Foreword

In line with the agreement between the member countries of the Association South East Asia Nation (ASEAN),  harmonization of Asean pharmaceutical market will start in  2008. There are two substances  of the agreement. First, all Asean products of pharmaceutical are required to have the same standards as Asean Common Technical Dossier (ACTD) for administration data and  information products,  quality  and efficacy of  medicines. Second, all Asean products of pharmaceutical having the quality standard  are free to enter  the southeast Asian regional market.

The Asean market harmonization is widely seen as both a threat and an opportunity.  It is a threat to pharmaceutical companies producing low quality products (not up to the standard), but it is a big oppotunity for producers , which have fully met the standard, to expand sales and make bigger  profit.

Therefore, all Indonesian phamaceutical producers not yet meeting the standard , have to improve their quality  if they want to gain from the regional agreement.  All pharmacetical products of Asean are required to have the same  Ba-Be (Bioavailability  and  Bioequivalence) standard . That means that all products must show that they have passed a Ba-Be test.

The  Ba-Be test  could only be made at a Ba-Be Laboratory , which has met the criteria of the best tests nationally and internationally.  A Ba-Be laboratory must perform  Good Laboratory Practice (GLP)  and  Good Clinical Practice (GCP). A Ba-Be laboratory must have an accreditation from  the National Committee  of Accreditation (KAN)  and is in line with ISO/IEC 17025-2005.

For large pharmaceutical companies which make up  60% of 122 pharmaceutical companies in the country  it might be a small matter to meet the standard, but for small companies it would be a big problem that could signal their death.

Analysts said there are two big opportunities coming with the Asean Market Harmonization scheme  -- first, market expansion and second , new business in offering Ba-Be laboratory service.

An estimate puts the cost of starting business in Ba-Be laboratory at  around Rp6 billion-Rp7 billion to build and operate the laboratory. The costs of testing a pharmaceutical product range from Rp100 million to Rp800 million. It would not be easy for small pharmaceutical producers to spend that much money only for testing. Small companies  may cope with the problem through contract manufacturing in cooperation with large producers having a Ba-Be laboratory .

So far, Indonesia has only 9  Ba-Be  laboratories for 10,000-15,000 items of pharmaceuticals needing  Ba-Be tests. It is most likely   pharmaceutical companies from advanced countries like the United States and Europe  will want to do the testing in this region  as the costs of Ba-Be tests in their countries are much more expensive.

The new business is quite promising . With the lowest testing cost of Rp100 million per item the Ba-Be testing market could reach more than Rp1 trillion a year. The market value could be much larger if operation is expanded to other countries in Asean.

PT Media Data Riset has carried out a study of various aspects  related to the Ba-Be laboratory business  and government policy related to the implementation of Asean Market Harmonization scheme.  The results of the study are compiled in a 350-page report that should be useful for the decision makers in pharmaceutical industry  and other related industries in Indonesia.

For detail of the report, please find enclosed the Report Outline and its ORDER FORM or please contact us anytime PT Media Data Riset through telephone number 021-8093140, mobile phone: 085217061945 or through e-mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it / This e-mail address is being protected from spam bots, you need JavaScript enabled to view it for other enquiries.

Table of Content

TABLE OF CONTENT

I. INTRODUCTION
1.1. Backgrounds
1.2. Scope of study
1.3. Sources of data and information

II. INDONESIAN POPULATION AND  HEALTH  CONDITION
2.1.  Population
2.1.1. Population
2.1.2. Population growth
2.1.3. Age groups
2.1.4. Sex ratio, households and average number of  household members 
2.2.  Indonesian health condition  2007

III. DEVELOPMENT OF PHARMACEUTICAL INDUSTRY
3.1. General description of domestic pharmaceutical industry
3.2. Types of  medical management
3.3. Locations of pharmaceutical factories
3.4. Pharmaceutical whole sales companies 
3.5. Pharmaceutical market potential

IV. MEDICINES  AND  PROBLEMS
4.1. Pharmaceutical basic matrials
4.2. Types of pharmaceutical products
4.3. Classification of pharmaceutical products
4.4. Patent medicines   
4.5. Generic medicines
4.2. Conditions of medical contribution

V. ASEAN HARMONIZATION
5.1. Harmonization of Asean Pharmaceutical 2008
5.2. Readiness of Indonesian Pharmaceutical industry
5.2.1. Opportunity for large pharmaceutical companies
5.2.2. Threat to small pharmaceutical companies
5.2.3. Harmonization of Asean cosmetic industry
5.2.4. Harmonization of Asean herbal medicine industry
5.2.5. Impact on oleochemical industry
5.3. Asean free pharmaceutical market strategy
5.4. Asean tariff harmonization
5.5. Asean harmonization and regulation on Ba-Be Tests
5.6. Asean Single Window

VI. TECHNICAL ASPECT OF BA-BE LABORATOR
6.1. Interpretation
6.2. Ba-Be test techniques
6.2.1. Criteria for Ba-Be tests
6.2.2. Designs and study of bioequivalence
6.3. Ba-Be tests to guarantee quality of medicines
6.4. Clinical tests valid in Indonesia

VII. BA-BE LABORATOR AS FUTURE’S BUSINESS
7.1. Opportunity in Ba-Be laboratory business
7.1.1. Number of pharmaceutical products circulating 
7.1.2. Number of  Ba-Be test laboratories
7.1.3. Ba-Be testing capacity
7.2. Market Size of Ba-Be Laboratories
7.3. Main players in Ba-Be laboratory business in Indonesia
7.4. Cost of building Ba-Be laboratory
7.5. Market prospects of Ba-Be laboratories

VIII. NEW MEDICINES CIRCULATING IN 2002 - 2006
8.1. 26  new pharmaceutical products in  2002
8.2. 20  new pharmaceutical products in 2003
8.3. 24  new pharmaceutical products in 2004
8.4. 17 new  pharmaceutical products  in 2005
8.5. One new pharmaceutical product  in  2006

IX. DISTRIBUTION OF PHARMACEUTICALS
9.1. Mechanism of  distribution
9.2. Distribution of pharmaceutical preparations
9.3. Challenge in pharmaceutical distribution
9.4. Marketing and distirbution strategy
9.5. Procedure of receiving and distributing pharmaceutical donation  in Indonesia

X. POLICY RELATED TO PHARMACEUTICAL SECTOR

XI. CONCLUSION AND PROSPECTS
11.1. Conclusion
11.2. Prospects

DIRECTORY OF PHARMACEUTICAL PRODUCERS