This Circular issues a list of toxic herbal medicines of plant, animal, and mineral origin that must be processed according to the methods prescribed by the Ministry of Health before being used in medical practice.
Scope of application
For medicinal herb production and trading establishments and organizations and individuals related to the use of toxic herbal medicines in treatment.
Key points
- Plant-based herbal medicines: including 38 types such as Bocopa monnieri, Pinellia ternata, Ophiopogon japonicus...
- Animal-based herbal medicines: including 4 types such as Blister Beetle, Chinese Alligator, Bombyx Batryticatus, Gecko.
- Mineral-based herbal medicines: including 8 types such as Realgar, Cinnabar, Arsenic Trioxide.
- Processing according to the prescribed method before use to ensure user safety.
- The listed herbal medicines must comply with management and circulation regulations within the healthcare sector.
🌐 Social impact of this document
- Minimize the risk of poisoning due to improper use of toxic herbal medicines.
- Ensure quality, efficacy, and safety when using herbal medicines in disease treatment.
❓ Frequently asked questions
Which herbal medicines are listed in this catalog?
The catalog includes 38 types of plant-based herbal medicines, 4 from animals, and 8 mineral-based herbal medicines with toxicity.
Why must these herbal medicines be processed according to the prescribed method before use?
To minimize the risk of poisoning and ensure user safety during the treatment process.
Full text
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM |
|
Number: 42/2017/TT-BYT |
Hanoi, November 13, 2017 |
CIRCULAR
ISSUING THE LIST OF TOXIC DRUG RAW MATERIALS
Based on the Drug Law No. 105/2016/QH13 dated April 6, 2016;
Pursuant to Decree No. 75/2017/NĐ-CP dated June 20, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
At the proposal of the Director of the Traditional Medicine Management Department;
The Minister of Health issues the Circular on the List of Toxic Herbal Medicines.
Article 1. Scope of Regulation
This Circular stipulates the principles for building, criteria for selecting toxic herbal medicines; the List of Toxic Herbal Medicines and responsibilities for implementation.
Article 2. Principles for Building and Criteria for Selecting Raw Materials into the List of Toxic Drug Raw Materials
1. Principles for Building the List of Toxic Drug Raw Materials:
a) Ensuring safety for users;
b) Ensuring timely access to medicines and herbal medicines for users;
c) Being consistent with the actual use and supply of herbal medicines in Vietnam;
d) Harmonizing with the principles and regulations on classifying toxic herbal medicines in countries in the region and worldwide;
đ) Being consistent with medical literature on the use of herbal medicines, experience in using toxic herbal medicines, databases on toxic herbs globally, scientific journal articles, and other relevant materials;
2. Criteria for selecting herbal medicines for inclusion in the List of Toxic Herbal Medicines:
Herbal medicines that meet the following criteria will be considered for inclusion in the List of Toxic Herbal Medicines:
a) Herbal medicines used as drugs with high toxicity that adversely affect the health and lives of users;
b) Herbal medicines during use may cause serious adverse reactions known or recommended by the World Health Organization, competent authorities in Vietnam or abroad to potentially cause serious adverse reactions;
c) Herbal medicines used as drugs require careful attention to usage methods, strict control over dosage, user groups, and must be processed according to strict procedures and correct techniques;
d) Herbal medicines have a narrow dosage range, requiring cautious use, affecting diagnosis and treatment of diseases, and clinical monitoring is necessary;
đ) Must be prescribed under the supervision and follow-up of a physician when indicated for treatment;
Article 3. List of Toxic Drug Raw Materials
Attached to this Circular is the "List of Toxic Herbal Medicines" including:
1. The List of toxic plant-based herbal medicines specified in Appendix I.
2. The List of toxic animal-based herbal medicines specified in Appendix III.
3. The List of toxic mineral-based herbal medicines specified in Appendix III.
Article 4. Purpose of issuing the List of Toxic Herbal Medicines
The List of Toxic Herbal Medicines serves as the basis for competent state management agencies to implement regulations governing toxic herbal medicines in business operations, registration, labeling, prescription writing, distribution, processing, storage, use, inspection, testing, violation handling, and other related activities.
Article 5. Effective Date
1. This Circular takes effect from December 28, 2017.
2. Circular No. 33/2012/TT-BYT dated December 28, 2012, issued by the Minister of Health on the issuance of the List of Toxic Herbal Medicines Used as Drugs in Vietnam shall cease to be effective from the date this Circular takes effect.
Article 6. Transitional Provisions
1. In cases where drugs containing parts with toxicity of herbal medicines listed in the List of Toxic Herbal Medicines have been granted circulation permits still valid before the date this Circular takes effect, pharmaceutical businesses must classify, update, and supplement information on labels and usage instructions related to the classification of herbal medicines as stipulated in this Circular before putting the drugs on the market before January 1, 2018.
2. In cases where drugs containing toxic herbal medicines have submitted registration applications but not yet completed before the date this Circular takes effect, pharmaceutical businesses must supplement information on labels and usage instructions related to the classification of herbal medicines as stipulated in this Circular.
Article 7. Responsibility for Implementation
1. Responsibilities of Pharmaceutical Entities and Medical Examination and Treatment Facilities:
a) Implement regulations on managing toxic herbal medicines according to special control drug regulations issued by the Minister of Health;
b) Propose amendments and supplements to the List of Toxic Herbal Medicines to ensure they are up-to-date with practical situations, ensuring timely provision of drugs and herbal medicines for disease prevention and treatment.
2. Responsibilities of the Traditional Medicine Management Department:
a) Take the lead and coordinate with relevant agencies to implement this Circular;
b) Regularly review, revise, and supplement the List of Toxic Herbal Medicines based on proposals for amendments and supplements from units or medical literature, or reports on adverse drug reactions related to the toxicity of herbal medicines, and report to the Minister of Health.
During implementation, if there are any issues, please promptly reflect them to the Traditional Medicine Management Department (Ministry of Health) for consideration and resolution./.
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|
DEPUTY MINISTER |
ANNEX I
LIST OF TOXIC HERBAL MEDICINES OF PLANT ORIGIN
(Issued together with Circular No. 42/2017/TT-BYT dated November 13, 2017, by the Minister of Health)
|
No. |
Name of medicinal substance |
Scientific name of medicinal plants |
Toxic parts used as medicine |
Other names |
|
(1) |
(2) |
(3) |
(4) |
(5) |
|
1 |
Three beans (*) |
Croton tiglium L., family Spurge (Euphorbiaceae) |
Seed Semen Crotonis tiglii |
Seedpod, Màn đề, Three seeds, Old Yangzi, Mac vat |
|
2 |
Southern Ba Dou (*) |
Jatropha curcas L., family Spurge (Euphorbiaceae) |
Seed Semen Jatrophae curcas |
Sesame oil, Sesame rape, East tree, Nhao (Tay) |
|
3 |
White flower snake |
Plumbago zeylanica L., family Plumbaginaceae (Plumbaginaceae) |
Root, leaf Folium, Radix Plumbaginis zeylanicae |
Snow flower, Zeylanic plumbago |
|
4 |
Southern Pinellia (*) |
Typhonium trilobatum (L.) Schott., family Arum (Araceae) |
Rootstock Rhizoma Typhonii trilobati |
Choc root, Three-leaved leaf, Mouse chok |
|
5 |
Northern Pinellia (*) |
Pinellia ternata (Thunb.) Breit., family Arum (Araceae) |
Root, stem Rhizoma Pinelliae ternatae |
Chinese Pinellia |
|
6 |
Belladonna |
Atropa belladonna L., family Nightshade (Solanaceae) |
Leaf, root, seed Folium, caulis, fructus, Semen Atropae belladonae |
|
|
7 |
Thornapple |
Datura metel L. form alba., family Nightshade (Solanaceae) (Solanaceae) |
Flower, leaf Flos, Folium Daturae metelis |
Mandala, Devil's trumpet, Six-pointed nightshade |
|
8 |
Licorice vine (***) |
Abrus precatorius L., family Legume (Fabaceae) |
Seed Semen Abri precatorii |
Coral creeper, Chi vine, Love pea, Similar pea |
|
9 |
Kansui root (*) |
Euphorbia sieboldiana Morren et Decaisne., family Spurge (Euphorbiaceae) |
Root Radix Euphorbiae sieblodianae |
|
|
10 |
Medicine seedpod |
Lobelia pyramidalis Wall., family Lobelia (Lobeliaceae) |
Whole plant Herba Lobeliae pyramidalis |
Sang ding (H'Mong) |
|
11 |
Wormseed |
Chenopodium ambrosioides L., family Goosefoot (Chenopodiaceae) |
Essential oil Oil |
Goosefoot, earth sage |
|
12 |
Madagascar periwinkle |
Rose periwinkle L., family Dogbane (Apocynaceae) |
Leaf Herba Roseae |
Longevity flower |
|
13 |
Yellow rehmannia |
Digitalis purpurea L., Digitalis spp., family Figwort (Scrophulariaceae) |
Leaf Folium Digitalis |
Digitalis |
|
14 |
Peking spurge |
Euphorbia pekinensis Rupr., family Spurge (Euphorbiaceae) |
Root Root of Peking Euphorbia |
|
|
15 |
Peach kernel (*) |
Prunus persicae (L.) Batsch, family Rosaceae |
Seed Semen Pruni |
|
|
16 |
Giam đẹp |
Mitragyna speciosa (Korth.) Havil., family Rubiaceae |
Leaves, bark, and roots Folium, cortex, caulis Mitragynae speciosae |
|
|
17 |
Bitter Apricot Kernel (*) |
Prunus armeniaca L., family Rosaceae |
Seed Semen Armeniacae amarum |
Bitter Apricot Kernel |
|
18 |
Stramonium (*) |
Strychnos wallichiana Steud. ex DC., family Loganiaceae |
Bark of trunk and branches Cortex Strychni wallichianae |
Cortex |
|
19 |
Nerium oleander leaf |
Nerium oleander L., Nerium indicum Miller, family Apocynaceae |
Leaf Folium Nerii oleanderis |
|
|
20 |
Lobelia |
Lobelia nicotianifolia Roth ex Schult, family Lobeliaceae |
Whole plant Herba Lobeliae inflatae |
|
|
21 |
Male Lu lu |
Solanum nigrum L., family Nightshade (Solanaceae) |
Whole plant Herba Solani nigri |
|
|
22 |
Ephedra |
Ephedra sinica Staff. E. equisetina Bunge. E. intermedia Schrenk. et C. A. Meyer; family Ephedraceae |
Above-ground parts Herba Ephedrae |
|
|
23 |
Aristolochia |
spp., including: A. contorta Bunge; A. debilis Sieb.et Zucc., family Aristolochiaceae Fructus Aristolochiae |
Root Radix Aristolochiae Fruit Herba Aristolochiae Above-ground parts Tree with torn skin |
Genkwa |
|
24 |
Daphne genkwa |
Siebold & Zuccarini, family Thymelaeaceae Flos Daphnes genkwae |
Seed Dammar |
Brucea sumatrana |
|
25 |
, family Simaroubaceae |
Fructus Bruceae sumatranaeSeeds of Brucea sumatrana |
Climbing stem Caulis Aristolochiae |
|
|
26 |
Rat's Soursop |
Aconitum spp. A. fortunei |
Flower Hemsl.; |
|
|
27 |
A. carmichaeli |
Debx., family RanunculaceaeRoot tuber branch |
Seed Bear paw, Lesser bear paw, Grass aconite, Sichuan aconite |
Aconitum spp., Main root tuber |
|
28 |
Bear paw, Lesser bear paw, Grass aconite, Sichuan aconite |
Pilocarpusincluding: Pilocarpus spp. , family Rutaceae Folium Pilocarpi Guang Fangji |
A. westlandii Radix Aconiti |
Hemsl..; |
|
29 |
A. heterophylla |
Hemsl.,... family Aristolochiaceae including: Pilocarpus spp. , family Rutaceae Folium Pilocarpi Guang Fangji |
Stone calamus (*) Radix Aconiti |
Acorus gramineus |
|
30 |
Soland. |
var. macrospadiceusYamamoto Contr.; |
Leaf Acorus calamus L. var. angustatus |
|
|
31 |
Bess., family Araceae |
Fructus Bruceae sumatranaeincluding: Rhizoma Acori Calamus, Stone calamus with large leaves, Water calamus. Castor bean Ricinus communis |
Root Radix Aristolochiae |
|
|
32 |
Semen Ricini communis |
Tymallus, Castor bean Arisaema spp. A. consanguineum Schott; A. heterophyllum Blume, family Araceae |
Rootstock Living Heavenly Immortal |
Hyoscyamus niger |
|
33 |
L., leaves and seeds |
Folium, semen Hyoscyami nigeris L., family Spurge (Euphorbiaceae) |
Seed Skyward |
Thevetia peruviana |
|
34 |
Pinellia tuber (*) |
Pers., family Apocynaceaeincluding: Semen Thevetiae peruvianae Phytolacca esculenta Van Hout., family Phytolaccaceae Radix Phytolaccae esculentae |
Rootstock Rhizoma Arisaematis |
|
|
35 |
Goldenroot, Longevity |
Garlic Lily L., family Nightshade (Solanaceae) |
Colchicum autumnale L., family Colchicaceae |
|
|
36 |
Semen Colchici autumnalis |
Longevity Cycas revoluta |
Seed , family Cycadaceae |
|
|
37 |
Phytolacca root (*) |
Seeds, leaves, cones, roots Semen, Folium, Conus et Radix Cycatis Revolutae. |
Root Elephant's Trunk |
Heliotropium indicum |
|
38 |
L., family Boraginaceae |
Herba Heliotropii Centipede |
Seed Melia azedarach |
|
|
39 |
L., family Meliaceae |
Bark of trunk, thick branches, and roots(*) Is a medicinal material that must be processed according to the processing method prescribed by the Minister of Health before being used as medicine. |
(**) Is a medicinal material for external use only (not for oral administration) (***) Is a medicinal material where the part containing toxicity listed in the Catalogue does not contain toxicity, while other parts used as medicine do. |
|
|
40 |
LIST OF MEDICINAL MATERIALS WITH TOXICITY FROM ANIMAL SOURCES |
Scientific name of animal Part containing toxicity used as medicine |
Whole plant Ground beetle (*) |
Catharsius molossus |
|
41 |
Melia bark |
L., family Ground Beetles (Geotrupidae) Body without head, legs, wings |
Chinese Angelica Cortex Meliae |
|
Centipede (*)
Scolopendra morsitans
, family Centipedes (Scolopendridae)
ANNEX II
Whole body
(Issued together with Circular No. 42/2017/TT-BYT dated November 13, 2017, by the Minister of Health)
|
No. |
Name of medicinal substance |
, Remove intestines, remove head, blanch, stir-fry until golden yellow |
Centipede, Thousand-foot insect, Hundred-legs insect, Hundred-feet insect |
Other names |
|
(1) |
(2) |
(3) |
(4) |
(5) |
|
1 |
Scarlet Beetle (*) |
Mylabris cichorii Mylabris phalerata |
Pallas, family Scarlet Beetles (Meloidae) |
Whole body |
|
2 |
Scarlet Beetle, Original purity, Scarlet man, Scarlet hair, Bean worm |
Toad (*) L.Bufo melanostictus Schneider, Bufo gargarizans Cantor |
, family Toads (Bufonidae) ScolopendraToad secretion (latex) |
Whole Gecko (*) |
|
3 |
Buthus martensii |
Karsch, family Scorpions (Buthidae) L., Scorpion, Whole insect, Scorpion tail, Scorpion seed. (*) Is a medicinal material that must be processed according to the processing method prescribed by the Minister of Health before being used as medicine. |
LIST OF MEDICINAL MATERIALS WITH TOXICITY FROM MINERAL SOURCES Mylabris |
Scientific name of mineral |
|
4 |
Mirabilite (*) |
BoraxSodium tetraborate (Na |
Venom from glands behind the ears and on the skin of the frog Venenum Bufonis |
.10H |
|
5 |
O) |
Mirabilite, Snowflake, Mirabilite, Snowflake, Snowflake, Moonstone Red Cinnabar (*) |
, family Toads (Bufonidae) Scorpio |
Minium |
Lead oxide (Pb
ANNEX III
Red Cinnabar, Yellow Cinnabar, Red Cinnabar, Cinnabar Powder, Pine Cinnabar, Pearl Cinnabar, Pearl Powder
(Issued together with Circular No. 42/2017/TT-BYT dated November 13, 2017, by the Minister of Health)
|
No. |
Name of medicinal substance |
Red Cinnabar Powder (*) |
Main chemical component |
Other names |
|
(1) |
(2) |
(3) |
(4) |
(5) |
|
1 |
Cerussite |
Lead carbonate, usually contains Ag, Sr, Zn, Cs |
White Cinnabar Powder2B4O7Realgar, Dragon's Blood, Goldstone, Red Cinnabar Powder, Mercury Powder, Orange Powder2Cinnabar (*) |
Litharge |
|
2 |
Lead oxide (PbO), a small amount of unoxidized lead and impurities such as Al |
, Sb |
, Fe3O4). |
, Ca |
|
3 |
, Mg |
Lead Glaze, Cinnabar, Cinnabar Seed, Red Cinnabar, Red Powder, Red Cinnabar Seed, Red Powder |
Cinnabar Sulfide (HgS). |
Cinnabar, Red Cinnabar, Cinnabar Seed, Red Powder, Red Cinnabar Seed, Red Powder |
|
4 |
Realgar (*) |
Realgar |
Arsenic disulfide (As2Provincial People's Committees set specific prices2). |
Stone yellow, Trustworthy, Golden stone |
|
5 |
Mercury chloride sublimate (*) |
Calomelas |
Mercury chloride sublimate |
Red part, Mercury powder, Orange powder |
|
6 |
Sulphur (*) |
Sulfur |
Pure sulfur |
Salt well, Yellow rice, Realgar, Orpiment |
|
7 |
Muc da tang (*) |
Litharge |
Lead oxide (PbO), a small portion of unoxidized lead and impurities such as Al3+, Sb3+, Sb4+, Fe3+, Ca2+, Mg2+. |
Li tac, Da tang, Gold da tang, Lo de |
|
8 |
Cinnabar (*) |
Cinnabaris |
Mercury sulfide (HgS). |
Cinnabar, Red cinnabar, Single cinnabar, Red pill, Official cinnabar |
Centipede (*)
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