REGIONAL MEETING ON TRADITIONAL MEDICINES/MEDICINAL PLANTS - GUATEMALA CITY

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REGIONAL MEETING ON TRADITIONAL
MEDICINES/MEDICINAL PLANTS -GUATEMALA CITY

• 2003 FEBRUARY 18-20

Jamaica
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UPDATE ON PROPOSED AMENDMENTS TO THE FOOD
DRUGS ACT AND REGULATIONS- JAMAICA

• Princess Thomas Osbourne
• Director, Standards Regulation
• 2003 February.

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HISTORICAL OVERVIEW

• INTRODUCTION OF NEW CATEGORY CALLED HERBAL
  PRODUCTS-1993
• ESTABLISHMENT OF WHOLISTIC HERBAL ASSOCIATION-
  1995
• LONG CONSULTATIVE PROCESS WITH STAKEHOLDERS - six
  years

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HISTORICAL OVERVIEW contd.

• WHA suggestions -not all accepted by MOH
• Further discussions
• Consensus

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OVERVIEW contd

• WHO Regional Workshop on Regulation of Herbal
  Medicines- Jamaica Nov. 2000
• Representatives from Drug Regulatory bodies from
  11 Countries. Looked at-
• Issues relating to safety, efficacy, quality
  control of herbal products
• Requirements for registration
• Proposal on harmonized standards regulations to
  ensure safety and quality

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OVERVIEW contd

• 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

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OVERVIEW contd.

• MOH proposal to Cabinet based on
• Consultations with other Regulatory Bodies
• (UK, Canada, USA, Australia, Germany etc.)
• WHO Publications providing definitions
• Info. Gleaned from WHO workshop
• Local stakeholder input

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OVERVIEW contd.

• First Special Stakeholder Meeting of the Cabinet
  Select Committee on Human and Social Development
  - January 2001- examined MOH proposal,
  accomodated hearing from WHA, other stakeholders.
• Total of three meetings- MOH proposal accepted by
  Cabinet.

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ACHIEVEMENTS-PRESENT STATUS

• APPROVED
• Five categories of substances for human
  consumption recommended - included in Draft Food
  Drugs Bill
• i. HERBS
• ii HERBAL REMEDIES
• iii HERBAL MATERIALS
• iv. FINISHED HERBAL PRODUCTS
• v. HEALTH FOODS

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- Food Drugs Act to be amended to include
Over-the-Counter category -in Draft Bill,
completed- Foods and Drugs to remain in Act
without amendment- Food Drugs
Regulation to be amended to reflect new
requirements, standards for sale of herbal
products.
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IMPLEMENTED-

• OFFICIAL LIST OF REQUIREMENTS FOR REGISTRATION OF
  HERBAL DRUGS DEVELOPED- IN USE
• VITAMINS/MINERALS INCLUDED IN HEALTH FOOD
  CATEGORY but
• registered as prescription drug if in injectable
  form, mega doses for specific therapeutic
  indications
• registered as Over-the Counter drugs at
  concentrations deemed to exceed specific levels
• Permit required

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- Other Health Foods regulated - not
registered as drugs- Permit required- Special
requirements for labels to include warnings
and any particular conditions for use -
Injectible forms remain as Prescription Drugs
only.- Finished herbal products singly or in
combination currently regd. As drugs.
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- Advisory Panel Mechanism implemented - Panel
on Complementary Medicines functional.- Other
Panels include -Professional Affairs
-Ehtics Medicolegal Affairs
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OTHER RELATED MATTER

• Meeting of the 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

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CHALLENGES

• Cosmetics with herbs?
• Teas?
• Persistence of local Alt Med. Practitioners in
  use of prohibited herbs eg. Chaparral, Comfrey,
  Ma Huang

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MOH INTERVENTION

• Kava Kava no longer approved for use.
• Ephedra containg preps. Not allowed.
• Established partnership with industry results in
  increased compliance
• More vigilant Inspectorate
• Local publications help build consumer awareness
  eg. Poisonous Plants of Jamaica, Jamaicas
  Ethnomedicine- Its Potential in the Healthcare
  System

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MUCHAS GRACIAS !

• THANK YOU!