COMPARATIVE POSITION OF INDONESIAN PHARMA INDUSTRY WITH INDIA AND GUJARAT INDEX

No Particulars (A)Overview of the Pharmaceutical industry in Indonesia Regulatory Framework Indonesia Major Players in the Pharmaceuticals Industry in indonesia The Indonesian Pharmaceuticals Market Growth of the Pharmaceuticals industry in indonesia Revenue of Pharmaceutical companies in Indonesia ,as of 2011 Potentials for enhanced cooperation Opportunities and Challenges (B)Overview of the Pharmaceutical industry in India Regulatory Framework India Major Players in the Pharmaceuticals Industry in India The Indian Pharmaceuticals Market Growth of the Pharmaceuticals industry Revenue of Pharmaceutical companies in India ,as of 2011 Opportunities and Challenges (C)Overview of the Pharmaceutical industry in Gujarat Major Players in the Pharmaceuticals Industry in India The Gujarat Pharmaceuticals Market Growth of the Pharmaceuticals industry Revenue of Pharmaceutical companies in gujarat ,as of 2011 Opportunities and Challenges The Gujarat Scenario (D)Relations with European Pharmaceuticals Market Regulatory Framework India Top 15 Pharmaceuticals companies in EU by 2011sales were International Human Development indicator Topic covered by Nirav Gamit

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Overview of the Pharmaceutical industry in Indonesia.

Indonesias pharmaceutical indusery has been growing steadily with double digit compound growth since 2010 and projections of 15% growth for 2012 according to the Indonesian Pharmaceutical Association. The high growth figures are a reflection of the rising disposable incomes of the population, but placed into context the value of the market itself is very small for a country of 240 million people. The lack of healthcare coverage, low quality of services on offer and the high cost of drugs relative to average wages has given rise to trends such as self medication and going abroad for treatment for those who can afford it. Considering the size of the market and changes in lifestyle, the sector is poised for considerable growth but manufacturers face a challenge in lack of local raw material supply, increased competition in the generic drugs market, regulatory barriers holding back international investment and a lack of innovation that has marred the sector. Indonesia is a highly attractive market for the pharmaceutical industry given its large population as the fourth most populous country in the world, but spending on healthcare is very low in comparison to neighbouring countries of similar GDP. Indonesians spend on average $17 USD per capita on pharmaceuticals; 25% below that of the Philippines while total spending on healthcare is $52 USD a year, compared to $300 in Malaysia, according to the World Economic Forum (2011). In terms of consumer preferences, sales for over the counter drugs are growing faster than that of prescription drugs with growth at 17.3% and 9.9% respectively for 2011, but the latter has the dominant market share at $2.4 billion USD or 54.5% of total consumption for 2011 (Statistics Indonesia). Vitamin and nutritional supplements are also growing in popularity among more health conscious consumers. Total sales reached $4.4 billion USD at the end of 2011 (out of $700 billion globally), an increase of 11% from 2010. Yet more dramatic growth is expected with the increased awareness of the need for healthcare and eventual introduction of the National Social Security System that is scheduled to be implemented in 2015 under Law 40/2010. The sector is highly competitive and heavily fragmented among more than 200 companies, 35 of which are foreign owned including the worlds largest producers such as Pfizer and GSK. The local producers are dominant in the market, making up 79% of total market share. Of the top ten companies, 7 of them are local companies with Kalbe Pharma leading the pack at 14% of the market. The top three global drug producers namely Pfizer, Bayer and GSK collectively hold only 8% of the market. The sector is heavily concentrated among the top companies with around 20 companies accountable for 80% of total production and locally produced drugs making up 75% of total consumption. State Owned Enterprises play a key role in generics and vaccine production through Kimia Pharma, Indofarma and Bio Farma and the prospect of a merger in the future has been discussed to increase competitiveness in distribution and expertise.

The Indonesian Pharmaceutical Association states that 95% of locally produced drugs are being consumed domestically, with the remaining 5% exported. Yet, exports of Indonesias pharmaceutical products have been growing over the past Five years by an average of 15% from 2005-2010. State owned Bio Farma produces the worlds cheapest polio vaccine and has recently seen a surge in exports, mainly to India where animal based vaccines cannot be produced due to religious reasons .Overall, Indonesias main pharmaceutical export destinations are India, Japan and Thailand for generic drugs. Future export potential lies in the ASEAN market under the AFTA in which Indonesia can compete effectively if given the correct regulatory measures to encourage investment and expand production. The outlook for the pharmaceutical sector is positive in terms of steady (albeit unremarkable) sales growth to 2014-15. The young demographics of the country, increasing life expectancy with improved living standards and rising incomes are all positive conditions for growth. The real impact on the industry will come with the eventual introduction of a national social security system that will grant coverage to an estimated 50% of the population that is currently uninsured. However, boosting the competitiveness of the pharmaceutical manufacturing sector is a necessity to keep drug prices down and within reach of the general population to avoid local producers losing out to imports from India and China.

Regulatory Framework Indonesia

Registration of Pharmaceuticals in Indonesia There are improvements in 2010 compared to last year. There are still bottlenecks of registration load because the process is still manual. Previously, the documents can be provided in form of soft copy, but now the documents must be provided in hard copy. Registration is the most important step. Registration process takes a very long time in Indonesia, sometimes up to 12 months, and it is impairing the industry. Many investors want to see this changed. Although there are products from 2009 whose registration numbers have been issued this year, BPOM is requested to speed up the process. Another concern is that in 2011 the government is likely to complicate import procedures. However, starting this year there is a lot of improvement in the registration process, for example as by now the registration can be done electronically. Also there is no quota in documents anymore, and the evaluation process is now faster than before, however, the bottleneck is still in the issuance of certificate. It is not the queuing to go to the higher level, but the queuing to get the certificates issued, because the company has to be checked again one by one.

 Standards and Technical Regulations Standardization benchmark is the Good Manufacturing Practice (GMP), introduced in 1971. The National Quality Control Laboratory (QC Lab) and the provincial QC Lab weredeveloped with the assistance of WHO. The government controls quality by sampling. At the central level, the regulatory authority for pharmaceuticals is the BPOM (Drug and Food Control Agency). BPOM performs drugs registration, provides licenses for drugs imports and exports, controls drug promotion, monitors and supervises for implementation of GMP, assures the quality of drugs and monitors distribution. GMP includes following assessments: (1) General; (2) Quality Management System; (3) System of Building, Supporting Infrastructure and Equipment; (4) Ingredient Management System; (5) Production System; (6) Packaging and Labeling; and (7) Quality Control System. A mapping has been performed by BPOM in 2004 to assess the implementation of GMP in anticipating the ASEAN pharmaceutical harmonization. The mapping grouped the industry into four categories of producers (A, B, C, and D). Category A (29%) manufacturers are eligible to produce in their own facilities; B (29%) to produce in their own facilities if internal improvements are implemented; Category C (26%) are allowed to produce only partly in own facilities and the rest through outside facilities; and D (16%) have to produce through outside facilities (toll manufacturing).

Distribution Pharmaceutical producers are allowed to manage their own distribution, but they usually outsource sometimes through subsidiaries - activities for the sake of efficiency. The distributors are called "PBF" (pharmaceutical wholesale companies). In terms of distribution, around 50% of the pharmaceuticals are distributed through pharmacies, 30% through drug stores, and the remaining 20% are distributed directly by physicians and hospitals. Drug stores sell pharmaceuticals at relatively cheaper prices, often 10% to 20%, and generally serve as pharmacies in small towns and rural areas. In addition to OTC drugs, ethical medicines often also available at the drug stores. The Ministry of Health released regulation Nr. 1010/2008 that does not allow foreign pharmaceutical companies from selling drugs in Indonesia unless they have local production facilities.

 Major Players in the Pharmaceuticals Industry 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Pfize GlaxoSmithKlin Novarti Sanofi-Aventis AstraZenec Teva Pharmaceutical Industries Johnson & Johnson Merck & Co. Abbot Eli Lilly and Company Boehringer Ingelheim Amgen Inc Bristol-Myers Squibb Co Amgen Inc Bayer

 The Indonesian Pharmaceuticals Market

The market size of pharmaceutical products in Indonesia is estimated to be around IDR 37.5 trillion (US$ 3.9 billion, 2011), with an impressive average annual growth in the last five years of 10%. The market consists of 170 local companies including four state owned companies and 32 foreign companies. The foreign companies have a 40% market share. Out of the estimated 32 multinational pharmaceuticals companies operating in Indonesia, there are an estimated 20 European companies with an active presence. The Indonesian pharmaceutical industry consists of chemical-pharmaceutical and nonchemical traditional (herbal) medicine manufacturers. There are around 232 chemical and pharmaceutical companies. Local companies account for around 90% of sales, mostly these are "formulators" of medicines that import basic (active) materials/ingredients, also explaining the increased demand for pharmaceutical basis materials (90% growth in imports since 2009 to US$ 338 billion in 2010)

Most of the manufacturers have facilities to produce four types of medicines: tablet, syrup, cream and caplets and some can also produce medicines in the form of drop, powder and granule. Many local companies produce medicines under special production license from overseas manufacturers, particularly for ethical products

Indonesian Pharmaceutical Market 2006 2011 (Five year)

2006 Total Market (IDR Bn) Growth (%) Ethical (IDR Bn) Ethical Growth (%) OTC (IDR Bn) OTC Growth (%) 23,589 13.6 14,622 15.5 8,967 10.8 2007 23,047 9.4 14,033 - 4.0 9,014 5.4 2008 2009 2010 2011 37,531 10.5 21,142 10.0

25,708 29,981 33,969 11.5 16.6 13.3

14,837 16,969 19,225 5.7 14.4 13.3

10,871 13,012 15.0 19.6

14,744 16,389 13.3 11.2

 Over the Counter (OTC) Indonesian OTC market has a double-digit growth rate according to some estimates. This can also be linked to a long history of self-medication in the country. Another factor that will help the OTC market grow is the fast-growing pharmacy sector. The success of pharmacy companies such as Apotek K-24 with franchising has forced the state-owned company, Kimia Farma, to follow suit. This is likely to increase sales of OTC products throughout Indonesia, making it an attractive market. Generics Indonesia is a major generic market with the generics market estimated to make up 75% of the total pharmaceutical market in Indonesia. But, despite the country possessing huge manufacturing capabilities, the lack of R&D in domestic companies could cause the market to stagnate, especially if IPR regulations are not tightened For generics Indonesia cannot yet compete with India or China. Those two countries have suffient raw materials for manufacturing available on the local market. For Indonesian producers to produce they have to import and the main challenge is the high import duties for the raw material, which makes production in Indonesia relatively uncompetitive. The competitiveness of Indonesian generics pharmaceuticals manufacturing is also limited by the weak infrastructure in the country and expensive financing, making products more expensive. Additional issues hampering the development of the pharmaceuticals sector in Indonesia is the lack of skilled labor. Furthermore there is a perception that Indonesian products do not have the sufficient level of quality and the country is not yet export driven enough. The support from the Government to exporting companies in the pharmaceutical sector is still very weak. The future growth of the generics industry in Indonesia is uncertain, and is dependent on a number of factors. The first of these is the value of the Rupiah against the US Dollar as the market is heavily reliant on imported raw materials. Another factor is government price cuts of branded generics, which are intended to give poor citizens access to branded drugs. However, the cuts could also be viewed as biased towards the government, which owns most of the non-branded drugs (worldpharmaoutlook.com). Raw Materials Indonesia still imports over 90% of the pharmaceutical raw materials it needs, showing that its dependence on overseas industries is very high - with about 70% of the imported raw materials coming from China.

 LAST 6 YEAR GROWTH (%) IN PHARMACEUTICAL INDUSTRY

YEAR 2006 2007 2008 2009 2010 2011

GRWTH(%) 13.6 9.4 11.5 16.6 13.3 10

List of Top 15 Pharmaceutical Companiesin Indonesia

Revenue of Pharmaceutical companies in Indonesia, as of 2011 Revenu 2011 No Company (Billion USD) 66.8 1 2 3 4 5 6 7 8 9 10 11 12 Bristol-Myers Squibb Co 13 15.1 14 15 Amgen Inc 46.1 Bayer 19.5 Pfize 45.7 GlaxoSmithKlin 50.6 Novarti 41.2 Sanofi-Aventis 33.3 AstraZenec 15.5 Teva Pharmaceutical Industries 61.6 Johnson & Johnson 44.0 Merck & Co. 35.2 Abbot 23.1 Eli Lilly and Company 17.7 Boehringer Ingelheim Takeda Pharmaceutical Co Ltd 15.8

 Potentials for enhanced cooperation A survey with EU Member States mentioned the following advantages of Indonesia for investors: The largest and considered the most stable democracy in Southeast Asia; on of the largest economies in a dynamic ASEAN and Asian region; Consumer market growing strongly (especially middle income market segments); ASEAN potential internal market production networks and FTAs; Availability of natural resources; Large labour force, especially young people. All these points should be taken into consideration when discussing Indonesias potential with regards to the pharmaceutical industry.

General Opportunities
How can we enlarge trade and investment opportunities in these sectors benefiting both - Indonesia as well as the EU? Based on statistics on average spending on drugs, Indonesia has a very low level of spending on drugs. This is an opportunity for EU business. EU pharmaceutical exports to Indonesia are increasing in the past 5 years and can be improved, by solving technical issues, and EU can have benefits of this. Indonesias level of export statistics to EU is low, how can we increase Indonesia export to EU? This will be benefiting for Indonesia as well for EU. Out of 40 thousand of types of jamu (herbal medicines), 30 thousand types are found in Indonesia. It is an area of interest to EU, and also will be benefiting to Indonesia. Indonesia has very big opportunities to export pharmaceuticals to the EU, but a mobilization from both business and Government is required

Opportunities
Despite the immense size of the Indonesian market, low labour costs and the potential of the ASEAN as a whole for pharmaceutical sales; investors are still weary of the country. Recent changes in regulations have been viewed as protectionist and largely in favour of existing local companies which already dominate the market. The sector is in need of a major boost in order to best serve the population, particularly the poorest stratum that is being priced out of the market due to the myriad of taxes and duties that keep Indonesias pharmaceutical prices among the highest in Asia, while being the least innovative.
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One of the major weaknesses in the sector is the lack of locally available raw materials that leaves producers at the mercy of fluctuating global prices. High oil prices will maintain the countrys high drug costs that already stand at 25-30% above average world prices, according to the Health Research and Development Agency. Like many of the industries that make up the manufacturing sector, pharmaceutical producers were hit hard by the industry electricity tariff increase in 2010 that raised prices by 18%. In addition, the import tax of 5% imposed on raw materials under Minister of Finance Regulation 240/2010 heavily impacts drug producers. It is estimated that between 9098% of all pharmaceutical raw materials have to be imported mainly from China, and to a much smaller extent from America and India. The expensive price of drugs in the country is therefore easily explained considering that on average, raw materials and energy make up 35% of the total selling price for drug companies.

The Ministry of Industry has requested a removal of tariffs for 20 of the raw materials covered under the regulation while the pharmaceutical manufacturers through The Business Players Association request that 80 should be exempted. As of the beginning of 2011, the amendments to the regulation, No. 41/2010 have not been signed into law by the Ministry of Finance thus import duties still stand and some prices of generic medicines have gone up. The Ministry of Health is under pressure to keep drug prices low in the generic market (over which it has jurisdiction) and in line with the purchasing power of the country to provide greater access to pharmaceuticals, but manufacturers must react to the rising prices of materials for their bottom line. At the beginning of 2011, the 15 major drug producers put their prices up by 10-15% and then brought them down again at the end of the first quarter encouraged by the Ministry of Health and helped by a strengthened Rupiah. In order to keep prices low, the requested tariff removals are the first step in the short term but for the long term, action must be taken to ensure the local supply of the raw materials.

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 Challenges

The Indonesian health care sector has a wide range of problems to tackle that also could be turned in to challenge, these include: Growing and ageing population; Inefficiency in pharmaceuticals distribution; Shortage of pharmaceuticals; Lack of physical resources; Non conducive investment climate in pharmaceuticals sector.

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Overview of the Pharmaceutical industry in India

The Pharmaceutical market in India is the world's third-largest in terms of volume and stands 14th in terms of value. According to Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, the total turnover of India's pharmaceuticals market between 2008 and September 2010 was US$21.04 billion. While the domestic market was worth US$12.26 billion. Sale of all types of medicines in the country is expected to reach around US$19.22 billion by 2012. Exports of pharmaceuticals products from India increased from US$6.23 billion in 2008-09 to US$8.7 billion in 2010-11 a combined annual growth rate of 21.25%. According to PricewaterhouseCoopers (PWC) in 2010, India joined among the league of top 10 global pharmaceuticals markets in terms of sales by 2020 with value reaching US$50 billion. Some of the major pharmaceutical firms including Sun Pharmaceutical, Cadila Healthcare and Piramal Healthcare. The government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970. However, economic liberalization in 90s by the former Prime Minister P.V. Narasimha Rao and the then Finance Minister, Dr. Manmohan Singh enabled the industry to become what it is today. This patent act removed composition patents from food and drugs, and though it kept process patents, these were shortened to a period of five to seven years. The lack of patent protection made the Indian market undesirable to the multinational companies that had dominated the market, and while they streamed out. Indian companies carved a niche in both the Indian and world markets with their expertise in reverse-engineering new processes for manufacturing drugs at low costs. Although some of the larger companies have taken baby steps towards drug innovation, the industry as a whole has been following this business model until the present. [5] India's biopharmaceutical industry clocked a 17 percent growth with revenues of Rs.137 billion ($3 billion) in the 2009-10 financial year over the previous fiscal. Biopharma was the biggest contributor generating 60 percent of the industry's growth at Rs.8,829 crore, followed by bio-services at Rs.2,639 crore and bio-agri at Rs.1,936 crore.

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Regulatory Framework India

Regulatory & legal aspects

The pharmaceutical industry is highly regulated in India. The Drugs Controller General of India (DCGI), established under the Government of Indias Ministry of Health and Family Welfare, is the nodal agency that regulates Indias drug market including product safety and efficacy, clinical trials, market authorization, and post-market surveillance. The Drugs and Cosmetics Act, 1940 (Drugs Act) and the Drugs Rules, 1945 (Drugs Rules) regulate the import, manufacture, licensing, testing, distribution, and sale of drugs in India. The DCGI heads the Central Drugs Standard Control Organization and formulates policies in order to implement the Drugs Act. The DCGI also coordinates the activities of the different State Drug Control Organizations. Drug prices in India are regulated under the Drug Prices Control Order, 1995 (DPCO). Regulations in India Central Governments Statutory Functions

DCGI: Drugs Controller General of India DGFT: Directorate-General of Foreign Trade DBT:Department of Biotechnology GEAC: Genetic Engineering Approval Committee RDAC: Recombinant DNA Advisory Committee IBSC: Institutional Biological Safety Committees
RCGM: Review Committee on Genetic Manipulatio

Features of the Indian Market Indias pharmaceutical industry has a compounded annual growth rate of 13.7%, and employs 3,300,000 people. The domestic pharmaceutical market is estimated to be worth US$5.1 billion, and comprises of 60% Indian and 40% multinational companies. It consists of around 15,000 small-scale generic manufacturers and 260 research-based drug companies. According to industry estimates, 13-14% of the products in the Indian market are patented. The industry manufactures almost the entire of range of therapeutic products and is capable of producing raw materials to manufacture a wide range of bulk drugs from the basic stage onwards

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 Generics The global generics market is growing significantly, and presents huge opportunities for developing countries like India. More than 90-95% of the drugs available in India and specified on the World Health Organizations List of Essential Drugs are off-patent. Further, drugs worth US$40 billion were reported to have gone offpatent in 2005, and US$70 billion worth of drugs are expected to go off-patent by the end of 2008. Considering the availability of quality manpower and low production costs, India expects to hold about 30% share of the increasing generics market. Many Indian companies have approvals related to cardiovascular, anti-infective, or central nervous system stimulants from the United States Food and Drug Administration (USFDA), the UKs Medicine and Health products Regulatory Agency, and the South African Medicine Central Council. Research & Development (R&D) Indias leading pharmaceutical companies have demonstrated their ability to engage in commercially viable R&D activities, and have become major players in the international market. In 2003, Ranbaxy Laboratories, which has several molecules under development, had an R&D expenditure of US$52 million. Dr. Reddys Laboratories recorded 11% of its gross turnover from R&D. In order to promote R&D in the drugs and pharmaceutical sectors, the Department of Science and Technology and the Government of India have initiated several policy measures and tax incentives for strengthening R&D activities.

Legal & regulatory framework for clinical trials in India The DCGI regulates clinical trials in India. Clinical trials are defined as systematic studies of new drugs in human subjects to generate data for discovering and verifying the clinical or adverse effects of the drug in addition to determining the safety and efficacy of the new drug. Schedule Y to the Drugs Act provides for the manner in which such trials should be conducted: Phase I, Human Pharmacology, involves a preliminary evaluation of the safety of the drug on healthy volunteers. Phase II, Therapeutic Exploratory Trials, involves efficacy trials on a small number of patients. Phase III, Therapeutic Confirmatory Trials, involves an assessment of safety on the basis of large-scale multi-centric trials.

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Phase IV, Post-Marketing Trials, is related to assessment of the drug subsequent to approval by the licensing authority.

Indian patent law

In 1995, India became a member of the World Trade Organization and a signatoryto the Trade Related Intellectual Property Rights (TRIPS) Treaty, which markedthe beginning of the revolution in Indias legal framework relating to IP protection. Further, India honored its promise to the world and ushered in a product patents regime for drugs and food products by enacting the Patents Amendment Act, 2005 (the Amendment Act). Prior to 2005, Indias Patent Act, 1970 (IPA) recognized only process patents as against product patents,which allowed generic drug manufacturers to reverse engineer.

India is a member of the Paris Convention for the Protection of Intellectual Property, enabling international protection in convention countries. India is also a party to the Patent Co-operation Treaty (PCT). The pharmaceutical industry can obtain product patents in India because the Amendment Act permits the patenting of substances to be used as food, medicine, or drugs. However, the mere discovery of a new form of a known substance that does not enhance the known efficacy of the substance cannot be patented. Although plants and animals in whole or part cannot be patented, microorganisms can be patented if they satisfy the patentability criteria. In addition to the earlier provisions with respect to patent infringement, an applicant will be regarded as a patentee during the period between the publication of the application and grant of patent. However, infringement proceedings can be initiated only after the patent is granted. Moreover, the defendant in an infringement suit must prove that he used a process different than the patented process in order to shift the burden of proof. Additionally, the patent holder of a mailbox application (applications filed between 1995 and 2005) cannot initiate infringement proceedings against Indian companies that have made significant investment and commenced production of the mailbox patent holder's product prior to January 1, 2005. However, the patent holder will be entitled to receive a royalty from such Indian enterprises for use of the patented invention.

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 Major Players in the Pharmaceuticals Industry in India 1. Cipla 2. Ranbaxy 3. Dr. Reddy's Laboratories 4. Lupine Ltd 5. Aurobindo Pharma 6. Piramal Healthcare 7. Sun Pharmaceutical 8. Cadila Healthcare 9. GlaxoSmithKline Pharmaceuticals Ltd 10. Alembic 11. Ipca Laboratories 12. Sterling Bio 13. Piramal Healthcare 14. Orchid Chemicals & Pharmaceuticals Limited 15. Aventis Pharma

The Indian Pharmaceuticals Market

India currently represents just U.S. $6 billion of the $550 billion global pharmaceutical industry but its share is increasing at 14 percent a year, compared to 8 percent annual growth for the world market overall.Also, while the Indian sector represents just 8 percent of the global industry total by volume, putting it in fourth place worldwide, it accounts for 13 percent by value,2 and its drug exports have been growing 30 percent annually. The organized sector of India's pharmaceutical industry consists of 250 to 300 companies, which account for 70 percent of products on the market, with the top 10 firms representing 30 percent. However, the total sector is estimated at nearly 20,000 businesses, some of which are extremely small. Approximately 75 percent of India's demand for medicines is met by local manufacturing.

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According to the German Chemicals Association, in 2005, India's top 10 pharmaceutical companies were Ranbaxy, Cipla, Dr. Reddy's Laboratories, Lupin, Nicolas Piramal, Aurobindo Pharma, Cadila Pharmaceuticals, Sun Pharma, Wockhardt Ltd. and Aventis Pharma.5 Indian-owned firms currently account for 70 percent of the domestic market, up from less than 20 percent in 1970. In 2008, nine of the top 10 companies in India were domestically owned, compared with just four in 1994.6 India's potential to further boost its already-leading role in global generics production, as well as an offshore location of choice for multinational drug manufacturers seeking to curb the increasing costs of their manufacturing, R&D and other support services, presents an opportunity worth an estimated $48 billion in 2010.

Over-the-Counter Medicines
The Indian market for over-the-counter medicines (OTCs) is worth about $940 million and is growing 20 percent a year, or double the rate for prescription medicines.8 The government is keen to widen the availability of OTCs to outlets other than pharmacies, and the Organisation of Pharmaceutical Producers of India (OPPI) has called for them to be sold in post offices. Developing an innovative new drug, from discovery to worldwide marketing, now involves investments of around $1 billion,9 and the global industry's profitability is under constant attack as costs continue to rise and prices come under pressure. Pharmaceutical production costs are almost 50 percent lower in India than in Western nations, while overall R&D costs are about one-eighth and clinical trial expenses around one-tenth of Western levels. India's long-established manufacturing base also offers a large, well-educated, English-speaking workforce, with 700,000 scientists and engineers graduating every year, including 122,000 chemists and chemical engineers, with 1,500 PhDs.10 The industry provides the highest intellectual capital per dollar worldwide, says OPPI.

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 LAST 6 YEAR GROWTH (%) IN PHARMACEUTICAL INDUSTRY India's US$ 9.4 billion pharmaceutical industry is growing at the rate of 14 percent per year. It is one of the largest and most advanced among the developing countries. The Indian pharmaceutical industry can reach a market size of US$ 11.6 billion by 2011.

YEAR 2006 2007 2008 2009 2010 2011

GRWTH(%) 8.2 8.7 9.4 10.1 12.8 14

A beginning has been made with the signing of General Agreement on Tariffs and Trade in January 2008 with which India began recognizing global patents. Soon after, the Indian pharmacy market became a sought after destination for foreign players. Foreign direct investment into the countrys pharmacy industry touched US$ 172 million during 2008-09 having grown at a CAGR of 62.6 per cent during the period beginning 2006-07. The sector recorded strong growth in the second quarter ended September 2007, driven by launch of new generic drugs with 180 days exclusivity period in the US market. The top ten pharmacy companies reported an impressive 57 per cent growth in consolidated net profit at US$ 314.3 million, as against US$ 200.7 million in the same quarter of the previous year, while consolidated net sales were up 51 per cent at US$ 1.7 billion.

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 Revenue of Pharmaceutical companies in India, as of 2011 Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Company Cipla Ranbaxy Dr. Reddy's Laboratories Lupine Ltd Aurobindo Pharma Piramal Healthcare Sun Pharmaceutical Cadila Healthcare Alembic GlaxoSmithKline Pharmaceuticals Ltd Ipca Laboratories Sterling Bio Biocon Orchid Chemicals & Pharmaceuticals Limited Aventis Pharma Revenue 2011(USD billion) 37.637 41.989 41.622 22.155 20.801 13.464 24.635 16.136 12.318 17.734 9.804 14.256 13.125 12.141 9.838

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 Challenges and Opportunities Underdeveloped new molecule discovery program The main weakness of the industry is an underdeveloped new molecule discovery program. Even after the increased investment, market leaders such as Ranbaxy and Dr. Reddys Laboratories spent only 5-10 per cent of their revenues on R&D, lagging behind Western pharmaceuticals like Pfizer, whose research budget last year was greater than the combined revenues of the entire Indian pharmaceutical industry. This disparity is too great to be explained by cost diffentials, and it comes when advances in genomics have made research equipment more expensive than ever. The drug discovery process is further hindered by a dearth of qualified molecular biologists. Due to the disconnect between curriculum and industry, pharmas in India also lack the academic collaboration that is crucial to drug development in the West Hue & cry against exploitation In clinical testing persons from developing countries will be used to generate data about possible effects of a drug. A feeling of unrest among them or some section of society might develop that we are being used as guinea pigs. It might lead to demonstrations or legislations which will hamper the growth of industry. Back lash against outsourcing Similar to BPO there might be unrest in developed nations that outsourcing of clinical trials will lead to job loss culminating into legislation banning the whole procedure. . IP leakage IP leakage is one of the major concerns by companies outsourcing research work to India. So any major incident of IP leakage by Indian company can taint the image of wholeindustry. Restricted items There are a lot of items that are restricted under the EXIM policy from free trading. These items are given under annexure 1. These restrictions are a weakness for the industry and hence pose to be a threat for its development.

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 Reservation for small scale industries Some drugs are reserved for exclusive manufacture by the small scale units. These are Niacinamide, Paracetamol, Glycero Phosphates, Nicotinic Acid. The present investment limit for units to qualify as a small scale unit is Rs. 30 million.

No brand value India has a low beep on the radar screen of MNC drug companies as no potential clinical testing has been ever outsourced to India. So we have a low brand value in global arena. Safety concerns With recent high profile product withdrawals, there are also concerns that regulatory agencies will tighten up safety and efficacy testing requirements. A particular focus will be onthe application of pharmacogenomic techniques to improve safety profile, but the advent ofsuch techniques in the long run will improve industry productivity as more pharmacogenomic data is collated. Generic competition Generic substitution is a policy for healthcare cost containment. National reimbursement and insurance bodies are providing physicians and pharmacists with incentives for prescribing cheaper generic drugs. There is increased pressure on revenues for pharmaceutical companies, which have to concentrate on lifecycle management. The pharmaceutical industry will experience a significant reduction in the revenues associated with their blockbuster products as generic competition captures market share. As a result, given that R&D productivity is low and the cost of developing new drugs at an all time high he pharmaceutical industry faces considerable hurdles with respect to maintaining revenue and earnings growth in the future.

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 Opportunities
The Indian pharmaceutical industry has a lot of strengths and hence ample of opportunities. A few important strengths are mentioned below. Competent workforce India has a pool of personnel with high managerial and technical competence as skilledworkforce. It has the largest English speaking population in the world. Professional services are easily available. Cost-effective Chemical Synthesis Its track record of development, particularly in the area of improved costbeneficial chemical synthesis for various drug molecules is excellent. It provides a wide variety of bulk drugs and exports sophisticated bulk drugs. Legal & Financial Framework Corporate Catalyst India Indias Pharmaceutical Industry India has a 53 year old democracy and hence has a solid legal framework and strong financial markets. There is already an established international industry and business community. Information & Technology It has a good network of world-class educational institutions and established strengths in Information Technology. Globalization The country is committed to a free market economy and globalization. It has a 70 million middle class market, which is continuously growing. Consolidation The international pharmaceutical industry is finding great opportunities in India as the process of consolidation has started taking place in India. Low priced products

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The industry has thrived so far on reverse engineering skills exploiting the lack of process patent in the country. This has resulted in the Indian pharmaceutical players offering their products at some of the lowest prices in the world. Quality assurance The quality of the products is reflected in the fact that India has the highest number of manufacturing plants approved by US FDA (61 plants), which is next only to that in the US. Dominance in the market Multinational companies have traditionally dominated the industry, which is another trend seeing a reversal. Currently, it is the Indian companies which are dominating the marketplace with the local players dominating a number of key therapeutic segments. Self-reliance Displayed by the production of 70 per cent of bulk drugs and almost the entire requirement of formulations within the country. Other Strengths Low cost of production, Low R&D costs, Innovative Scientific manpower and Increasing balance of trade in Pharma sector are also significant strengths of the Indian pharmaceutical

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Overview of the Pharmaceutical industry in Gujarat

A Detailed Overview History State of Gujarat emerged as an independent state from the than Greater Bombay state on Ist May, 1960. In the pre-independence era & until about emergence of pharmaceutical industries in Gujarat, India was not self sufficient for medicines and was a net importer of the most of bulk drugs & many formulations. In 1947 the year of Independence India's Pharmaceutical production was to the tune of Rs. 100 million only

The synergistic efforts of Central & State Governments & Indian Pharmaceutical Industry resulted in the increase of production of bulk drugs (API) and finished formulations targeting the goal of self reliance in pharmaceutical sector Gujarat leads India in pharmaceuticals and enjoys the share between 35% and 46% of the national share in pharmaceutical production over the last two decades. Ahmedabad and Vadodara are leaders in the production ofgenerics while Ankleshwar and Vapi produce much of India's bulk drugs.

The history of the pharmaceutical industry in Gujarat begins in 1907 when Alembic Chemical Works Co Ltd was formed by taking over distilleries in Baroda (Vadodara) with a view to manufacturing alcohol and tinctures primarily for pharmaceutical products.

During the 1940s and 50s, companies like Sarabhai Chemicals, The Gujarat Pharmaceutical and Chemical Works, Atul Products Ltd, Allied and Cadila Laboratories were established in the post WW2 period, referred to globally as the 'therapeutic revolution'. An important landmark in the industry's history was the establishment of LM College of Pharmacy at Ahmedabad in 1947. This college has provided many entrepreneurs, technocrats and drug controllers to the pharmaceutical industry in the state The pharmaceutical industry grew rapidly after Gujarat was declared a state with Dr Jivraj Mehta as its first chief minister in 1960. The number of manufacturers in Gujarat grew from 117 in 1962 to more than 900 in 1985 with a major share in the country's pharmaceutical production. The revisions in the Patent Act also benefited the domestic industry in India (see foreword). Another development that impacted the pharmaceutical sector during this period was the establishment of pharmaceutical machinery manufacturing unit, Cadmach in 1967 by Shri Ramanbhai Patel with products catering to various needs of the pharma industry.

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During the 1990s and 2000s, Gujarat's companies saw a quantum leap in production and exports with a strong focus on regulated markets as they geared up for globalisation. The large manufacturers successfully entered the capital markets to make the most of the stock market boom to raise resources for increasing production and research facilities. During the last decade, Gujarat's pharmaceutical companies like Sun Pharma, Zydus Cadila, Torrent and Dishman have been expanding their global footprint through acquisitions, mergers and alliances with international companies and setting up subsidiaries and marketing offices overseas. Gujarat's pharma companies have also been increasingly working towards getting their facilities approved by USFDA and other international regulatory bodies to augment their market presence across regulated and semi-regulated markets. On the international horizon, there are abundant opportunities for Gujarat's pharmaceutical companies. The outsourcing of R&D with more and more products going off-patent and declining R&D productivity in many countries offers considerable possibilities for india, a preferred off-shoring destination for many countries, specially for companies involved in contract research, manufacturing and clinical trials to leverage their potential. The growth of the generics sector, in which Gujarat already has a substantial share of India's production and exports, also offers much scope of sustainable growth and production expansion.

Gujarat's pharma majors have also started scaling up their R&D operations to tap the huge potential of therapeutic categories that offer opportunities for those who take the lead in becoming global, innovative research-based pharmaceutical companies Major Players in the Pharmaceuticals Industry Zydus_Cadila Cadila_Pharma Jubilant Dishman_Pharma JB_Chemicals Alembic Piramal Healthcare

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 LAST 6 YEAR GROWTH (%) IN PHARMACEUTICAL INDUSTRY

YEAR 2006 2007 2008 2009 2010 2011

GRWTH(%) 5.7 6.9 6.4 8.2 8.7 9.5

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 Revenue of Pharmaceutical companies in Gujarat, as of 2011 NAME Zydus_Cadila Cadila_Pharma Jubilant Dishman_Pharma JB_Chemicals Alembic Piramal Healthcare 12.318 13.364

Revenue 2011(USD billion)

18.254 16.136 9.298 11.236 6.245

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 Emerging Opportunities: Medical Tourism: With India rapidly emerging as an attractive medical tourism hub, Gujarat is also making big strides in this segment. It is fast competing with other places such as Delhi, Maharashtra and Andhra Pradesh in this segment. The state offers high quality and specialised healthcare services and infrastructure at very low costs, thus making it a preferred destination for medical tourism. Gujarat has highly qualified specialists particularly in the ophthalmology, urology, embryology, orthodontics, oncology and orthopedics therapeutic areas. It also offers other advantages such as_Englishspeaking_healthcare personnel, no waiting periods for treatment, and high standards of international transport. Given the growing attractiveness of India as a global destination for medical tourism, the government of Gujarat laid down the 2006 Medical Tourism policy. This will furthe rimprove the healthcare infrastructure of the state and attract a Higher number of patients. The following factors can further boost medical tourism: Assisted healthcare institutions such as day care centres Support services such as nursing associations Linkages with infrastructure facilities for transportation of patients from Airports and railway stations Linkages with organisations/ NGOs, etc., in overseas countries to acquire Knowledge and leverage opportunities Contract Research Organisations: Gujarat is home to approximately 40 Percent of CROs in the country. Its well established healthcare sector, strong infrastructure facilities and relatively low real estate costs has lured many global and local CROs to set up shop in the state. Globally, contract research is a high growth segment led by increasing outsourcing activities of pharma MNCs. Given all these growth enablers, Gujarat can capture a larger pie of this global opportunity by establishing a strong ancillary services industry base such as bioinformatics and clinical data management centres which can facilitate and boost R&D and other high-end activities.

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 Pharmaceutical Machinery: There is a strong local and global opportunity for Gujarat in the manufacturing of pharmaceutical machinery, given its strong and Well established engineering sector. According to industry estimates, Approximately 35-40 percent of Indias pharmaceutical machinery is produced in Gujarat. The strong growth prospects of the pharmaceutical exports segment and Growing demand from the domestic market, will further fuel growth in the Pharmaceutical machinery sector. However, Gujarats engineering sector is highly fragmented, especially the pharma machinery manufacturing segment. Due to the highly fragmented nature, there_is a dearth of pricing power and critical scale. This in turnrestricts the ability to produce the technology-driven products Required for operating in global markets. The pharma machinery manufacturing Industry in Gujarat needs to consolidate and synergise the skills and Complementarities available in the broader engineering sector (like the Class players with the scale And resources required, to tap the global as well as local demand.

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 The Gujarat Scenario Gujarat accounts for about 40% of pharmaceutical production. Total 3507 manufacturing units engaged in manufacturing of Allopathic, Ayurvedic, Homeopethic drugs & Cosmetics.
Statistical Information of Food & Drugs Control Admn. (Gujarat State) NO. DETAILS 2007-08 2008-09 2009-10 2010-11

A. MANUFACTURING :- UNITS 1 2 3 4 ALLOPATHIC AYURVEDIC COSMETICS HOMEOPATHIC 3352 574 318 14 4258 2808 604 368 15 3795 2355 656 401 16 3428 2439 681 394 16 3530

TOTAL B. LICENCES (T0TAL) 1 2 3 4 ALLOPATHIC AYURVEDIC COSMETICS HOMEOPATHIC

4919 578 318 14 5829

4620 604 368 15 5607

4355 660 394 15 5424

4399 668 419 16 5502

TOTAL C. FRESH LICENCES (ISSUED) 1 2 3 4 ALLOPATHIC AYURVEDIC COSMETICS HOMEOPATHIC

794 47 28 0 869

834 39 24 1 898

1159 56 30 0 1245

1439 43 24 0 1506

TOTAL D. RENEWAL LICENCE (ISSUED) MFG 1 2 3 4 ALLOPATHIC AYURVEDIC COSMETICS HOMEOPATHIC

121 83 23 0 227
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373 45 4 0 422

305 90 22 0 417

261 153 40 0 454

TOTAL

E. SALES DETAILS: 1 2 3 4 UNITS NO OF SALES LICENCE FRESH LICENCE ISSUED RENEWAL LICENCES 24155 54339 6688 5916 24639 54986 7076 10616 26073 56188 6754 3676 26411 60348 5717 2690

F. INSPECTION 1 2 3 4 MANUFATURING SALES COMPLAINTS VALUE OF DRUGS DESTROYED IN RS. NO. OF RAIDS CARRIED OUT G. DRUGS PROSECUTIONS 1 2 3 4 5 6 PENDING LAUNCHED DECIDED CONVICTED ACQUITTALS PENDING 341 17 11 8 3 347 347 21 7 4 3 361 361 9 19 11 8 351 351 17 6 1 5 362 1318 9004 20 1833 12184 0 2934 14143 133 2104 12263 97

6406979 2030552 3177084 6255973 6 10 12 7

H. TESTING OF DRUG SAMPLES 1 2 3 4 5 NO. OF SAMPLE RECEIVED NO.OF SAMPLE TESTED NO.OF SAMPLE FOUND STD. NO.OF SAMPLE FOUND NOT OF STD. TOTAL NO. OF NSQ. SAMPLES 1138 2349 2025 324 324 0.1379 6 A) MFG. IN GUJARAT STATE 93 0.0396 7 B) MFG.IN OTHER STATE 231 2906 1837 1385 296 296 0.1611 106 0.0577 190 2547 2567 2242 325 325 0.1266 140 0.0545 185 4728 5037 4465 317 317 0.0629 144 0.0286 173

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0.0983 I. ACTION TAKEN DRUGS (T.R + INSEP) 1 2 3 4 5 6 LICENCES SUSPENDED PRODUCT PERMISSION WITHDRAWN P.P.W. & LICENCE SUSPENDED LICENCES CANCELLED WARNING ISSUED STOP MANUFACTURING 235 17 14 0 51 13

0.1034

0.0721

0.0343

88 8 0 0 28 22

188 3 19 1 38 18

58 1 4 0 16 15

J. TESTING OF FOOD SAMPLES: ( DETAIL WITHOUT CORPORATION) 2007 1 2 3 4 5 6 NO.OF SAMPLES TAKEN NO.OF SAMPLES TESTED NO.OF SAMPLES FOUND ADULTERATED /MISBRANDED PERCENTAGE OF ADULTERATION/MISB PROSECUTION LAUNCHED PROSECUTION DECIDED 6016 6081 219 3.60% 292 152 2008 5949 5885 272 4.62% 295 141 2009 5243 4766 133 2.79% 141 113 2010 5159 5183 199 0.0384 171 122

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Relations with European Pharmaceuticals Market

Indonesia is important to the EU: it is fast becoming a middle income country with an impressive growth record (positive throughout the economic crisis). Indonesia is the largest market in ASEAN with an economic growth target of 7.7%. Even though Indonesia only represents 0.5% of EU exports less than smaller countries such as Malaysia and Thailand - the EU is very interested in Indonesia, not the least because of its potential. Indonesia has gained an important role in G-20 and its potential inclusion in the list of BRI[I]C countries. The European Pharmaceuticals Market EUs pharmaceutical sector is substantial. On average approximately EUR 430 was spent on medicines in 2010 for each European and this amount will likely continue to increase as the population in Europe ages. Overall, in 2010, the market for prescription and nonprescription medicines for human use in the EU was worth over EUR 138 billion ex-factory and EUR 214 billion at retail prices. The drug development costs for a new chemical or biological candidate was estimated at over EUR 1 billion in 2010 and on average it takes 12-13 years to bring a new medicine to the market. Out of every 10,000 substances synthesized in laboratories, only one or two will successfully pass all stages to become marketable medicines. (IMI Press Release, 2010) In 2010 EFPIA countries pharmaceutical exports totaled EUR 203,800 million. This amount also includes the trade flows between the EFPIA countries, w hich were estimated to EUR 124,300 million in 2010. Exports to non-EFPIA countries amounted to EUR 86,400 million, i. e. 37.4% of total exports. Pharmaceuticals represented 5.6% of total EU manufacturing exports in 2010 against 2.1% in 1990.

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Regulatory Framework EU Registration of Pharmaceuticals When comparing the registration procedures and price for registration there are great discrepancies between EU and Indonesia. To register a new pharmaceutical product in Indonesia would cost in the range IDR 5-20.000.000 (EUR 450 1,800), emergency pharmaceu ticals could take a short as three months to register. But generally the registration process in Indonesia is long. Issues that still appear as challenges related to the registration process, these include GMP (Good Manufacture Process) and Data Exclusivity. Drug registrations required to be in line with ACTD (ASEAN Common Technical Dossier). To register pharmaceutical products in EU costs about EUR 100,000 and is a multi-year process. The high cost for registration of pharmaceuticals in EU is one of the major hurdles keeps Indonesian players out off the market.

REACH Regulation The new European Chemicals regulation, REACH, was adopted in December, 2006. REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals. REACH entered into force on June 1, 2007, and will be implemented in phases over an eleven year period. REACH was designed to systematically identify the hazards and risks of chemicals allowing for appropriate risk management measures by industry and, if necessary, provide for further regulatory action by the public authorities. EU manufacturers and importers are obligated to register substances they produce or import in quantities over one ton per year. This registration requirement applies to substances on their own, in preparations and in articles if they are intentionally released. Timing and other factors affect the required registration date, which could be as early as 1st of June 2008, through as late as 1st of June 2018. The European Pharmaceuticals Market EUs pharmaceutical sector is substantial. On average approximately EUR 430 was spent on medicines in 2009 for each European and this amount will likely continue to increase as the population in Europe ages. Overall, in 2007, the market for prescription and nonprescription medicines for human use in the EU was worth over EUR 138 billion ex-factory and EUR 214 billion at retail prices. The drug development costs for a new chemical or biological candidate was estimated at over EUR 1 billion in 2009 and on average it takes 12-13 years to bring a new medicine to the market. Out of every 10,000 substances synthesized in laboratories, only one or two will successfully pass all stages to become marketable medicines. (IMI Press Release, 2010)
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In 2010 EFPIA countries pharmaceutical exports totaled EUR 203,800 million. This amount also includes the trade flows between the EFPIA countries, w hich were estimated to EUR 124,300 million in 2010. Exports to non-EFPIA countries amounted to EUR 86,400 million, i. e. 37.4% of total exports. Pharmaceuticals represented 5.6% of total EU manufacturing exports in 2010 against 2.1% in 1990. The top 15 pharmaceutical companies in EU by 2011 sales were:

The top 15 pharmaceutical companies in EU by 2011 sales were:

Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Company Pfizer GlaxoSmithKline Novartis Sanofi-Aventis AstraZeneca HoffmannLa Roche Johnson & Johnson Merck & Co. Abbott Eli Lilly and Company Amgen Taj Pharmaceuticals Wyeth Teva Bayer Takeda Sales ($M) 43,363 36,506 36,506 35,642 32,516 30,336 29,425 26,191 19,466 19,140 15,794 16,234 15,682 15,274 15,660 13,819 Based/Headquartered in US UK Switzerland France UK/Sweden Switzerland US US US US US India US Israel Germany Japan

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Indonesia International Human Development Indicators

Human Development Index Year 2011 2010 2009 2008 2007 2006 2005 2000 1995 1990 1985 1980 Indonesia 0.617 0.613 0.607 0.598 0.591 0.579 0.572 0.543 0.527 0.481 0.460 0.423 Medium human development 0.630 0.625 0.618 0.612 0.605 0.595 0.587 0.548 0.517 0.480 0.450 0.420 East Asia and the Pacific 0.671 0.666 0.658 0.651 0.642 0.631 0.622 0.581 0.544 0.498 0.463 0.428 World 0.682 0.679 0.676 0.674 0.670 0.664 0.660 0.634 0.613 0.594 0.576 0.558

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FINDINGS AND CONCLUTION Indonesia has very big opportunities to export pharmaceuticals to the india , Gujarat and EU , but a mobilization from both business and Government is required. In Indonesia higher growth opportunity against india, Gujarat .

Indonesias level of export statistics to EU is low, how can we increase Indonesia export to EU? This will be benefiting for Indonesia as well for EU. Indias and gujarats level of export statistics to indonesia is low, how can we increase India and Gujarat export to Indonesia? This will be benefiting for India and gujarat as well for indonesia.

Indonesian regulatory framework and Regulations are much bettr then Indai.

Standards

and

Technical

Indonesian OTC market has a double-digit growth rate according to some estimates.

The research findings support the rationalization of the argumentation on the economic dimension of patented drugs in Indonesia.

India is becoming an integral part of theglobal pharmaceutical valu chain and Their organic as well as inorganic Many Indian companies are participating in this global growth potential through initiatives. Pharma companies from Gujarat haveAlso contributed significantly to this process through acquisitions of foreign Assets or by having export-led business models reflected in Gujarats increasing Share in Indias pharma exports as well as industry turnover.

Going forward, as India further increases its dominance in the world pharma market, Gujarat with its Growth enablers and strong building blocks can become a global pharmaceutical hub. However, this would call for an enormous change in mindset and transformation to attract global capital and talent. The path to globalization is full of opportunities but also fraught with risks. Companies which would develop the right framework that wouldhelp them capitalize on this opportunity and mitigate risks will benefit the most risks will benefit the most
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The findings demonstrate that it will take some time until substantial investment can be stimulated by TRIPS within the context of the international pharmaceutical industry. However, the erosion of the market share of copy products will take some time as well, due to the necessary availability of Indonesian patents. In a way, this will be a rather balanced scenario until the benefits derived from innovation and investment clearly outweigh the economic downsides from limiting imitations for a developing country. Pipeline protection would be expected to accelerate the stimulation of investment and innovation.Moreover, the research findings support the rationalization of the argumentation on the economic dimension of patented drugs in Indonesia. These economic dimensions clearly indicate that significant economic benefits of IPR are mostly related to the long-term future. In a way these findings suggest that TRIPS allows significant time of adjusting an economy from imitation to innovation and to buffer negative implications on local industry.

BIBLOGRAPHY
www.gbgindonesia.com www.pharmacy.org www.medilexicon.com www.list-of-companies.org www.marketresearch.com www.emergingmarketsdirect.com www.thejakartapost.com www.pharmaceutical-drug-manufacturers.com www.eximbankindia.com

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