regulation of homeopathic drugs pub… · center for drug regulation and research 2 . ... identity...

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




HIGHLIGHTS OF MEETING

Small Group Discussion

24 March 2014

Representatives from PITAHC, the academe, research, homeopathic associations, and homeopathic practitioners



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



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



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





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





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


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



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



Since 1963 – homeopathic drugs are classified as drugs – subject to registration





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


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


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


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)


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)





REGULATION OF HOMEOPATHIC DRUGS

National Regulatory Authorities

Malaysia Undergo registration

No specific regulation for TM and CAM

GMP


Singapore Not registered

Set of guidelines to be followed by manufacturer/importer


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


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


Canada Undergo registration

OTC only

Ingredients must be listed in pharmacopoeias

Criteria for not accepting as homeopathic drug

With safety data

GMP


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


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


Switzerland Undergo registration

With indications – shall require quality, safety, and efficacy depending on the scheme

Ingredients – must be from the approved list

GMP


Summary Registered or listed

GMP is required

Quality data is required

For approved indications, efficacy data is required





DISCUSSION

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