PERKEMBANGAN PENGOBATAN HERBAL:

SEJARAH, KEBIJAKAN DAN REGULASI

oleh :
Prof.Dr.dr.M.T.Kamaluddin, MSc.,SpFK
Ketua Bagian Farmakologi
Fakultas Kedokteran Unsri

Kuliah Pilihan
Fakultas Kedokteran
Universitas Muhammadiah Palembang
Palembang, 8 Desember 2014

Objektif
1.Sejarah perkembangan penggunaan
herbal/Obat Tradisional Indonesia (OTI)
dan luar negeri
2.Kebijakan dan regulasi pemerintah RI

The Economist Dec 13th -19th 2003

The Economist Dec 13th-19th 2003

Traditional, Complementary
and Alternative Medicine

I think that TCAM

1. belongs to the trash bin
2. has no role or place in
health care given its lack of a
scientific base
3. has some therapeutic
possibilities

Key facts

In some Asian and African countries,

80% of the population depend on
traditional medicine (TM) for primary
health care.
Herbal medicines are the most lucrative
form of traditional medicine, generating
billions of dollars in revenue.
Traditional medicine can treat various
infectious and chronic conditions: new
antimalarial drugs were developed from
the discovery and isolation of artemisinin
from Artemisia annua L., a plant used in
China for almost 2000 years.
Counterfeit, poor quality, or adulterated
herbal products in international markets
are serious patient safety threats.
More than 100 countries have
regulations for herbal medicines.

Users of TM

In some Asian and African countries,

80% of the population depend on
traditional medicine for primary
health care.
In many developed countries, 70%
to 80% of the population has used
some form of alternative or
complementary medicine (e.g.
acupuncture).
Herbal treatments are the most
popular form of traditional medicine,
and are highly lucrative in the
international marketplace. Annual
revenues in Western Europe reached
US$ 5 billion in 2003-2004. In China
sales of products totaled US$ 14
billion in 2005. Herbal medicine
revenue in Brazil was US$ 160
million in 2007.

Background

Traditional medicine (TM) has always

maintained its popularity worldwide. In
addition, over the last decade, we have
seen an increasing use of
complementary and alternative
medicines (CAM) in many developed
and developing countries. The safety
and efficacy of traditional medicine and
complementary and alternative
medicines, as well as quality control,
have become important concerns for
both health authorities and the public.
Various traditional medicine practices
have been developed in different
cultures in different regions, but
without a parallel development of
international standards and appropriate
methods for evaluating traditional
medicine Therefore, sharing national
experience and information is crucial.

Herbal medicines users

TCAM Research
Institute for Traditional Medicines
(CSIR, MRC & WHO)
Indigenous Knowledge Systems
National Research Foundation
Universities
Useful Plants Garden - Kirstenbosch
Ethno veterinary practice
Ref: Moorman & Pick, 1998

Prescription
Once the muti is obtained, it can be
taken in various ways, depending on
its form and nature. While some muti
is just good for washing with, smearing
on one's body, or for burning and
inhaling, other muti is designed for
elaborate uses like ukuphalaza
(regurgitating), ukuchatha (applying
by means of an enema), or
nokugquma (steaming). BMJ 2001;322:164-167
( 20 January )

Prescription
"Isende lehashi" (horse penis)
"Zamafufunyane" (for nightmares and
hysteria), "Owobusoka" (guaranteed
to improve the romantic fortunes of a
bachelor), "Zikatokoloshe" (to ward
off an imaginary evil goblin said to
spread terror at night)

Zimbabwe healer
moots magic
chastity potion

Ayurvedic Preparations
Bronchial asthma, ischaemic heart
disease and hyperlipidaemia
Curcumin - rheumatoid arthritis
Acute viral hepatitis
Pterocarpus marsupium effective in
reducing levels of blood glucose and
glycosylated haemoglobin in patients with
non-insulin-dependent diabetes mellitus
Fistula-in-ano patients were randomised
to surgery or application of medicated
thread (Ksharsootra). Surgical treatment
led to a faster cure but recurrence rates
were lower with medicated thread.

Traditional Chinese
Systems of Medicine
Herbal remedies, acupuncture,
acupressure, massage and moxibustion
40% of all health care delivered in China
The first documented source of Chinese
medical theory, the Huangdi Nei Jing
("Inner Classic of the Yellow Emperor")
was written between 300 BC and 100 BC

Traditional Chinese
Systems of Medicine

BMJ 1997;315:115-117 (12 July)

Origin of Traditional Chinese

Medicine
Recorded history
over 4,000 years
old
earliest books on
the foundation of
TCM, originating as
early as 1000 B.C.

Huang Di Nei Jing or Yellow Emperors

Classic of Medicine

Taoist Philosophy
TCM derived from
Taoist philosophy
belief that human
experience is affected
by causative
principles in the
environment
principles, correlate to
fate as decreed by
heaven
BaGua

Development of Traditional
Chinese Medicine
originally handed down only through
personal apprenticeship
now 25 major colleges of TCM
totaling about 20,000 students in each
school at any given time
courses range from undergraduate to
the doctoral, in both Western medicine
and TCM

Main Concept of TCM: Yin Yang

Theory that everything in the universe contains the two aspects
of Yin and Yang, which are in opposition and also in
unison.They are polar opposites inherent and discernable in
everything, and are never absolute.
Yang qualities: dynamic, external, upward, ascending,
brilliant, progressive, hyperactive, superficial, heat, light, open,
energy
Yin qualities: static, internal, downward, descending, dull,
retrogressive, hypoactive, dark wet, cold, matter

Wu Xing: Five Phases (elements)

originally a philosophical theory in

ancient China, later adapted to
medical practice, becoming an
important part of TCM theory
universal interdependence of all
things and events
used to explain and expand a series
of medical problems by comparing
with and deducing from mutual
relationships

Two Examples of Relationships

Between Phases:
Xiang Ke ( inter- inhibition, or control ) :
wood inhibits earth, earth inhibits water,
water inhibits fire, fire inhibits metal, and
metal inhibits wood
Xiang Sheng ( inter-generation ): wood
generates fire, fire generates earth, earth
generates metal, metal generates water, and
water generates wood

Jing Luo (Channels or Meridians)

and Their Collaterals
passages through which Qi ( energy ) and blood circulate
connect the Viscera with the limbs, connect the upper and lower
parts with the interior and exterior of the body, and regulate the
mechanisms of the various parts of the body
include the jing-mai ( the channels or meridians ) and luo-mai
( the collateral channels ); it is specifically through these
structures that the human body becomes an an organic whole
no objective proof as to the actual existence of Jing and Luo.
However, the channels have long been confirmed through clinical
usage, and they are also confirmable subjectively

Distribution of the 14 meridians of the hand and foot

Methods of Treatment
Acupuncture
Herbs
Tui Na

How does TCM work?

Vital energy called Qi is the life force that
drives all living things. Qi flows through
meridians (also called channels) in the
body similar to water flowing in a river.
Twelve primary meridians, each
associated with an organ system
Disease occurs with imbalance, resulting
in excess of deficient amounts of Qi in
the meridians.
TCM works to alleviate this imbalance
and restore harmony

How does Acupuncture

work?

points are located throughout the body and

act as gateways to influence, redirect,
increase or decrease the vital substance of
Qi
corrects imbalances that cause disease
research programs have been conducted
towards understanding the mechanism of
acupuncture with impressive results.

Ancient Acupuncture: Nine needles

What is Tui Na?

relatively new to the western world
combines the work of massage therapy,
chiropractic and TCM
establishes a more harmonious flow of Qi
throughout the system of channels and
collaterals, allowing the body to naturally heal
itself.
Tui Na encompasses three techniques
1. Massage to treat the soft tissue (muscles and
tendons of the body
2. Acupressure to affect the flow of the Qi
3. Adjustments for realignment

Tui Na Hand Positions

About Chinese Herbs

important component of TCM
herbal formulas are as effective now as
they were more then 4,000 years ago
when they were first introduced
formulas contain 2 - 18 different types of
herbs
used to treat a wide variety of symptoms
while stimulating the bodys natural
healing process
not addictive, powerful nutritional agents

Chinese Herb Leaves

TCM Broad Range of

Treatments
Asthma

Allergies

Cold/Flu

Cough/Bronchitis Headaches

TMJ

Tinnitus

Arthritis

Osteoporosis

Back/neck ache

Sciatica

Pain Mgmt

Infertility

Depression

Stress

Addictions

Skin diseases

Fibromyalgia

PMS

Rhinitis

Vision

Hemilplegia

Sexual
dysfunction

High blood
pressure

Stroke

High Cholesterol

Injuries

Trauma

Children's
Diseases

Frozen Shoulder

CAM and Traditional Medicine

Use in the USA

www.CDC.gov: 2002 NHIS survey

Prevalence and
demographics
Use 75%
p year 62%
Female > male
Higher education level
Ethnicity determines
type of CAM used
Hospitalized p year

Herbal medicines Shiatsu Homeopathy , Qi gong Osteopathy Tai ji

Unani Tuina Acupuncture/acupressure Chinese medicine
Ayruveda
Chiropractic
Naturopathy
Siddha
Native American
Yoga Curanderismo Folk practices Laying on of hands Kampo

Evidence-based medicines ?

A total of 129 countries

answered this question; for
the detailed responses.

The category chosen by the

most countries was that of
a lack of research data (109
countries), followed by lack
of appropriate mechanisms
for the control of herbal
medicines (93 countries),
lack of education and
training (86 countries), lack
of expertise within the
national health authorities
and control agency (70
countries) and other (33
countries).
WHO, 1991

CAM becomes popular

1995

NIH Office of Dietary Supplements

FDA declassifies Acupuncture
needles as experimental product

1996

NIH Consensus Conference on

Acupuncture

1997

First large trial of CAM therapy, St. Johns

Wort for depression

 1998

National Center for Complementary &

Alternative Medicine (NCCAM) established
http://nccam.nih.gov/
First full scale article in JAMA on herbal
medicine
Office of Cancer Complementary and
Alternative Medicine (OCCAM) established
http://www.cancer.gov/cam/

2001

CAM on PubMed (NCCAM and NLM)

2009 - $296 million in NIH CAM research

Impact of CAM
CDC Report (2007)

38% of adults used some form of CAM

Children whose parent used CAM were 2x as
likely to have used CAM
CAM use more prevalent for: women, adults
aged 30-69, higher levels of education, adults
who were not poor, adults living in the West,
and former smokers

Full report:
http://nccam.nih.gov/news/camstats/

Complementary and
Alternative Medicine (CAM)
Complementary medicine
Used together with conventional medicine
Also called allopathy, Western, mainstream,
orthodox, biomedicine

Alternative medicine
In place of conventional medicine
Generally incorporates a holistic approach,
focus on treating whole body and mind
Changes as some CAM practices become more
mainstream

Used widely throughout the world

Complementary and Alternative

Medicine (CAM)
Who uses it?
36% of adults in U.S. used CAM within the
past 12 months
More women than men
People with higher education levels
Those hospitalized within the last year
Former smokers
People with back, neck, head, joint aches or
other painful conditions
Those with gastrointestinal disorders or
sleeping problems

Complementary and Alternative

Medicine (CAM)
CAM in the U.S. today

Relaxation
Chiropractic
Massage
Self-help
Energy healing
Other therapies

Reasons Adults in the United

States Use CAM

Figure 17.1

Jamu sebagai Obat Asli

Indonesia (1)

Minum
Jamu

Dapat dilihat pada Relief

Karmawibhangga Candi
Borobudur

Jamu (Jampi): Bahasa Jawa,

dapat ditemukan pada naskah
kuno, seperti Ghatotkacasraya
(Mpu Panuluh)

Naskah Jamu berikutnya: Serat

Centhini (1814), Serat Kawruh
Bab Jampi-Jampi Jawi (1831)
43

Jamu sebagai Obat Asli

Indonesia (2)

Naskah Jamu oleh Orang Eropa (era kolonial)

Historia Naturalist et Medica Indiae (Yacobus Bontius,

1627)
Herbarium Amboinense (Gregorius Rhumpius)
Het Javaansche Receptenboek (Buku Resep Pengobatan
Jawa) (Van Hien, 1872)
Indische Planten en Haar Geneeskracht (Tumbuhan Asli
dan Kekuatan Penyembuhannya) (KloppenburgVersteegh, 1907)
De Nuttige Planten van Indonesie (K. Keyne, 1913)
Heilkunde und Volkstum auf Bali (W. Weck, 1937)
44

Alternative Medical Systems

Traditional Chinese medicine
Proper balance of Qi (chi)
Acupuncture, herbal medicine, massage,
qigong

Ayurveda
Traditional in India
Science of life

Homeopathy
Like cures like
Herbal medicine, minerals, and chemicals in
diluted forms

Alternative Medical Systems

Naturopathy
Restore health rather than cure disease
Diet, clinical nutrition, homeopathy, acupuncture,
herbal medicine, hydrotherapy, manipulation, light
therapy, therapeutic counseling, pharmacology

Have you ever used one of these nontraditional practices?

Complementary and Alternative

Medicine (CAM)
Major domains of CAM (nonallopathic)

Manipulative and body-based practices

Energy medicine
Mind-body medicine
Biologically based practices

The Domains of Complementary

and Alternative Medicine

Figure 17.2

 Tujuan terapi

adalah :

1. Memperpanjang harapan hidup dengan

harapan mencegah kematian lebih dini.
2. Memperpanjang kualitas hidup (quality of
life ) sehingga kecacatan akibat suatu
penyakit dapat dihindari atau diminimalisir.
3. Mengatasi keluan atau gejala yang
menjadi masalah penderita.

Adapun cara mencapai tujuan tersebut melalui

penanganan penderita secara komprehensip yang meliputi
upaya promotif, preventif, kuratif dan rehabilitatif.

CAM
- Pelengkap
-- pilihan lain
--diversifikasi

Manipulative and Body Based

Practices
Chiropractic medicine
Massage therapy
Body work

Feldenkrais
Rolfing
Shiatsu
Trager bodywork

 Energy medicine

Biofields
Qigong
Reiki
Therapeutic touch

Energy Medicine
Acupuncture
Needles inserted at critical points (meridians)
Qualifications
Many get relief

Acupressure
Uses pressure instead of needles

Mind-Body Medicine
Psychoneuroimmunology (PNI)
Excessive stress can lead to immune system dysfunction
Activities that involve quieting the mind

Biologically Based Practices

Foods as healing agents
Functional foods
Nutraceuticals

Diseases and Conditions

Top CAM Therapies

Asean users
WHO South-East Asia
Region: Bangladesh, Bhutan,
Democratic Peoples Republic of
Korea, India, Indonesia,
Maldives, Myanmar, Nepal, Sri
Lanka, Thailand, Timor Leste2.
2 Not a WHO Member State at
the time of distribution of the
questionnaire, and therefore
not included in the Global
Survey.

International diversity
Traditional medicine
practices have been
adopted in different
cultures and regions
without the parallel
advance of
international
standards and
methods for
evaluation.

Different concept

Complementary/alternative medicine
(CAM): often refers to a broad set of health
care practices that are not part of a countrys
own tradition and are not integrated into the
dominant health care system.
Other terms sometimes used to describe these
health care practices include natural
medicine, nonconventional medicine and
holistic medicine.
Herbal medicine: plant derived material or
preparations with therapeutic or other human
health benefits, which contain either raw or
processed ingredients from one or more plants.
In some traditions, material of inorganic or
animal origin may also be present.
Traditional medicine (TM): is the sum total
of knowledge, skills and practices based on the
theories, beliefs and experiences indigenous to
different cultures, whether explicable or not,
used in the maintenance of health as well as in
prevention, diagnosis, improvement or
treatment of physical and mental illnesses.

WHO response

WHO and its Member States cooperate

to promote the use of traditional
medicine for health care. The
collaboration aims to:
support and integrate traditional
medicine into national health systems
in combination with national policy and
regulation for products, practices and
providers to ensure safety and quality;
ensure the use of safe, effective and
quality products and practices, based
on available evidence;
acknowledge traditional medicine as
part of primary health care, to increase
access to care and preserve knowledge
and resources; and
ensure patient safety by upgrading the
skills and knowledge of traditional
medicine providers.

DRAFT REGIONAL STRATEGY FOR

TRADITIONAL MEDICINE
Traditional medicine is the knowledge, skills
and practice of holistic health care,
recognized
and accepted for its role in the maintenance
of health and the treatment of diseases.
It is based on Indigenous (originating
where it is found) theories, beliefs and
experiences that are handed down from
generation to generation.

DRAFT REGIONAL STRATEGY FOR

TRADITIONAL MEDICINE
In the West, the umbrella term complementary
and alternative medicine (CAM) is widely accepted
as including both traditional medicine and more
recent forms of non-standard medicine.
A recent modification of the well-known
Cochrane definition described CAM as including:
"all such practices and ideas self-defined by their
users as preventing or treating illness or
promoting health and well-being.

DRAFT REGIONAL STRATEGY FOR

TRADITIONAL MEDICINE
WHO will work with countries:
to ensure the safe and effective use of
traditional medicine of an acceptable
quality; and
to promote the recognition of traditional
medicine and to support its integration
into mainstream health services.

DRAFT REGIONAL STRATEGY FOR

TRADITIONAL MEDICINE
Traditional medicine has an established promotive,
preventive, curative and rehabilitative role.
It can be the main form of health care, or an
integrated component of mainstream health care,
or an alternative or complement to the main form
of health care.

DRAFT REGIONAL STRATEGY FOR

TRADITIONAL MEDICINE
The WHO Regional Committee has adopted two
resolutions,
WPR/RC36.R6 in 1985 and the WPR/RC38.R16
in 1987, recognizing that traditional medicine
practices, particularly herbal medicine and
cupuncture, constitute appropriate health
practices that can be integrated into national
health strategies.

DRAFT REGIONAL STRATEGY FOR

TRADITIONAL MEDICINE
Countries are encouraged to identify
how far traditional medicine has been
recognized and integrated into
mainstream health services.
The formulation of strategic goals,
action plans and time frames depends
on the level of recognition and
integration in each country.

Utilization patterns
Different reasons bring consumers to
traditional medicine. Cultural beliefs may still
be the major reason for using traditional
medicine.
people living in rural and remote areas in
developing countries often seek first line
health service from traditional systems of
medicine because they are the only available
and affordable form of health care.

Utilization patterns
Some patients may go to traditional medicine after
unsatisfactory treatment from modern medicine.
In all these cases, the effectiveness of traditional
medicine and consumer satisfaction with services
plays an important role in maintaining and
increasing public interest in traditional medicine.

Utilization patterns
In some countries, traditional medicine
is practised not only at the primary
health care level but also in hospitals
providing secondary and tertiary care.
In other countries, traditional medicine
is used mainly as family and
community-based practice.

Need for an evidence-based approach

Demands from the public have led to
increasing involvement in traditional
medicine by the scientific community. Many
medical doctors have begun to use traditional
remedies and techniques in their daily
practice.
Universities and medical schoolsoffer fulltime degree courses or short introductory
courses on traditional medicine.

Need for an evidence-based approach

Engaged in research
on traditional
medicine. Some
researchers are
attempting to
evaluate the safety
and efficacy of
traditional medicine,
while others are
engaged in research
into new drugs and
other products
derived from plants.

Need for an evidence-based approach

An evidence-based
approach to
traditional
medicine will be an
important step
towards in
harmonizing
traditional and
modern medicine
and enabling the
two systems to
work effectively
side by side.

Assessing the Risks and

Benefits of CAM Treatments

Figure 17.3

Integrated Medicine
Initiative
integration
complementarities
rivalry
co-existence

Review of TCAM major domains

traditional & alternative systems
mind body interventions
biological based therapies
manipulative & body movement methods
energy therapies

Menurut UU No. 36 Tahun 2009 tentang

Kesehatan menyebutkan definisi
Obat tradisional adalah bahan atau ramuan
bahan yang berupa bahan tumbuhan, bahan
hewan, bahan mineral, sediaan sarian (galenik)
atau campuran dari bahan tersebut, yang secara
turun-temurun telah digunakan untuk pengobatan
dan dapat diterapkan sesuai dengan norma yang
berlaku di masyarakat
Jamu adalah obat tradisional Indonesia
Obat herbal terstandar adalah sediaan obat bahan alam yang
telah dibuktikan keamanan dan khasiatnya secara ilmiah dengan
uji praklinik dan bahan bakunya telah di standarisasi.

Fitofarmaka adalah sediaan obat bahan alam yang telah dibuktikan

keamanan dan khasiatnya secara ilmiah dengan uji praklinik dan uji klinik,
bahan baku dan produk jadinya telah di standarisasi.

KELOMPOK OBAT TRADISIONAL

3 KELOMPOK OBAT TRADISIONAL DAN KRITERIA

DALAM PENGEMBANGANNYA
BENTUK SEDIAAN SEDERHANA
JAMU

KHASIAT & KEAMANAN

EMPIRIK
STANDARDISASI BAHAN BAKU

OBAT HERBALTERSTANDAR

TEK. FARMASI
UJI PRAKLINIK
UJI PRAKLINIK

FITOFARMAKA

TEK. FARMASI
UJI KLINIK

HASIL RISET KESEHATAN DASAR 2010

Jamu
% kelompok umur
(15 th keatas) yang
minum jamu

Ya,
Setiap hari

Ya,
kadang@

Tidak,namun
Dulu pernah

Tidak
Pernah

Jenis sediaan

Kapsul/
tsblet

Racikan
Yg disedu dgn
air panas

Decocti
on

Cairan

Potensi
Pengembangan Obat Tradisional (1)

40.000 spesies tanaman hayati dunia

30.000 di Indonesia
Data penelitian: 87% pengguna obat herbal mengakui
bahwa jenis obat tersebut berkhasiat
Hasil riset FMIPA UI dari Koran Seputar Indonesia tgl 6
Mei 2011 membuktikan 54% masyarakat Indonesia
menggunakan jamu, dari pengguna jamu itu, 95%
mengakui ada manfaatnya
Transaksi perdagangan OT >>>
Beberapa unggulan yang khas Indonesia (temulawak,
dll) dan telah diminati

Potensi
Pengembangan Obat Tradisional (2)

Standar-standar yang dimiliki:

Farmakope Herbal Indonesia 70 monografi
(37 simplisia dan 33 ekstrak)
Farmakope Herbal Indonesia Suplemen I
55 monografi (26 simplisia dan 29 ekstrak)
Materia Medika Indonesia I s/d VI,
244 Monografi Tumbuhan Obat
Monografi EkstrakTumbuhan Obat Indonesia I & II
65 monografi, revisi Jilid I 35 monografi.
Pedoman CPOTB

Pengembangan OT / Obat Herbal di

Indonesia
Lokal
IOT = 80
IKOT = 1284

No. TR....

No. TR....

No. FF....

* 33 PRODUK

6 PRODUK

Pengembangan Obat Tradisional (1)

Perspektif bisnis: berorientasi pada kebutuhan
pasar, dan diarahkan pada pola pengembangan
produk obat modern.
Perspektif Farmasi: berdasarkan pada kaidah
keilmuan dan teknologi farmasi agar produk yang
dihasilkan memenuhi persyaratan yang ditetapkan.
Perspektif Kedokteran:Mengacu persyaratan medik
(uji pre-klinik, uji klinik)

Pengembangan Obat Tradisional (2)

Teknologi Produksi : Tumbuhnya industri dengan
produksi cara modern
Penggunaan : Dari swa pengobatan oleh
masyarakat ke konsep yang dapat disejajarkan
dengan obat modern dalam pelayanan kesehatan
Perubahan konsep : Pembuktian keamanan dan
khasiat secara empirik bertahap berkembang
menjadi pembuktian secara ilmiah.

PELUANG DAN TANTANGAN (1)

PELUANG :
Sistem
Kesehatan
Nasional
(SKN)
mendukung
pengembangan & pemanfaatan obat tradisional yang
bermutu aman, berkhasiat teruji secara ilmiah untuk
pengobatan sendiri dan dalam yankes formal
Tersedia hasil penelitian ilmiah bahwa sediaan obat
herbal terbukti memiliki efek terapi yang efektif
Penerimaan kalangan profesi dokter dan penggunaan obat
herbal meningkat
Rekomendasi WHO penggunaan pengobatan tradisional,
termasuk obat herbal, dalam pemeliharaan kesehatan
Telah tersedia Farmakope Indonesia edisi Herbal sebagai
standar mutu

PELUANG DAN TANTANGAN (2)

TANTANGAN :
Sumber daya alam tumbuhan obat belum dikelola
secara optimal & kegiatan budidaya belum
diselenggarakan secara profesional
Mutu herbal belum konsisten
Suplai dan permintaan berbasis bukti ilmiah tidak
seimbang
Pembiayaan pengembangan obat tradisional
terutama penelitian masih sangat terbatas
Upaya pengembangan obat tradisional kurang
terkoordinasi dengan baik dan belum sinergis

TUJUAN PENGEMBANGAN
OBAT TRADISIONAL/HERBAL
Diterimanya dalam sistem pelayanan kesehatan
Berkembangnya industri obat tradisional /herbal,
juga peluang ekspor
Dapat bersaing di pasaran termasuk pasar global
Berkembangnya agro industri tanaman obat

TAHAPAN PENGEMBANGAN OBAT ASLI INDONESIA

FROM RESEARCH TO MARKET
Fase Penemuan
Budidaya
dan
Konservasi

Validasi Target
BB/
Etnofarmakog
nosi

Penelusuran Penapisan
Etnofarmakogn
berdasarkan
osi
data
Inventarisasi
data ilmiah

Fase Teknologi Menuju Komersialisasi Produk

Pengembangan
Pengembangan Produk
Pengembangan BB / / BB terstandar (Pra- Produk Fitofarmaka
(Fase Klinik)
Desain formula ,jamu klinik)

Standardisasi BB
Pedoman CPOTB
Pedoman CPOTB BB
Formularium OT

Sertifikasi BB
(untuk ekspor)
Registrasi Produk
Herbal terstandar

Registrasi
Fitofarmaka

Sertifikasi CPOTB

Sertifikat
CPOTB

Sertifikasi Fasilitas
Produksi (IOT, CPOTB,
IKOT : bertahap)

Sertifikasi Fasilitas
Produksi Bahan
Baku (CPOTB)

Pedoman Uji
Klinik
Fitofarmaka

Sertifikasi Fasilitas
Produksi Bahan Baku

Pedoman uji PraKlinik produk/BB

Promosi BB &Jamu
termasuk Gerakan
Nasional Minum
Temulawak dan
Gerakan Nasional
Minum Jamu

Sertifikasi Jamu

Registrasi OT

Sertifikasi Fasilitas
Produksi Jamu

Pema-saran

perumahan
Penggunaan
sendiri
Nasional
Ekspor

DUKUNGAN PEMERINTAH

ROADMAP PENGEMBANGAN OTI/OAI

DAN PROGRAM STRATEGIS PENGAWASAN OBAT TRADISIONAL
2001 2004:

2005 2009

2010 2014:

2015 2019:

2020 2025:

Era
Penataan
Kembali

Era
Standardisasi

Era Daya
Saing
Kompetitif

Era
Keunggulan
Kompetitif
(Efisiensi)

Era
Keunggulan
Kompetitif
(Inovasi)

Regulasi
dan
Infrastruk
tur

Standardisasi
BB dan Produk
OT

Pengembang
an BB OT dan
Herbal
Terstandar
untuk Ekspor

untuk
menghasilka
n produk jadi
dan bahan
baku yang
memiliki
tingkat
efisiensi
melalui
pemenuhan
persyaratan,
standar, dan
pedoman
yang
ditentukan

untuk
menghasilk
an produkproduk
inovasi
dalam
rangka
penetrasi ke
pasar global
dengan
tetap
melalui
pemenuhan

Penelusuran
dan Penapisan
Kualitas SDM
(pelatihan
CPOTB bagi
industri dan
cara memilih
simplisia yang
baik)
Penertiban
Produk Ilegal

Peningkatan
Kualitas SDM
(pelatihan
CPOTB,
Pelatihan
CPOTB BB,
dan cara
ekstraksi
yang baik)
Penertiban
Produk
Impor Ilegal

PARADIGMA BARU
UNDANG-UNDANG RI No.36/2009
(HAK INISIATIF DPRRI)
tentang KESEHATAN, mendorong Reformasi dan
Reorganisasi Kemenkes RI
PASAL 48 Ayat 1
UPAYA KESEHATAN
TERDIRI DARI 17 JENIS PELAYANAN
(2) Pelay. KESEHATAN TRADISIONAL
di Puskesmas (utamanya Promotif dan
Preventif)
di Rumah Sakit (utamanya Kuratif dan
Rehabilitatif)
31/05/16

92

Pembangunan Kesehatan
Nasional
Pemerintah

Akademisi

Medis

Swamedikasi

Tradkom

UUD45

Pelaku
Usaha

Preventif,
Promotif,
Kuratif,
Rehabilitatif

Masyarakat

Perilaku hidup
sehat

Olah Raga

Tradko
m

HDI

VISI dan MISI

VISI
Masyarakat Sehat yang mandiri dan Berkeadilan

MISI
1. Meningkatkan derajat kesehatan masyarakat, melalui
pemberdayaan masyarakat, termasuk swasta dan
masyarakat madani.
2. Melindungi kesehatan masyarakat dengan menjamin
tersedianya upaya kesehatan yang paripurna, merata,
bermutu, dan berkeadilan.
3. Menjamin ketersediaan dan pemerataan sumberdaya
kesehatan.
4. Menciptakan tata kelola kepemerintahan yang baik.

PELAYANAN KESEHATAN
(WHO)

MODERN MEDICINE
Disebut juga :
Allophatic
Konvensional
Biomedisin
Scientific medicine
Western medicine

TRAD. MEDICINE
Disebut juga :
Komplementer
Alternatif
Non Konvensional
Oriental Medicine
Holistik
Alamiah
Natural
95

KLASIFIKASI BATTRA
(Pasal 59 ayat 1 UU 36/2009)

Dikelompokkan berdasarkan
metode
yang
dominan digunakan

KETERAMPILAN

RAMUAN
MANUAL

Battra
Jamu, Gurah,
Homoeopath,
Aromaterapi,
SPA terapi,
Sinshe,
Api/sengat terapi

Battra
pijat
urut,
shiatsu,
patah
tulang,
refleksi,
akupress

ALAT/TEKNOLOGI

Battra
akupunktur,
chiropraksi,
battra bekam,
Pnta-kecantikan

MENTAL/O.F
IK
Battra
reiki, qigong,
kebatinan,
tenaga
dalam,
paranormal,
Hipnoteraphi
96

ALUR PROSES INTEGRASI YANKES

TRADKOM
INTEGRASI
YANKES
TIMUR

BARAT
(KONVENSIONAL)
EVIDENCE BASED
WESTERN/MODERN
DOKTER
(Fas Kes)

(NON KONVENSIONAL)
HILIR

EVIDENCE BASED

BUKTI EMPIRIS

KESTRAD TERUJI

KESTRAD

HULU

DOKTER Plus
(Fas Kes)
MASYARAKAT
-UKBM
-BATTRA

PENAPISAN

MASYARAKAT
-UKBM
-BATTRA

- KAJI
- UJI
- LIT

JEJARING LITBANG
(termasuk SP3T/BKTM/LKTM)

97

Kebijakan dan Peraturan

UU Kesehatan No. 36/2009
PP 72/ 1998 : Pengamanan Sediaan Farmasi dan Alat
Kesehatan
Permenkes No. 246/1990) Produksi dan Registrasi Obat
Tradisional
Permenkes No. 1076/2003 Penggunaan Obat Tradisional
Permenkes No. 131/ 2009 Sistem Kesehatan Nasional
Permenkes No. 381/2007 Kebijakan Nasional Obat
Tradisional
Permenkes No. 1109/2007 Pengobatan Tradisional

17 UPAYA KESEHATAN
(Ps 48 ayat 1 UU 36/2009 ttg Kesehatan)
1.

PELAYANAN KESEHATAN

2. PELAYANAN KESEHATAN TRADISIONAL

3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.

PENINGKATAN KESEHATAN DAN PENCEGAHAN PENYAKIT

PENYEMBUHAN PENYAKIT DAN PEMULIHAN KESEHATAN
Pasal 47 : Up.Kes diselengg dalam
KESEHATAN REPRODUKSI
Bentuk keg dg pendekatan Promotif,
KELUARGA BERENCANA
Preventif, Kuratif dan Rehab yang
KESEHATAN SEKOLAH
dilaks sec TERPADU, MENYELURUH
dan BERKESINAMBUNGAN
KESEHATAN OLAHRAGA
PELAYANAN KESEHATAN PADA BENCANA
PELAYANAN DARAH
KESEHATAN GIGI DAN MULUT
PENANGGULANGAN GANGGUAN PENGLIHATAN DAN GANGGUAN
PENDENGARAN
KESEHATAN MATRA
PENGAMANAN DAN PENGGUNAAN SEDIAAN FARMASI DAN ALAT
KESEHATAN
PENGAMATAN MAKANAN DAN MINUMAN
PENGAMANAN ZAT ADIKTIF, DAN/ATAU
BEDAH MAYAT
99

PASIEN DATANG
PEMERIKSAAN & DIAGNOSA OLEH DOKTER
( Penegakan Diagnosa Tetap secara Konvensional)
Pilihan terapi yang diberikan dokter:
Konvensional saja
Konvensional +Yankes Tradisional
(komplement)
Murni Yankes Tradisional (alternatif)
Terapi dapat diberikan oleh:
Dokter yg telah memiliki sertifikat kompetensi
Tenaga kesehatan yg mendapat pelatihan
khusus dibidang Tradkom (dalam pengawasan
dokter)

K
O
N
S
E
P
I
N
T
E
G
R
A
S
I

Rencana Stratregis 09 14
No

INDIKATOR

2010

2011 2012

2013

2014

1.

Cakupan kab/kota yg menye

lenggarakan progr bina
yankestrad, alternatif dan
komplementer

10%

20%

30%

40%

50%

Jlh RS yang menyelenggara

kan yankestrad yg aman dan
bermanfaat sbg yankes
alternatif dan komplementer

26

36

46

56

70

2.

101

NSPK
1.
2.

Pedoman Pelayanan Kesehatan Tradisional Ramuan

Ped Pembinaan Pengobat Tradisional Akupresur Bagi Pet
Kesehatan
3. Pedoman pengelolaan dan pemanfaatan TOGA
4. Formularium Obat Herbal Asli Indonesia
5. Pedoman Pembinaan Salon Kecantikan
6. Tata Laksana BKTM/LKTM (Permenkes No 002 Tahun 2012)
7. Pedoman Penyelenggaraan Pel Kes Trad Ketrampilan
8. Pedoman Pendayagunaan Pengobat Tradisional Asing (PTA)
9. Standar Pelayanan Medik Akupunktur
10. Kurikulum dan Modul TOT Tenaga Pelatih Akupresur di Propinsi
11. Kurikulum dan Modul Pelatihan Akupresur Bagi Pet.Kes di Pusk

PRIORITAS PROGRAM 2012

1. Implementasi
NSPK dan
Regulasi dengan
STRATEGI
2012
Penegakan
IMPLEMENTASI

2.
3.
4.
5.

pendekatan pembinaan, kompetensi, tertib dan

bertanggungjawab pada fasilitas Yankestrad Pemerintah dan
Masyarakat.
Implementasi Integrasi pelayanan kesehatan Tradkom di
fasilitas kes formal/konvensional sesuai sasaran Renstra
Kes 2010-2014.
Penguatan peran 17 Sentra P3T dan pengemb fungsi
pelayanan di BKTM/LKTM, serta mendorong pembentukan 9
SP3T baru di Provinsi.
Penguatan kerjasama Kemitraan Lintas Program untuk
penguatan Yankestrad Pemerintah dan kemitraan LS untuk
peningkatan ketersediaan bahan/OT.
Mendukung pencapaian MDGs, meningkatkan
pemberdayaan masyarakat di wilayah DTPK/DBK melalui
kemandirian pemanfaatan ramuan dan Yan Tradisional.

Conclusion
TM, CAM use should follow
therapeutic concept based
on dynamic homeostatic
aspects.
Users should be aware of
adverse reaction since no
guarantee manner as no
evidence-based medicines

HARAPAN BERSAMA

BADAN POM RI