2. Introduction
In 2005, the WHO global survey on National Policy on
Traditional Medicine and Regulation of Herbal Medicines
pointed out that there has been increasing use of
complementary and alternative medicines (CAM) in many
developed and developing countries. The safety and efficacy of
traditional medicine, complementary and alternative medicines,
as well as quality control, have become important concerns for
both Health Authorities and the public.
3.
4. Herbal
supplements,
sometimes called
botanicals, are
one type of
dietary
supplement
available for
purchase. Herbal
supplements
aren't new —
plants have been
used for
medicinal
purposes for
thousands of
years..
Herbal supplements generally haven't been subjected to the
same scientific scrutiny and aren't as strictly regulated as
medications.
Makers of herbal supplements must follow good manufacturing
practices (GMP) — to ensure that supplements are processed
consistently and meet quality standards.
Don't have to get approval from the Food and Drug
Administration (FDA) before putting their products on the
market.
However, Europe has very firm regulation for the registration and
marketing of herbal supplement.
5. Challenges
Countries face major challenges in the development and implementation
of the regulation of traditional, complementary /alternative and herbal
medicines.
- Challenges are: Regulatory status, assessment of safety
and efficacy, quality control, safety monitoring and lack of knowledge
about TM/CAM within the national drug regulatory authorities.
6. 1. Challenges related to the regulatory status of herbal medicines: A
single medicinal plant may be defined as a food, a functional food, a dietary
supplement, or an herbal medicine in different countries
2. Challenges related to the assessment of safety and efficacy
Requirement and methods for research and evaluation for safety and efficacy.
3. Challenges related to the quality control of herbal medicines
Quality of source of raw materials used in their production and GMP (IPQC and FPQC)
7. 4. Challenges related to the safety monitoring of herbal medicines
Adverse events arising from the consumption of herbal medicine- due to wrong species of the plant
my mistake, adulteration, undeclared medicine, contamination, overdosage, misuse of herbal
medicine, and concomitant use with other medicine.
5. Lack of knowledge about herbal medicine within national drug
authorities
Lack of knowledge on herbal medicine and challenges on creating /updating the national level
policy
8.
9.
10. In the USA…
There is no registration (with FDA) of herbal medicines and they are not
included in the NEML.
The Dietary Supplement, Health and Education Act of 1994 forms the
National Regulation on herbal medicines.
Manufacturers do not need to analyze the biological and chemical properties
of their herbal products.
US regulations prohibit the claim that any herbal product prevents disease.
11. Cont.…
Manufacturers are responsible to ensure that the information on the herbal
product label is truthful and not misleading,- FDA monitors — alongside
reports of adverse effects from the use of dietary supplements.
Herbal products formulated to treat more serious ailments — a category
that covers many traditional Asian preparations — fall between the
regulatory cracks.
12. Cont.…
Makers of products are marketed as food supplements cannot make
claims about the conditions they aim to treat — thus people suffering
from maladies will be unaware of these potentially beneficial treatments.
To make therapeutic claims, the products must be registered as medicinal
drugs and undergo the FDA’s rigorous, expensive and lengthy drug
approval process — which, like the European regulations, requires
complex biochemical analyses and three phases of clinical trials.
13. First herbal Approved in
2006
Sinecatechins, a tea polyphenol for the
topical treatment of cervical warts.
Registered as a ‘botanical’ — a separate
classification from synthetic, chemically
pure drugs.
14. Veregen® is a topical ointment indicated for the treatment of external
genital and perianal warts (Condylomata acuminata) in immunocompetent
patients of 18 years and older
15. Second herbal Approved
in 2013
Botanical prescription drug approved by the FDA is
crofelemer (Fulyzaq™) to treat diarrhea symptoms
associated with antiretroviral therapy for HIV/AIDs.
Individuals taking antiretroviral drugs frequently
experience side effects such as nausea and diarrhea.
According to the statement issued by the FDA, taking
crofelemer (Fulyzaq™) twice daily may relieve the
associated diarrhea side effects.
16. Crofelemer is derived from the red
sap of the Croton lechleri plant, also
called Sangre de grado.
Sangre de grado - meaning
"blood of the dragon," is a
medium-sized tree that grows
in the upper Amazon region
of Peru, Ecuador, and
Colombia.
17. What made the Europe to adopt a strictest
guidelines on the herbal products?
Aristolochia fangchi Stephania tetrandra
18. Around a third of UK adults use
herbal products.
In the early 1990s, thousands of women attending a slimming clinic in
Belgium were accidentally given a weight-loss treatment containing the
toxic herb Aristolochia fangchi rather than the anti-inflammatory agent
Stephania tetrandra.
For practitioners and adherents of herbal medicine, it was one of their
worst nightmares: more than 100 of the women suffered kidney failure.
Many later developed cancer of the urinary system.
19. Why was that nightmare happened in
Europe?
Mistaken identity.
Chinese herbs are traded using their common names, which can
confuse Western practitioners of traditional medicine.
The term fang ji describes the roots of both A. fangchi and S.
tetrandra.
Western doctors might be unfamiliar with the language and
traditional practice.
20. Cont.…
The Belgian case has prompted the European Medicines Agency (EMA) to create
a new and world strictest regulations on the registration of herbal products.
EMA took utmost care to ensure the efficacy and safety of the herbal products
before they are registered and marketed in Europe.
The Traditional Herbal Medicinal Products Directive (THMPD) came into force
across the European Union (EU) in April 2011.
•aims to protect public health and at the same time secure the free
movement of herbal products within the EU.
21. Cont.…
Under the directive, herbal medicines intended as treatments for minor
health ailments must be registered as traditional-use products with the
regulatory agency in every EU member state in which the product is to
be sold (although each national regulatory agency is supposed to
recognize licenses already granted by other EU members).
This system is designed to make it less likely that a product is sold as a
traditional herbal medicine in one country and as something else in
another.
22. France received 160 applications but has granted only 7 registrations.
Germany is one of the leading Member States in respect of total
registrations, it nevertheless has granted only 154 registrations out of
426 applications.
At the time of the EMA report in 2012, 149 applications were still
under assessment whilst 123 applications had failed or been
withdrawn.
Last 10 years - Registered only a few THMPs - often less than ten
products
23. Cont.…
The THMPD does not cover practitioners of herbal medicine, who
are still permitted to mix herbal remedies from individual components
for personal prescriptions.
Products are eligible for license as a traditional herbal medicine only
if they have been used to treat a specified health complaint for at least
30 years, including a minimum of 15 years in Europe.
Herbal products are held to similar safety and quality standards as
pharmaceutical drugs.
24. India and regulatory status
The Government of India created a separate department known as the
Department of Indian Systems of Medicine and Homeopathy in 1995,
later renamed as the Department of Ayurveda, Yoga, Unani, Siddha
and Homeopathy (AYUSH), to serve as the national office for
T&CM, which is administered under the MoH. The independent
Ministry of AYUSH was formed in 2014.
Adherence to manufacturing information in pharmacopoeias and
monographs is required.
25. Herbal medicines are also included under Schedule E of the Drugs
and Cosmetics Rules.
Licenses given to manufacturing units are renewed every 3 years, to
ensure compliance with GMP.
Herbal medicines categorized as prescription medicines are sold in
pharmacies; herbal medicines categorized as non-prescription
medicines, self-medication or OTC medicines are sold in
pharmacies and other outlets, and by licensed practitioners.
26. Malaysia
Herbal products in Malaysia fall under the category of regulated products.
Any marketer intending to place the herbal products in the market require to
register the product first.
The applicant is required to have a registered with the Malaysia Registrar of
Business or Suruhanjaya Syarikat Malaysia under two classifications:
The product must undergo premarket registration with NPRA, Malaysia
Halal Requirement
27. Cont…
Health Supplements
a) General or Nutritional Claims – Abridge evaluation
b) Functional Claims (Medium) – Abridge evaluation
c) Disease Risk Reduction Claims (High) – Full Evaluation
Natural Products (Includes herbal and traditional products )- Full
Evaluation
28. Cont.
Natural Products
◦ Traditional medicine
◦ Finished Herbal Product (one or more herbs)
◦ Herbal Remedy
◦ Homeopathic Medicine
Food – Drug Interphase
Functional Foods and Foods
29. Singapore - HSA
TM are not subject to approvals and licensing
HSA prohibits the addition of medicinal ingredients such as steroids in
TM.
HSA also sets strict limits on toxic heavy metals in these products.
Dealers (importers, manufacturers, wholesale dealers and sellers) have
the obligation to ensure that their products are not harmful or unsafe,
and that they conform with the following guidelines before supplying
TM into Singapore.
30. Toxic heavy metal limits
Heavy metal Permissible limits
Arsenic 5 parts per million (ppm)
Cadmium 0.3 ppm
Lead 10 ppm
Mercury 0.5 ppm
For existing products imported
or locally manufactured before 1
September 2019, dealers had a
one-year grace period to ensure
compliance to the above revised
limits. With effect from 1
September 2020, all products
sold in Singapore should not
exceed the revised limits.
31. Microbial limits: Oral Products
Microbe Microbial limits
Total aerobic microbial count Not more than 105 CFU per g or ml
Yeast and mould count Not more than 5 x 102 CFU per g or
ml
Escherichia coli, Salmonellae and
Staphylococcus aureus
Absent in 1g
32. Microbial limits: Topical Products
Dealers are encouraged to comply to the ASEAN Guidelines on the Limits of
Contaminants for microbial limits.
Microbe Microbial limits
Total aerobic microbial count Not more than 104 CFU per g or ml
Yeast and mould count
Not more than 5 x 102 CFU per g or
ml
Pseudomonas aeruginosa and
Staphyloccocus aureus
Absent in 1g or ml
33. Singapore ensures…
Labelling requirements
List of Prohibited ingredients
Substances from endangered species - Trade in
Endangered Species of Wild Fauna and Flora (CITES) import
and export permits.
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34. China
Governed by the State Food and Drug Administration (SFDA)
Registered as functional food or drugs.
Regulatory approval of functional food is the responsibility of the
Department of Food License whereas that of Chinese herbal drugs is
controlled by the Division of TCMs & Ethno-Medicines under the
Department of Drug Registration.
Drugs in China cover not just chemical drugs but also traditional
medicines.
35. Cont…
Traditional Chinese Medicines refer to medicinal
substances and their preparations used under the
guidance of traditional Chinese medical theory;
whereas natural medicinal products refer to natural
medicinal substances and their preparations used under
the guidance of modern medical theory.
36. Philippines
At least 5 or more decades as documented in medical, historical, and
ethnological literature are permitted to be marketed under this category.
The Bureau of Food and Drugs (BFAD) mandate registration of the
traditionally used herbal products before manufactured, imported or
marketed.
The extent of control of BFAD includes the brand names of the
traditional herbal products as well, and their prior clearance is required,
before filing for product registration.
37. Cont.
Authentication of the plant specimen needs to be obtained from the
Philippine National Museum or any BFAD recognized taxonomist, and
for imported products, the certificate of authenticity of the plants from
the authorized government agency of the country of origin is accepted.
The quality control requirements further lay down that the
pharmacopoeia standards. BFAD further mandates that product
indications should not require supervision by a physician.
38. Nigeria
The trade of herbal products is regulated by National Agency for Food
and Drug Administration and Control (NAFDAC).
Herbals products are classified as "Herbal Medicines and Related
Products." Premarketing registration of herbal medicines and related
products is mandatory in Nigeria.
All advertisements require a preclearance from NAFDAC.
No advertisement can be made as a cure for any disease conditions
listed in "Schedule 1" to the Food and Drug Act 1990.
39. Saudi Arabia
They are allowed if they have at least 50 consecutive years of traditional use.
Their dose and the method of preparation must be same as those used,
traditionally.
According to the evidence provided, they may fall under the sub-categories:
Pharmacopoeial evidence for traditional products
Nonpharmacopoeial evidence for traditional products.
40. Cont.…
For the former, the medicinal ingredients, quantity, recommended dose, route of administration,
duration of use, dosage form, directions of use, risk information should be same as the
Pharmacopoeia and the method of preparation must be traditional.
For the latter category, any two independent references must be provided to supplement the
evidence supporting the safety and efficacy of the product, from clinical studies, pharmacopoeias,
and textbooks
References, peer-reviewed published articles, data from nonclinical studies on pharmacokinetics,
pharmacodynamics, toxicity information, reproductive effects, and the potential genotoxicity or
carcinogenicity of an ingredient or information based on previous marketing experience of a
finished product.
41. Australia
Medicinal products containing such ingredients as herbs, vitamins, minerals,
nutritional supplements, homoeopathic and certain aromatherapy preparations are
referred to as 'complementary medicines' and are regulated as medicines under the
Therapeutic Goods Act 1989 (the Act).
A complementary medicine is defined in the Therapeutic Goods Regulations 1990
as a therapeutic good consisting principally of one or more designated active
ingredients mentioned in Schedule 14 of the Regulations, each of which has a
clearly established identity and traditional use
42. How complementary medicines are regulated in Australia
Australia has a risk-based approach,
Lower risk medicines can be listed on the Australian Register of Therapeutic Goods (ARTG).
Higher risk medicines must be registered on the ARTG.
Some complementary medicines are exempted from the requirement to be included on the
ARTG, such as certain preparations of homoeopathic medicines.
The TGA Manufacturing Quality Branch inspects manufacturers on an ongoing basis for
compliance with good manufacturing practice.
Post marketing surveillance is required.
43. Canada
All NHPs sold in Canada are subject to the Natural Health Products Regulations
(The Government of Canada, 2003), which came into force on January 1, 2004.
All producers of NHPs need to apply for licenses before selling them in Canada.
To apply for a license, the person or company shall apply to Natural Health
Products Directorate (NHPD), Minister of Health Canada.
It is interesting to note that evidence is not necessarily from clinical trial data but
can also be references to published studies, journals, pharmacopoeias and
traditional resources.
44. Japan
2 overlapping types of traditional herbal medicines coexisted for centuries.
1. The traditional Japanese and Chines medicine- These medical systems were
damaged by the first Medical Care Law in 1874 that proclaimed the
abrogation of traditional Japanese medicine.
2. The second type of herbal medicine used in Japan originated in Europe and
south-east Asia and became popular after the law in 1874 was announced.
Regulation of quality standards of those herbal products was established in
Japanese Pharmacopoeia for more than 90% of them.
45. Cont.…
Kampo medicines are the main traditional herbal medicines in Japan and are
classified as pharmaceuticals.
They are based on ancient Chinese medicine and have evolved to the Japanese
original style over a long period of time.
Kampo medicines are prescription based as well as OTC
Crude drugs and Kampo extracts have been listed in The Japanese Pharmacopoeia.
Pharmaceuticals and Medical Devices Agency (PMDA) under the Ministry of
Health, Labour and Welfare
46. Conclusion
The global acceptance and use of herbal medicines and related products
continue to assume exponential increase.
adverse reactions in recent times are also becoming more vivid.
previous misconception of regarding or categorizing herbal medicinal
products as “safe” because they are derived from “natural” source.
The reality is that “safety” and “natural” are not synonymous.
Therefore, regulatory policies on herbal medicines need to be standardized
and strengthened on a global scale.
