PHARMACEUTICALS EXPORT PROMOTION COUNCIL PHARMEXCIL

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PHARMACEUTICALS EXPORT PROMOTION COUNCIL
(PHARMEXCIL) Set up by Ministry of Commerce and
Industry GOVERNMENT OF INDIA For more details,
please visit our website www.pharmexcil.com
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GLOBAL OPPORTUNITIES FOR HERBALS ROLE OF
PHARMEXCIL IN EXPORT PROMOTION
Date 17th December 2008 Business Exchange
Programme, 3rd WAC, JAIPUR
PRESENTATION By Dr. P. V. Appaji Executive
Director PHARMEXCIL (PHARMACEUTICALS EXPORT
PROMOTION COUNCIL) Set up by Ministry of
Commerce and Industry GOVERNMENT OF INDIA
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The Pharma Industry of India Indian
Pharmaceutical sector exports stands at Rs.
29,140 Crs (2007-08) growing at 20.Estimated
to cross Rs.90,000 Crs in the XIth Plan
period.The Herbal Ayurved, Siddha and Unani
sector have also registered a substantial growth
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The Pharma Industry of India Ø      US 15
billion industry Ø      Produces 70 APIs,
almost all formulations within the country
Ø      Ranks 4th in the world, accounts 8 by
vol and 2 by value. Ø   Very strong in
Indian medicine systems of Ayurvedic, Homoepathy,
Unani, Siddha and Herbals
medicines Ø      Fast growing Biotech industry
with US 2 billion market Ø      Low cost of
production  Low RD costs Ø      Abundant
scientific, technical intellectual manpower,
Ø      Excellent world-class national
laboratories, specialized in
development processes and cost effective
technologies Ø     An efficient and cost
effective source for procuring generic drugs,
especially the drugs going off patent
shortly. Ø      An excellent center for clinical
trials. Ø      USFDA/WHO complying manufacturing
facilities. Ø      15 of Indian Pharma
scientists are in USA, hence good network
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• Indian Pharmaceutical Industry Key Strengths
• Strong manufacturing base
• Cost competitiveness
• Network of laboratories and RD infrastructure
• Highly trained pool of scientists and
  professionals
• 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.

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• Global Pharma Exports
• 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 20.00
• 2005 348.62 45.70
• 2006 502.65 44.12
• Total Countries (227)
• 2005 Indias Contribution 5.02 (1.45 Share)
• Source Data Intracen

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• Indian Pharma Export Performance
• Total Pharma Herbal Medica(me)nts
• 2003-04 Rs. 15213.24 Crs. 511.20
• 2004-05 Rs. 17857.80 Crs. 693.46
• 2005-06 Rs. 21578.96 Crs. 540.55
• 2006-07 Rs. 26895.00 Crs. 636.55
• 2007-08 Rs. 29140.00 Crs. 792.17
• Ranks 4th in Exports Principal Commodity wise
  with 4.74 Contribution

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• 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

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Indian Export of Crude DrugsTop 10 Products
Rs in Crs.

• S. No. COMMODITY 2004-2005 SHARE
• 1 Psyllium Husk (Isobgul Husk) 154.00
  58.54
• 2 Senna Leaves Pads 27.39 10.41
• 3 Sandal Wood Chips Dust 14.22
  5.41
• 4 Other Parts of Plants used in 12.02
  4.57
• 5 Other Leaves, Pwdr, Flurs Pods
  9.43 3.58
• 6 Jajoba Seed 8.53
  3.24
• 7 Psyllium Seed (Isobgul) 8.01
  3.05
• 8 Other Seeds Frsh/Drid W/N Cut 6.21
  2.36
• Other Bark, Husk Rind 4.86
  1.85
• 10 Pyrethrum 2.96 1.13
• Total Exports (40 Items) 263.08 100.00

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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

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   Medicinal Plants / Ayurvedic / Herbal
Exporters Top 5 States Maharashtra 102 Guja
rat 65 New Delhi 38 Tamil Nadu 35 Andhra
Pradesh 32 Total Medicinal Plants / Herbals
370, Total Pharmexcil Members2800
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Medicinal Plants their Value Added Products
in International MarketMedical Plants / Crude
Drugs, Herbal Extracts / ConcentratesHerbal
Medicines, Ayurvedic MedicinesNeutraceuticals
/ Cosmoceuticals, Dietary SupplementsHealth /
Functional Foods Indian Natural Ingredients used
in Formulations, Cosmetics Dietary
SupplementsAmla / Indian Gooseberry(Emblica
officinalis) Aloe Vera Gel and
juice, Ashwagandha (Withania somnifera) Gudmar
(Gymnema sylvestre), Guggul (Commpihora wightii)
Isabgol / Physillium, Kalihari / Glory lily
(Gloriosa superba)Kalmegh (Andrographis
paniculata) Kutki / Picrorhiza, Mulethi /
Liquorice (Glycyrrhiza glabra) Safed Musali
(Chlorophytum borivillianum) Sarpgandha /
Rauwolfia (Rauwolfia serpentina) Senna (Cassia
angustifolia), Tulsi / Holy basil (Ocimum
sanctum )
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Indian Pharma-Emerging Trends

• Alternative Medicines (Herbals/Ayurvedics)
• Indian Opportunities
• Indias ancient knowledge about herbs and
  Ayurveda-is KNOWN WORLDWIDE
• India is among the 12 mega biodiversity countries
  in the world with more than 4500 plant species
• About 400 Medicinal Plants under Active usage
• Scope for joint research to develop
• Nutraceuticals
• Dietary Supplements
• Natural Remedies

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Indias Vast Natural Resources

• India is one of the major raw material-producing
  nations of South Asia and posses about 8 of the
  estimated bio diversity of the world with
  approximately 8000 Medicinal Plants species from
  flowering plants available in the wild. Many
  species are being used in Traditional Systems of
  Medicine as,
• Ayurveda 7000 species
• Siddha- 600 species
• Unani- 700 species
• Homeopathy- 450 species
• Modern medicine- 30 species
• Provides gt 35 million workdays of employment a
  year.

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Registration ProceduresAlmost all Countries
require prior registration of productsSource of
getting registration formalities, forms
etc.Preparation of dossiers for submission to
the regulatory affairs Payment of Registration
Fees Receipt of paymentObtaining registration
certificate from the regulatory authorities
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Indian Pharma-Emerging Trends Alternative
Medicines (Herbals/Ayurvedics)Herbal product
(World scenario) USD Billions Herbal (Indian
scenario)World market 55 Indian market 0.85
North America 6.3 Indian exports 0.11 Europe
15.0 Asia 7.8 Japan 7.2 WHO
projections 5 trillion USD by 2050We need to
Adhere to Good Agricultural and collection
practices (GACP) Good Manufacturing Practices
(GMP) Good Laboratory Practice (GLP)
standardsEstablish Appropriate specifications
for Raw / Intermediate / Finished
ProductsComprehensive documentation on
manufacture and testing
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Status IssuesTM is widely and increasingly
used for a wide spectrum of diseases by people in
both developed and developing countries.A
growing number of countries are adopting national
policies on TM and developing specific regulatory
capacity, especially for herbal medicines.Much
of the scientific literature on TM provides
inadequate evidence on safety and
efficacyIndividual case reports and patient
series, with no control or comparison
group.Protection and preservation of TM
knowledge is essential to ensure access to
traditional forms of health care and respect for
those who hold TM knowledge.
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Pharmaceuticals Export Promotion Council1.
Set up by Ministry of Commerce on 12 May, 20042.
Objective To give Focused Attention to Pharma
Exports3. Supported by All Major Pharma
Associations IDMA, BDMA, OPPI, IPA, etc. and
Govt., of A.P.4. Rs. 3 Crores Contribution by
Government of Andhra Pradesh5. H.O. at
Hyderabad , R.O. at Mumbai New
Delhi Autonomous in Nature Government nominees
on the Board Provides commercially useful
information Assistance Professional advise in
technology related matters Export Promotion
Councils their RoleRole of PharmexcilOrganize
visits of Delegations to Explore Overseas
MarketsParticipation in Trade Fairs /
ExhibitionsOrganize BSMs in India inviting
overseas buyersTake up problems of members with
the Government AgenciesBuild a statistical base
provide data on ExportsIssue of RCMCs
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• Pharmexcil - Categories Covered
• 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.

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• Herbal Ayurvedic CELL
• Pharmexcil opened Herbal Ayurvedic CELL
  exclusively to cater to the needs of Herbal
  Ayurvedics Exports Operative from December 2006
• Few salient points covered
• Constituted separate Committee for
  Herbal/Medicinal plants involving eminent persons
  from the Indian industry and Academicians, which
  make suggestions to the Council on various
  issues.
• Efforts are made to introduce Export
  Certification scheme specifying the limits for
  heavy metals, pesticide residue, aflatoxins and
  bio burden.

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EXPORT PROMOTION BY GOVT. OF INDIADGFTAdvance
Licence , DEPB (Duty Entitlement Pass
Book)DFRC (Duty Free Replenishment
Certificate)Duty Draw Back, Focus
MarketsFocus Products, Target
PlusPharmaceuticals Export promotion Council
(PHARMEXCIL)Reimbursement of Product
Registration cost _at_ 50 and upto Rs 50 Lacs paM
D A (Market Development Assistance), M A I
(Market Access Incentives)
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MDA Scheme Basically to assist the SMEs to
promote exports of their productsExplore new
markets for their productFocus areas have been
identified by the Government of India 1. Focus
CIS, 2. Focus Africa, 3. Focus Asean 2 (i.e.
Australia New Zealand.), 4. Focus
LACEligibility CriteriaExporting companies
with an FOB value of exports of up to Rs.15.00
crores in the preceding yearAssistance for
Travel (economy excursion class) built up
furnished stall in Focus Areas (Assistance Amount
subject to ceiling Show in separate slide).
Assistance available for participation through
Council sponsored activities.Application
available for download from our Website.
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MDA Scheme Maximum no. of permissible
participations is 5(five) in a financial year
i.e. one each in Focus Areas one in General
area.Company applying for MDA shall not be under
investigation/charged / prosecuted / debarred /
black listed under the Foreign Trade Policy of
India or any other law relating to export and
import business.Maximum MDA assistance shall be
inclusive of MDA assistance received from all
Govt. bodies / EPCs/ FIEO / ITPO etc Member
exporters of EPCs etc would also be eligible for
MDA assistance for participation in events
organized by ITPO abroad. Their applications /
claims would be routed / reimbursed through the
concerned EPC etc.A maximum of 3(three)
participations in a particular trade fair /
exhibition would be eligible for MDA
assistance.Companies participating for more
than 3 times including past cases for a
particular fair/exhibition have to participate in
that fair on self financing basis.
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MDA Scheme Ceilings on Max. Amount No. of
Visits
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MARKET ACCESS INITIATIVE (MAI) SCHEME

• Market Access Initiatives (MAI) Scheme is an
  Export Promotion Scheme envisaged to act as a
  catalyst to promote Indias export on a sustained
  basis.
• The scheme is formulated on focus product focus
  country approach to evolve specific market and
  specific product through market studies / survey.
  
• Assistance provided to EPCs / TPOs etc for
  enhancement of export through accessing new
  markets or through increasing the share in the
  existing markets.
• Level of assistance for each eligible activity is
  fixed

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• MARKET ACCESS INITIATIVE (MAI) SCHEME
• Eligible activities for financial assistance
  under the scheme Marketing Projects abroad
• Opening of Showrooms/Warehouses
• Organizing Trade Festival of India
• Promotion of Brand India
• National level participation in major
  international Fairs
• Display in International departmental stores
• Publication of World class Catalogues
• Publicity campaign and brand promotion
• Research and Product Development
• Industrial clusters for marketing abroad
• Reverse BSMs in India

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• Market Access Initiative Scheme (contd)
• Capacity Building
• - Imparting training for Indian exporters
• - Up gradation/improvements in Laboratories
• - Quality up gradation of select products for
  export markets
• - Developing Common facility centers,
  design centers, packing
• - Hiring consultants in the buyer/prospective
  country

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• Market Access Initiative Scheme (contd)
• Statutory Compliances
• Charges for statutory compliances in the buyer
  country like registration charges
• For contesting litigation in the buyer country on
  anti dumping duties etc.
• Studies
• Market studies/export potential studies
• WTO related studies
• Trade related studies like FDA, RDA etc.
• For other schemes visit the sites of
• AYUSH
• NMPB
• APEDA
• Vishesh Krishi Upaj Yojana
• Backward Regions Grant Fund

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Deptt of Ayush Centrally Sponsored Scheme of QC
of Ayurveda, Siddha, Unani and HomeopathyScheme
No 4Rs 30 lakhs or 30 of expenditure for in
house QC LaborScheme No 5 Assistance of Rs
30 lakhs or 30 of expenditure for up gradation
of facilities to US FDA / EU Good Mfg Practices
certification standards
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NMPB Various schemes for Cultivation of MAPs,
preparation of Project Reports, Documentary Film
preparation, Establishment maintenance of
Herbal Gardens Nursery etc. (evaluated cost of
about Rs. 630 lacs for 11th 5 Yr
plan.Nurseries 4 20 LacsCultivation 20 -
75 (depending on the species of cultivation
selected)Post Harvestment Management 5 Lacs
(50-100)Processing Value addition 10- 50
lacs _at_ 25- 50Further details available on the
NMPB web site
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APEDA 50 of analytical charges are reimbursed
for testing Egg powder, Honey Grapes.Vishesh
Krishi Upaj Yojana Duty Credit at 5 of the FOB
ValueBackward Regions Grant Fund Grant of Rs
10 crore per District (total 250 Districts) for
providing technical assistance, office infra
structure, training, conduct of surveys, etc at
Panchayat level. Cluster development from DST
for new ideaswww.tdb.gov.in
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Pharmexcil Activities in 2008 - 09

• Delegations/BSM to Abroad
• 1.      Argentina, Chile, Peru Aug08 Completed
• 2.      Uzbekistan, Turkmenistan, Kyrgyztan Feb
  09
• 3.      Herbal Delegation to Brussels EU
  countries Oct 09
• Exhibitions Abroad Completed
• CPhI Japan 9th-11th April 2008, Supply Side
  East, USA 28th-30th April 2008, MediPharma Expo,
  Vietnam 21st-24th May 2008, CPhI, South America,
  Brazil 19th 21st Aug 2008, Apteka, Russia
  October 2008, CPhi Worldwide, Germany 30th 2nd
  Oct 2008
• CphI India, Mumbai 28th 30th November -
  Postponed
• Informex 2009 USA, Jan 2009, Arab Health 2009
  Dubai, Jan 2009, Asia Pharma Expo, Jan 2009
• Seminars Work Shops Completed
• Hyderabad - April 2008, Mumbai- June 2008, Delhi
  July 2008, Bhubaneswar Nov 2008
• Kolkata, Ahmedabad, Lucknow, Baroda, Dehradun
  Proposed 2009
• Deptt of Ayush proposed Pharmexcil to have 3
  international events in 2009-10
• Interested members may kindly send their
  proposals

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• Requirements for Membership
• Import Export Code Number
• SSI Certificate
• Bankers Certificate
• Drug License
• Fees (Rs.3000 / Rs. 4500 / Rs. 15000)
• For details visit our Website www.pharmexcil.com

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