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Indonesia has a market-based economy where a significant role is played by the government. There are a lot of state-owned enterprises. The government administers prices on several basic goods: fuel, rice, electricity. A

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

fter financial and economic crisis that began in mid-1997, the government took care of a great portion of private sector propriety. It acquired non-performing bank loans and corporate assets. Indonesia's economy grew f

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

om a per capita GDP of $70 to $1,000 by 1996. Inflation was held in the 5%-10% range with the help of effective monetary and fiscal policies. The government managed to avoid domestic financing of budget deficits, it was

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

financed by foreign aid. (Lindblad J. 1996)

In the mid-1980s,the government began eliminating obstacles to economic activity. Its policy was aimed at the external and financial sectors. The government tried to stimula

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

e employment and growth in different export sectors. Annual real GDP growth averaged nearly 7% from 1987-1997. As a result most analysts recognized Indonesia as a newly industrializing economy and emerging major market.

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

But nevertheless there were some structural weaknesses in Indonesia's economy during 1987-1997, the legal system was very weak, and there was no effective way to enforce contracts, collect debts. Non-tariff barriers, do

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

estic subsidies, barriers to domestic trade, and export restrictions all created economic distortions. (Howard D.,Vincent J.H., Lindblad J. 2002)

The regional financial problems influenced Indonesia in late 1997 and c

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ause economic and political crisis. But in October 1997, Indonesia and the IMF reached agreement. It concerned an economic reform program aimed at macroeconomic stabilization and elimination of some of the most damaging

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

economic policies.

The effects of financial and economic crisis were considerable. In 1998, real GDP was 13.7%, but in mid-1999 real GDP growth for the year was only 0.3%. Inflation reached 77% in 1998. Events of 1997-

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

998 forced Indonesia to import great amounts of rice. It reduced domestic demand and caused the absence of new investment. Formal sector employment lowed significantly. Economic data provide evidence that the economic t

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

rnaround of 1999 has continued. Real GDP growth reached 4.13% in August 2000. Results of GDP growth are record exports, manufacturing growth, and increase household consumption. Besides there has been a significant incr

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ase in corporate debt restructuring. But Indonesia's banking and corporate sectors are still extremely weak. Banking sector reform has stalled. Progress on corruption cases is slow. Since the late 1980s, there have been

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

significant changes that encouraged its economic growth. This growth was financed from private investment, both foreign and domestic.

But new foreign investment approvals fell by two-thirds between 1997-1999. The crisi

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

pointed out areas where additional reform was needed. They were legal and judicial system, competitive processes, and adoption of internationally acceptable accounting.

After improvements in the laws recently, Indones

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ia's intellectual property rights regime remains weak; lack of effective enforcement and the area of private infrastructure projects are of a great concern Indonesia. It has a large labor force, abundant natural resourc

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

s and modern infrastructure, but nevertheless private investment in projects ceased during the crisis. Conclusion.

So, what is happening in East Asia now? Strictly speaking, the same, that happened before it: the coun

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ries of Confucian culture play formation of new global center of economic and political power, and still the leading role. Certainly, the region cannot equally compete with 3 main centers of world economy and policy - t

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

e USA, ЕС, Japan. Most of the countries of the region still are poor, frequently inwardly unstable, and their development is based on the use of the adopted technologies. However great achievements of "tiger

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

" and their “students” show that the region not only has enormous potential but also knows how to use its potential. Certainly, Singapore with its north-american indexes of GDP per capita is still the exception, but the

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

rates of growth of this region are such, that it is clear: their output on the European level is the matter of time and, possibly, not too long.

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tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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