TRADITIONAL / COMPLEMENTARY MEDICINE (T/CM) IN THE MALAYSIAN HEALTHCARE SYSTEM

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TRADITIONAL /COMPLEMENTARY MEDICINE (T/CM)IN
THE MALAYSIAN HEALTHCARE SYSTEM

• 4th International Conference for
• Traditional/Complementary Medicine
• 14 October 2002 - Sunway Pyramid Convention
  Centre
• Keynote Address
• Tan Sri Datu Dr Mohamad Taha bin Arif
• Director General of Health
• Ministry of Health Malaysia

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Introduction

• In tandem with rapid economic development -
  health, social, cultural and psychological
  aspects are equally important
• Aspiration of the nation. NATIONAL HEALTHCARE
  VISION

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NATIONAL HEALTHCARE VISION

• to be a nation of healthy individuals, families
  and communities through a health system that is
  equitable, affordable, efficient, technologically
  appropriate, environmentally adaptable and
  consumer-friendly, with emphasis on quality,
  innovation, health promotion and respect for
  human dignity, and which promotes individual
  responsibility and community participation
  towards enhanced quality of life
• multi-disciplinary collaboration is crucial

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Traditional Medicine

• present healthcare system in Malaysia, based on
  western medical sciences
• for decades traditional medicine has undoubtedly
  played a remarkable role in primary healthcare
• (WHO) through Traditional Medicine Programme has
  encouraged countries to formulate national
  policies on traditional medicine

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WHO Traditional Medicine Prog. Objectives

• to facilitate the integration of traditional
  medicine into national health care systems
• to promote the rational use of traditional
  medicine through the development of technical
  guidelines and standards
• to disseminate information on various forms of
  traditional medicine

6
Malaysia T/CM Policy

• Malaysia has established its own National Policy
  on Traditional/ Complementary Medicine in 1999
• outlines our vision, mission, objectives and
  strategies, with emphasis on practice, education
  and training, raw materials and products, and
  research

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T/CM Policy - Objectives

• to develop regulatory and legal reforms to ensure
  good practice, and to extend primary healthcare
  coverage, while ensuring the authenticity, safety
  and efficacy of these medicines
• to achieve the desired goals

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T/CM Policy Goals.

• recognition of traditional medicine as an
  integral part of national healthcare systems
• cooperation between modern and traditional
  medicine practitioners
• promotion of rational use of products
• Introduction of quality assurance systems
• consistent supply of raw materials
• enhancement of research and reinforcement of
  regulatory actions

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T/CM Primary Healthcare

• large section of the population in many
  developing countries still relies on traditional
  practitioners
• important resource for primary healthcare
• 1978, the Declaration of Alma-Ata recommended,
  inter alia, the inclusion of proven traditional
  remedies into national drug policies and
  regulatory measures

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T/CM Status

• Traditional medicine has maintained its
  popularity in a number of Asian countries such as
  China, India, Japan, Pakistan, Sri Lanka and
  Indonesia.
• During the last decade, there has also been a
  resurgence of interest in traditional and
  alternative systems of medicine in many developed
  countries.

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T/CM Development

• herbal remedies have emerged as a preferred
  common choice among self-care therapies
• towards integrating traditional/ complementary
  medicine into the allopathic healthcare system
• MOH has taken a positive and proactive approach
  towards development of the domestic traditional
  medicine sector.

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T/CM Development

• WHO reported that legislative controls in respect
  of medicinal plants have not evolved around a
  structured control model
• different countries have adopted various
  approaches to licensing, dispensing,
  manufacturing and trading to ensure safety,
  quality and efficacy

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T/CM Malaysia

• implemented registration of traditional medicines
  in 1992 under the Control of Drugs and Cosmetics
  Regulations 1984
• to ensure safety and quality
• Criteria for registration

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Registration Criteria

• limits for heavy metals
• microbial contamination
• absence of adulterants
• approved claims and indications
• prohibition of herbs with known adverse effects
• prohibition of endangered animal species
• compliance to Good Manufacturing Practice (GMP)
  as well as Good Storage Practice (GSP).

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T/CM Malaysia

• 22 training courses related to registration, GMP,
  licensing and quality control testing were
  conducted from 1996 to 2000
• Program Anak Angkat
• 500 advisory services on GMP
• Technical Working Groups (TWG) involving Malay,
  Chinese and Indian traditional groups
• Guidelines on GMP and Registration of Traditional
  Medicines and Monograph of Plant Species have
  also been published

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T/CM Malaysia

• Guidelines for GMP of Traditional Medicines and
  approach adopted in developing the traditional
  medicine industry have earned reputation and
  international recognition by the WHO, United
  Nation Industrial Development Organisation
  (UNIDO) and Pharmaceutical Inspection Cooperation
  Scheme (PIC/S).

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T/CM Enforcement Licensing

• Increasing concern on quality and safety - to
  improve surveillance and enforcement
• number of applications for product registration
  has not declined - indicating the significant
  prevalence of TCM
• As of August 02 143 licensed traditional
  manufacturers, 129 importers and 412 wholesalers
  involved in over-the-counter (OTC) products
  including traditional medicines

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Threats and Health Risks

• Problems
• unregistered traditional medicines rampantly
  available in the market
• existence of unlicensed premises
• product adulteration
• contamination and counterfeits
• misleading claims and advertisements
• authentication of products
• lack of standardization

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Ensuring Product Safety

• post-marketing surveillance and monitoring of
  adverse drug reactions (ADR)
• Quality control tests and screening of labels are
  routinely conducted
• screened and tested for specific prohibited
  ingredients
• Despite our vigilance, the bitter episode of the
  Slimming Pill still haunts many of us

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Enforcement

• as of June 2002, the MOH has licensed 1,112
  retail, 321 wholesale, and 258 retail plus
  wholesale premises
• 1,874 inspections on licensed plus non-licensed
  retail and wholesale premises have been carried
  out nationwide
• registered clinics - 337 have been inspected

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Enforcement

• Ministry has raided 326 premises during the first
  half of this year, of which 222 or 68.1 were
  successful
• 3,040 items valued at RM 1.534 million have been
  confiscated
• 1,531 items of unregistered products with a total
  value of RM 1.229 million have also been seized

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Prosecutions

• involving 232 cases have been mentioned from
  January to August this year
• 105 were found guilty with total fines imposed
  amounting to RM 191,000.00
• For traditional medicines, a total of 784 items
  valued at RM 982,180.00 have been confiscated

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DCA - Registration

• 1985 2001 48,324 applications
• 21,445 or 44.2 are for traditional medicines
• 30.4 are for prescription drugs
• 21.7 for over-the-counter (OTC)
• 3.8 for cosmetics
• Year 2001 a total of 9,894 traditional medicines
  which represents 36.9 of the drug registry have
  been approved

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T/CM Export

• last 2 years, 756 free sale certificates have
  been issued for export
• gained market access into 42 countries ASEAN
  region, Asia Pacific, Middle East, Eastern
  Europe, Australia, United States, United Kingdom
  and Germany

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T/CM RD

• BioMalaysia 2002 has shed light on the challenges
  confronting us
• plant-based biopharmaceuticals and nutraceuticals
  must be fully explored
• National Institute for Pharmaceutical and
  Nutraceutical Biotechnology, established under
  the BioValley master plan will enable public and
  private sector to gain access to RD technology

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T/CM Future

• outlook for Malaysias herbal industry is bright
• one of the 12 mega-biodiversity nations in the
  world
• untapped biodiversity resources can push for a
  viable biopharmaceutical industry
• research areas Biodiversity prospecting,
  isolation and synthesis of active compounds,
  ethnomedicine, ethnobotany, pharmacognosy,
  toxicology, evidence-based evaluation, clinical
  trials, intellectual property rights and
  commercialization

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T/CM Future

• Local plants with clinical potential values
• Andrographis paniculata (Hempedu bumi)
• Centella asiatica (Pucuk pegaga)
• Citrus hystrix (Daun limau purut)
• Eurycoma longifolia Jack (Tongkat Ali Putih)
• Orthosiphon aristatus (Misai Kucing)
• Punica granatum L. (Buah Delima)

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T/CM Future

• Prime Minister experience..
• using Chinese traditional medicine to cure his
  chronic cough using tigers milk or kulat susu
  rimau which belongs to the same family as lingzhi
  (Ganoderma lucidum)
• Fungus popularly used by older generations of
  Chinese, Malay and Orang Asli is known for its
  curative properties in treating chronic
  bronchitis and asthmatic cough
• ? to produce the product commercially

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Conference Focus

• global trends, safety and legislation issues, and
  evidence-based practice
• Progress in RD - clinical trials of Misai Kucing
  for kidney stone, clinical studies of Hempedu
  Bumi as a prophylactic for diabetes, properties
  of Kacip Fatimah, and hypoallergenic preparations
  from Temu Lawak and Lempoyang

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T/CM Act

• statutory requirements for the practice of T/CM
  have not been implemented yet as there are no
  relevant laws governing it
• gradually advance towards a systematic regulatory
  control when the appropriate law is enacted
• proposed provisions for T/CM Act

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Proposed T/CM Act

• Provisions
• powers of the T/CM Council
• address various aspects of practice such as Code
  of Ethics and Code of Practice
• registration and licensing
• medical emergencies and notifiable diseases
• training, research and development, facilities,
  audits, fees and charges, research related to
  safety, quality and efficacy, etc.

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T/CM integration to national healthcare system

• new alliances and new initiatives we can make a
  difference
• energy, time and resources necessary to scale up
  our efforts towards ensuring availability,
  accessibility, acceptability and affordability of
  safe and quality T/CM practices and products, and
  to facilitate the integration of T/CM into the
  national healthcare system.

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Conclusion

• Integrated medicine, being holistic, can provide
  an excellent prospect for meeting the needs of
  the communities
• Weaving T/CM into the threads of our current
  healthcare system may be our greatest tribute to
  our national heritage
• hallmark of our socio-economic development is the
  holistic approach

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Thank You