What is the definition of a Herbal Medicine?
A herbal medicine is a MEDICINAL product.
- Not food or dietary supplement or cosmetic product.
- Contains one or more HERBAL substances as active ingredient.
- Excipients can be synthetic.
What is the definition of a Traditional Medicine?
A traditional medicine is a MEDICINAL product.
- Not food or dietary supplement or cosmetic product.
- Contains one or more “TRADITIONAL” substances as active ingredient. This includes Herbal, Mineral & Animal origin.
- Excipients can be synthetic.
What does “traditional” substances include?
- Herbal substances
- Mineral substances
- Animal originated substances
All of the ingredients contained in a Herbal Medicinal product must NOT be synthetic.
T/F?
False.
The active ingredients are not synthetic, but the excipients and inert substances can be synthetic!
A Herbal medicine is a Traditional Medicine.
T/F?
True
A Traditional Medicine is a Herbal Medicine.
T/F?
False
What are the minimal product quality requirements for T/HMP?
- Limits of microorganisms
2. Limits of toxic heavy metals
What are the 5 key challenges in regulating T/HMP?
The need for:
- Harmonization of GMP Standard for T/HMP
- Harmonization of Quality Standard for T/HMP
- Combating Adulterated T/HMP
- Levelling up of T/HMP Industry
- Implementation of GACP (Good Agricultural & Collection Practice)
Between the need for harmonization of GMP Standard versus Harmonization of Quality Standard of T/HMP, which is more challenging?
Harmonization of Quality Standard
GMP -> We alr have an annex under PIC/S GMP
(Chapter 4, Annex 11)
However, the EMA Guidance Note on Quality of Herbal Medicinal Products can provide a good starting basis for the Harmonization of Quality Standards
In combating adulterated T/HMP, what is the main strategy?
Buys beware, Regulators beware
Multi-prong strategies
What is a reason why adulterated T/HMP are hard to detect?
Manufacturers use analogues instead of the actual adulterant in their products :(
What is a good starting point for Harmonization of Quality Standards for T/HMP?
EMA Guidance Note on Quality of Herbal Medicinal Products - contains details on QC of Herbal Active Ingredients, other starting materials INCLUDING WATER, control of container closure systems, stability testing, heavy metals and microbial limits etc.
Name 5 strategies to combat Adulterated T/HMP?
==> Buyers and Regulators Beware
- Consumer/public education
- Industry Vigilance
- Exchange of Information among regulators internationally
- Sharing of Test Methods and Reference Standards
- Inspectors: Robust GMP/GDP (Good Documentation Practice) Audit + Tight Supply Chain control for BOTH local and international suppliers
Why is Water Quality important and also regulated?
- It is a main starting material in liquid preparations
- Quality of Feed Water can vary depending on source and seasonal variations (Feed water: Rivers, Wells etc NOT PREFERRED)
- Contains Chemical/Mineral Impurities - affects quality
- Contains microbiological impurities
Name some suspected adulterants for slimming products
Fenfluramine, Thyroxine, Sibutramine & Analogues (e.g. Nitroso-fenfluramine in Slim10)
=> All synthetic, not traditional
Note: Fenfluramine and Sibutramine are Appetite Suppressants
Thyroxine increases metabolic rate of the body.
Name some suspected adulterants for Balding products
Minoxidil
=> Synthetic
Name some suspected adulterants for Arthritis products
Steroids (e.g. Dexamethasone), NSAIDs
Name some suspected adulterants for Fever, Cold, Flu, Typhoid products
Paracetamol, Aminopyrine, Chlorpheniramine
=> Synthetics
Name some suspected adulterants for Erectile Dysfunction/Decreased Libido products
Sildenafil, Tadalafil and Analogues
=> All synthetic ED drug compounds
May also sometimes include anti-diabetic agents (E.g. Gilbenclamide), but those ingredients may also be accidentally incorporated by clandestine laboratories
Note: Tongkat Ali is the natural herbal/traditional substance believed to help in ED/low libido, allowed
Name some suspected adulterants for Epilepsy products
Phenytoin (Synthetic)
What does levelling up T/HMP entail?
What needs to be considered when levelling up the T/HMP industry?
Balancing interests of stakeholders
- Fast market access vs Public Safety/Quality Issues
- Commercial interests vs societal interests
- National considerations vs Globalization/Harmonization (e.g. Jamu is indigenious to Indonesia, political consequences of imposing strict compliance on the Jamu Medicinal Industry)
- T/HMP Regulation vs Pharmaceutical Regulation
There are not alot of quality requirements for T/HMP, but name two requirements required for T/HMP products to meet
Limits for Microorganisms and Toxic Heavy Metals
