Consultative Meeting Regulation of Homeopathic Drugs FDA Conference - PowerPoint PPT Presentation

Republic of the Philippines Department of Health Food and Drug Administration Consultative Meeting Regulation of Homeopathic Drugs FDA Conference Room, 2F, Main Building 24 March 2014 9:00am-12:00nn 1

General Objectives  To have a clear understanding of the practice of homeopathy from the academe and practitioners perspective  To understand why the regulation of homeopathy is necessary Center for Drug Regulation and Research 2

Specific Objectives  To identify the number of homeopathic practitioners in the Philippines  To understand how practitioners prescribe homeopathic drugs  To know how homeopathic drugs are prepared (source, compounding practice etc.) Center for Drug Regulation and Research 3

Specific Objectives  To know how homeopathic drugs are dispensed  To know how homeopathic drugs are used  To know how the quality, safety and efficacy are ensured in the absence of specific regulation Center for Drug Regulation and Research 4

Discussion Flow  Introduction  Homeopathy in the Philippines  Homeopathic Drugs and Allopathic Drugs  Composition and Preparation of Homeopathic Drugs  Regulation of Homeopathic Drugs  Discusion Center for Drug Regulation and Research 5

Republic of the Philippines Department of Health Food and Drug Administration INTRODUCTION Center for Drug Regulation and Research 6

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 7

Republic of the Philippines Department of Health Food and Drug Administration An Introduction HOMEOPATHY IN THE PHILIPPINES Center for Drug Regulation and Research 8

The Philippine Setting  Allopathic medicine – predominant  1997 – 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 9

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 10

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 11

The Philippine Setting  Since 1963 – homeopathic drugs are classified as drugs – subject to registration  Evaluated and registered following the requirements for conventional or allopathic drugs – no specific regulation Center for Drug Regulation and Research 12

The Philippine Setting  Drugs – prescription pharmaceutical productssingle and multi-component vitamin and mineral products, vaccines and biologics, traditional medicines, over-the- counter preparations, household remedies, medical gases, and veterinary products.  Regulation specific for homeopathic registration is required Center for Drug Regulation and Research 13

Republic of the Philippines Department of Health Food and Drug Administration Use, Composition, and Preparation HOMEOPATHIC DRUGS Center for Drug Regulation and Research 14

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 15

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 16

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 17

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 18

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 19

Republic of the Philippines Department of Health Food and Drug Administration National Regulatory Authorities REGULATION OF HOMEOPATHIC DRUGS Center for Drug Regulation and Research 20

Malaysia  Undergo registration  No specific regulation for TM and CAM  GMP Center for Drug Regulation and Research 21

Singapore  Not registered  Set of guidelines to be followed by manufacturer/importer Center for Drug Regulation and Research 22

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 23

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 24

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 25

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 26

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 27

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 28

Summary  Registered or listed  GMP is required  Quality data is required  For approved indications, efficacy data is required Center for Drug Regulation and Research 29

Republic of the Philippines Department of Health Food and Drug Administration DISCUSSION Center for Drug Regulation and Research 30