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    FDI IN INDIAN PHARMA SECTOR

    ECONOMY OF INDIA

    The economy of India is the twelfth largest economy in the world by nominal value and

    the fourth largest bypurchasing power parity (PPP). In the 1990s, following economic reform

    from the socialist-inspired economy of post-independence India, the country began to experience

    rapid economic growth, as markets opened for international competition and investment. In the

    21st century, India is an emerging economic power with vast human and natural resources, and a

    huge knowledge base. Economists predict that by 2020, India will be among the leading

    economies of the world.

    A revival of economic reforms and better economic policy in 2000s accelerated

    India's economic growth rate. By 2008, India had established itself as the world's second-fastest

    growing major economy. However, the year 2009 saw a significant slowdown in India's official

    GDP growth rate to 6.1% as well as the return of a large projected fiscal deficit of 10.3% of GDP

    which would be among the highest in the world.

    India's large service industry accounts for 62.6% of the country's GDP while the industrial and

    agricultural sector contribute 20% and 17.5% respectively. Agriculture is the predominant

    occupation in India, accounting for about 52% of employment. The service sector makes up a

    further 34%, and industrial sectoraround 14

    India'sper capita income (nominal) is $1032, ranked 139th in the world, while its per capita

    (PPP) of US$2,932 is ranked 128th. Previously a closed economy, India's trade has grown fast

    India currently accounts for 1.5% of World trade as of 2007 according to the WTO. According

    to the World Trade Statistics of the WTO in 2006, India's total merchandise trade (counting

    exports and imports) was valued at $294 billion in 2006 and India's services trade inclusive of

    export and import was $143 billion. Thus, India's global economic engagement in 2006 covering

    both merchandise and services trade was of the order of $437 billion, up by a record 72% from a

    level of $253 billion in 2004. India's trade has reached a still relatively moderate share 24% of

    GDP in 2006, up from 6% in 1985.

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    http://en.wikipedia.org/wiki/List_of_countries_by_GDP_(nominal)http://en.wikipedia.org/wiki/List_of_countries_by_GDP_(PPP)http://en.wikipedia.org/wiki/List_of_countries_by_GDP_(PPP)http://en.wikipedia.org/wiki/Economyhttp://en.wikipedia.org/wiki/Economic_development_in_Indiahttp://en.wikipedia.org/wiki/List_of_countries_by_GDP_(real)_growth_ratehttp://en.wikipedia.org/wiki/List_of_countries_by_GDP_(real)_growth_ratehttp://en.wikipedia.org/wiki/Agriculture_in_Indiahttp://en.wikipedia.org/wiki/Service_(economics)http://en.wikipedia.org/wiki/Industrial_sectorhttp://en.wikipedia.org/wiki/Per_capita_incomehttp://en.wikipedia.org/wiki/List_of_countries_by_GDP_(nominal)_per_capitahttp://en.wikipedia.org/wiki/List_of_countries_by_GDP_(PPP)_per_capitahttp://en.wikipedia.org/wiki/List_of_countries_by_GDP_(PPP)http://en.wikipedia.org/wiki/List_of_countries_by_GDP_(PPP)http://en.wikipedia.org/wiki/Economyhttp://en.wikipedia.org/wiki/Economic_development_in_Indiahttp://en.wikipedia.org/wiki/List_of_countries_by_GDP_(real)_growth_ratehttp://en.wikipedia.org/wiki/List_of_countries_by_GDP_(real)_growth_ratehttp://en.wikipedia.org/wiki/Agriculture_in_Indiahttp://en.wikipedia.org/wiki/Service_(economics)http://en.wikipedia.org/wiki/Industrial_sectorhttp://en.wikipedia.org/wiki/Per_capita_incomehttp://en.wikipedia.org/wiki/List_of_countries_by_GDP_(nominal)_per_capitahttp://en.wikipedia.org/wiki/List_of_countries_by_GDP_(PPP)_per_capitahttp://en.wikipedia.org/wiki/List_of_countries_by_GDP_(nominal)
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    GROWTH RATE OF INDIA.

    The Gross Domestic Product (GDP) in India expanded at an annual rate of 7.20 percent in the

    last quarter. India Gross Domestic Product is worth 1217 billion dollars or 1.96% of the world

    economy, according to the World Bank. India's diverse economy encompasses traditional village

    farming, modern agriculture, handicrafts, a wide range of modern industries, and a multitude of

    services. Services are the major source of economic growth, accounting for more than half of

    India's output with less than one third of its labor force. The economy has posted an average

    growth rate of more than 7% in the decade since 1997, reducing poverty by about 10 percentage

    points. This page includes: India GDP Growth Rate chart, historical data and news.

    Country

    Interest

    Rate

    Growth

    Rate

    Inflation

    Rate

    Jobless

    Rate

    Current

    Account

    Exchange

    Rate

    India 3.25% 7.20% 14.97% 7.32% -13 46.0850

    Year Mar Jun Sep Dec Average

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    http://www.tradingeconomics.com/Economics/Currency.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/Interest-Rate.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/GDP-Growth.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/Inflation-CPI.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/Unemployment-rate.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/Current-Account.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/Currency.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/Currency.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/Interest-Rate.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/GDP-Growth.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/Inflation-CPI.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/Unemployment-rate.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/Current-Account.aspx?symbol=INRhttp://www.tradingeconomics.com/Economics/Currency.aspx?symbol=INR
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    2010 7.20 7.20

    2009 6.70 6.70

    2008 9.00 9.002007 9.70 9.70

    In the third quarter of 2009, India's economy expanded 7.9%. And although it is expected that in

    the last three months of 2009, the third largest economy in Asia might have recorded growth

    over 8%, the beginning of 2010 may surprise us on the negative side.

    Indeed, recent data is indicating that GDP growth in the last quarter of 2009 may beat

    expectations. For example, since June industrial production has been accelerating, recording

    11.7% growth in November, the fastest in two years and exports grew 18% yoy in November.

    Yet, the stunning performance of the Indian economy has a lot to do with a significant fiscal

    stimulus and loose monetary policy. In fact, it is estimated that government contributed around

    50% of total GDP growth in the year to September. In addition, lower interest rates have

    supported domestic demand for consumer durables.

    However, despite some positive data, the rising inflation is a growing concern. Indeed, a weaker

    monsoon has pushed price of food significantly higher in the last few months. This price

    pressure combined with strong industrial production may soon lead to interest rate hikes and

    tighten credit availability. Also, there is another danger by the corner. It is likely that due toextensive spending, Indian government may record huge fiscal deficit in the year to March. And

    in order to balance the budget the authorities may decide to increase taxes thus crowding our

    private investments.

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    OVERVIEW OF PHARMACEUTICAL SECTOR

    The Indian Pharmaceutical industry has been witnessing phenomenal growth in recent years,

    driven by rising consumption levels in the country and strong demand from export markets.This

    segment of Industry has shown tremendous progress in terms of infrastructure development,

    technology base and wide range of products. The industry now produces bulk drugs belonging to

    all major therapeutic groups requiring complicated manufacturing processes and has also

    developed excellent GMP (Good Manufacturing Practices) compliant facilities for theproduction of different dosage forms. The strength of the industry is in developing cost effective

    technologies in the shortest possible time for drug intermediates and bulk activities without

    compromising on quality. This is realized through the country's strengths in organic chemicals'

    synthesis and process engineering. India is today recognized as one of the leading global players

    in pharmaceuticals. Europe accounts for the highest share of over 23% of Indian Pharma exports

    followed by North America and Asia. Exports to USA have crossed the land mark figure of US

    $1 billion during 2006-07. Internationally recognized as amongst the lowest-cost-producers of

    drugs, India holds fourth position in terms of volume and thirteenth position in terms of value of

    production in pharmaceuticals. It is estimated that by the year 2010, the Indian pharmaceutical

    industry has the potential to achieve over Rs.1,00,000 crore production of formulations and bulk

    drugs.

    The Domestic Pharma Industry :

    The domestic Pharma Industry has recently achieved some historic milestones through a

    leadership position and global presence as a world class cost effective generic drugs'manufacturer of AIDS medicines. Many Indian companies are part of an agreement where major

    AIDS drugs based on Lamivudine, Stavudine, Zidovudine, Nevirapine will be supplied to

    Mozambique, Rwanda, South Africa and Tanzania which have about 33% of all people living

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    97 to Rs. 13893 crores in 2007-08. Exports of pharmaceuticals registered a growth at the rate of

    16.22% during 2007-08. The share of exports of Pharmaceuticals products to the total national

    exports have been in excess of 2% during each of last 12 years ending 2007-08. It has exhibited a

    long-term upward trend from 2.01% in 1996-97 to 2.55% in 2007-08.

    Investment

    According to Ministry of Commerce and Industry, Domestic investment in the

    Pharmaceuticals sector is estimated at Rs. 31.43 thousand crores, which is equivalent to

    US $ 7.14 billions.

    The Drugs and Pharmaceuticals sector has been able to attract FDI amounting to US $

    1428.96 million in the sector from April 2000 to December 2008.

    So far, as domestic industrial proposals between August 1991-March 2008 are concerned,

    total Industrial Entrepreneur Memorandum (IEMs) filed including Letter Of Intent (LOI)

    & Direct Industrial Licences (DIL) add upto Rs. 31257 crores in Drugs & Pharmaceutical

    Sector, according to Ministry of Commerce & Industry.

    According to the Ministry of Commerce & Industry, Pharmaceutical sector is estimated

    to have created 2.20 lakh employment opportunities.

    According to Centre For Monitoring Indian Economy (CMIE), the aggregate sectoral

    income grew by 18.9% during the quarter ending June 2008 while the growth in net

    profits during 2007-08 was 8.2%.

    Key Strengths

    Strong manufacturing base

    Cost competitiveness

    Network of laboratories and R&D infrastructure

    Highly trained pool of scientists and professionals

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    FDI IN INDIAN PHARMA SECTOR

    World-class quality products

    Strong marketing and distribution network

    Strong process development skills

    Potential ground for clinical trials

    Fast growing health care industry

    Rich biodiversity

    Growing biotechnology industry

    Highest Quality approvals from USFDA, EDQM, MHRA etc.

    Ranks 4th in the world, accounts 8% by volume and 2% by value.

    Very strong in Indian medicine systems of Ayurvedic, Homoepathy, Unani, Siddha and

    Herbals medicines

    An excellent center for clinical trials.

    Research and Development

    In no other Industry segment innovative R&D is as critical as in Pharma industry. Here, the New

    Drug Discovery Research (NDDR) has to keep pace with the emerging pattern of diseases aswell as responses in managing existing diseases where target organisms are becoming resistant to

    existing drugs. The NDDR is also an expensive activity. It is encouraging to observe that at least

    10 Indian companies are into new drug discovery in the areas of infections, metabolic disorders

    like diabetes, inflammation, respiratory, obesity & cancer. Most of these companies have

    increased their R&D spending to over 5% of their respective sales turnovers. There is notable

    success from some Indian companies in out licensing new molecules in the asthma and diabetes

    segments to foreign companies. Introduction of Product Patent for Pharmaceuticals is an

    important feature for Indian Pharma R&D scenario. This has boosted the confidence of MNC

    Pharma companies in India where a number of western Pharma companies have already R&D

    collaborations with Indian Pharma companies in the field of NDDR. Some Indian companies

    have also got US-FDA approvals for their new molecules as Innovative New Drugs (lND).

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    Western Pharma companies have recognized the attractiveness of India as a R&D outsourcing

    destination due to low cost scientific manpower, excellent infrastructure, top quality with

    capability to conduct modern research under GLP, GCP guidelines. Many of them have set up

    independent R&D centres in India.

    Clinical Trials to establish safety and efficacy of drugs constitute nearly 70% of R&D costs.

    Considering the low cost of Research and Development in India, several MNC Pharma

    companies as well as global Clinical Research Organizations are increasingly making India a

    clinical research hub. In conclusion new drug discovery in India has made a promising start

    wherein at least five to six potential candidates in the areas of Malaria, Obesity, Cancer, Diabetes

    and Infections are likely to reach Phase II clinical trials.

    Contract Manufacturing

    Many global pharmaceutical majors are looking to outsource manufacturing from Indian

    companies, which enjoy much lower costs (both capital and recurring) than their western

    counterparts. Many Indian companies have made their plants cGMP compliant and India is also

    having the largest number of USFDA-approved plants outside USA.

    Indian companies are proving to be better at developing Active Pharmaceutical Ingredients

    (APIs) than their competitors from target markets and that too with non-infringing processes.Indian drugs are either entering in to strategic alliances with large generic companies in the

    world of off-patent molecules or entering in to contract manufacturing agreements with

    innovator companies for supplying complex under-patent molecules.

    Some of the companies like Dishman Pharma, Divis Labs and Matrix Labs have been

    undertaking contract jobs for MNCs in the US and Europe. Even Shasun Chemicals, Strides

    Arcolabs, Jubilant Organosys, Orchid Pharmaceuticals and many other large Indian companies

    started undertaking contract manufacturing of APIs as part of their additional revenue stream.

    Top MNCs like Pfizer, Merck, GSK, Sanofi Aventis, Novartis, Teva etc. are largely depending

    on Indian companies for many of their APIs and intermediates. The Boston Consulting Group

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    estimated that the contract manufacturing market for global companies in India would touch

    $900 million by 2010.

    Selected Contract Manufacturing Deals in India

    Indian company Multinational Product

    Lupin Laboratories Fujisawa Cefixime

    ApotexCefuroxime Axetil, Lisinopril

    (Bulk)

    Nicholas Piramal Allergan Bulk and Formulations

    Advanced Medical

    OpticsEye Products

    Wockhardt Ivax Nizatidine (anti- ulcerant)

    Dishman Pharmaceuticals Solvay Pharmaceuticals Eprosartan Mesylate

    IPCA Labs Merck Bulk Drugs

    Tillomed Atenelol

    Orchid Chemicals and

    PharmaceuticalsApotex

    Cephalosporin and other

    injectables

    Sun Pharma Eli Lilly CVS products, anti-infective

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    drugs and insulin

    Kopran SynpacPharmaceuticals

    Penicillin- G Bulk Drug

    Cadila Healthcare Altana Pharma Intermediates for Pantoprazole

    Boehringer IngelheimGastrointestinal and CVS

    Products

    Biocon Bristol Myers Squibb Bulk Drugs

    GROWTH OF INDIAN PHARMACEUTICAL INDUSTRY:

    The pharmaceutical industry in India is among the most highly organized sectors. This industry

    plays an important role in promoting and sustaining development in the field of global medicine.

    Due to the presence of low cost manufacturing facilities, educated and skilled manpower and

    cheap labor force among others, the industry is set to scale new heights in the fields of

    production, development, manufacturing and research.

    Industry Trends

    The pharma industry generally grows at about 1.5-1.6 times the Gross Domestic Product

    growth

    Globally, India ranks third in terms of manufacturing pharma products by volume

    The Indian pharmaceutical industry is expected to grow at a rate of 9.9 % till 2010 and

    after that 9.5 % till 2015

    In 2007-08, India exported drugs worth US$7.2 billion in to the US and Europe followed

    by Central and Eastern Europe, Africa and Latin America

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    The Indian vaccine market which was worth US$665 million in 2007-08 is growing at a

    rate of more than 20%

    In 2008, the domestic pharma market in India was expected to be US$ 10.76 billion and

    this is likely to increase at a compound annual growth rate of 9.9 per cent until 2010 and

    subsequently at 9.5 per cent till the year 2015.

    The retail pharmaceutical market in India is expected to cross US$ 12-13 billion by 2012

    The Indian drug and pharmaceuticals segment received foreign direct investment to the

    tune of US$ 1.43 billion from April 2000 to December 2008

    "The Indian pharmaceutical industry has grown from a humble Rs 1,500 crore turnover in

    1980 to approximately Rs 1,00,611 crore in 2009-10," the pre-Budget survey said.

    The growth of the Indian pharmaceutical industry has been fuelled by exports, which

    increased 25 per cent in 2008-09.

    FDI IN INDIA

    FDI in India has increased over the years due to the efforts that have been made by the Indian

    government. The increased flow of FDI in India has given a major boost to the country'seconomy and so measures must be taken in order to ensure that the flow of FDI in India

    continues to grow.

    Advantages of FDI in India:

    The Indian government made several reforms in the economic policy of the country in the early

    1990s. This helped in the liberalization and deregulation of the Indian economy and also opened

    the country's markets to foreign direct investment.

    As a result of this, huge amounts of foreign direct investment came into India through non-

    resident Indians, international companies, and various other foreign investors. The growth of FDI

    in India boosted the economic growth of the country. Major advantages of FDI in India have

    been in terms of -

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    Increased capital flow.

    Improved technology.

    Management expertise.

    Access to international markets.

    Amount of foreign direct investment in India

    The total amount of FDI in India came to around US$ 42.3 billion in 2001, in 2002 this figure

    stood at US$ 54.1 billion, in 2003 this figure came to US$ 75.4 billion, and in 2004 this figure

    increased to US$ 113 billion. This shows that the flow of foreign direct investment in India has

    grown at a very fast pace over the last few years. The various forms of foreign capital flowing

    into India are NRI deposits, investments in the commercial banks of India, and investments in

    the country's debt and stock markets.

    FDI in major sectors in India

    The major sectors of the Indian economy that have benefited from FDI in India are -

    Financial sector (banking and non-banking).

    Insurance

    Telecommunication

    Hospitality and tourism

    Pharmaceuticals

    Software and Information Technology

    Foreign Direct Investment (FDI) is permited as under the following forms of investments.

    Through financial collaborations.

    Through joint ventures and technical collaborations.

    Through capital markets via Euro issues.

    Through private placements or preferential allotments.

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    Forbidden Territories:

    FDI is not permitted in the following industrial sectors:

    Arms and ammunition.

    Atomic Energy.

    Railway Transport.

    Coal and lignite.

    Mining of iron, manganese, chrome, gypsum, sulphur, gold, diamonds, copper, zinc.

    FOREIGN INVESTMENT

    The Foreign Direct Investment (FDI) equity inflows during 2009-10, in the month of November

    2009 were estimated at US$ 1.73 billion.

    Cumulative amount of FDI inflows from August 1991 to November 2009 was US$ 125.92

    billion.

    The sectors attracting the highest FDI equity inflows during April-November 2009 have been the

    Services Sector, Computer Software & hardware, Telecommunication, Housing and real estate,

    Construction activities, Power, Automobile industry, Metallurgical industries, Petroleum &

    Natural gas and Chemicals.

    The top investing countries in terms of FDI equity inflows during April-November 2009 have

    been Mauritius, Singapore, U.S.A, U.K, Netherlands, Japan, Cyprus, Germany, U.A.E, France.

    A n Overview of Advantages of FDI

    Foreign Direct Investment in India is allowed through four basic routes namely, financial

    collaborations, technical collaborations and joint ventures, capital markets via Euro issues, and

    private placements or preferential allotments

    FDI inflow helps the developing countries to develop a transparent, broad, and effective

    policy environment for investment issues as well as, builds human and institutional capacities to

    execute the same.

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    Some of the biggest advantages of FDI enjoyed by India have been listed as under:

    Economic growth- This is one of the major sectors, which is enormously benefited from

    foreign direct investment. A remarkable inflow of FDI in various industrial units in India

    has boosted the economic life of country.

    Trade- Foreign Direct Investments have opened a wide spectrum of opportunities in the

    trading of goods and services in India both in terms of import and export production.

    Products of superior quality are manufactured by various industries in India due to

    greater amount of FDI inflows in the country.

    Employment and skill levels- FDI has also ensured a number of employment

    opportunities by aiding the setting up of industrial units in various corners of India.Technology diffusion and knowledge transfer- FDI apparently helps in the outsourcing

    of knowledge from India especially in the Information Technology sector. It helps in

    developing the know-how process in India in terms of enhancing the technological

    advancement in India.

    Linkages and spillover to domestic firms- Various foreign firms are now occupying a

    position in the Indian market through Joint Ventures and collaboration concerns. The

    maximum amount of the profits gained by the foreign firms through these joint ventures

    is spent on the Indian market.

    FOREIGN DIRECT INVESTMENT (FDI) IN PHARMA SECTOR

    FDI Inflows to Drugs and Pharmaceuticals industry in India has grown over the last few

    years due to the several incentives that have been provided by the Indian government. The

    increase in FDI Inflows to Drugs and Pharmaceuticals industry in India has helped in the

    growth of the sector

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    FDI IN INDIAN PHARMA SECTOR

    Drugs and Pharmaceuticals ranks 8th in Indias top 10 FDI-attracting sectors. The government of

    India has allowed foreign direct investment up to 100% through the automatic route in the drugs

    and Pharmaceuticals industry of the country, on the condition, that the activity should not fall

    into the categories that require licensing. Pharmaceutical industry accounts for about 2.91% of

    total FDI into the country. The FDI in Pharmaceutical sector is estimated to have touched US$

    172 million, thereby showing a compounded annual growth rate of about 62. The Industry has

    received almost Rs 2141 crore investment from 36 countries through FDI between April 2007 to

    April 2009 with most of the fund infusion directed to healthcare and biotech ventures. Out of the

    total investment, almost 82 per cent of the FDI in Pharmaceutical sector was from five countries

    - Mauritius, Singapore, USA, UAE and Canada. The increase in FDI Inflows to Drugs and

    Pharmaceuticals industry in India has helped in the expansion, growth, and development of the

    industry. This in turn has led to the improvement in the quality of the products from the drugs

    and Pharmaceuticals.

    Technologically strong and totally self-reliant, the Pharmaceutical industry in India has low

    costs of production, low R&D costs, innovative scientific manpower, strength of national

    laboratories and an increasing balance of trade. The Pharmaceutical Industry, with its rich

    scientific talents and research capabilities, supported by Intellectual Property Protectionregime is well set to take on the international market as a global leader.

    The Pharmaceuticals sector has been able to attract FDI amounting to Rs.21409 million during

    the period from April, 2007 to April, 2009 including Rs. 43.42 million in the first month of the

    current year. Out of 36 countries which contributed to FDI in India, 5 countries, led by Mauritius

    (56.36%), Singapore (11.18%), USA (5.81%), UAE(4.73%) and Canada(4.00%), accounted for

    over 82% of FDI in Drugs & Pharmaceuticals(Table-1).

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    FDI IN INDIAN PHARMA SECTOR

    There were 208 foreign collaborators during the period April, 2007 to April, 2009 in so far as

    Drugs & Pharmaceuticals are concerned. Of these, top 10 foreign collaborators contributed

    48.70% of FDI. Further, out of top 10 collaborators, 7 were from Mauritius and one each from

    Singapore, UAE and USA as may be seen from the Table-2.

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    INDIAN PHARMA ATTRACTS RS 2141 CR FDI IN 2007-09,

    MAJORITY FROM MAURITIUS

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    FDI IN INDIAN PHARMA SECTOR

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    FDI IN INDIAN PHARMA SECTOR

    FDI POLICY IN THE DRUGS AND PHARMACEUTICALS INDUSTRY IN

    INDIA

    In India, the Department of Chemicals & Petro-Chemicals, in the Ministry of Chemicals and

    Fertilizers, is the concerned authority for the drugs and phamaceutical sector. The Department

    aims at ensuring abundant availability of good quality pharmaceuticals of mass consumption, at

    reasonable prices within the country. It also formulates and implements policies and programmes

    for achieving growth and development of chemicals, petro-chemical and pharmaceuticals in the

    country.

    In order to attract investment into the sector, the Department has undertaken several initiatives.

    The major being the Pharmaceutical Policy, with the objective of:-

    Strengthening the indigenous capability for cost effective quality production and exports

    of pharmaceuticals by reducing barriers to trade in the pharmaceutical sector.

    Strengthening the system of quality control over drug and pharmaceutical production and

    distribution to make quality an essential attribute of the Indian pharmaceutical industry

    and promoting rational use of pharmaceuticals.

    Encouraging R&D in the pharmaceutical sector in a manner compatible with the

    countrys needs and with particular focus on diseases endemic or relevant to India by

    creating an environment conducive to channelising a higher level of investment into

    R&D in pharmaceuticals in India.

    Creating an incentive framework for the pharmaceutical industry which promotesnew investment into the pharmaceutical industry and encourages the introduction

    of new technologies and new drugs

    As per all such initiatives, foreign Direct Investment (FDI) upto 100% is permitted (subject to

    stipulations laid down from time to time) through the automatic route in the case of all bulk

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    drugs cleared by Drug Controller General (India) along with all their intermediates and

    formulations.

    MEASURES TAKEN BY GOVERNMENT TO ATTRACT FDI

    Recent Initiatives in Pharma sector

    Government has taken various policy initiatives for the Pharma sector

    Government has offered fiscal incentives to R&D units in Pharma sector

    Steps have been taken to streamline procedures covering development of new drug

    molecules, clinical research etc.

    A number of inhouse R&D units holding recognition of DSIR have come up in the

    Pharma sector. These units are eligible for weighted tax deduction@150% under Section

    35 (2AB) of the Income Tax Act 1961 for the R&D expenditure incurred.

    Government has also come up with two new schemes specially targeted at drugs &

    pharmaceutical research.These are: 'The New Millennium Indian Technology Leadership

    Initiative' (NMITLI) and the 'Drugs and Pharmaceuticals Research Programme' (DPRP).

    As per Union Budget 2010.

    Improving Investment Environment

    Foreign Direct Investment (FDI) inflows during the year have been steady in spite of the

    decline in global capital flows. India received FDI equity inflows of US$ 20.9 billion during

    April-December, 2009 compared to US$ 21.1 billion during the same period last year.

    Government has taken a number of steps to simplify the FDI regime to make it easily

    comprehensible to foreign investors. For the first time, both ownership and control havebeen recognised as central to the FDI policy, and methodology for calculation of indirect

    foreign investment in Indian companies has been clearly defined. A consistent policy on

    downstream investment has also been formulated. Another major initiative has been the

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    complete liberalization of pricing and payment of technology transfer fee, trademark,

    brand name and royalty payments. These payments can now be made under the automatic

    route.

    Government also intends to make the FDI policy user-friendly by consolidating all prior

    regulations and guidelines into one comprehensive document. This would enhance clarity

    and predictability of our FDI policy to foreign investors.

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    BUDGET 2010 - EXPECTATIONS OF PHARMA INDUSTRY

    The last budget being neutral, the Indian pharmaceutical industry has drawn its unfinished

    agenda with the hope that Budget 2010 would prove to be a remedy for the industry. Industry

    believes that its wish list has a merit for consideration in this budget as some of these items have

    not been covered in the aforesaid impending legislations.

    Research tax credits

    Drying pipeline of new drugs, increased R&D expenditure and increased pressure in the

    developed nations to bring the health care costs down has compelled MNCs to offshore R&Dfurther. While India is perceived as an attractive destination to outsource R&D work due to its

    low cost and high quality capabilities, to put India in a leading position, there is a need to

    provide impetus to such activities in the form of tax and fiscal benefits. While currently,

    weighted tax benefit is available for in-house R&D, there are no specific benefits available to

    units engaged in the business of R&D. In this regard, the Government can play its role by

    providing benefits to units engaged in the business of R&D by way of deduction from profits

    linked to investments. Further, benefits in the form of research tax credits, which can be used to

    offset future tax liability, similar to those given in developed economies can also be considered.

    Include expenses related to research done outside R & D lab

    The Indian pharma space has witnessed multiple innovative moves that have strengthened their

    ability to make it big in the discovery/R&D space. These Indian companies incur huge

    expenditure on overseas trials, preparations of dossiers, consulting/legal fees for NCE (New

    Chemicals Entities) and ANDA (Abbreviated New Drug Applications) filings with the US FDA.

    Also there is a significant amount of legal costs incurred in defending the patents and products.

    While currently, weighted deduction is available for expenditure on in-house R&D facility, the

    provisions do not specify that the expenditure incurred outside the R&D units are eligible for

    weighted deduction. Accordingly, industry bodies have sought the inclusion of expenditure

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    incidental to research carried outside R&D facility in India or in any foreign country, within the

    ambit of weighted deduction.

    Extend tax holiday to hospitals beyond rural areas

    The quality and low cost advantage has boosted the medical tourism in India. Industry report

    suggests that about 150,000 medical tourist visit India every year. Further, medical tourism to

    India is expected to bring revenue of $2 billion by 2012. In order to capitalise on the opportunity

    and to strengthen the position of India as a low cost health care tourist destination, there is a

    greater need to set-up more and more state of the art health care facilities. Even otherwise, there

    is a clear case of augmenting health care system in India. Given that large part of investment

    would need to be contributed by private sector, the Government can play its role by providing

    fiscal benefits and extending the existing tax holiday to hospitals set up beyond the rural areas.

    Subsidy for rural healthcare infrastructure

    Specifically with regard to rural and semi-urban areas, several companies have taken the

    initiative to build the supply chain infrastructure and develop specific products--these steps are

    not easy and carry huge investments. To promote the development of these areas and have better

    access to healthcare facilities, the Government, in addition to its own programs, should support

    the private sector as well--this could be in the form of subsidy, sharing infrastructure with privatesector, tax incentives and so on.

    Rationalise assessment procedure

    As per the industry practice, Pharma companies reach out to patients through doctors by

    providing free samples of drugs to doctors and incur other promotional expenditure on seminars

    and so on for education of doctors. This creates awareness about the drugs and ultimately helps

    in boosting the sales of the companies. During the course of assessment proceedings, the revenue

    authorities often challenge the promotional information and ask for voluminous documents

    which are cumbersome to provide. They also often deny tax deduction on an ad-hoc basis. In this

    regard, the Government can rationalize the provisions by providing for claim of expenditure on a

    self certification basis or on the basis of specified documents such as CA certificate and so on.

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    Harmonize pricing regulations

    Transfer pricing is another area needing special attention for pharmaceuticals industry. While

    transfer pricing regulations expect companies dealing in active pharmaceuticals ingredients

    (APIs)/finished drug formulations (FDFs) imported from related parties to maintain higher

    margins, Drugs Prices Control Order (DPCO) places restrictions on the end selling price. Equally

    customs regulations create a reverse pressure by seeking to check any undervaluation of

    imported APIs/ FDFs. There is a clear case to being in harmony in transfer pricing, customs and

    DPCO regulations. Other issues which pharma companies face is comparison of prices of

    innovator/ research oriented companies with generic companies without taking cognizance of

    quality and efficacy. This causes significant hardship for innovators companies who spendsignificant costs on research. There is an immediate need to address these issues as well. Also,

    while it is proposed that Advance Pricing Agreements (APAs) and safe harbor rules would be

    introduced, it needs to be expedited.

    Extend list of life saving drugs

    On the indirect tax front, the Government can look at extending the list of life saving drugs,

    which are eligible for customs duty exemptions in India. This will lead to availability of life

    saving drugs to the patients at reduced prices and bring down the cost of treatment for these

    ailments. Further, it could also consider reducing the duty on medical devices which would lead

    to overall reduction in the cost of treatment of patients. Also, Government could consider

    reducing basic custom duty for formulations to five percent in line with the Chelliah Committee's

    long-term fiscal policy recommendation.

    Rationalise duty structure

    The levy of excise duty on API at eight percent and on output of four percent has led to

    accumulation of Cenvat credit in the books of manufacturers, especially those who are not

    engaged in exports and cater only to the domestic market. Further, there are no provisions to

    recover the accumulated Cenvat credit, which becomes a cost to such pharma manufacturers.

    The Government could consider rationalising the duty structure by making it at par with duty on

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    final output. Another demand has been to increase the abatement limit allowed for computation

    of excise duty on medicaments, from 35 to 45 percent. Further, industry has sought

    rationalisation of Value Added Tax (VAT) on medicines across states with specific exemption of

    life saving drugs and life saving medical devices.

    In a nutshell, while the global developments have led to exciting opportunities for Indian pharma

    industry, it is once again in search of support from the Government to tap the same. On the other

    hand, the Government is making progress in bringing two major tax reforms, ie direct tax code,

    and goods and services tax; they carry an underlying agenda of bringing tax reforms,

    simplification of procedures and minimisation of tax incentives. Given that the Government

    intends to implement these legislations in the near future, it appears that it may not bring in anymajor changes in this budget.

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    IMPACT OF BUDGET ON PHARMA SECTOR

    The Indian Pharmaceutical Industry (IPI), valued at around US$20 bn (Share: Domestic

    59%, Exports 41%), is ranked 11th in value terms and fourth in volume terms in the

    world. It manufactures about 400 bulk drugs and almost the entire range of formulations.

    The industry, however, constitutes less than 2% of the total global industry turnover dueto low prices.

    The industry is highly fragmented with around 20,000 players, of which around 250 in

    the organised sector control over 70% of the total domestic market in value terms.

    The industry has been growing at a healthy rate of 11-12% annually over the last few

    years driven by good growth in both domestic and export markets. While growing share

    of generics in the developed markets and opportunity from Contract Research and

    Manufacturing Services (CRAMS) have been the primary drivers for exports, changing

    demographics and shift in disease profile have been the major factors contributing to the

    domestic market growth.

    The IPI has remained largely immune to the global slowdown. Though the industry

    achieved good growth in total turnover during FY2008-09, its profitability was

    negatively affected due to exchange fluctuation losses, high interest burden and volatility

    in raw material prices. Globally, the impact of economic slowdown has had varied impact

    across different markets with overall moderation in growth rate vis--vis previous year.

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    BUDGET PROPOSALS

    1. Increase in the weighted deduction on expenditure incurred on in-house Research &

    Development activities from 150% to 200% also increase in the weighted deduction on

    payments made to National Laboratories, research associations, colleges, universities and

    other institutions, for scientific research from 125% to 175%.

    2. Increase in peak rate of excise duty from 8% to 10%.

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    3. Increase in rate of Minimum Alternate Tax (MAT) from 15% to 18%.

    *Excluding 2% education cess and 1% secondary & higher education cess

    # On influenza vaccine and nine specified life saving drugs used for the treatment of breast

    cancer, hepatitis-B, rheumatic arthritis etc and bulk drugs used for the manufacture of such drugs

    IMPACT OF BUDGET ON PHARMA SECTOR

    1. Increased weighted deduction on in-house R & D expenditure will further encourage

    spending by pharmaceutical and biotech companies on research for New Chemical

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    Duty Structure

    (%) Existing Proposed

    CUSTOMS DUTY*

    BulkDrugs

    7.5 7.5

    Formulations

    10.0 10.0

    LifeSaving Drugs#

    5.0 5.0

    EXCISE DUTY

    BulkDrugs

    8.0 10.0

    Formulations

    4.0 4.0

    LifeSaving Drugs#

    Nil Nil

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    Entities (NCEs), New Drug Delivery Systems (NDDS) etc carried out in-house or

    outsourced to third parties like National Laboratories and research institutions.

    Expenditure of capital nature and cost incurred on clinical trials conducted domestically

    will also be eligible for enhanced rate of weighted deduction.

    2. Impact of increase in peak rate of excise duty would increase the cost of bulk drugs &

    drug intermediates for the formulation companies. However, the impact on bulk drug

    manufacturers would depend upon their ability to pass-on the increase to domestic clients

    while their export business would remain unaffected.

    3. Increase in MAT rate is expected to result in higher tax outgo for pharmaceutical

    companies covered under MAT and operating from tax-exempt locations.

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    BUDGET IMPACT: COMPANIES

    Company

    % of Sales

    Applicable

    ProposalsOverall Impact

    Bulk

    DrugsFormulations

    Ranbaxy Lab. 25 74 1,2 and 3 ??

    Sun Pharma 11 89 1 and 2 ??

    Dr. Reddy's Lab. 37 56 1 and 2 ?

    Cipla 12 84 1 and 2 ??

    GlaxoSmithKline 3 97 2 ?

    Biocon 92 8 1, 2 and 3 ??

    Aurobindo Pharma 56 44 2 ??

    Lupin 18 82 1, 2 and 3 ??

    Legends:

    ?? Highly Positive ?Marginally

    Negative?? Neutral

    ? Marginally Positive ? ? Highly Negative No Proposals

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    'PHARMA TO BE ONE OF TOP THREE FDI ATTRACTING SECTORS

    IN INDIA'

    Over the past few years, the number of FDI investors has been increasing with keen interest

    in the pharma Sector

    Could you explain the sudden FDI interest and activities in the Indian pharma and

    lifesciences sector?

    The confidence of the international investors has been growing in the Indian pharma sector post

    the enactment of product patents in January 2005. Many global pharma companies have/are in

    the process of setting up their own base in India by increasing stake in their own Indian

    subsidiaries or collaborating with local pharma companies. Post 2005, about 17 patents have

    been filed in India for new products. This number is expected to increase over time as more and

    more companies gain positive experience of doing business in India. The Indian pharma and life

    sciences sector is expected to grow through the launch of new products from India's own New

    Chemical Entities (NCE) pipeline, increasing number of in-licensing and out-licensing deals

    between Indian and foreign companies and consolidation in the sector with Indian companies

    acquiring assets in India as well as abroad.

    Another factor is that for the production of drugs and pharmaceuticals, an FDI of 100 percent is

    allowed, subject to the fact that the venture does not attract compulsory licensing and does not

    involve use of recombinant DNA technology.

    Who are the major global players in Private Equity (PE) activities, specifically for

    pharma?

    In the developed markets, many PE funds have been created with specific focus on pharma and

    life sciences sectors. Some of them have been increasing activity in India as well. Well known

    names that have been operating in the US and European markets are Domain Associates, MPM

    Capital, Alta Partners, SV Life Sciences Advisers, Burrill & Company, OrbiMed Advisors,

    Quaker BioVentures and Venrock Associates. On the Indian side, the Ajay Piramal Group

    sponsored IndiaVenture Fund. This fund is focused on making investments across the entire

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    healthcare and life sciences domain including hospitals, pharma and biotech, healthcare IT, retail

    pharmacies, clinical research, medical devices etc.

    In the current market situation, how are Venture Capital (VC) and PE companies

    structuring their investments and returns from pharma companies?

    While VC and PE firms looking at pharma and life sciences sector are being selective with their

    money, the economic crisis has not had a substantial negative impact on their activities. Pharma

    and life sciences investors are in it with intent to capture the opportunity offered by the sector as

    they are not very susceptible to short-term problems. In fact, the sector's desperation for cash has

    led to better deal terms for VCs. And companies that do secure funding are using it wisely, since

    they cannot afford to waste money anymore. In many cases, the best business plans are able to

    raise funding while less promising ideas fall by the wayside.

    Mostly PE companies structure their investments in order to protect their returns and to ensure

    that they are able to exit from their investments within their defined time frames (typically three

    to five years). The nature of the sector is such that VCs need to look at all the avenues for value

    creation once they have made the investment. In order to accomplish value creation, the PE

    companies negotiate for at least one board seat. PE funds also look for opportunities to create

    value through cross sector synergies across their portfolio of companies. In case of our

    IndiaVenture Fund, we get benefited by the relationships of Ajay Piramal group that have been

    created over two decades across the entire healthcare and life sciences domain.

    What has been the estimated FDI in the pharma/lifesciences industry over the past five

    years?

    The total cumulative FDI that has come into India till date is about $110 billion. However, 80

    percent of this FDI inflow has happened from April 2000 to March 2009 (nearly $90 billion). In

    the financial year 2009, the total FDI was $27 billion and in the financial year 2008, the FDI

    inflow was at $24 billion.

    So far the Indian drug and pharmaceutical sector has attracted close to $2 billion in FDI in

    cumulative value. The sector has been able to attract FDI amounting to $1.4 billion from April

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    2000 to December 2008. This sector has become one of the top sectors for FDI in India.

    However, with the recent downfall in the global economies, PE investments declined 34 percent

    to $303.0 million in 2008, compared to $459.2 million invested during first 10 months of 2007.

    Average PE deal size in 2008 came down to $16.8 million from $30.6 million in 2007.

    Till now, which country has shown keen interest in India? Why?

    Mauritius has contributed the maximum (about 40 to 50 percent of the total FDI), $40 billion

    from FY 2000 to FY 2009 and about $2.5 billion in FY 2010 so far. The top five countries with

    highest cumulative FDI into India are--Mauritius (44 percent), Singapore (nine percent), USA

    (seven percent), UK (six percent) and Netherlands (four percent). Mauritius and Singapore offer

    significant tax and regulatory advantages to the investors. That is the primary reason majority of

    the PE funds are housed in Mauritius and a few are based in Singapore.

    What kind of returns have been observed by FDI investors?

    There are not many examples in the Indian pharma and life sciences sector where the FDI

    investors have exited their investments. However, just to give an example, early investors in

    Biocon have made tremendous returns. ICICI venture paid Rs 18 crore for a 15 percent in March

    2000, and sold its holding (it was diluted to 12.5 percent after intra-group mergers) in 2002 for

    Rs 46 crore to AIG investments and GW capital. That's a 156 percent return in just over twoyears. In March 2004, Biocon went in for an IPO at a price of Rs 315 per share. AIG investments

    and GW capital made huge returns on this investment. Not every investment would yield these

    kinds of returns, but the sector offers unique opportunities for making good returns if invested

    properly.

    Why are developed countries investing their funds via other countries, and how does this

    channel of investment benefit them?

    Each country has different regulations, taxes and exchange restrictions, as well as limitations on

    personal freedoms of speech, privacy and petition of grievancesthat affects the decisions of

    investors about where to put their investments. Some countries have become highly specialised

    in attracting international investors and have created conducive environment for these investors.

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    However, countries where the growth investment opportunities exist may not necessarily offer

    specialised tax or regulatory incentives even though they may have well defined tax treaties with

    countries offering better tax and regulatory environment.

    What are the factors affecting the growth of FDI investments?

    FDI in any country, directly or indirectly impacts the environmental, governance and social

    issues. Typically, the host country limits the extent of impact that may be made by the FDI to

    ensure adequate protection for small scale businesses. At times certain foreign policies may not

    be appreciated by the workers of the recipient country. Some disadvantage of FDI pertain to the

    fact is that there is a chance that a company may lose out on its ownership to an overseas

    company. This has often caused many companies to approach foreign direct investment with a

    certain amount of caution. India showed initial resistance to FDI because of the above reasons.

    However, the overall impact of the FDI investments has been positive for the growth of the

    country.

    The Government of India has a well-defined and transparent FDI policy. This includes opening

    of many new sectors to FDI, raising FDI equity caps in sectors already opened and procedural

    simplification. The FDI policy in India is widely reckoned to be among the most liberal in

    emerging economies and FDI up to 100 percent is allowed under the automatic route in most

    sectors and activities.

    Given the critical role that technological innovation plays in the sector and the role that IPRs

    play in the ability of the pharma sector to capitalise on that innovation, it is not surprising to find

    a positive relationship between IPRs and FDI in the sector. The strength of IPR protection

    appears to be one important factor, among others, influencing trade and investment decisions in

    the sector.

    Where do you see FDI investments in the pharma and lifesciences sector in India in the

    future?

    The Indian pharma and life sciences sector will continue to internationalise and seek to capitalise

    on new market opportunities around the world.

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    Moreover, as intellectual property standards in India continue to provide increasing comfort to

    the international community, one could reasonably anticipate geographic diversification in the

    types of investments in the sector, including R&D.

    In this context, one can expect growth in the FDI as firms seek to exploit locational advantages

    of sites around the world and thereby contain costs or position themselves strategically.

    In the coming years, I expect this sector to be one of the top three sectors attracting FDI in India.

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    CONCLUSION

    The Indian pharmaceutical industry is a success story providing employment for millions

    and ensuring that essential drugs at affordable prices are available to the vast population of

    this sub-continent.

    The increase in FDI Inflows to Drugs and Pharmaceuticals industry in India has helped in

    the expansion, growth, and development of the industry. This in its turn has led to the

    improvement in the quality of the products from the drugs and pharmaceuticals industry.

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