Transcript REGULATION OF HERBAL PRODUCTS

MEDICINAL PLANTS – THE
JAMAICAN/CARIBBEAN
EXPERIENCE
MINISTRY OF HEALTH JAMAICA
PRINCESS THOMAS OSBOURNE
2006 March 24
OBJECTIVES
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Provide a Caribbean/Jamaican
Perspective on herbal medicinals
Update WG participants regarding
status of Regional regulatory
framework governing herbal
medicines
Briefly outline challenges faced in
developing the framework.
Recommend a way forward for
harmonisation on herbal medicines
INTRODUCTION
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PUBLIC HEALTH :
 STATE RESPONSIBILITY
SCOPE OF PUBLIC ROLE/
RESPONSIBILITY
 INTEGRITY OF INDIVIDUAL
CHOICE
 Access to safe goods & services
Situation Analysis - English
Speaking Countries of CARICOM
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Increasing use of, and demand for products of
“natural origin”
Rapid introduction to markets of new, unfamiliar
medicinal plants, from local and international
sources, in dosage forms not necessarily
regulated.
False notion that “natural” is synonymous with
safe i.e. free of adverse effects. Supported by
many alternate medicinal practitioners.
Situation Analysis contd.
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Truth regarding beneficial medicinal
effects often blurred
Territories without regulatory mechanisms
more at risk or vulnerable
Other Challenges e.g. the right to trade.
Regulatory Intervention
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Regulatory mechanism supported by legislation
absent in all but three English speaking
Caribbean territories
Strong Supporting evidence exists for:
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benefits
potentially harmful effects
In the absence of therapeutic claims every
product is a “Dietary Supplement” but no
significant value over carefully “planned and
balanced diet’.
Basis for harmonised regulatory approach
therefore long established.
Why RegulateShared Caribbean Position
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Protect consumer interests– unsubstantiated
product claims
Protect product integrity- evaluation parameters
Maintain requisite standards – batch to batch
consistency
Ensure public safety not compromised – toxicities
 Are safe, effective, beneficial
 Products, practices lead to positive clinical
outcomes.
HISTORICAL OVERVIEWJamaica
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INTRODUCTION OF NEW CATEGORY
CALLED “HERBAL PRODUCTS”-1993
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ESTABLISHMENT OF WHOLISTIC
HERBAL ASSOCIATION- 1995
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LONG CONSULTATIVE PROCESS
WITH STAKEHOLDERS - > 6 years
Contd.
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WHA recommendations
reviewed by MOH
Further discussions
Consensus
WHO Regional Workshop on
Regulation of Herbal Products Nov. 2000
Representatives from drug regulatory bodies
from 11 Caribbean countries participated on :
Issues relating to safety, efficacy, quality
control of herbal products
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Requirements for registration
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Proposal on harmonized standards &
regulations to ensure safety and quality
Workshop Outcome- Jamaica
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WHO General Guidelines for Methodologies on
Research and Evaluation of Traditional Medicine
introduced
WHO Guidelines for Assessment and Safety of
Herbal Medicines used as guide for
categorization and definition of categories for
purpose of amendment to Food & Drugs Act
MOH Prepared Proposal for Cabinet
based on:
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consultative process:
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MOH, Wholistic Herbal Assoc.,
Open fora with Select Committee on Human
Resources & Social Development
Reference to legal approach taken by Competent
Authorities in Australia, Canada, Germany,
England, United States, others.
Reference to WHO Guidelines on the Assessment
of Herbal Products. Definitions adapted, in use.
OVERVIEW contd.
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First Special Stakeholder Meeting of Cabinet
Select Committee on Human and Social
Development - January 2001- examined MOH
proposal, accomodated hearing from WHA, other
stakeholders.
Total of three meetings- to consider MOH
proposal to Cabinet.
Proposal approved .
Scope of Amendment to F&D Act:
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Five new categories of substances included in
Draft Amendment:
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Herbs
Herbal Materials
Herbal Remedies
Finished Herbal Products
Health Foods
Drugs, Foods remain in Act as previous
Herbal remedies only registered.
Over-the-Counter category introduced
Draft Regulations to Act to reflect new
requirements including standards for sale
of herbal products completed.
Awaiting gazetting by CPC
Definitions:
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Herbs:
Include crude plant material e.g. leaves,
flowers, seeds, fruit, stems, wood, bark, roots,
rhizomes or other plant parts ,which may be
entire, fragmented or powdered.
Herbal Material:
Include in addition to herbs, fresh juices, gums,
fixed oils, essential oils, resins, dry powders of
herbs.
Herbal Remedy:
Any botanical product consisting of a substance
produced by subjecting a plant /plants to drying,
crushing or any other process or mixture whose
sole ingredients are two or more substances so
produced. May have potential to be used for risk
reduction, therapeutic or treatment purposes.
Include traditionally used and new ones.
Finished Herbal Product
“herbal preparation made from one or
more herbs. If more than one herb is
present the term mixture may be used.
These may contain excipients in addition
to the active ingredients. Where
chemically defined active substances are
added they are not considered to be herbal.”
Health food:
“Any product other than tobacco taken by
mouth that is intended to supplement the diet,
such as, vitamin, mineral, amino acid, enzyme,
neutraceutical, dietary substance or
concentrate, metabolite, constituent, extract or
combination of these ingredients”
Definitions in existing
Legislation - Food & Drugs Act
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Food – “ any article used for food or
drink by man, including chewing gum
and any ingredient that may be mixed
with food or drink for any purpose”
Drug – “any substance or mixture of
substance manufactured, sold or
represented for use in -
contd.
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‘The diagnosis, treatment, mitigation or
prevention of a disease, disorder, abnormal
physical state or the symptoms thereof in man
or animal;
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Restoring, correcting or modifying organic
functions in man or animal;
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Disinfection in premises in which food is
manufactured, prepared, preserved, packaged
….for sale or sold for the control of vermin or
insects in such premises..”
Implemented so far -Jamaica:
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Official list of requirements for registration of herbal
drugs developed- in use
Vitamins/minerals included in health food category
however
 registered as prescription drug if in injectable
form, mega doses for specific therapeutic
indications, or make therapeutic claims
substantiated or otherwise
 registered as Over-the Counter drugs at
concentrations deemed to exceed levels specified
for “free sale”
 Permit required
Other Health Foods:- Not registered as drugs but Permit required
- Special requirements for labels to include
warnings and any particular conditions for use
- Finished herbal products singly or in
combination may also be registered as drugs.
Advisory Panel Mechanism
established –
Panel on Complementary
Medicines functional.
Consultation with English speaking
sister territories in Caribbean:
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Meeting of the RABDAT, TAC, St. Vincent
2002- need for harmonization on
regulation of herbal products unanimously
accepted;
Jamaica, Trinidad et al to prepare position
paper for submission to CARICOM Health
Desk;
CRDTL provides critical linkage among
English speaking territories.
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Jamaica willing to provide support for countries without
Regulatory systems.
Numerous attempts made to harmonize on
requirements for product regulation since 2000
Principle of registration requirements similar for T&T,
Jamaica, Guyana.
Now working towards mechanism for harmonisation
involving territories without existing regulatory
framework
Discussed at length at recent TAC meeting (Feb. 2006)
in Guyana. Draft proposal in preparation
Regulatory Intervention
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Regulation of “Herbalists”:
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Ensures purchase of medicines and
ingredients from reputable suppliers
Ensures practitioners take responsible,
informed approach regarding safety issues
Appropriate training and skills necessary
Products -Integrity
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QUALITY: “Certificate of Analysis”
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Conformity assessment for proper identity
Content verification
Impurities/contaminants
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Heavy metals, aflatoxins, moisture.
Synthetic material added?
Raw materials - source etc.
GMP, GAP
Product stability
Integrity contd.
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EFFICACY
 Ability to effect label claim indication/action
 Pharmacological activity
 Potency -justification for effective
dose.
 Rationale for combination therapy –
multi-herb combination a matter of
concern
 Nature of claims - justification
Integrity contd.
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SAFETY
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Toxicity
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Acute
Long-term
Mild, severe
Reporting responsibility
Interactions, contraindications
Use in children
Requirements for Health Foods:
Review of :
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Active ingredients. Concentration a
consideration
Validification of Label claims
Verification of purity - Certificate of Analysis
Samples
Proof of approval in country of origin
Scientific support claims may be requested.
Documentation Requirements for
Registration- Herbal Remedies
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Statement of content
Posology
Rationale for combinations
Toxic/side effects
Tests to confirm quality, potency
Approval in country of origin
Samples
Fees
Other pertinent information
Regional Challenges:
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Availability of resources to effectively
address issues.
Geographical barriers- distance,
absence of physical borders
Commitment to follow-up
Matter of Whose priority
Regulatory Challenges
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Attempts to circumvent existing
legislation
Need for constant market vigilance Cosmetics with herbs?
Teas & other beverages
Persistence of local Alt Med.
Practitioners in use of prohibited herbs
eg. Chaparral, Comfrey, Ma Huang
Customs. Trinidad has dedicated
inspectorate
Regulatory Challenges
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Public suspicion-inadequate public
education.
Insufficient scientific information on
many herbs presents barrier to proper
scientific review
Inability of many applicants to provide
requisite documentation
Lack of resources to develop adequate
laboratory support.
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Local publications help build consumer
awareness eg. “Poisonous Plants of
Jamaica, Jamaica’s Ethnomedicine- Its
Potential in the Healthcare System”
published by local authors.
Work by local scientists on medicinal
plants – UWI & others
Present Regulatory Framework
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Encompasses recommendations based
on collaborative work.
Similar product classification scheme
presently used.
Legislation amended to reflect position.
Advisory Panel Mechanism for
Complimentary Medicines established
(Jamaica).
Note: Jamaica
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All products regulated except
 Homeopathic preparations more dilute than a
one thousand fold dilution of a mother
tincture.
 Herbal teas except where there are claims.
 Products which exist and function principally
as food if they make no therapeutic claims
e.g. garlic
Fees required for passive assessment
All injectible presentations registered as
prescription drugs
New Drug Applications
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More stringent requirements:
Clinical pharmacology: pharmacokinetics,
pharmacodynamics, bioavailability,
bioequivalence
Chemistry: chemical composition,
morphology- structure activity relationship
Proof of efficacy: controlled, un0controlled
studies
Safety: scientifically established
Toxicology
Some Herbs Restricted in JamaicaInfo. Shared with other territories
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Chaparral
Comfrey- external use only
Germander
Lobelia
Magnolia
Jin Bu Huan
Ma Huang
Stephania
Willow Bark
Yohimbe
Kava Kava?
THE WAY FORARD
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Territories to agree on mechanism for
harmonisation
Seek representation on political agenda
Develop Regional legislation to address
key issues on timely basis
THANK YOU!