DR. P. V. APPAJI M.Pharm, Ph.D EXECUTIVE DIRECTOR

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1 Date: 7 th July 2006 Dehradun PRESENTATION BY DR. P. V. APPAJI M.Pharm, Ph.D EXECUTIVE DIRECTOR PHARMACEUTICALS EXPORT PROMOTION COUNCIL PHARMACEUTICALS EXPORT PROMOTION COUNCIL SET UP BY MINISTRY OF COMMERCE AND INDUSTRY GOVERNMENT OF INDIA

2 Well developed industry w ith strong manufacturing base Cost competitiveness Well-established network of laboratories and R&D infrastructure Highly trained pool of scientists and professionals World-class quality products Strong marketing and distribution network Very strong process development skills Potential ground for clinical trials Fast growing health care industry Rich biodiversity A growing biotechnology industry

3 Indian Pharmaceutical Industry - Current Global 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

4 Year Value % Growth US $ Billions (Rs.1100 thousand Crs) Source Data : Intracen 2004 India s Contribution 3.71 (1.55% Share - appr.)

5 Source : Data from DGCIS March,06 COMMODITY EXPORT VALUE SHARE % (Rs. Crs.) 1. Gems & Jewellary Petroleum (CRUDE & PRODUCTS) RMG Cotton (INCL ACCESSORIES) Drugs, Pharma Machinery & Instruments All Commodities

6 Rs in Crs. Value Growth % Share % Formulations Basic Drugs Crude Drugs

7 : Rs Crs : Rs Crs : Rs Crs : Rs Crs : Rs Crs. Ranks 4 th in Exports Principal Commodity wise with 4.74% Contribution

8 COMPANIES / FACILITIES FDA - UNITED STATES 75 TGA - AUSTRALIA 19 MCA- SOUTH AFRICA 45 EDQM - EUROPE 13

9 Top 5 Pharma Export Countries Source : Data from DGCIS March,06 COUNTRY EXPORT VALUE GROWTH % (Rs. Crs.) USA Germany Russia UK China P Rp ALL COUNTRIES :

10 World Herbal Exporters Top 10 Countries Plants &pts of plants (used in pharma,perf,insect etc nes) 2004 S.No. COUNTRY VALUE SHARE % US $ Millions 1 China % 2 Germany % 3 USA % 4 Hong Kong (SARC) % 5 France % 6 India % 7 Singapore % 8 Poland % 9 Mexico % 10 Chile % World Estimate (79 Countries) % Liquorice & Ginseng Total Crude Drugs Rs Crs.

11 World Herbal Importers Top 10 Countries Plants &pts of plants (used in pharma,perf,insect etc nes) 2004 S.No. COUNTRY VALUE SHARE % US $ Millions 1 USA % 2 Germany % 3 Japan % 4 France % 5 Hong Kong (SARC) % 6 UK % 7 Italy % 8 Canada % 9 Korea % 10 Spain %. 20 India % World Estimate (79 Countries) % Liquorice & Ginseng Total Crude Drugs Rs Crs.

12 Indian Export of Crude Drugs Rs in Crs. S.No. COMMODITY SHARE % GROWTH % 1 Psyllium Husk (Isobgul Husk) Senna Leaves & Pads Sandal Wood Chips & Dust Other Parts of Plants used in Other Leaves, Pwdr, Flurs & Pods Jajoba Seed Psyllium Seed (Isobgul) Other Seeds Frsh/Drid W/N Cut Other Bark, Husk & Rind Pyrethrum Total Exports (40 Items)

13 Indian Export of Crude Drugs Top 10 Fast Growing Products Rs in Crs. S.No. COMMODITY SHARE % GROWTH % 1 Sarsaparilla Galangal Rhizomes & Rts Incl Ipecac Dried Rhizomes & Roots Liquorice Roots Frsh/Drid W/N Unab (Indian Jujube or Chinese) Basil, Hyasop, Rose Mary Cambodge Fruit Rind / The Dried Psyllium Husk (Isobgul Husk) Chirata Cascara Sagrada Bark Total Exports (40 Items)

14 Medicinal Plants & their Value Added Products 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

15 Herbal Medicines & Regulatory Status Region Wise Region Regulatory Non-Regulatory American Region 14 4 Eastern Mediterranean Region 11 5 European Region (selected) 20 1 CIS & others 15 2 South East Asia 7 3 Western Pacific Region African Region 12 24

16 Some selected Natural Ingredients used in Cosmetics & Dietary Supplements Aloe Vera gel and juice American ginseng root Black cohosh rhizome Cayenne fruit (Capsicum) Cranberry fruit Echinacea herb & root Essential oils Flaxseed (Linseed) & oil Ginger rhizome Ginkgo leaf

17 Major Crude Drugs Imported by Western 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

18 Products Rs in Crs. S.No. COMMODITY GROWTH % 1 Ayurvedic System Bio-Chemic System Homeopathic System Unani System Siddha System Total

19 Top 10 Countries MEDICAMENTS OF AYURVEDIC SYSTEM S.No. COUNTRY SHARE % GROWTH % 1 Russia Nepal UK U A E Ukraine U S A Sri Lanka DSR Netherlands Australia Finland Rs in Crs. Total (152 Countries)

20 Top 10 Countries MEDICAMENTS OF AYURVEDIC SYSTEM S.No. COUNTRY SHARE % GROWTH % 1 Ireland U S A Russia Nepal U A E Italy Ukraine Nigeria Netherlands South Africa Rs in Crs. Total (153 Countries)

21 1. Lack of Quality & Standardization norms 2. Lack of adequate Marketing & Trade Information 3. Inadequate Investment in Research & D evelopment 4. Inadequate Awareness

22 Pharmaceuticals Export Promotion Council 1. Set up by Ministry of Commerce on 12 May, 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

23 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.

24 Authorised Agency for Pharmaceuticals Foreign Trade Policy - August 2004 Pharmaceutical items shifted from purview of Chemexcil to Pharmexcil. Focus areas : Focus CIS Focus Africa Focus Asean +2 Focus LAC

25 Top 5 States Maharashtra 93 Gujarat 56 New Delhi 30 Tamil Nadu 33 Andhra Pradesh 28 Total Medicinal Plants / Herbals 305 Total Pharmexcil 1925

26 Issue of RCMC certificates Delegations to foreign countries Buyer seller meetings Foreign buyer details Embassy assistance Exhibition participation Seminars and Conferences Technology assistance

27 Example of Public + Private Partnership 1. Reimbursement of AirFare in Foreign D elegation 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

INDO-AFRICA PHARMA BUSINESS MEET

INDO-AFRICA PHARMA BUSINESS MEET AYUSH Exports & Potentials by: Ranjit Puranik, Chief Executive Officer, Shree Dhootapapeshwar Limited Overall Exports from ASU&H Industry Economic region wise Export Analysis