Date: 7th July 2006

DehradunDehradun

PRESENTATIONBY

DR. P. V. APPAJIDR. P. V. APPAJIM.Pharm, Ph.DM.Pharm, Ph.D

EXECUTIVE DIRECTOREXECUTIVE DIRECTOR

PHARMACEUTICALS EXPORT PROMOTION COUNCILPHARMACEUTICALS EXPORT PROMOTION COUNCILSET UP BY MINISTRY OF COMMERCE AND INDUSTRY

GOVERNMENT OF INDIA

Well developed industry with strong manufacturing baseCost competitivenessWell-established network of laboratories and R&D infrastructureHighly trained pool of scientists and professionalsWorld-class quality productsStrong marketing and distribution networkVery strong process development skillsPotential ground for clinical trialsFast growing health care industryRich biodiversityA growing biotechnology industry

Indian Pharmaceutical Industry Indian Pharmaceutical Industry -- Current Current Global StatusGlobal Status

Emerging as tough Competitor to Europe as a Growing Pharma R&D Hub

An emerging hub for Collaborative R&D in Drug Development, Biotechnology and Process Developments

Shift from Business Driven Research to Research Driven Business

Topped in Drug Fillings with the U.S. FDA in 2003 (126 DMFs)

Topped in COS granted by EDQM in 2004 (14.59%)

A preffered destination for Several Multinationals (ROCHE, BAYER, AVENTIS, CHIRON) for sourcing of APIs

Fast growing Clinical Research activity with increased activity of MNCs like PFIZER, NOVARTIS, ASTRA ZENICA, ELI LILLY, ETC.

Largest number of US FDA approved Plants out side the US

Current GMP requirements under Indian Drugs Act meet the WHO-GMP requirements

Year Value % GrowthUS $ Billions

2000 106.51 2.682001 131.75 23.682002 163.80 24.332003 199.39 21.732004 239.27 (Rs.1100 thousand Crs) 20.00

2004 India s Contribution 3.71 (1.55% Share - appr.)

Source Data : Intracen

Source : Data from DGCIS March,06

COMMODITY EXPORT VALUE SHARE %

(Rs. Crs.)

1. Gems & Jewellary 68830.10 15.13

2. Petroleum (CRUDE & PRODUCTS) 50979.05 11.21

3. RMG Cotton (INCL ACCESSORIES) 28104.45 6.18

4. Drugs, Pharma 21578.96 4.74

5. Machinery & Instruments 21233.47 4.67

All Commodities 454799.97 100.00

2004-2005Rs in Crs.

Value Growth % Share %

Formulations 8967.40 17 52.59

Basic Drugs 7779.40 8 48.62

Crude Drugs 306.00 -4 1.79

2001-02: Rs. 9856.29 Crs.

2002-03: Rs. 12826.10 Crs.

2003-04: Rs. 15213.24 Crs.

2004-05: Rs. 17857.80 Crs.

2005-06: Rs. 21578.96 Crs.

Ranks 4Ranks 4thth in Exportsin Exports Principal Commodity wise with 4.74% Contribution4.74% Contribution

COMPANIES / FACILITIES

FDA - UNITED STATES 75

TGA - AUSTRALIA 19

MCA- SOUTH AFRICA 45

EDQM - EUROPE 13

Top 5 Pharma Export CountriesTop 5 Pharma Export CountriesSource : Data from DGCIS March,06

COUNTRY EXPORT VALUE GROWTH %

(Rs. Crs.)

USA 3062.24 12.80

Germany 1062.97 14.50

Russia 1051.12 35.84

UK 820.63 39.99

China P Rp 762.55 36.96

ALL COUNTRIES : 227 21578.96 20.84

World Herbal Exporters World Herbal Exporters Top 10 Countries

Plants &pts of plants (used in pharma,perf,insect etc nes)20042004

S.No. COUNTRY VALUE SHARE %US $ Millions

1 China 206.80 20.57%2 Germany 82.98 8.25%3 USA 62.79 6.25%4 Hong Kong (SARC) 58.45 5.81%5 France 58.28 5.80%6 India 57.88 5.76%7 Singapore 39.21 3.90%8 Poland 35.62 3.54%9 Mexico 31.10 3.09%10 Chile 27.15 2.70%

World Estimate (79 Countries) 1005.22 100.00%

Liquorice & Ginseng 272.25Total Crude Drugs 1277.47 Rs. 5750 Crs.

World Herbal ImportersWorld Herbal ImportersTop 10 Countries

Plants &pts of plants (used in pharma,perf,insect etc nes)20042004

S.No. COUNTRY VALUE SHARE %US $ Millions

1 USA 148.25 13.56%2 Germany 113.12 10.35%3 Japan 94.56 8.65%4 France 53.25 4.87%5 Hong Kong (SARC) 45.46 4.16%6 UK 44.79 4.10%7 Italy 40.49 3.70%8 Canada 39.47 3.61%9 Korea 34.97 3.20%10 Spain 33.54 3.07%.

20 India 15.10 1.38%

World Estimate (79 Countries) 1093.13 100.00%Liquorice & Ginseng 283.73Total Crude Drugs 1376.86 Rs. 6200.00 Crs.

IndianIndianExport of Crude DrugsExport of Crude Drugs

Rs in Crs.

S.No. COMMODITY 2004-2005 SHARE % GROWTH %

1 Psyllium Husk (Isobgul Husk) 154.00 58.54 162.78

2 Senna Leaves & Pads 27.39 10.41 -24.32

3 Sandal Wood Chips & Dust 14.22 5.41 -25.91

4 Other Parts of Plants used in 12.02 4.57 -13.14

5 Other Leaves, Pwdr, Flurs & Pods 9.43 3.58 -39.34

6 Jajoba Seed 8.53 3.24 -90.42

7 Psyllium Seed (Isobgul) 8.01 3.05 -67.43

8 Other Seeds Frsh/Drid W/N Cut 6.21 2.36 34.97

9 Other Bark, Husk & Rind 4.86 1.85 -20.63

10 Pyrethrum 2.96 1.13 -27.91

Total Exports (40 Items) 263.08 100.00 -12.92

IndianIndian

Export of Crude DrugsExport of Crude Drugs

Top 10 Fast Growing ProductsRs in Crs.

S.No. COMMODITY 2004-2005 SHARE % GROWTH %

1 Sarsaparilla 0.07 0.02 499.08

2 Galangal Rhizomes & Rts Incl. 1.81 0.69 369.20

3 Ipecac Dried Rhizomes & Roots 0.86 0.33 25.022

4 Liquorice Roots Frsh/Drid W/N 0.39 0.15 243.53

5 Unab (Indian Jujube or Chinese) 0.03 0.01 227.50

6 Basil, Hyasop, Rose Mary 2.24 0.85 192.85

7 Cambodge Fruit Rind / The Dried 0.90 0.34 171.33

8 Psyllium Husk (Isobgul Husk) 154.00 58.54 162.78

9 Chirata 0.46 0.17 113.01

10 Cascara Sagrada Bark 0.44 0.17 56.58

Total Exports (40 Items) 263.08 100.00 -12.92

Medicinal Plants & their Value Added Medicinal Plants & their Value Added Products in International MarketProducts in International Market

1. Medical Plants / Crude Drugs

2. Herbal Extracts / Concentrates

3. Herbal Medicines

4. Ayurvedic Medicines

5. Neutraceuticals / Cosmoceuticals

6. Dietary Supplements

7. Health / Functional Foods

Herbal Medicines & Regulatory Status Herbal Medicines & Regulatory Status Region WiseRegion Wise

Region Regulatory Non-Regulatory

American Region 14 4Eastern Mediterranean Region 11 5European Region (selected) 20 1CIS & others 15 2South East Asia 7 3Western Pacific Region 12 10African Region 12 24

Some selected Natural Ingredients used in Some selected Natural Ingredients used in Cosmetics & Dietary SupplementsCosmetics & Dietary Supplements

Aloe Vera gel and juiceAmerican ginseng rootBlack cohosh rhizomeCayenne fruit (Capsicum)Cranberry fruitEchinacea herb & rootEssential oilsFlaxseed (Linseed) & oilGinger rhizomeGinkgo leaf

Major Crude Drugs Imported by Major Crude Drugs Imported by Western Europe, USA & JapanWestern Europe, USA & Japan

Drugs Italy France FRG UK Japan USA Switzerland

Pyrethrum Yes Yes - Yes - Yes -

Liquorice Roots Yes Yes Yes Yes Yes Yes -

Tonka Bean Yes - - Yes Yes - -

Cichona Bark Yes Yes Yes Yes - Yes Yes

Chiratta Yes Yes Yes - - Yes Yes

Galangal Rhozones Yes Yes Yes - Yes Yes

Zedovery Roots Yes Yes Yes Yes - Yes -

Psylium Seeds Yes - Yes Yes Yes Yes Yes

Psyllium Husk Yes Yes Yes Yes Yes Yes Yes

Senna Leaves & Pods Yes Yes Yes Yes Yes Yes Yes

Sarsaparila Yes - - - - Yes -

Vincea Rosea Roots Yes Yes Yes - - Yes Yes

Products

Rs in Crs.S.No. COMMODITY 2004-2005 GROWTH %

1 Ayurvedic System 387.92 101.25

2 Bio-Chemic System 10.11 21.60

3 Homeopathic System 2.05 -80.07

4 Unani System 1.89 -9.14

5 Siddha System 0.42 -1.49

Total 402.39 88.15

Top 10 CountriesMEDICAMENTS OF AYURVEDIC SYSTEM

Rs in Crs.S.No. COUNTRY 2004-2005 SHARE % GROWTH %

1 Russia 19.58 18.38 -15.11

2 Nepal 10.01 9.39 101.16

3 UK 6.61 6.20 115.15

4 U A E 6.46 6.06 106.19

5 Ukraine 6.16 5.78 -4.33

6 U S A 4.30 4.04 -34.42

7 Sri Lanka DSR 3.56 3.34 84.84

8 Netherlands 3.49 3.28 74.40

9 Australia 2.60 2.44 155.01

10 Finland 2.19 2.05 126.20

Total (152 Countries) 106.56 100.00 15.28

Top 10 CountriesMEDICAMENTS OF AYURVEDIC SYSTEM

Rs in Crs.S.No. COUNTRY 2004-2005 SHARE % GROWTH %

1 Ireland 88.74 31.54 8869.08

2 U S A 81.73 29.05 306.18

3 Russia 13.83 4.91 26.95

4 Nepal 11.99 4.26 -12.85

5 U A E 8.63 3.07 55.75

6 Italy 5.93 2.11 67.51

7 Ukraine 5.58 1.98 1040.14

8 Nigeria 4.27 1.52 431.47

9 Netherlands 3.70 1.32 -11.52

10 South Africa 3.06 1.09 101.22

Total (153 Countries) 281.36 100.00 180.47

1. Lack of Quality & Standardization norms

2. Lack of adequate Marketing & Trade Information

3. Inadequate Investment in Research & Development

4. Inadequate Awareness

Pharmaceuticals Export Promotion Council

1. Set up by Ministry of Commerce on 12 May, 2004

2. Objective : To give Focused attention to Pharma Exports

3. Supported by : All major Pharma Associations IDMA, BDMA, OPPI, IPA, etc. and Govt., OF A.P.

4. H.O. at Hyderabad & R.O. at Mumbai, New Delhi

Bulk drugs / drug intermediates

Drug formulations

Herbals / Ayurvedics / Homeopathic / Unani

Medicinal Plants

Bio-tech / Biological products

Diagnostics and Surgicals

Neutraceuticals

Collaborative /contract research

Clinical trials

Pharma consultancy services etc.

Authorised Agency for PharmaceuticalsAuthorised Agency for Pharmaceuticals

Foreign Trade Policy - August 2004

Pharmaceutical items shifted from purview of Chemexcil to Pharmexcil.

Focus areas : Focus CISFocus AfricaFocus Asean +2Focus LAC

Top 5 States

Maharashtra 93Gujarat 56New Delhi 30Tamil Nadu 33Andhra Pradesh 28

Total Medicinal Plants / Herbals 305

Total Pharmexcil 1925

Issue of RCMC certificatesDelegations to foreign countriesBuyer seller meetingsForeign buyer detailsEmbassy assistance Exhibition participationSeminars and ConferencesTechnology assistance

Example of Public + Private Partnership

1. Reimbursement of AirFare in Foreign Delegation

2. Support for participation in Foreign Exhibitions

3. Part Reimbursement of Product Registration Charges

4. Market Survey Reports

5. National / International Conferences etc.

6. Warehouse facilities in Foreign Countries