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
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
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
Year Value % Growth US $ Billions 2000 106.51 2.68 2001 131.75 23.68 2002 163.80 24.33 2003 199.39 21.73 2004 239.27 (Rs.1100 thousand Crs) 20.00 Source Data : Intracen 2004 India s Contribution 3.71 (1.55% Share - appr.)
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
2004-2005 Rs 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 4 th in Exports Principal Commodity wise with 4.74% Contribution
COMPANIES / FACILITIES FDA - UNITED STATES 75 TGA - AUSTRALIA 19 MCA- SOUTH AFRICA 45 EDQM - EUROPE 13
Top 5 Pharma Export Countries Source : 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 Top 10 Countries Plants &pts of plants (used in pharma,perf,insect etc nes) 2004 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 272.25 Total Crude Drugs 1277.47 Rs. 5750 Crs.
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 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 283.73 Total Crude Drugs 1376.86 Rs. 6200.00 Crs.
Indian Export 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
Indian Export of Crude Drugs Top 10 Fast Growing Products Rs 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 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
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 12 10 African Region 12 24
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
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
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 Countries MEDICAMENTS OF AYURVEDIC SYSTEM 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 Rs in Crs. Total (152 Countries) 106.56 100.00 15.28
Top 10 Countries MEDICAMENTS OF AYURVEDIC SYSTEM 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 Rs in Crs. 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 & D evelopment 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 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
Top 5 States Maharashtra 93 Gujarat 56 New Delhi 30 Tamil Nadu 33 Andhra Pradesh 28 Total Medicinal Plants / Herbals 305 Total Pharmexcil 1925
Issue of RCMC certificates Delegations to foreign countries Buyer seller meetings Foreign buyer details Embassy assistance Exhibition participation Seminars and Conferences Technology assistance
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