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Republic of the Philippines Department of Health
Food and Drug Administration
Public Hearing Regulation of Homeopathic Drugs
3/F FDA AVR, Annex Building, Alabang Muntinlupa 02 June 2014
1:30pm-3:00pm
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Discussion Flow 1) Highlights of Meeting 2) Introduction 3) Homeopathy in the Philippines 4) Homeopathic Drugs and
Allopathic Drugs 5) Composition and Preparation of
Homeopathic Drugs 6) Regulation of Homeopathic Drugs 7) Discussion
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Republic of the Philippines Department of Health
Food and Drug Administration
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HIGHLIGHTS OF MEETING
Small Group Discussion
24 March 2014
Representatives from PITAHC, the academe, research, homeopathic associations, and homeopathic practitioners
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Small Group Discussion
Accreditation – started in 2013
Small number of accredited practitioners, but growing
Scientific basis to establish homeopathic effect - “probing”; in some instances, clinical trials
Homeopathic drugs – mostly compounded; but here are available imported ready-to-use preparations
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Small Group Discussion
Homeopathic pharmacists – compound and dispense homeopathic preparations – mostly from raw materials
Small number of pharmacists, but growing
ADRs vs Healing Crisis
Identity of products – measured by Life-force measuring machines
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Small Group Discussion
Quality and safety data are the major reqts for homeopathic drug registration – unfair for other products which require efficacy data
Conclusion
• safety, efficacy, and quality data is required
• availability should be monitored in terms of compounding, prescription, and indications
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Republic of the Philippines Department of Health
Food and Drug Administration
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INTRODUCTION
Introduction “Like cures like”
Homeopathy – most commonly used forms of herbal medicine; part of national health system of several countries
Second-most used medical system
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Republic of the Philippines Department of Health
Food and Drug Administration
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HOMEOPATHY IN THE PHILIPPINES
An Introduction
The Philippine Setting Allopathic medicine – predominant Republic Act No. 8423 – Traditional and Alternative
Medicine Act PITAHC’s mission:
• accelerate the development of traditional and complementary/alternative health care in the Philippines;
• provide for a development fund for traditional and complementary/alternative health care; and
• support traditional and complementary/alternative medicine in other ways
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The Philippine Setting
Traditional and alternative healthcare - the sum total of knowledge, skills and practices on health care, other than those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical or mental disorder
Homeopathy is considered as traditional and alternative healthcare
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The Philippine Setting
2012 – National Certification of Homeopaths/Homotoxicologists and Accreditation of Homeopathy/ Homotoxicology Training Programs, Training Centers and Clinics
Expected rise of practitioners – need of homeopathic drugs
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The Philippine Setting
Since 1963 – homeopathic drugs are classified as drugs – subject to registration
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Republic of the Philippines Department of Health
Food and Drug Administration
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HOMEOPATHIC DRUGS
Use, Composition, and Preparation
USE
Allopathic Drugs
Treat symptoms
Provide prophylaxis
Induce structural or biochemical changes
Homeopathic Drugs
Principally for the treatment of symptoms
Rarely used for prophylaxis
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COMPOSITION
Homeopathic Drugs or stocks/mother tinctures – from natural or synthetic sources referenced in pharmacopoeial monographs
Composition
• Plant materials – roots, stems, leaves, flowers, bark, pollen, lichen, moss, ferns and algae
• Microorganisms - fungi, bacteria, viruses and plant parasites
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COMPOSITION
Homeopathic Drugs or stocks/mother tinctures – from natural or synthetic sources referenced in pharmacopoeial monographs
Composition
• Animal materials - whole animals, animal organs, tissues, secretions, cell lines, toxins, nosodes, blood products
• Human materials - tissues, secretions, cell lines and endogenous molecules
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STRENGTHS AND POTENCIES
Different strengths or potencies
• nX – decimal fold dilution (i.e. 1X = 1:10, 3x = 1:1000)
• nC – centesimal fold dilution (i.e. 1C = 1:100, 2C = 1:10,000)
• nM – 1000 potentization steps in the centesimal scale (i.e. 1M = 1000C dilution, 2M = 2000C dilution)
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STRENGTHS AND POTENCIES
Different strengths or potencies
• nLM = each dilution from a mother tincture first potentized to a 3C starting material is a quinquagintamillesimal or 50,000-fold dilution and ‘n’ is the number of dilutions, such that the total dilution is 50,000n (i.e. LM/01 = 1:50,000 dilution from a 3C starting potency)
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Republic of the Philippines Department of Health
Food and Drug Administration
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REGULATION OF HOMEOPATHIC DRUGS
National Regulatory Authorities
Malaysia Undergo registration
No specific regulation for TM and CAM
GMP
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Singapore Not registered
Set of guidelines to be followed by manufacturer/importer
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Australia Listing – products diluted greater than 1000
fold
Registered for stronger concentrations/with indications
Contain only ingredients from a published list (human and animal are not allowed);
May not be sterile; may not be used for prevention/treatment of serious disease
GMP
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United States Undergo registration by monograph
approval
Finished products must have monographs; otherwise the ingredients – must be listed under HPUS
With claims – Rx; without and may be used for self-limiting conditions – OTC
GMP
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Canada Undergo registration
OTC only
Ingredients must be listed in pharmacopoeias
Criteria for not accepting as homeopathic drug
With safety data
GMP
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European Union Undergo registration
Simplified procedure – for oral or external use, no indication, dilution of 1:10,000 or more (no efficacy data required); otherwise - usual registration procedure
With safety data
GMP
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United Kingdom Undergo registration
Simplified registration following EU; National Rules – requires safety, efficacy, and quality and are allowed to make claims for minor symptoms and conditions
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Switzerland Undergo registration
With indications – shall require quality, safety, and efficacy depending on the scheme
Ingredients – must be from the approved list
GMP
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Summary Registered or listed
GMP is required
Quality data is required
For approved indications, efficacy data is required
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Republic of the Philippines Department of Health
Food and Drug Administration
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DISCUSSION
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