorities -Documented history of use: classical texts,
published document from scholar or expert that reports the traditional use
of the ingredient concerned.

6.5.2 Category II: Health Supplements with structural/functional claims

i. Good quality scientific evidence from human studies -Authoritative
reference textbooks , pharmacopoeias, monographs -Scientific opinion
from scientific organizations or regulatory authorities
ii. Scientific evidence from animal studies -Documented history of use
evidence from published scientific review.

6.5.3 Category III: Health Supplements with disease Risk reduction claims
i. Scientific evidence from human intervention study on ingredient or
product.
ii. Authoritative reference texts -Scientific opinion from scientific
organizations or regulatory authorities -Evidence from published
scientific reviews or meta-analysis

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6.6 Original product label/samples
6.6.1 One product sample or original product packaging/labels should be submitted.

6.6.2 Labelling Requirements

i. Health Supplement product shall not be described or presented on any label or in

any labeling in a manner that is false, misleading or deceptive or is likely to create an
erroneous impression regarding its character in any aspect.

ii. Health Supplement product shall not be described or presented on any label or in
any labeling by words, pictorial or other devices which refer to or are suggestive either
directly or indirectly, of any other product.

iii. The principal display panel shall be large enough to accommodate all the
mandatory label information required to be placed there on with clarity and
conspicuousness and without obscuring design.

iv. The label must not contain objectionable terms as listed in table 5.

v. The label information should be English and/or Dzongkha

6.6.3 The following minimum information should be available on the label:

i. Product Name
ii. Dosage Form
iii. Name and Strength of Active ingredient
iv. Batch or Lot Number
v. Manufacturing and expiry date or Expiry date only
vi. Directions of use
vii. Indication or Intended use
viii. Storage condition
ix. Name and address of manufacturer
x. Pack Size
xi. Warning/precaution if any

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Table1: Guiding Principles for inclusion into or exclusion from the negative list
of substances for Traditional Medicines & Health Supplements.
Name of Harmful Compound or
Scientific Name & Photos Common name(s) Harmful Animal/plant parts Compound Classes Ban Status in HS
Abrus precatorius L. Indian Licorice, Precatory bean, Jequerity, Seed
Mutual, love Bean (China), Kudri Mani, Abrin, which consists of abrus,
Banned
(Tamil), Guru Ginja (Telegu) agglutinin, and toxic lectins, abrins
Aconitum spp. (all species)
containing aconite alkaloids Monkshood, Aconite Whole plant Aconite alkaloids Banned
Adonis vernalis L. Pheasant's eye Whole plant Adonitoxin Banned
Growth hormone,
prolactin, adrenocortico-tropic
Banned
hormone,
Thyroid-stimulating hormone,
Follicle-stimulating
hormone, luteinizing
hormone,
oxytocin,
Antidiuretic
hormone, thyroid hormone,
calcitonin,
Parathyroid
hormone, mineralocorti-coids,
Parts that may contain glucocorti-coids, sex hormones,
hormones: Pituitary gland, insulin, glucagon,
Animal parts containing Thyroid gland, Parathyroid thymosin, estrogens,
hormones (all species) glands, Adrenal progesterone, testosterone
Cardiac glycoside (antiarin),
Upas tree (Javanese Language- Cardenolides &
arrow poison), Alkaloids (with cardiac arresting
Antiaris toxicaria Lesch. Bark cloth Tree potential) Banned
Birthwort, Pelican flower,
Aristolochia spp. (all species) Sangree root, Sangrel, Serpentaria,
containing aristolochic acid Snakeroot, Snakeweed Whole plant Aristolochic acid Banned
Artemisia spp. (all species
containing artemesinin) Wormwood Leaf Artemisinin Banned
Aspidosperma quebracho-
blanco Schltdl. Quebracho Bark Aspido-spermine Banned

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Atropa belladonna L. Scopolamine; Hyoscyamine;
Deadly Nightshade Whole plant Atropine Banned
Azadirachta indica A.Juss. Nimba, Neem Seeds Azadirachtin and derivatives Banned
Mahonia Aquifolium: Oregon Grape , Banned
Mountain Grape, Barberry. Mahonia Repens:
Creeping Barberry, Creeping
Mahonia, Creeping Oregon- Grape
Mahonia
Berberis spp. (all species) Nervosa: Dwarf Oregon-grape, Cascade
containing berberine e.g. Oregon-grape, Dull
Berberis vulgaris L. Oregon –grape Root, bark, rhizome Berberine
Bruceine, Bruceantinol and
Brucea javanica (L.) Merr. Sumatrana amarissimus, Java brucea Dried fruits & seed Bruceoside Banned
Bufo gargarizans Cantor
Bufo melanostictus Cinobufagin, resibufagenin,
Schneider Venom, dried, secretion, bufagins, catecholamines:
Bufo vulgaris Lour. Toad, Samsu, kodok kerok whole body asbufothionine Banned
Calotropis gigantea (L.)
Dryand.
Calotropis procera (Aiton)
Dryand. Crown flower, Giant milkweed Latex Cardiac glycosides, calotropin Banned
Cannabis sativa L.
Cannabis indica Lam. Marijuana Whole plant Cannabinoids Banned
Vinca rosea,
Catharanthus roseus (L.) Periwinkle Madagascar,
G.Don Old Maid Whole plant Vinca alkaloids Banned
Dog bane, Digitoxinglyco-side,
Cerbera manghas L. Pink eyed cerbera Seed Cerberine, Cerberoside, thevetin Banned
Cerberin, cerebroside,
Indian Suicide odollin, odolotoxin,
Tree, thevetin and
Cerbera odollam Gaertn. Sea Mango Seed cerapain. Banned
Celandine, Berberine, chelidonine,
Great Celandine, Dried, whole or cut aerial sanguinarine, coptisine,
Chelidonium majus L. Nipplewort parts chelerythrine Banned
Chondrodendron
tomentosum Ruiz &
Pav. Curare Stems Tubocurarine chloride Banned
Cinchona alkaloids ex. Quinine
Cinchona spp. Quine bark Bark and Derivatives Banned

Page 15 of 28
Citrullus colocynthis (L.)
Schrad. Bitter apple Seed, fructus Curcubitacin Banned
Ergot alkaloids
(including ergotamine
Claviceps purpurea (Fr.) Tul. Ergo Sclerotium and ergometrine) Banned
Meadow
Colchicum autumnale L. Saffron Seed Cochicine Banned
Conium maculatum L. Hemlock Whole plant Coniine Banned
Croton oil containing:
Crotonic acid, tiglic acid, crotin,
Croton tiglium L. Croton Fruit, seeds and oil cocarcinogen Phorbol ester Banned
Jimson weed,
Datura spp. Devil’s apple, Green Dragon,
(all species) Zombie’s Cucumber,
containing hyoscyamine, Moon Weed, Leaf, seed,
atropine, scopolamine and Trumpet Lily, flowering or fruiting parts with Hyoscyamine, atropine,
apoatropine Stinkweed branches scopolamine, apoatropine Banned
Delphinium staphisagria L. Stavesacre Seeds Delphinine, Staphisine Banned
Digitalis spp.
(all species)
containing glycoside - Leaf Cardiac glycoside Banned
Drimia maritima (L.) Stearn Sea squill,
Syn. Urginea maritima (L.) red squill,
Baker sea onion, squill Bulb Cardiac glycoside Banned
Dryobalanops sumatrensis
(J.F.Gmel.)
Kosterm.
Syn. Dryobalanops Borneo camphor, Kapur,
aromatica Malay Camphor, Banned in oral
C.F.Gaertn. Sumatra camphor Whole plant Borneol (Borneo camphor) preparation
Dryobalanops lanceolata
Burck
Dryopteris filix-mas (L.) Male Fern, aspidium, Filicin,
Schott Male Shield Fern Rhizome aspidinol Banned
Euphorbia antiquorum L. Alpha euphorbol,
Euphorbia trigona Mill. Triangular spurge Latex Beta amyrin cycloartenol Euphol Banned
Alkaloid: chinpeimine, fritimine,
beilupeimine hashimirine
peimine
Fritillaria spp. Fritillary bulb Dried bulb peimisine Banned

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Garcinia elliptica Wall. ex
Wight
Garcinia hanburyi Hook.f. Cambogic acid,
Garcinia morella (Gaertn.) β-guttiferin,
Desr. Gamboge Gum resin α-1-guttiferin Banned
Gelsemium elegans
(Gardner &
Chapm.) Benth. Gelsemium Gelsemine &
semperivirens (L.) J.St.-Hil. Palaung Thay Root, leaves and rhizomes Gelseminine (Gelsemium indole Banned
Gluta usitata (Wall.) Ding Hou
Syn. Melanorrhoea usitata Urushic acid, Urushiol, Cardanol,
Wall. Vanish tree Latex Cardol, Anacardic acid Banned
Hyoscyamus muticus L.
Hyoscyamus niger L. Henbane, Henblain, Jusquaime Whole plant Hyoscyamine, atropine, hyoscine Banned
Coral Bush,
Coral Plant,
Physic nut,
Guatemala Fruits/Seeds Phytotoxin (Toxalbumin
Jatropha multifida L. Rhubarb - Curcin) Banned
Sabinyl acetate,
Savin, Extracted Essential oil sabinene, podophyllo-toxin and
Juniperus sabina L. Savine (i.e. Savin Oil) others Banned
Tembelekan Lantadene 2,2% from dry leave
Lantana camara L. (tahi ayam) Whole plant and stem Lancamaron Banned
Larrea tridentata (Sessé & Main harmful compounds in
Moc. ex DC.) chaparral are Lignans, in which
Coville, Larrea mexicana nordihydro-guaiaretic acid
Moric. Chaparral Whole plant (NDGA) is the major compound Banned
Lobelia nicotianifolia Roth ex
Schult.
Lobelia inflata L.
Lobelia chinensis Lour. Indian
Lobelia tupa L. Tobacco Whole plant Lobeline Banned
Lytta vesicatoria Linn. Spanish flies Whole body, tinktur Cantharidin Banned
Bark:level of magnolol 2-11%,
honokiol 0.3-4.6%,eudes mol <1%,
Houpo, < 200mg of bark/dosage
Houpohua, form has to be
Magnolia officinalis Rehder & Lamp post, from a Chinese
E.H.Wilson Officinal magnolia Whole plant formulation Banned

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 and contraindicated in
pregnancy
(emmena-gogue)
Melaleuca alternifolia
(Maiden &
Betche) Cheel Tea tree oil (TTO) Tea tree oil Tea tree oil Banned
Mitragyna speciosa (Korth.)
Havil. Kratom Whole plant Mitragynine indole, alkaloid Banned
Dopamine, Nicotine,
Mucuna pruriens (L.) DC. Cowhage, Cowage Seed Physostigmine Banned
Mylabris phalerata Pall.
Mylabris cichorii Linnaeus Blister beetle, Mylabris Dried body Cantharidin Banned
Nerium oleander L.
Syn. Nerium indicum Mill. Indian oleander, Exile Tree Whole plant Neriin Banned
Nicotiana tabacum L. Tobac Leaf Nicotine Banned
Papaver spp.
(all species) containing Morphine and
morphine & derivatives,
derivatives and codeine Opium poppy Whole plant codeine Banned
Pausinystalia johimbe
(K.Schum.) Pierre
ex Beille Yohimbe Bark Yohimbine Banned
Physostigma venenosum
Balf. Calabar bean Seed, bean Physostigmine Banned
Pilocarpus microphyllus Stapf
ex, Wardleworth
Pilocarpus jaborandi Holmes
Pilocarpus pinnatifolius
Lem. Jaborandi Bark Pilocarpine Banned
Piper methysticum G.Forst. Kava Kava Whole plant Pyrones, ethanol extract Banned
Plumbago zeylanica L. White leadwort Roots Plumbagin Banned
Plumbago indica L. Rose-coloured leadwort Root, root bark Plumbagin Banned
Podophyllum emodii Wall. ex
Hook.f. &
Thomson American mayapple,
Podophyllum peltatum L. Mandrake Roots, leaves Podophyllin resin Banned
Psilocybe cubensis (Earle)
Singer Boomers, Gold caps Whole plant Psilocybine, Psilocin Banned
Punica granatum L. Pomegranate Stem bark and root bark Pomegranate alkaloids Banned
Rauvolfia serpentina (L.) Rauwolfia, Indian snakeroot, Root, whole plant Reserpine, Rescinnamine, Banned

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Benth. ex Kurz Snakeroot ajmalane
Syn. Ophioxylon serpentinum
L.
Rauvolfia vomitoria Afzel.
Sanguinarine, chelerethrin,
Sanguinaria canadensis L. Bloodroot, Indian Paint Rhizomes and roots sanguirulin, berberine, protopine Banned
Schoenocaulon officinale
(Schltdl. &
Cham.) A.Gray Sabadilla Seed Veratrine Banned
Scilla sinensis (Lour.) Merr. - Bulb Cardiac glycoside Banned
Senecio aureus L.
Senecio jacobaea L.
Senecio bicolor Sch.Bip.
Senecio nemorensis L.
Senecio vulgaris L.
Senecio longilobus Benth. Whole plant Pyrrolizidine alkaloids Banned
Solanum dulcamara L.
Solanum americanum Mill. Bittersweet,
Syn. Solanum nigrum L. Nightshade Leaf, flowering tops Solanaceous alkaloids Banned
Spigeline (a strychinine-like
Sophora tomentosa L. Sea coast Laburnum, Silver Bush Seed alkaloid) Banned
Fang ji
Fen fang ji
Han fang ji
Stephania tetrandra S.Moore Stephania-root Whole plant Aristolochic acid Banned
Strophanthus spp.
(all species)
containing strophanthus Strophanthus
alkaloids Kombe Whole plant alkaloids Banned
Strychnos nux-vomica L.
Strychnos ignatii P.J. Bergius
Strychnos lucida R.Br.
Strychnos roborans A.W.Hill Nux-vomica Seed Strychnine Banned
Symphytum officinale L.
Symphytum asperum
Lepech.
Symphytum × uplandicum
Nyman
Symphytum peregrinum
Ledeb. Comfrey Whole plant Pyrrolizidine alkaloids Banned

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 Veratrum viride Aiton
Veratrum album L.
Veratrum mengtzeanum
O.Loes.
Veratrum nigrum L.
Veratrum stenophyllum Diels
Veratrum maackii Regel,
Vinca minor L.
American Hellebore, Indian Poke, Veratrum alkaloids including
Indian Hellebore, False Hellebore, veratramine, cyclopamine,
Green False Hellebore, White cycloposine, jervine, and
Hellebore Whole Plant muldamine Banned
Indole alkaloids: Vincamine,
Periwinkle, Myrtle Whole plant eburnamenine Banned

Note 1: table 1 is adopted from appendix 2: Annexure I ASEAN Guiding

Principles for Inclusion into or exclusion from the negative list of substances
for traditional medicines and Health Supplements.

Page 20 of 28
 Table 2 List of Prohibited Diseases/Conditions for Health Supplements

1. Cardiovascular diseases & disorders including 12. Metabolic disorders including obesity
Hypertension, stroke, cholesterol disorder, etc.
reduces cholesterol etc. 13. Musculoskeletal diseases & disorders of
2. Dental & Periodontal diseases & disorders. joint, bone, collagen including rheumatic
3. Diseases & disorders of the eye, ear or nose diseases, osteoporosis, anti-
likely to lead to severe impairment, blindness inflammatory etc.
or deafness, cataract etc. 14. Neoplastic diseases including all types
4. Diseases of the liver, biliary system or pancreas of cancers.
including Hepatitis, fatty liver, liver cirrhosis 15. Nervous system and neurological
etc. disorders including epilepsy, fits,
5. Endocrine disease & disorders including paralysis, Alzheimer’s disease,
diabetes, thyroid disorders, thymus disorders, dementia, etc.
prostrate disease etc. 16. Physiological process, enhance or
6. Gastrointestinal diseases and disorders depress, e.g. immunity, enzyme
including ulcers, gastritis, diarrhea, deficiency, anti-ageing, hormonal
constipation etc. imbalance, hormone release stimulants
7. Hematological diseases e.g. Increases or etc.
decreases platelets etc. 17. Renal diseases, diseases of the
8. Immune disorders and diseases including genitourinary tract including UTI,
AIDS, allergies etc. symptoms of nephritis etc.
9. Immunization e.g. vaccines, protects body 18. Respiratory disease including asthma,
against all types of diseases etc. tuberculosis etc.
10. Infectious diseases including sexually 19. Skin diseases & disorders including
transmitted disease, bacterial or viral eczema, fungal infections, ulcers, warts,
infections, leprosy etc. mole, pigmentation disorders etc.
11. Mental disorders and conditions including 20. Reproductive disease, disorders and
substance abuse, addiction, depression, eating conditions including sexual dysfunction,
disorders etc. conception and pregnancy, infertility,
menstrual disorders, impotency, frigidity
etc.

Note 2 Table 2 is adopted from table 5 examples of diseases/conditions/disorders

not allowed for Health Supplements, Health Supplement Guidelines (Revised August
2017) Health Sciences Authority, Singapore.

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Table 3 Maximum Levels of Vitamins & Minerals in Health Supplements.

Vitamin Maximum Level Minerals Maximum Level

Vitamin A (Retinol) 1.5 mg/day (5000 IU/day)
Calcium 1200 mg/day

Vitamin D 0.025 mg/day (1000 IU/day) Phosphorus

800 mg/day

Vitamin E 536 mg/day (800 IU/day Magnesium 350 mg/day

Vitamin K 0.12 mg/day Boron 6.4 mg/day

Vitamin C 1000 mg/day Chromium

0.5 mg/day

Vitamin B1 100 mg/day Copper

2 mg/day

Vitamin B2 40 mg/day Iodine

0.15 mg/day

Vitamin B6 100 mg/day

Iron 15 mg/day

Folic acid 0.9 mg/day Manganese 3.5 mg/day

Vitamin B12 0.6 mg/day

Molybdenum 0.36 mg/day

Biotin 0.9 mg/day Selenium 0.2 mg/day

Nicotinic acid 15 mg/day 15 mg/day

Zinc

Nicotinamide 450 mg/day

Pantothenic acid 200 mg/day

Note 2 Table 3 is adopted from Appendix I, Annexure X ASEAN Maximum

Levels of Vitamins & Minerals in Health Supplements.

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 Table 4 RDA for Vitamins

RDA for Vitamins

Vitamins Per 100kJ Per 100kcal
Minimum Maximum* Minimum Maximum*
Vitamin A (µg RE) 8.4 43 35 180
Vitamin D (µg) 0.12 1.65 (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
Pantothenc Acid (mg) 0..35 0.35 0.15 1.5
Biotin (µg) 0.18 1.8 0.75 7.5
Vitamin E (mgα-TE) 0.5/g of 0.75 0.5/g of 3
polyunsaturated polyunsaturated
fatty acids fatty acids
expressed as expressed as
linoleic acid but linoleic acid but
in no case less in no case less
than 0.1mg per than 0.1mg per
100 available kJ. 100 available
kcal.
(1) : For products intended for children of 1-10 years of age; NE-Niacin Equivalent; TE-Tocopherol
Equivalent.
• When no upper safe maximum level (maximum permissible level higher than 1(100percent)
RDA) has been specified for a particular vitamins or 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).

Note 3; Table 4 is adopted from schedule-III Food Safety & Standards regulation 2016,
Food Safety and Standards Authority of India.

Table 5 List of objectionable terms and claims

Page 23 of 28
 1. Miraculously
2. The only product to use
3. World’s best
4. 100% safe
5. No side effects
6. Guaranteed
7. Other drugs/products cannot compare with it
8. Sensational relief
9. The number one (unless substantiated)
10. Efficacious/effective
11. Perpetual youth
12. Anti-ageing
13. Longevity
14. Anti-stress (unless substantiated)
15. Boost immunity
16. Enhances immunity
17. Breast enhancement, enlargement, growth
18. Height growth
19. Enhance IQ/intelligence
20. Increase/improve memory
21. Hormone releaser/enhancer/amplifier
22. Regulate hormone
23. Enhancement of sexual organs
24. Sexual power
25. Arousal and libido

Note 4; Table 4 is adopted from page 12 on examples of objectionable terms and

claims, Health Supplements Guidelines, Revised August 2017, Health Sciences
Authority, Singapore

Page 24 of 28
Table 6 type, scope and example of Health Supplement Claims
1 General or Nutrient Claims
2 Functional Claims
3 Disease Risk reduction Claims
1. For nutritional support and general
maintenance
2. Benefits derived from
supplementation beyond a
person’s daily dietary intake.
1. Relate to a positive contribution to
health or to the improvement of a
function or to modifying or
preserving health in the context of
the total diet on normal function
or biological activities of the body
2. Maintains or enhances structure or
function of the body, excluding
disease related claims.
3. Supports health and to relieve/
reduce/ lessen/ ease minor body
discomforts in some physiological
processes (e.g. ageing, menopause,
pregnancy).
1. Significantly altering or reducing a
risk factor of a disease or health
related condition
At least one: 1. Supports healthy
growth and
Authoritative reference texts: reference textbooks,
development
pharmacopoeia, scientific journals -Scientific opinion from
scientific organizations or regulatory authorities - 2. Nourishes the body
Documented history of use: classical texts, published
document from scholar or expert that reports the
traditional use of the ingredient concerned
1. Good quality scientific evidence from human studies - 1. Maintains / Supports
Authoritative reference textbooks, pharmacopoeias, healthy joints
monographs -Scientific opinion from scientific 2. Supports health in
ageing
organizations or regulatory authorities Or
3. Promotes healthy skin
2. Scientific evidence from animal studies -Documented
history of use -evidence from published scientific
review.
1. Scientific evidence from human intervention 1. Helps to reduce risk of
study on ingredient or product osteoporosis by
strengthening bone
2. Authoritative reference texts -Scientific opinion
from scientific organizations or regulatory
Page 25 of 28
authorities -Evidence from published scientific
reviews or meta-analysis

Page 26 of 28
 APPLICATION FOR LISTING OF HEALTH SUPPLEMENTS

I/we …………………………………hereby apply for listing of following Health

Supplements manufactured
by…………………………………………………………………………………………………
………………………………………..

Details of Health Supplement (Use one application per product)

Name of Product Pack size Intended Use/Indication as printed on

label

Application fee has been deposited to the Royal Government of Bhutan vide Revenue
Receipt no …………………. (Attach copy)

Declaration (please tick the boxes):

I hereby declare that the documents submitted above/all information provided is

true to my knowledge and will be liable for any consequences if any information
provided is proved to be false or misleading.

Evidence to substantiate claims will be furnished when requested by the

Authority
Signature of applicant………………………

Name:…………………………………………

Address……………………………………….

E-mail :……………………………………….

Phone no:…………………………………........

Date:……………………………………………

Page 27 of 28
 Vision: The most dynamic, reliable and client-centric model regulatory organization.

Mission: Promoting availability of quality, safe, and efficacious medicinal products for consumers.

Drug Regulatory Authority

Royal Government of Bhutan

P.O. BOX NO. 1556, THIMPHU, BHUTAN

Phone: +975-2-337074/337075,

Fax: +975-2-335803, Email: dra@dra.gov.bt

Website: www.dra.gov.bt