BEP - Neeraj

Indian Pharmaceuticals Export IndustryContemporary scenario, critical analysis & future trends

Sumeet Shekhar Neeraj Date: 05-10-2011+91 78428 88751MBA (IB) 2nd YearGITAM School of International Business

Abstract

India has emerged as a preferable manufacturing destination for global pharma majors namely Roche, Eli- Lilly, Johnson & Johnson, Glaxo etc., the world leaders who have already ingrained themselves deep into the Indian market in line with Indian majors like Cipla, Dr. Reddys Labs, Ranbaxy and various others savouring high quality, cost effective production capabilities of India for their exports to the world market. The Indian Pharmaceutical industry has grown from a $333.33m turnover in 1980 to approximately $22.5bn by 2010 and the country now ranks 3rd in terms of volume of production (10% of global share) and 14th by value (1.5%). Exports ($12bn) of pharmaceuticals have consistently outstripped imports ($6.5bn). India currently exports drug intermediates, active pharmaceutical ingredients (APIs), finished dosage formulations, bio–pharmaceuticals and clinical services. The sooner India manages to close the infrastructure gap (major central infrastructure projects mainly roads, ports, airports and power plants, 55% delayed, 2009 data), the financial gap (huge costs and time for international approvals and registration processes) the faster the growth will be in Indian pharmaceutical industry (Economic Survey of India 2010). The focus markets of Indian pharmaceutical exports industry largely needs R&D spending, financial aids, policy in action, mergers and acquisitions to be improved, reviewed and critically identified, modulated and studied respectively to grab the largest pie of the export market plethora for the future growth of the industry.

INTRODUCTION

India's pharmaceutical sector has seen unprecedented changes in the past decades ensuing for a remarkable

growth in its exports (pharmaceutical exports occupy a share of 4.4% to 5.2% of India's total exports i over

the last 6 years) and exports grew at a CAGR of around 22% in the 6 year period of 2004-05 to 2009-10.

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Indian Pharma Exports ($bn) & % Share of Total Exports

Pharma Exp($Bn)Share of total Exp

Indian Pharmaceutical Export Industry: Contemporary scenario, critical analysis and future trends.

The industry in the country now ranks 3rd in terms of volume of production (10 per cent of global share) and

14th by value. Exports ($10.3bn) of pharmaceuticals have consistently outstripped imports ($6.5bn)ii.

India’s growth story in itself vindicates its potential, it had a $333.33m turnover in 1980 to around $22.30 bn

by 2010-11 and a number of the country's largest pharmaceutical companies are attaining global-player

status (viz. Cipla, Ranbaxy, Dr. Reddy’s Labs, Lupin, Sun Pharma, Cadila etc.) as existing markets expand

(the less regulated markets/LRMs viz. Thailand, Cambodia, Malaysia, Pakistan, Vietnam, Ukraine, Belarus

and Moldova, with other importing LRMs in Azerbaijan and Kyrgyzstan), and new ones open up (Iran,

Saudi Arabia, China, Georgia , South Africa etc.), for high quality, affordable generic drugs in the highly

lucrative markets.

Approximately $123bn of generic products is at risk (subject to patent renewal approvals by regulators) of

losing patents by 2012. Even at a conservative estimate of 15% opportunity this translates into $18.4bn

opportunity for Indiaiii. However the figures need to be appropriately deflated since Indian opportunity will

lie in generics equivalent of branded drugs, which would be cheaper.

Ageing populations of the US (plus the 2010 US Healthcare Reforms in action), China & European

economies leading to the more and more expenditure on medicines and appreciation in the per capita

consumption value of the drug products with cheaper rates, which is India forte (an astounding e.g.: In India,

100 tablets of Zinetac, a drug used in common peptic ulcers cost $2 while, in Chile, it’s as much as $ 196).

Generics business: The aforesaid companies have boosted their capacities, as demand continues to grow for

the generics offered in the fields of antiretroviral therapy (Cipla), oncology (Cipla & Dr. Reddys), antibiotic

therapy (Micro Labs, Aventis Pharma, Glaxo), insulins and vaccines (Biocon, Serum Institute of India) and

other hormonal drugs; India manufactures more than 96 generic group drugs (including Para IV high risk

high return products and Plain-Vanilla generics) offered to the global market. The Para IV’s of Indian

manufacturers have been a large revenue driver for some of the R&D based companies Viz. Ranbaxy, Dr.

Reddys Labs, Hetero Drugs, Cipla etc. Para IV is one of the key strategies that have been believed to

dominate thinking in the pharmaceutical industry; in order to grow fast; companies aggressively pursue

investment in both new chemical entities and new products, which could successfully challenge existing

patented drugs. This is a high risk-high reward business model; a strategy that has been found very useful is

to file for a patent challenge under Para IV of the Hatch Waxman Act, 1984. Paragraph IV is an important

aspect of the Hatch-Waxman Act- USA. Under this system, generic drug firms challenge pioneers drug

patents in court. The claim is that that the generic version proposed to be launched by the

manufacturer/claimant does not infringe the patent holder’s version. If successful, the prevailing generic

firm obtains a “180-day marketing exclusivity period” as the economic reward for its litigation efforts, and

consumers benefit from earlier access to low-cost generic alternatives to the brand-name drug)

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Regulations: A 100% foreign direct investment through automatic route, liberalisation of rules related to

foreign technology agreements as well as of the import regime, the introduction of Schedule-M, Schedule-T

and revision of Schedule-Y (to permit conduct of phase II-IV clinical trials in India) of The Drugs and

Cosmetics Act, 1940 had put upon a great impulse to the industry. There has been a recent tussle between

industry leaders and heads of other institutions on reconsidering the industry to be regarded as sensitive one

and reduce the automatic FDI route to 49% from prevailing 100%. The reconsideration is as of now been

handed over to the Competition Commission of India (CCI)iv.

PHARMEXCIL: The creation of PHARMEXCIL as well as a National Pharmaceuticals Policy with the

objective of, among other things, has been rendering India as a preferred global destination for

pharmaceutical R&D and manufacturing followed by exporting the drugs has proved successfulv. The recent

creation of a separate Department of Pharmaceuticals is only a manifestation of the importance government

of India has accorded to the sector.

Markets & regulations: Currently India exports full basket of pharmaceutical products comprising

intermediates, APIs, Finished Dosage Combinations (FDCs), biopharmaceuticals, vaccines, clinical services,

etc., to various parts of the world. India is among the top 20 pharmaceutical exporters world-wide and with

the largest number of US FDA inspected plants (119 plants), outside the USA. Various other agencies like

MHRA (Medicines & Healthcare Regulatory Agency) UK, MCC (Medicines Control Council) South Africa,

TGA (Therapeutic Goods Administration) Australia, HPB (Health Promotion Board) Canada have approved

scores of plants in India5. Notably the global pharmaceutical markets are estimated at $773.1bn (2008)

growing at 4.8% over the previous years.

Broadly, Asia is the largest importing region from India with a share of 30% of India's pharmaceutical

exports followed by Europe (24%) and North America (21%). During 2008-09 United States of America had

been the top export destination with a share of approx. 18% in India's pharmaceutical exports valued at

$1.55bn followed by Russia’s valued at $0.33bn with a share of 3.84%, Germany ($0.31bn and 3.65%),

Austria ($0.31bn and 3.58%) and UK ($0.27bn and 3.12%). In the year 2008-09, 58% of India's

pharmaceutical exports comprised formulations valued at $5.03bn followed by Bulk Drugs (48%) valued at

$3.6bn and herbals exports 3% valued at $251mvi.

Pharma SMEs: According to the CII (Confederation of Indian Industries), there are around 80,000 small-

scale units engaged in the areas of pharmaceutical formulations and bulk drugs. The present decade has

opened up newer opportunities for the SMEs (Small- to Medium-Sized Enterprise) in the field of CRAMS

(Contract Research and Manufacturing Services), Clinical trials etc. A number of them have received

approvals from international regulatory authorities mentioned below for facilities and expertise; they can

avail opportunities in CRAMs (e.g. Macleods Pharmaceuticals, Micro Labs, Alkem Ltd, Hetero Drugs,

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Ankur Drugs etc.). The product launches may help SMEs to secure manufacturing contracts and

opportunities to supply Active Pharmaceutical Ingredients (APIs) and allied chemicals. The German

Technical Cooperation has entered into a memorandum of understanding (MoU) with the Drugs &

Pharmaceuticals Manufacturers Association (DPMA) of India to help pharma-SMEs that need interventions

to brave the intense competition. India government has been making every attempt to support SMEs through

several incentives. One such effort is the development of SMEs clusters in various parts of the country (e.g.

Indore- SEZ, Baddi- Export Promotion Industrial Park- EPIP).

Pricing & policy controls: The uncertainty in the pricing policy (governed by the National Pharmaceutical

Pricing Committee and the Drug Price Control Order 1995) of drugs imposed by the Indian government at

various levels of the industry on a number of essential drugs despite an increase in the price of raw material

has taken a toll on the bottom lines of manufacturing companies, thereby hampering its R&D initiatives.

A significant boost in certain critical areas such as manufacturing regulatory infrastructure (The Drugs and

Cosmetics Act 1940 recent amendments in Schedule M, guiding the Good Manufacturing Practices have

come in line with the standards of USFDA regulations) and new drug discovery programme (Schedule Y of

the act), the improvised Indian Pharmacopoeial Compendia (in quasi equal standards to the United States

Pharmacopoeia and the British Pharmacopoeia) can place India among the top pharmaceutical industries in

the world.

Bilaterals and International agreements: Post liberalization, the pharmaceutical export industry has had to

reorganize itself to keep pace with the economic reforms that were taken on by India, the abolition of

industrial licensing as well as the international export commitments mainly the bilaterals and agreements

and/or pacts signed which testify a lot of decisive work and agreement on pharmaceutical tariff lines curb

e.g. India-Ghana, India-Peru, India-Russia, India-Kenya, India-South Africa, India-Singapore, India-

Mongolia, India-Japan EPA, other comprehensive treaties and joint workings with almost all of the

developing economies of the world for pharmaceuticals trade and businesses, now has begun exploring the

greener pastures of countries like African countries (Nigeria, Kenya and various others etcvii.), India-Japan

EPA (Economic Partnership Agreement, September 2010) would boost the industry as Japan is one of the

global leaders in per capita drug consumption i.e. more than $412 followed by Germany- $222 and USA-

$191). India exported $1.38bn worth drugs & Pharmaceutical to Asia (approx. 19% of India’s total pharma

exports) and ASEAN countries accounted for $497.73m (approx. 36%)viii.

Labour Costs: Skilled scientists/technicians/management personnel at affordable costs have kept India one

of leading in the list, as studied by BLS (Bureau of Labour Statistics) Hourly labour compensation costs in

India are among the lowest when compared with the 36 countries which are huge cost advantages (in 2005,

India’s average hourly compensation cost for all employees in manufacturing i.e. $0.91 was approximately

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3.1% of the level seen in the United States i.e. $29.74) for the Western pharmaceutical companies of up to

60-70% aptly have made the country to be the choicest manufacturing & exporting destinations in the sector.

Comparison of Cost Advantage in India (%)ix

Costs in the Western Countries (Taking) 100.0%

Production costs 50.0%

R&D Costs 12.5%

Clinical Trials Cost 10.0%

Source: Pharmexcil Research

Manufacturers’ Internal Infrastructure: The Indian skilled workforce and Western-equivalent research

infrastructure owned by the Indian MNCs (Multi-National Companies) viz Lupin, Cipla, Ranbaxy, Dr.

Reddys Labs etc. with well-equipped R&D labs with advanced imported technologies such as Nuclear

magnetic resonance (NMR), advanced Chromatography (HPLC- High Performance Liquid

Chromatography, Gas Chromatography etc.) based equipments, Infra-Red (IR) Spectroscopes etc., Clinical

Research facilities and tie-ups with major clinical services providers viz. Clingene (Biocon), Quintiles, and

various other Clinical Research Organizations (CROs) for their outsourced researches and clinical trials.

Employment Costs Viz. Skilled scientists/technicians/management personnel at affordable costs have kept

India one of leading in the list, as studied by BLS (Bureau of Labor Statistics) Hourly labour compensation

costs in India are among the lowest when compared with the 36 countries which are huge cost advantages

(in 2005, India’s average hourly compensation cost for all employees in manufacturing i.e. $0.91 was

approximately 3.1% of the level seen in the United States i.e. $29.74) for the Western pharmaceutical

companies of up to 60-70% aptly have made the country to be the choicest manufacturing & exporting

destinations in the sector.

Scientific & Educational Institutions: The quality knowledge dissemination by institutions like Council of

Scientific and Industrial Research (CSIR), National Research Development Corporation, Central Drug

Standard Control Organization (CDSCO), Indian Council of Medical Research (ICMR), Indian Drug

Manufacturers Association (IDMA) and various others, during the last few years there has been

phenomenal growth in the number of institutions imparting pharmaceutical education and combined

admission capacity of the courses is about 61,000 seats scored through 500 plus colleges (teaching 2 years

Diploma, 4 years Graduation, 2 years Post Graduation and 5 Plus years in PhD etc. regulated jointly by

Pharmacy Council of India and All India Council of Technical Education).

Expertise from institutions viz. CDRI (Central Drug Research Institute), IISc (Indian Institute of Science),

NIPER (National Institute of Pharmaceutical Education and Research), NRDC (National Research

Development Corporation) and various others, R&D capabilities, Science-Technology infrastructure and

industry during the last five decades have also selectively developed to extraordinary levels as compared to

that in most developing nations impelling greatly to the exports sector of the industry.

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India Pharma Patent Regime: The improved Intellectual Property protection after the introduction of

TRIPS (Trade-Related Aspects of Intellectual Property Rights) and compulsory licensing (such licenses

provide generics companies with restricted access to intellectual property in order to manufacture generic

versions of patented medicines in good faith of the country’s health)x, protected patent regime after the

TRIPS (commitments taken by India under the WTO Agreement on Trade Related Aspects of Intellectual

Property Rights (TRIPS) forced a change in The Patents Act regime in 2005, bringing to the fore a major

challenge for the country’s pharmaceutical industry to comply with the TRIPS guidelines, the Product patent

was reintroduced after 35 years again) provided a safe platform on which pharmaceutical exporters has

helped them grow in India and also meet the need for increased production rather than relying on imports,

which was once critical for the infant Indian national economy. The fact of the matter is that Indian

manufacturers are still not able to encash the opportunity due to the lack of investments and government

promotion in the Pharmaceuticals research (only a handful of government clinical and manufacturing

research promotion and development institutions exist as mentioned above) and Public Private Partnership

in the sector for promoting Orphan Drugs research and other similar projects as opportunities for the sector.

Government’s Schemes & Initiatives: Reduced pro-manufacturing, CAPEX costs by duty exemption upto

zero percent by EPCG scheme of Foreign Trade Policy) and expenditure to run cGMP compliance facilities

and high quality documentation and process understanding is grossly being supported by the Government

(DGFT & Deptt. Of Commerce) by the promotional policies viz. EPCG (Export Promotion Capital Goods),

other duty drawback schemes (except DEPB which was discontinued from Oct-2011xi), MAI (Market

Access Initiative, financial assistance is also provided for contesting litigation(s) in the foreign country

concerning restrictions/anti-dumping duties etc. on particular product(s) of Indian origin), MDA (Marketing

Development Assistance) DGFT (Directorate General of Foreign Trade) has been supportive to the

exporters by leveraging the zero duty benefits and schemes of the Foreign Trade Policy 2009-2014, revised

2010.

To promote pharmaceutical exports PHARMEXCIL-Hyderabad (works closely with the Department of

Commerce and the Export Promotion Cell in the Department of Chemicals and Petrochemicals to undertake

activities such as promoting exports, preparing country-profiles, assessing export potential across the

countries and to have greater degree of interaction internationally), EXIM Bank (indulged in leveraging

cheaper loans to the exporters and also does contract rating of importers), the creation of Pharma Parks,

SEZs’ (Special Economic Zones) and EPZs’ (Export Processing Zones) dedicated to pharmaceutical

manufacturers, export dedicated SEZs’ e.g. Indore EPZ, Pune SEZ, Vizag Pharma City (largest) etc. have

helped promoting the exports. In the Union Budget- 2011xii, the honourable Finance Minister (India) had

proposed an increase in allocation towards healthcare from Rs. 19,354 Crore to Rs. 22,300 Crore & is it’s

expected that a significant part of this increased allocation will be utilized in improving healthcare

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infrastructure and delivery systems, in the country. Under section 10B, extension of sunset clause is

expected to benefit the Export Oriented Units (EOUs)

Tax Environment: In SEZs for the corporate taxes front, pharma units set up in SEZs enjoy 100% income

tax exemption on export profits in the first five years of operation, 50% exemption for the next five years,

and 50% exemption on the reinvested export profits in the following five years. Companies located in SEZ

also benefit from various Indirect Tax benefits such as exemption from payment of Customs Duty; Excise

Duty; Central Sales Tax and refund and exemption of Service Tax. The bottom line is that India Govt. and

EPCs (Export Promotion Council) offer attractive tax benefits, reimbursements and reductions in customs

duties which also help global manufacturers compete in the price-sensitive LRMs environment. Also in the

Union Budget- 2011 tax incentives for the business of setting up and operating “Cold Chain” infrastructure,

which is an integral part in the logistics for vaccines and many biotech products, has been provided.

Key Challenges:

R&D & Investments: Low investments by Indian drug makers (e.g. Ranbaxy maximum 12.6%) in

innovative R&D compared to the Global players investing upto 20% (Eli Lilly maximum 20%) of their sales

revenue continue to be a major weakness of Indian pharmaceutical exporters lacking capacities for filing

more and more ANDA’s and penetrating into the generic markets globally only and not in the Novel Drug

Delivery Systems.

The diffused nature of the Indian pharmaceutical industry has also been a concern that only about 20 to 30

companies (viz. Ranbaxy, Cipla, Dr Reddy's Labs, Lupin, Sun Pharmaceuticals, Nicholas Piramal, Zydus

Cadila, Biocon, Glenmark Pharmaceuticals, Wockhardt Ltd, Torrent, Biocon, Matrix Labs etc.xiii are large

enough to bear the transactions costs associated with sustained exports to and compliance with entry

regulations of the developed markets which scores to crores. Their segment-wise generics account for 58 per

cent of the total exports, active pharmaceutical ingredients (APIs) 40 per cent and

Ayurveda/herbal/neutraceuticals two per cent, according to industry reports.

Non-Tariff Measures: The importing countries’ regulations have been one of the bothering concerns, e.g.

insistence on completing long process (e.g. average 3-4 years for a ANDA Stability Batch, for generics, till

the Product’s launch after approval, Novel Drug Delivery Systems call for average 10-16 years for a drug

development till launch after NDA filing and approvals) for registration to the international (country

specific) quality auditing agencies such as the USFDA (USA), MHRA (EU), TGA (Australia), EMEA (EU),

MOH (Ministry of Health)-Thailand, China SFDA (State Food Drug Administration), GCC (Gulf

Cooperation Council), MCC (South Africa), Canada FDA, MOH-Mexico, etc. and the mandates on allowing

imports of only those drugs which are registered in some developed countries etc. The multiplicity of drug

approval agencies in various countries has raised drug registration costs and site inspections costs. These

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regulatory agencies insist on pharmaceutical standards & quality procedures of their country, which often

varies from country to country and ask for discrete quality audits to be conducted by their agencies

independently.

Indian manufacturers are prevented from bidding for government contracts as US permits bidders only from

countries that are signatories to WTO Agreement on Government Procurement. The have to submit separate

state level applications for marketing drugs in the United States as there is no nation-wide system of

application even where FDA approval has been received

Indian firms have often been accused of making counterfeit drugs by drug makers in the US and European

markets unanimously cited to be allegations used to erect non-tariff measures for restricting competition

from Indian companies who sell their low-cost drugs in the developed markets. As per a health ministry

study, about 0.3% of drugs in with ‘Made in India’ tag are spurious, while about 5% are counterfeit and not

actually ‘Made in India’. The Supply of spurious drugs, fake drugs with “Made in India” claims e.g. cases of

such exports from China containing Indian Manufactured tags being caught in Nigeria.

Data Exclusivity: In 2006, the USA placed India on the Special 301 Priority Watch List for not granting

monopoly rights for clinical trial data (data exclusivity) that would give the patent holder five years of

marketing exclusivity. Some pharmaceutical companies also pressured the Indian government. This

occurred even though India’s current law is TRIPS compliant. It allows the Indian drug regulatory authority

to use the patent holder’s clinical data to approve generic medicines rapidly. Implementing data exclusivity

would reduce generic competition and devastate the ability of poor Indians to access affordable medicines

There had been a number of protests against the recent (2010-2011) discussions on India-EU FTA with the

data exclusivity clauses to be removed from the same have been successful and the strong lobbying by

innovators have been carefully handled by the Ministry of External affairs and Ministry of Commerce, India

in these regards to serve the cause/purpose of keeping maximum access of patients to the medicines they

need mainly for endemics which are not completely curable as of now Viz. Cancer and AIDS medications

across the nation and to keep a price control on such drugs. A study by Oxfam found that of 103 medicines

registered and launched since 2001 that had no patent protection in Jordan, at least 79% had no competition

from a generic equivalent as a consequence of data exclusivity. The study also found that prices of these

medicines under data exclusivity were up to 800% higher than in neighbouring Egypt. India should not

repeat others’ mistakes, or the effect would be felt far beyond India’s borders. The country is the source of

the vast majority of drugs used to treat AIDS in developing countries. Affordable medicines produced in

India have played a major part in reaching the more than five million people receiving HIV/AIDS treatment

across the developing world today. India needs to stand strong and resist European demands in their FTAs.

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Monetary Resources: Majority of Indian SMEs lack the ability to compete with MNCs for New Drug

Discovery, research and commercialization of molecules on a worldwide basis due to lack of monetary

resources compared to the risk associated (research costs, patent litigations post-discovery, registration costs

etc.).

FUTURE TRENDS

All in all Indian drug sales are expected to rise by an annual 8% to nearly $26.59bn between 2006 and

2015xiv. To be sure, this growth rate is higher than that seen for Germany (+5% p.a.) and the entire world

(+6%). Nonetheless, India’s share in world pharmaceutical sales will rise only marginally to a good 2%.

It is likely that many of the Indian small companies will merge or disappear from the market altogether. The

Commerce Ministry is mulling to formulate a policy on mergers and acquisitions by multinationals in the

pharma sector e.g. Ranbaxy by Daichi Sankyo Japan, Dabur Pharma by Fresenius Kabi AG Germany,

Piramal Healthcare by Abbott Labs USA.

In the coming years, opening up of US generics market and antiretroviral therapy of AIDS market in Africa

will boost exports since in the absence of a medical support. [Notably each day, 6,000 Africans die from

AIDS. Each day, an additional 11,000 are infected.]

The Pharma market in Thailand is fastest growing in Asia-Pacific region. It has a strong pharma Industry

producing mostly generics. It depends on imports for patented drugs. The market is expected to be worth US

$1 .82 billion by 2012xv.

Contributions from unconventional markets in Latin America, Australia and the emerging markets in the

Middle East and African Region and increased Abbreviated New Drug Applications (ANDAs) approvals in

the US would lead the industry to shine in the upcoming days, SMEs will benefit from boosted contract

production for western firms as gradually they would learn to comply the standards of the developed nations

e.g. Dishman and GVK-Biosciences undertake contract research for western companies, Sun pharma

manufacturing for Eli Lilly. Acquisition of foreign companies will lead to a strong increase in foreign

production by Indian manufacturers, which will have a dampening effect on exports.

SUMMARY

The global state of affairs direct us to the fact that tackles the non-tariff measures namely the strict quality

regulations to exports of pharma products in various countries and the lengthy documentation processes

demanded by the importing country regulatory authorities etc. need to be addressed through consistent

efforts and greater interaction with the concerned agencies of the choicest markets for the exporters. The

Indian companies are putting their act together to tap the generic drugs markets in the regulated high margin

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markets of the developed countries. The US market remains to be the most lucrative market for the Indian

companies led by its market size and the intensity of blockbuster drugs going off patent.

Based on the retrospective data USA, Germany, Russia, UK, China, Brazil, Canada, South Africa, Nigeria,

Netherlands, Spain, Turkey, Ukraine, Viet Nam, Israel, Italy, Mexico, UAE, Singapore, Iran had been

potential importers of Indian Drugs. Countries like South Africa, Israel, Turkey, Kenya, Singapore, UK,

China, Russia, Italy and Vietnam etc. have been identified to be potential prospective markets with high

growth rates of imports from India. Africa, Latin America, ASEAN and CIS countries with huge demands

deem them to be put in the category of focus countries as these are the emerging markets and have a huge

potential with day in day out incremental growth rates of per capita drugs consumptions supported by

treaties like SAFTA (with SAARC), treaties with GCC, EU, Japan, Korea etc.

If India is able to take a 10% slice in the emerging market in developed countries it will open an opportunity

of around $50bn at current prices of patented and branded drugs and shall be able to surpass the major

exporters of the world.

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[

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iREFERENCES

Foreign Trade Performance of India: Accessed on 30, Sep-2011: http://tinyurl.com/6y24otl

ii Economic Survey of India, 2010: Accessed on 30, Sep- 2011: http://indiabudget.nic.in/

iii Report of the Task Force on Pharmaceuticals (2009): http://tinyurl.com/6jorkda

iv Let all pharma M&As be cleared by CCI: Plan panel group: Accessed on 05, Oct-2011:

http://tinyurl.com/645nswl

v The introduction of Pharmaceutical patents in India- NBER Working Paper:

http://www.nber.org/papers/w6366

vi Report of the Task Force on Pharmaceuticals- Feb 2009: http://tinyurl.com/6jorkda

vii Global Bilaterals data: Accessed on 26, Sep-2011: http://www.bilaterals.org/spip.php?

rubrique88

viii Third round up of Developments in Pharmaceuticals Sector, July 2009:

http://pharmaceuticals.gov.in/Round%20Up-Pharma-310709-NIC.pdf

ix Report of the Task Force on Pharmaceuticals 25 February 2009: http://tinyurl.com/6jorkda

x TRIPS: India - Patent Protection for Pharmaceuticals: http://tinyurl.com/6znswqz

xi Delayed demise of DEPB scheme: Accessed on 26, Sep-2011: http://tinyurl.com/62es48p

xii Union Budget of India:: Accessed on 30, Sep- 2011: http://indiabudget.nic.in/

xiii Report of the Task Force on Pharmaceuticals 25 February 2009: http://tinyurl.com/6jorkda

xiv Mc Kinsey Report on Indian Pharma Industry 2015:

http://bw.businessworld.in/PDF_upload/Indian_Pharma.pdf

xv Third round up of Developments in Pharmaceuticals Sector, July 2009:



http://bw.businessworld.in/PDF_upload/Indian_Pharma.pdf

http://tinyurl.com/6jorkda

http://indiabudget.nic.in/

http://tinyurl.com/62es48p

http://tinyurl.com/6znswqz



http://www.bilaterals.org/spip.php?rubrique88

http://www.bilaterals.org/spip.php?rubrique88


http://www.nber.org/papers/w6366

http://tinyurl.com/645nswl


http://indiabudget.nic.in/

http://tinyurl.com/6y24otl

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BEP - Neeraj