PHARMACEUTICAL INDUSTRY

Credit to Bapak Victor S. Ringoringo

(Head of R&D/RA PT. Graha Farma)
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CLASSIFICATION OF DRUGS

ORIGINATOR
PATENT

UNBRANDED
GENERIC BRANDED
GENERIC

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TYPE OF DRUGS

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SECTORS IN PHARMACEUTICAL INDUSTRY

PHARMACY HOSPITAL DRUGSTORE TOTAL

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10 PERUSAHAAN FARMASI
TERBESAR DI DUNIA

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PHARMACEUTICAL INDUSTRIES IN INDONESIA

DOMESTIC MNCs BUMN

180 33 4

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 PETA SEBARAN INDUSTRI DI INDONESIA

KALIMANTAN SULAWESI
3,75% 7,17%
MALUKU & PAPUA

0,96%

SUMATERA
12,54%

JAWA
67%
BALI, NTB, NTT
8,63%
INDUSTRI FARMASI 95%
DI JAWA
KARAKTERISTIK INDUSTRI FARMASI DI INDONESIA

FORMULATION
BASED

HIGHLY
REGULATED
HIGHLY
FRAGMENTED PHARMACEUTICAL
INDUSTRY

IMPORT

HIGH API EXCIPIENTS

TECHNOLOGY

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INDONESIA

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TOP 10 COMPANIES IN PHARMACY SECTOR - 2017

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TOP 10 COMPANIES IN HOSPITAL SECTOR - 2017

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TOP 10 COMPANIES IN DRUGSTORE SECTOR - 2017

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JALUR DISTRIBUSI OBAT DI INDONESIA
PHARMACEUTICAL
INDUSTRY
217

DISTRIBUTOR
PBF
2,810

PHARMACY
HOSPITAL PHARMACY
14,200

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 PRESIDENTIAL DECREE NO. 6 / 2016
ON
ACCELERATION OF PHARMACEUTICAL INDUSTRY DEVELOPMENT

 ACCELERATION OF PHARMACEUTICAL INDUSTRY DEVELOPMENT

 MONITORING AND EVALUATION ON LOCAL CONTENT OF
PHARMACEUTICAL INDUSTRY
 API INDUSTRY
 CHEMICALS AND INTERMEDIATE AVAILABILITY
 ROAD MAP 2025 OF PHARMACEUTICAL INDUSTRY
 DOMESTIC 450 T IDR
 EXPORT 250 T IDR
 RANK 10 BY 2025
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BUSINESS DEVELOPMENT

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HEALTH CARE BUSINESS

HEALTH CARE BUSINESS

COSMETICS
GF

SUPPLEMENT
PHARMA

HEALTH
HERBAL
60% 20% 10% 10%
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INDONESIA PHARMA TREND GLOBAL PHARMA TREND

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CURRENT ISSUES IN PHARMA INDUSTRY

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 1. JKN / BPJS KESEHATAN
NATIONAL HEALTH INSURANCE SCHEME
UNIVERSAL COVERAGE

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 NATIONAL HEALTH INSURANCE SCHEME
 MANDATORY
 MONTHLY PREMIUM
 CLASS 1, 2 AND 3
 CIVIL SERVANTS
 MILITARY
 PRIVATE COMPANIES
 PERSONAL
 POOR PEOPLE  FULLY SUBSIDIZED BY THE GOVERNMENT
 KARTU INDONESIA SEHAT / INDONESIA HEALTH CARD
 LESS PROFIT

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 STAKE HOLDERS

INDUSTRY

DISTRIBUTOR PATIENTS PHARMACIES

HOSPITALS

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2. E-CATALOG

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 E-CATALOG
SUPPLY TO GOVERNMENT FOR NATIONAL HEALTH INSURANCE HOLDERS

1. PRICE COMPETITION
2. DECREASING PRICE TREND
3. MARGINAL PROFIT
4. 2 YEARS PERIOD SUPPLY ARRANGEMENT / COMMITMENT
1. NON-PERFROMANCE
2. PENALTY
3. FREEZING FOR NEXT 2 YEARS TENDER PARTICIPATION

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 E-CATALOG
SUPPLY TO GOVERNMENT FOR NATIONAL HEALTH INSURANCE HOLDERS

5. FOREIGN CURRENCY EXPOSURE

6. NO PRICE ADJUSTMENT OPPORTUNITY
7. DELAYING PAYMENT PROBLEM
8. STOP SUPPLY

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3. JAMINAN PRODUK HALAL

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 PERATURAN PERUNDANGAN DI INDONESIA YANG MENGATUR
TENTANG PRODUK HALAL

1. UU NO. 18 TAHUN 2012 TENTANG PANGAN

2. UU NO. 33 TAHUN 2014 TENTANG JAMINAN

PRODUK HALAL

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 UNDANG-UNDANG REPUBLIK INDONESIA NOMOR 33 TAHUN 2014
TENTANG JAMINAN PRODUK HALAL
HALAL CERTIFICATION

1. VOLUNTARY RATHER THAN COMPULSORY

2. IMPORT
1. ACTIVE PHARMACEUTICAL INGREDIENTS (API)
2. EXCIPIENTS
3. 95% IMPORT
3. NEGATIVE IMPACT
1. SUPPLY
2. JKN / BPJS KESEHATAN
3. SELF MEDICATION
4. HEALTH SERVICES

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4. REGULATORY ISSUES

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REGULATORY ISSUES

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PRE-MARKETING ASSESSMENT

QUALITY

SAFETY EFFICACY

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POST-MARKETING ASSESSMENT

SAMPLING INSPECTION

PHARMACO
VIGILANCE

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CLINICAL TESTING AND COMPLIANCE

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 REGISTRATION PROCESS

1ST PRODUCTION
3 BATCHES

MANUFACTURER PRE- APPROVABLE NIE

REGISTRATION
APPROVAL REGISTRATION LETTER (Nomor Ijin Edar)

COMPLETED 60 DAYS 120 – 150 DAYS 30 DAYS

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CAREER IN PHARMACEUTICAL INDUSTRY

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Standar kompetensi 5:
Formulasi dan Produksi Sediaan Farmasi
UNIT KOMPETENSI KOMPETENSI INTI
5.1 Prinsip dan Prosedur Pembuatan Sediaan Mampu menjelaskan prinsip-prinsip dan prosedur
Farmasi pembuatan sediaan farmasi

5.2 Formulasi Sediaan Farmasi Mampu menetapkan formula yang tepat, sesuai standar
dan ketentuan perundang-undangan

5.3 Pembuatan Sediaan Farmasi Mampu membuat dan menjamin mutu sediaan farmasi
sesuai standar serta ketentuan perundang-undangan

5.4 Penjaminan Mutu Sediaan Farmasi Mampu menjamin mutu sediaan farmasi
sesuai standar dan ketentuan
perundang-undangan

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 CAREER IN PHARMACEUTICAL
INDUSTRY
1. PRODUCTION
2. QUALITY CONTROL
3. QUALITY ASSURANCE
4. R&D
5. PPIC
6. PROCUREMENT
7. REGULATORY AFFAIRS
8. SALES AND MARKETING
9. BUSINESS DEVELOPMENT
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 3 PERSONIL KUNCI DI INDUSTRI FARMASI

PRODUCTION QUALITY CONTROL QUALITY ASSURANCE

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CAREER IN PHARMACEUTICAL INDUSTRY

MARKETING BUSINESS DEVELOPMENT

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 CAREER DEVELOPMENT IN
MARKETING AND BUSINESS DEVELOPMENT
SALES MARKETING BUSINESS
MANAGEMENT MANAGEMENT DEVELOPMENT
BUSINESS DEVELOPMENT
SALES DIRECTOR MARKETING DIRECTOR
DIRECTOR

BUSINESS DEVELOPMENT
SALES MANAGER MARKETING MANAGER
MANAGER

BUSINESS DEVELOPMENT
SALES SUPERVISOR PRODUCT MANAGER
SUPERVISOR

BUSINESS DEVELOPMENT
SALES REPRESENTATIVE PRODUCT EXECUTIVE
EXECUTIVE

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Standar kompetensi 7:
Pengelolaan Sediaan Farmasi dan Alat Kesehatan
UNIT KOMPETENSI
7.1 Seleksi Bahan Baku, Sediaan Farmasi, Alat
Kesehatan
7.2 Pengadaan Bahan Baku, Sediaan Farmasi, Alat
Kesehatan
7.3 Penyimpanan dan Pendistribusian Bahan Baku,
Sediaan Farmasi, Alat Kesehatan
KOMPETENSI INTI
Mampu merancang dan melakukan seleksi kebutuhan
bahan baku, sediaan farmasi, alat kesehatan secara
efektif dan efisien.
Mampu merancang dan melakukan pengadaan bahan
baku, sediaan farmasi, alat kesehatan sesuai ketentuan
peraturan perundangan secara efektif dan efisien.
Mampu merancang dan melakukan penyimpanan serta
pendistribusian bahan baku, sediaan farmasi, alat
kesehatan sesuai ketentuan perundangan secara efektif
dan efisien
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Standar kompetensi 7:
Pengelolaan Sediaan Farmasi dan Alat Kesehatan

UNIT KOMPETENSI KOMPETENSI INTI

7.4 Pemusnahan Bahan Baku, Sediaan Farmasi, Alat
Kesehatan
7.5 Penarikan Bahan Baku, Sediaan Farmasi, Alat
Kesehatan
7.6 Pengelolaan infrastruktur
Mampu merancang dan melakukan pemusnahan bahan
baku, sediaan farmasi, alat kesehatan sesuai ketentuan
perundangan
Mampu menetapkan sistem dan melakukan penarikan
bahan baku, sediaan farmasi, alat kesehatan secara
efektif dan efisien.
Mampu mengelola infrastruktur sesuai kewenangan
bidang kerjanya secara efektif dan efisien, termasuk
pengelolaan SDM.

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 Standar kompetensi 7 ini tidak hanya untuk apoteker yang bekerja di
Industri Farmasi, JUGA berlaku di Sarana Distribusi Farmasi dan Sarana
Pelayanan Kefarmasian

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THANK YOU

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