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

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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

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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.)

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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

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Discussion Flow

• Introduction
• Homeopathy in the Philippines
• Homeopathic Drugs and Allopathic

Drugs

• Composition and Preparation of

Homeopathic Drugs

• Regulation of Homeopathic Drugs
• Discusion

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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

• f 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 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

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The Philippine Setting

Traditional and alternative healthcare - the sum total of knowledge, skills and practices

• n 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 Evaluated and registered following the requirements for conventional or allopathic drugs – no specific regulation

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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

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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
• rgans, 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

• f 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;

• therwise 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