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

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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

• ther products which require efficacy data

Conclusion

• safety, efficacy, and quality data is required
• availability should be monitored in terms
• f 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

• 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 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

• 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

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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

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