Public Hearing Regulation of Homeopathic Drugs 3/F FDA AVR, Annex - PowerPoint PPT Presentation

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 1

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 Center for Drug Regulation and Research 2

Republic of the Philippines Department of Health Food and Drug Administration HIGHLIGHTS OF MEETING Center for Drug Regulation and Research 3

Small Group Discussion  24 March 2014  Representatives from PITAHC, the academe, research, homeopathic associations, and homeopathic practitioners Center for Drug Regulation and Research 4

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 Center for Drug Regulation and Research 5

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 Center for Drug Regulation and Research 6

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 Center for Drug Regulation and Research 7

Republic of the Philippines Department of Health Food and Drug Administration INTRODUCTION Center for Drug Regulation and Research 8

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 Center for Drug Regulation and Research 9

Republic of the Philippines Department of Health Food and Drug Administration An Introduction HOMEOPATHY IN THE PHILIPPINES Center for Drug Regulation and Research 10

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 Center for Drug Regulation and Research 11

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 Center for Drug Regulation and Research 12

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 Center for Drug Regulation and Research 13

The Philippine Setting  Since 1963 – homeopathic drugs are classified as drugs – subject to registration Center for Drug Regulation and Research 14

Republic of the Philippines Department of Health Food and Drug Administration Use, Composition, and Preparation HOMEOPATHIC DRUGS Center for Drug Regulation and Research 15

USE Allopathic Drugs Homeopathic Drugs  Treat symptoms  Principally for the treatment of  Provide prophylaxis symptoms  Induce structural or  Rarely used for biochemical prophylaxis changes Center for Drug Regulation and Research 16

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 Center for Drug Regulation and Research 17

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 Center for Drug Regulation and Research 18

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) Center for Drug Regulation and Research 19

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) Center for Drug Regulation and Research 20

Republic of the Philippines Department of Health Food and Drug Administration National Regulatory Authorities REGULATION OF HOMEOPATHIC DRUGS Center for Drug Regulation and Research 21

Malaysia  Undergo registration  No specific regulation for TM and CAM  GMP Center for Drug Regulation and Research 22

Singapore  Not registered  Set of guidelines to be followed by manufacturer/importer Center for Drug Regulation and Research 23

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 Center for Drug Regulation and Research 24

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 Center for Drug Regulation and Research 25

Canada  Undergo registration  OTC only  Ingredients must be listed in pharmacopoeias  Criteria for not accepting as homeopathic drug  With safety data  GMP Center for Drug Regulation and Research 26

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 Center for Drug Regulation and Research 27

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 Center for Drug Regulation and Research 28

Switzerland  Undergo registration  With indications – shall require quality, safety, and efficacy depending on the scheme  Ingredients – must be from the approved list  GMP Center for Drug Regulation and Research 29

Summary  Registered or listed  GMP is required  Quality data is required  For approved indications, efficacy data is required Center for Drug Regulation and Research 30

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Republic of the Philippines Department of Health Food and Drug Administration DISCUSSION Center for Drug Regulation and Research 32

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