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ECONOMY. Indonesia is a market-based economy but the government plays a significant role in the country's economy with 160 government-owned enterprises. Indonesia’s GDP per capita ranks fifth after Singapore, Brunei, Malaysia and Thailand. The Asian economic crisis of 1997 adversely affected the country ec

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

onomy and businesses and caused spiralling prices of necessities resulting in social unrest. Future prospects of Indonesia's economy are bright with economic structural reforms in placed since the Asian economic crisis.

Indonesia’s GDP was US$258.3 billion with a GDP per capita of US$1,193 in 2004. Indone

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

Examples of combination products may in

ia's real GDP grew at an average of 4.6% annually from 2000 to 2004 driven by domestic consumption accounting for nearly three-quarters of Indonesia's GDP. Inflation rose from 3.8% in 2000 to 11.9% in 2002 but eventually declined to 6.1% by 2004. GDP per capita increased from US$801 in 2000 to US$1,193 in

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

004 but unemployment also increased from 6.1% to 9.9% during the period.

The manufacturing sector contributed towards 43.7% of Indonesia's GDP in 2004 while the service sector contributed 40.9%. Though nearly 45.0% of the country's workforce is involved in agriculture, this sector contributed only 15.4% o

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

the country's GDP during the period. Major industries include petroleum and natural gas, textiles, apparel, footwear, mining, cement, chemical fertilisers, plywood, rubber, food and tourism. Major agriculture products include rice, palm oil, rubber, cacao, peanuts, copra and cloves.

DEMOGRAPHY. Indonesia

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

Combination pro

comprises nearly 18,000 islands and has the largest population among the Southeast Asian countries with 217 million people in 2004. Main islands are Java accounting for 55% of the population followed by Sumatra (18%), Kalimatan (5%) and Sulawesi (6%). Other less populated islands include Irian Jaya, Bali a

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

d Nusa Tenggara.

Indonesia is a country of diverse ethnic and sub-ethnic communities with different languages and dialects, cultures and foods. The Javanese accounts for 45% of the population followed by Sundanese (14%) and Madurese (8%) and coastal Malays (8%). Chinese who migrated to Indonesia during th

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

e Dutch colonial period account for nearly 5% of the population. Islam is the predominant religion followed by Christianity and minority religions include Buddhism and Hinduism. The national language is Bahasa Indonesia (similar to Malay used in Malaysia, Singapore and Brunei). English is not widely used b

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

t many businesses and government officials dealing with foreign companies and foreigners are fluent in the language.

More than half of the population live in the rural areas but the proportion of the urban population is increasing from 36.0% in 1995 to 45.0% by 2004. Major cities include Jakarta with a po

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

ulation of 10 million followed by Surabaya, Bandung, Semarang, Yogyakarta, Surakarta, Medan and Padang. Nearly 25% of the population live below the poverty level while another 60% are from the lower income group. The remaining 10% belong to the middle income and 5% in the higher income group. Though Indon

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

sia has a relatively small proportion of middle to high-income consumers, this equates to nearly 33 million consumers. This is more than Singapore’s 4.3 million population with a GDP per capita on par with many advanced economies of the European Union.

INFRASTRUCTURE. Indonesia's domestic telecommunicatio

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

Following aspects would a

system is generally fair while its international services can be categorised as good. Internet broadband services are mainly concentrated in the major cities. Road systems are more developed on Indonesia's populated island of Java, fairly developed in Sumatra and Sulawesi but poorly developed on the islan

dd to the challenges in developing combination products:

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

of Kalimantan. Besides sea ports serving the international shipping lines, Indonesia are also served by smaller sea ports serving coastal shipping. All the cities and major towns are connected by airline services.

INTERNATIONAL TRADE. Indonesia's major trading partners include Japan, US, Singapore, South

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

Korea and China. Much of the imports from Singapore are Singapore’s re-exports from other countries and exports to Singapore are re-exported to other countries. Main exports from Indonesia include oil and gas, electrical appliances, plywood, textiles and rubber products. Main imports include machineries an

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

d equipments, transport equipments, chemicals, fuels and foods.

CONSUMER USAGE OF TECHNOLOGY. Mobile phone penetration is just 13% of the populations, which is lower than Singapore (93%), Malaysia (67%) and Thailand (45%). Furthermore, there are only 10 million fixed-line telephones serving the whole coun

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

ry. The penetration of computers is less than 2% of the households and the country has only 1.2 million internet subscribers with an estimated 12 million internet users i.e. a penetration of only 0.5% of the population. Most middle and high-income homes would own televisions but the penetration in lower in

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

Professional from academic institutions, pharmaceutical industries, health care indust

ome homes is lower. Thus the household penetration of television in Java is nearly 60% and in Sumatra 52%. Similar scenario exists for refrigerators.

RETAIL MARKET. Retail sales of food and non-food items totalled an estimated US$32 billion in 2004. Many Indonesians still shop at the traditional markets o

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

“mom and pop” establishments but shopping at modern shopping malls, hypermarkets, supermarkets, mini-markets and supermarkets is increasingly popular. There are nearly 5,000 such modern establishments in Indonesia accounting US$4.5 billion in retail sales in 2004. Most of these establishments are concentr

.

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

ted on the island of Java followed by Sumatra. Since 1998, the government opened the retail industry to foreign investments and participation.

FOOD CULTURE. Indonesia's food culture is diverse because of the various ethnic and sub-ethnic communities that comprise the country's population. Typical meals ea

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

Companies that provide selfless information through particip

en are rice-based dishes and occasionally noodles. However, there are many western franchise fast food outlets located mainly in the major cities such as Jakarta, Surabaya, Bandung, Semarang and Yogyakarta. Mid to high-end bakery outlets serving western and local bakeries are also found in the major cities

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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