Tantangan dalam

produksi obat generik yang berkualitas

(bahan baku, infra-struktur, efisiensi proses)
IAI PIT 2016
Yogyakarta
Pre Agusta Siswantoro

Winning The New Business Landscape

Winning The New Business Landscape
 Trends that will impact the Pharmaceutical
Regulation Industry: Indonesia
(cGMP)
• BPOM following PIC
regulation for GMP Economy
implementation
(GDP growth)
• GDP Growth
• Indonesia economy is
expected to growth +/- 6%
• Indonesia healthcare spending
projected 2.7-5% of GDP
• Pharma market growth 10.7% by
Political 2017
• Asia harmonization
(JKN _BPJS) implementation
• Implementation of
universal coverage
(BPJS) to all citizen
• Increasing pressure for good and
clean government
Winning The New Business Landscape
 Quality
BIO EQUIVALENCE Assurance

Winning The New Business Landscape

 Pharma Market (2014)-Bill.US$
1000 929
1000 World market
900
Growth 4-6%
800
700
600
500
400
300
200
Indonesia
100 5,9
4,5 market
0
Growth 10-11%
2012

 The global pharmaceutical market is forecast

to grow to $1000 billion in 2014, an
equivalent compound annual growth rate
(CAGR) of 5.5% over the next five years.

Winning The New Business Landscape

 Pharma Market update (IMS Q2 ‘ 2014)

Indonesia Pharma Market : Rp. 55.3 T (+/- :

7.9%)
OTC market : Ethical market :
Rp. 22.6 T (+/- : Rp. 32.7 T (+/- :
7.4%) 8.3%)
MS : 40.9% MS : 59.1%
Branded market :
OGB market :
Rp. 28.2 T (+/- : 7.1%)
Rp. 4.5 T (+/- : 15.9%)
MS : 86.2%
MS : 13.8%

Winning The New Business Landscape 6

125,0% 214-224
Manufacturers
100,0% 26,9%
30,9% 30,2% 29,6% 29,9% 28,9%
75,0%
50,0% 2680-2700 PBF
69,1% 69,8% 70,4% 70,1% 71,1% 73,1%
25,0%
0,0% Pharmacies
Drugstore
Q1 08 Q1 09 Q1 10 Q1 11 Q1 12 Q1 13 20.500 –
N.A.
21.000 (in 2013)
LOCAL MNC

Market share of domestic companies continue to dominate the market (± 70%)

Fragmented market
10 Comps  40 %
market share
20 Comps  60 %
Winning The New Business
marketLandscape
share
 Posisi 2011 PREDIKSI The Economist:
Posisi
Indonesia
sekarang The Economist published its annual series
called The World in 2011.
dimana? the Economist was bullish on Indonesia. It
predicted that, with 245 million people in
2011, Indonesia’s GDP will reach around
US$ 806 billion,
resulting in a GDP per capita of $ 3,280.

By this figure, Indonesia’s GDP is predicted to

exceed those of Turkey and the Netherlands,
making Indonesia the
16th largest economic
power in the world.
Indonesia is forecast to have 6% per year
GDP growth in 2011 and 2012.

Winning The New Business Landscape

 PDB
PDB Populatio per
No Negara
$bn n million kapita
$
Posisi 2008 PDB
1 USA 14.093 308,8 45.638
Negara 1-20, PDB per 2 Japan 4.911 127,9 38.397
Kapita dan Populasi 3 China 4.327 1.336,20 3.238
4 Germany 3.649 82,5 44.230
$
5 France $bn 2.857 61,9 46.155 78.47
2050
26.679
6 United Kingdom 2.674 61 43.836 8$
7 Italy $bn 15 2.303 58,9 39.100 44.500
2045 8 Rusia -17.5 –
1.679 141,8 11.841 49.000
$
9 Spain $bn 1.604 44,6 35.964
2030 6.460 1.575
20.60
10 Brazil 194,2 8.110 0$
11 Canada $bn 4 – 1.501 33,2 45.211 14.250
2025 12 India 4.5 –
1.159 1.186,20 977 15.500
2014 13 Mexico $bn 1.088 107,8 10.093 $
14 Australia 1.206 1.015 21 48.333 4.803
2011 15 South Korea $bn 806 929 48,4 19.194 $
16 Netherlands 871 16,5 52.788 3.280
17 Turkey 735 75,8 9.697
18 Poland 528 38 13.895
19 Indonesia 511 234,3 2.181
Winning TheThe
New Business Landscape
Economist 2011 20 Belgium 504 10,5 48.000
 The Purpose of SJSN
Semua Penduduk RI mendapat pelayanan kesehatan yang memadai ketika Sakit,
kapanpun dan dimanapun di tanah air
Semua penduduk lansia/penderita cacat total tetap mempunyai uang pensiun
bulanan sampai ia meninggal dunia
Semua anak, yg orang tua-nya meninggal/cacat total tetap sebelum usia
pensiun, mempunyai uang pensiun bulanan sampai ia bisa mandiri secara
ekonomi Health
Insuranc
e (JKN)

Work
Life
Types of Accident
Insuranc
Social Insuranc
e (JK)
Security e (JKK)
Programs

Public Old Age

Pension Pension
(JP) (JHT)

JKN= Jaminan Kesehatan Nasional JP= Jaminan Pensiun

JKK= Jaminan Kecelakaan Kerja JK= Jaminan Kematian
Winning The New Business Landscape
JHT= Jaminan Hari Tua
 Who has the right to get SJSN?
All Citizens of Indonesia (UUD 45 ps. 28 & 34)
Existing Healthcare Insurance Coverage

54 % of Indonesia population without

health insurance coverage

TOTAL POPULATION = 234.18 MIO

46 %
54 %

Scenario : Jan 2014 : start and done 2019

Winning The New Business Landscape
 Konsep BPJS dengan pembayar Tunggal
Melayani
Penduduk
RI
Iuran Wajib % gaji
RSUD, dan Nominal
Dr Spesialis,
RS Pusat Rujukan
Obat-MD
Pemerintah
RUJUKAN

BPJS APBN/APBD
Kes Subsidi
Iuran

DPU, DK, Klinik,

Puskesmas

Obat-MD
Winning The New Business Landscape

Layanan kesehatan
Fasilitas kesehatan baik
pemerintah maupun sebagian
besar swasta akan ikut dalam
program JKN
COB & OPE menjadi pilihan pada
private sector untuk menjaga
sustainabilitynya
Challenge di profitability outlet
Primary care akan makin
berkembang terkait perbaikan JKN
Winning The New Business Landscape
Pasien
Private insurance
Pasien lower segment dan
chronic disease menikmati Diduga Peran asuransi swasta
layanan JKN akan makin meningkat jika ada
Saat ini upper level masih implementasi yg jelas dari JKN
berobat seperti semula (OPE) untuk layanan COB & TopUp
market
Profesi kesehatan
Pengaruh JKN-BPJS
Pada layanan kesehatan yang
terhadap Industri
menerima JKN, terjadi load
kesehatan pelayanan pasien yang tinggi,
Indonesia namun terjadi
penurunan/peningkatan income
Pilihan obat possibility ke low
cost product
Industri Farmasi
Market obat2 untuk common diseases akan
terjadi commoditization
Market share obat2 generik akan terus
meningkat (2014 :13.8%  2020 :20%)
Pengembangan produk dengan added value
menjadi pilihan ke depan (Orphan drugs, Biology,
DDS, Vaccine )
 Impact SJSN
• PESERTA SJSN (penduduk RI)
– Pengobatan Gratis
– Ada iuran bulanan
– Sistem pelayanan Kesehatan diatur (sistem rujukan)

• PROVIDER SJSN (Industri dan Distributor Framasi

– Volume penjualan bertambah banyak
– Harga”dikontrol”
– Margin mengecil

Winning The New Business Landscape

 New Business Landscape
Non JKN/BPJS JKN/BPJS

•High Margin-high Price •Low Margin-Low Price

•Low Volume •High Volume
•Innovative Product •Generic Product
•Special/High tech •Mass Production
•Out-pocket •Goverment Insurance
•Negotiating •Bidding/ e Catalog

200
10 – 20% Pharm Co. 80 – 90%

Winning The New Business Landscape

 Shifting Strategy
to Efficient Generic Drug Comppany
• Product Port folio
• Marketing strategy
• Production strategy

Winning The New Business Landscape

 Provide Good
Quality
Raw Material Process Efficiency Product,
Cost & Affordable in
Availability Infra-Structure acceptable
Optimizing price

Production Process of Pharmaceuticals

Strategic Initiative
• Improve Sourcing of Raw Material
• Infra structure Optimizing

• Process Efficiency
– Shortende lead tie
– Reduce Inventory cost

Winning The New Business Landscape

 “Sourcing” Bahan Baku Obat Indonesia Material
Cost &Availability
Nilai (Rp.Triliun)

2011 : Rp. 9,59 T

2012 : Rp.11,40 T
2013: Rp.13,00 T
4-5% Bahan Baku obat
yang di produksi
Indonesia kebanyakan
Bahan pembantu seperti
Sorbitol, ethyl alkohol,
Fructose. Sedang API
sangat sedikit, seperti China; Eropa;
India; 30%
Kina, Iodium, sedikit 60% 10%
Paracetamol dsb

Winning The New Business Landscape

 Indonesia

Winning The New Business Landscape

 Strict Quality
Lowest Price Standard
Win all from BPOM/MOH

E-catalog BPJS product supply

Bidding

Reducing COST &

Maintaining High Quality
Products
Challenges – HOW ?

Winning The New Business Landscape

 Cost Reduction
1.Incr.Volume
2.Incr. Price
3.New Prod.Mix Sales

Profit Margin

Marketing
And sales
Total Cost cost
Rp
Variable Operational
Cost RM-PM Excellent in
SCM
2.Direct Labor Reduce :
Fixed 3.Direct Energy
•COGS
Cost •Inventory Cost
0 People •Transportation Cost
Unit
Asset (deppr)

Winning The New Business Landscape

 Mengoptimalkan Biaya tanpa
mengorbankan Kualitas

• Optimasi COGS
– Raw material Cost
– FOH Cost
• Optimasi Inventory Cost
– NOC (nett Operatring Capital)
– DOI + DOAR – DOAP

Winning The New Business Landscape

 OPTIMASI BIAYA BAHAN BAKU

Quality of Product start with quality of Raw material- API

Critical Aspects of API – Raw Material :

ISSUE IMPACT

QUALITY • Sub-Potency EFFICACY

• Super-Potency SAFETY
• Impurities
• Contamination

COST High- Price Affordability

SUPPLY Limited Source/supply Availability

Winning The New Business Landscape

 OPTIMASI BIAYA BAHAN BAKU
– Negotiation Strategy base onRisk
Value Analysis
Strategic SLA & VMI
(High Risk,
High Value) Vertical Integration

“Squeezing”
Leverage Aggregation of orders
(Low Risk,
‘VMI’
High Value)
Analysis of High Risk High Risk
Supply
Markets
Low Value High Value

Holding emergency
Bottleneck stock
Long-term
(High Risk, contract
Low Risk Low Risk Modifying demand
Low Value) requirement
Low Value High Value

Routine Centralized
(Low Risk,
PARETO Analysis Long-term
of Materials Low Value)
contract
(based on value)

Winning The New Business Landscape

 OPTIMASI BIAYA FOH
Lean Factory Approach

Cost Effectiveness
Optimize Lead time
• Kaizen + Lean Manufacturing
– Eliminate Inefficiencies
• Better utilized Input
• Reducing Cost,
• Improving cycle time / Lead time

Winning The New Business Landscape

 Productivity measurement OPTIMASI BIAYA FOH

OEE : Overall Equipment Effectiveness

Ok, cukup jelas!
Apa saja komponen
OEE ?

Winning The New Business Landscape

 Perhitungan OEE

Winning The New Business Landscape

 OEE dapat dijaga dengan
• Desain Pabrik yg optimum
– System batch atau dedicated
• Pemilihan dan investasi mesin yang tepat

Winning The New Business Landscape

 Production Process

Mixing Drying Final Mixing

Packing Stripping Film/Sugar Coating Tableting

Winning The New Business Landscape

 Logistic
Computerized System, assure weighing process
free from mistakes, such as wrong material
weighted or wrong quantity of material weighted.

Winning The New Business Landscape

 OPTIMIZING INVENTORY

Net Operating Capital

(DOI) + (DOAR) - (DOAP)

The best way to Reduce NOC is reducing Days of Inventory.

Reducing DOAR will impact on competition
Increasing DOAP will impact on Company image

Winning The New Business Landscape

OPTIMASI NOC

Winning The New Business Landscape

OPTIMASI NOC
Managing Inventory
RM-PM WIP finished Good

SLA Lean Improve

VMI Manuf Forecast &
Improved More frequent
lead time delivery

Synchronized Planning – VMI

Winning The New Business Landscape

 Penutup
• Penerapan SJSN/BPJS1 akan meningkatkan secara
signifikan volume penjualan Obat (in unit) dengan
harga yang Murah
• Memaksa Industri farmasi untuk bekerja efisien
agar bisa bersaiang dalam lelang e-Catalog
• Harga murah tidak boleh dengan penurunan
Mutu sehingga perlu penghematan pada cost yg
tidak bersinggungan dengan mutu: (Inv Cost,
Transport Cost, dll)
• Diharapkan Keluhan masyarakat tentang harga
obat terasa mahal akan berkurang.
Winning The New Business Landscape
 THANK YOU

Winning The New Business Landscape

 Profile
Drs Pre Agusta Siswantoro, Apt , MBA (31st July 1962)
Education Background
Pharmacy Graduated, Gadjah Mada University, 1985
WM 16 (1986), MBA Graduated in IPPM Jakarta, 1992
WORKING EXPERIENCES

1. R&D - Production manager , PT PRAFA, 1987 - 1992

2. Production Manager- Assisten Director R&D, PT KALBE FARMA, 1992-2000
3. Plant /Manufacturing Director PT BINTANG TOEDJOE, 2000- 2008
4. Corporate R&D Director KALBE FARMA 2006 -2008
5. Director of PT Global Chemindo Megatrading (GCM)- Raw Material Trading, 2011- 2014
6. Director Logistic PT Enseval PM Tbk . 2013 -2015
7. Supply Chain Director KALBE Group 2008 – 2015
8. Manufacturing Director Kalbe (pharma division) 2016

OTHERS

1. Jury of “ Indonesia’s Innovation” organized by BIC and KNRT, 2008 – present

2. Wakil Ketua, Pengurus Pusat, IKATAN APOTEKER INDONESIA, 2009 -2013
3. Ketua Hisfardis (Himpunan Seminat Farmasi Distribusi)2009-2013
3.Pengurus Pusat Gabungan Perusahaan Farmasi Indonesia –GPFI ,2011- present

Excellence The
Winning Execution
New Business Landscape
 Prediksi dampak JKN/PKJS terhadap Industri Farmasi

• Innovative products,
Non JKN/ BPJS biosimilar, biology
products, etc
• Special Product for Private
Insurance
Kondisi • M&A

sebelum JKN

Maintaining % Profitability
JKN/BPJS

•OGB
•Common Dissease
•Brandedd Generic
(Increased in Volume)

2015 2019 Current condition

Strategy Scenario
Winning The New Business Landscape