Traditional/Herbal Medicines Flashcards
(17 cards)
Definition of traditional medicine
A medicinal product
Contains ≥ 1 traditional substance(s) as active ingredient
Traditional substance may be of herbal / animal / mineral origin
Active ingredient(s) are NOT synthetic
NOT a food/dietary supplement / cosmetic product
Definition of herbal medicine
A medicinal product (subset of traditional medicine)
Contains ≥ 1 herbal substance(s) as active ingredient
Active ingredient(s) are NOT synthetic
NOT a food/dietary supplement / cosmetic product
Regulation of T/HMP
1) Lack harmonized GMP standards
2) Minimal quality requirements - Only need to regulate microorganisms limits & heavy toxic metal limits
What are NOT mandatory in regulation of T/HMP
1) Control of active ingredients, excipients/other starting materials, container-closure system, herbal contaminants
2) Process validation & stability testing
Challenges/Issues in regulation of T/HMP
1) Harmonization of GMP standards & quality standards
2) Combating adulterated products
3) Level up T/HMP industry
4) Implement GACP
Good starting point for harmonization of GMP standard for T/HMP
PIC/S GMP Standard Annex 7 (Manufacture of Herbal Medicinal Products)
Harmonization of quality standard for T/HMP
Quality is independent of traditional/historical use
Good starting point: “EMA Guidance Note on Quality of Herbal Medicinal Products”
Contents of “EMA Guidance Note on Quality of Herbal Medicinal Products”
1) QC of herbal APIs, other starting materials
2) Control of container-closure system
3) Stability testing
4) Control of herbal contaminants (pesticides, fumigants, microorganisms, heavy metals)
Importance of controlling water quality
1) Water is main starting material in liquid dosage forms
2) Water quality may be variable depending on source of water & seasonal variation
3) Water may contain chemical / mineral impurities / microbiological impurities
Need to purify tap water
Restrictions for purified water more strict than tap water
Tap water is distributed via long distribution pipes
Tap water is disinfected with chlorine, which must be removed
List the suspected adulterant(s), based on the following product claims/indications:
1) Slimming
2) Baldness
3) Arthritis
4) Fever, cold, flu, typhoid
5) Epilepsy
6) Erectile dysfunction, decreased libido
1) Fenfluramine, Thyroxine, Sibutramine, & their analogues
2) Minoxidil
3) NSAIDs, Steroids
4) Paracetamol, Chlorpheniramine, Aminopyrine
5) Phenytoin
6) Sildenafil, Tadalafil, & their analogues
How do manufacturers avoid detection of adulterants
1) Use of analogues
2) Adulterants added to capsule shells
What are analogues/designer drugs
Formulated via addition of additional atoms / side chains / functional groups to original drug
Purpose: Circumvent drug laws
Currently, designer drugs are rampant in _____
Slimming, ED drugs
Regulation of analogues
US: Controlled Substances Act (CSA) - “any substance whose chemical structure is substantially similar to that of” original substance
SG: Based on US CSA - “Isomers / Stereoisomers / Salts / Derivatives of API”
Strategies to combat adulterants
1) Education of consumers / public
2) Increased industry vigilance
3) Exchange of information and alerts between regulators (internationally)
4) Sharing of test methods and reference standards for testing adulterants, including new analogues
5) Robust GMP/GDP audits, tight supply chain control
Considerations when levelling up T/HMP industry
Balance interests of stakeholders
1) Faster market access VS Public safety / quality issues
2) Trade/Commercial interests VS Societal interests
3) National considerations VS Globalization, harmonization
4) T/HMP regulation VS Pharmaceutical regulations
