Export Opportunities for Pharma

1
Export Opportunities for Pharma Herbal Industry
(PHARMACEUTICALS EXPORT PROMOTION COUNCIL)Set
up by Ministry of Commerce and IndustryGOVERNMENT
OF INDIA
Presentation byG.Vijay Kumar Consultant
Advisor
2
Pharmexcil In Service of Nation

• Pharmexcil is an autonomous export promotion
  council (EPC) set up by by Ministry of Commerce
  industry, Government of India setup on 12 May,
  2004
• With the objective of focusing on healthcare and
  pharmaceutical products in the global arena

3

• Pharmexcil is the designated authority for drugs
  
• pharmaceutical sector dealing in the following
  products/
• services from India
• ? Bulk drugs (APIs) ? Drug
  intermediates
• ? Drug formulations ? Biotechnology
• ? Biological products ? Veterinary Drugs
• ? Herbal products ?Nutraceuticals
  Phytochemicals
• ? Homeopathy ? Medicinal plants
• ? Diagnostics ? Surgical
  dressings
• Contract research ? Contract
  manufacturing
• Clinical research ? Collaborative
  research
• ? Pharma industry related services
• ? Technologies/consultancy

3
4

• In the duty of export promotion, Pharmexcil
  provides the following
• services to Indian pharmaceutical companies
• Dissemination of trade enquiries
• Organizing trade delegations from India to
  overseas markets as also reverse delegations
• Organizing buyers-sellers meets
• Organizing participation in international trade
  fairs
• Providing policy inputs to the government of
  India on Indias bilateral trade in
  pharmaceuticals

4
5

• Dissemination of Indias pharmaceutical trade
  statistics
• Preparing technical publications, exporters
  directory, etc.
• Resolving grievances of pharmaceutical importers
  and exporters
• Organizing national international seminars on
  areas related to pharmaceutical industry.
• Providing Patents related information through our
  Patents Facilitation Center
• Issuing Certificate of Origin

5
6

• Currently Pharmexcil is among the councils with
  member base of 2,869 (2008-09) in the industry
• Large 296 SSM 1270 ME 1302 Total 2869
• Which includes approx 500 herbal manufacturers
  from Maharashtra, Gujarat, Delhi, TN, AP
  10565403535 etc

7

• The Pharma Industry of India US 18 billion
  industry Produces 70 APIs, almost all
  formulations within the country Very strong in
  Indian medicine systems of Ayurvedic, Homoepathy,
  Unani, Siddha and Herbals medicines Abundant
  scientific, technical intellectual manpower,
  Excellent world-class national laboratories,
  specialized in development processes and cost
  effective technologies An efficient and cost
  effective source for procuring generic drugs,
  especially the drugs going off patent shortly.

8

• 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.

Herbal Ayurvedic Cell
9

• Indian Pharmaceutical Industry Key Strengths
• Strong manufacturing base, Strong process
  development skills
• Strong marketing and distribution network
• Cost competitiveness - Ranks 4th in the world,
  accounts 8 by vol and 2 by value.
• Network of laboratories and RD infrastructure
  Low cost of production  Low RD costs
• Highly trained pool of scientists and
  professionals - 15 of Indian Pharma scientists
  are in USA, hence good network
• World-class quality products
• Potential ground for clinical trials
• Fast growing health care industry
• Rich biodiversity
• Fast growing Biotech industry with US 2 billion
  market
• Highest Quality approvals for manufacturing
  facilities from USFDA, EDQM, MHRA etc.

10

• Global Pharma Markets
• Year Value Growth
• US Billions
• 2000 106.51
• 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
• 2007 712.00 41.65
• 2008 773.00 08.00
• Total Countries (229) 2008 Indias Contribution
  7.3 (1 Share)
• Source Data Intracen/ims health

11

• Indian Pharma Export Performance
• Total Pharma Herbal Medica(me)nts (ayush)
  
• 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
• 2008-09 Rs. 35402.50 Crs. 808.17
  (upto Feb 2009) (upto Jan 2009)
• Ranks 4th in Exports Principal Commodity wise
  with 4.74 Contribution

12

• Top World Herbal Exporters 2007
• Plants pts of plants (used in
  pharma,perf,insect etc)
• S.No. COUNTRY VALUEUS Millions SHARE
• China 418.24 23.6
• Germany 107.00 7.0
• USA 114.00 6.8
• Canada 90.51 6.7
• India 80.00 5.9
• HongKong SAR 67.22 4.9
• Others 35.60
• Top World Herbal Importers 2007
• S.No. COUNTRY VALUEUS Millions SHARE
• USA 247.60 16.30
• China. HongKong SAR 179.05 11.80
• Germany 154.25 10.20
• Japan 118.00 7.80
• France 80.01 5.30

13
Indian Export of Crude DrugsTop 10 Products
Rs in Crs.

• S. No. COMMODITY 2007-2008 SHARE
• Gaur gum 931.00 35.30
• CastorOil Fractions 543.50 20.60
• Psyllium Husk (Isobgul) 255.00 10.00
• Gaurgum Refined 193.00 7.30
• Peppermint Oils - Mentha 174.00 6.60
• Hydrogenated oils 87.00 3.30
• Pepper Oleoresins 80.00 3.00
• Capsicum Oleoresins 50.00 1.90
• Turmeric Oleoresins 42.00 1.60
• Others Senna 40.00 1.40
• Total Exports (40 Items) 2882 100.00

14
Indian Export of Herbal AYUSH Products -
Country wise
S.No Importing Country Value
1 China 88.69 20.59
2 USA 87.29 20.27
3 Germany 29.16 6.77
4 Singapore 25.25 5.86
5 Russia 19.44 4.51
6 Pakistan 10.81 2.51
7 UAE 10.28 2.39
8 UK 9.89 2.3
9 Japan 9.32 2.16
10 Netherlands 9.06 2.1
Total 430.66 100
includes menthol exports, Value million U.S. includes menthol exports, Value million U.S. includes menthol exports, Value million U.S.

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
• WesternPacific Region 12
  10
• African Region 12 24

16
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.

17
Special Export Promotion Schemes for Exporters

• Govt. of India extends financial assistance,
  through Export Promotion Councils, for the
  promotion of Pharma industry, under the following
  two schemes
• Market Development Assistance (MDA) Scheme
• Market Access Initiative (MAI) Scheme
• Market Development Scheme
• The Objectives of the MDA Scheme is basically to
  assist the SMEs to promote exports of their
  products and
• Explore new markets for their product
• Focus areas have been identified by the
  Government of India viz
• Focus CIS
• Focus Africa
• Focus Asean 2 (i.e. Australia New Zealand.)
• Focus LAC

18

• Complementary therapies or Alternative
  therapies were not always known as complementary
  or alternative.
• In the past these were the only available
  therapeutic agents. Traditionally plant,
  sometimes animal or mineral derived products were
  used for therapeutic purposes.
• In many developing countries patient care still
  relies extensively on herbal or similar
  preparations.
• The World Health Organization estimates that the
  extent of this reliance is as high as 80.
  WHO-2004.

19
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.

20
MDA SCHEMES

• Objective of the MDA Scheme is basically to
  assist the SMEs to promote exports of their
  products to Explore new markets for their
  product
• 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.

21

• Exporting companies with an FOB value of exports
  of up to Rs.15.00 crores in the preceding year
  are eligible for MDA scheme.
• Assistance for Travel (economy excursion class)
  built up furnished stall in Focus Areas
  (Assistance Amount subject to ceiling Shown in
  separate slide).
• Assistance available for participation through
  Council sponsored activities.
• Assistance permissible to one regular
  employee/director/ partner/proprietor of the
  company. Exporter of foreign nationality or
  holding foreign passport will not be eligible.
• Intimation application must be received in any of
  the offices of Pharmexcil with a minimum of 14
  days advance notice excluding the date of receipt
  of application in Pharmexcil the date of
  departure from the Country. (Application
  available for download from our Website
  www.pharmexcil.com

22

• 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.

Sl. No. Area / Sector No. of visits Maximum Financial ceiling per event   Maximum Financial ceiling per event  
      Trade Fair / Exhibition Rs.in lakhs Trade delegation Rs.in lakhs
      Trade Fair / Exhibition Rs.in lakhs Trade delegation Rs.in lakhs
1 Focus LAC 1 1.80 1.00
2 Focus Africa (including WANA countries) 1 1.50 0.70
  Focus Africa (including WANA countries)    
3 Focus CIS 1 1.50 0.70
4 Focus ASEAN 2 1 1.50 0.70
5 General 1 0.80 Nil
  Total visits 5    
23

• After completion of the activity, the exporters
  have to file their claims with Pharmexcil.
• Claim Form and list of documents to be submitted
  are available in our web site www.pharmexcil.com
• Claims must be filed immediately upon return to
  India after completion of activity but positively
  within 45 days from their return to India.

24
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 / ITPOs 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.
• Reimbursement of Product Registration cost _at_ 50
  and upto Rs 50 Lacs pa

25

• Eligible activities for financial assistance
  under MAI are as under
• 1. 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 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

26

• 2. 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
• 3. 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.
• 4. Studies
• Market studies/export potential studies
• WTO related studies
• Trade related studies like FDA, RDA etc
• Note Assistance under MAI scheme is available
  to Pharmexcil for the promotion of Pharma
  industry as whole. Individual exporters are
  eligible for assistance for reimbursement of
  product registration charges, RD projects for
  select export markets, hiring of consultants in
  the buyer country only

27

• 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

28

• 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

29

• NMPBVarious 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
• 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. Kerala has 2 districts which
  include Palakkad and Wynad. Cluster development
  from DST for new ideaswww.tdb.gov.in Provides
  for Reimbursement of RD Innovative activities.

30
Activities for 2009-10

• Delegations/BSM to Abroad
• South Africa, Nigeria, Kenya, Libya - July 09
• Vietnam, Cambodia, Philippines and Taiwan - Sep
  09
• Russia, Ukraine, Armenia, Belarus, Moldova -
  October 09/February 10
• Brazil, Bolivia, Paraguay, Uruguay, Venezuela -
  August 09
• Kuwait, Syria, Jordan, Egypt, Turkey - November
  09
• Hungary, Slovenia, Poland, Slovakia - January
  10
• Exhibitions Abroad
• 1. BIO 2009, Atlanta, USA UAE May 18-21
• 2. Vitafood, Geneva, Switzerland 5-7 May 2009
• 3. CPhI China June 09
• 4. Pharmed Healthcare 09, Vietnam 16-19 Sep 09
• 5. Apteka, Moscow or Apteka, Ukraine Oct 09 or
  Feb10
• 6. CPhI, South America, Brazil 26-28 Aug 09
• 7. CPhI Worldwide 09 13-15 Oct 09
• 8. CPhI, India, 1-3 Dec 09
• 9. Arab Health, 26-29 Jan 10
• International Conferences
• India CIS Countries January / February 2010

30
31
Pharmexcils other activities / services

• Patents Facilitation Center at Hyderabad offers
  following services to the members
• General Information on Patents, Patent status of
  pharmaceutical products in India and other
  countries, Interpretation of search information
• Search based intellectual property related
  technology and prior art search
• Invention mining, Patentability opinion, Guidance
  and opinion of IM launch
• Infringement analysis and opinion and Freedom to
  operate opinions
• Pharmacopoeia Other publications available with
  Pharmexcil
• IP 2007, Ayurvedic Pharmacopoeia of India, AFI
• BP 2009, BP Vet 2009, USP NF 2009 EP 2008 (EP6.0
  6.7, Extra Pharmacopoeia 2007
• Other Reference Books
• Merck Index 14th Edition, PDR-63rd Edition CCRAS
  Publications , 31 country reports
• Monographs provided at a nominal service charge

31
32
Offices of Pharmexcil
Head Office Pharmexcil 101, Aditya Trade Centre Ameerpet Hyderabad 500 034. Phone [phone] Fax [phone] Email info_at_pharmexcil.com
Regional Office, Mumbai Pharmexcil T.V. Industrial Estate, Unit No. 211 2nd Floor,248-A, S.K. Ahire MargWorli, Mumbai - 400 030. Phone   91 - 22 - 24938750 / 51Fax   91 - 22 - 24938822 Email romumbai_at_pharmexcil.com
Regional Office, Delhi Pharmexcil 305, Padma Tower II22, Rajendra Place New Delhi - 110008 Phone   91 - 11 - 41536654 / 45062550 Fax  91 - 11 - 41536658Email  rodelhi_at_pharmexcil.com
33

• Requirements for Membership
• 1. Import Export Code Number 2. SSI Certificate
• 3. Bankers Certificate 4. Drug License,
• 5. PAN
• Fees SSM ME LSM
• New Rs 6000 9000 28500
• Renewals Rs 4500 6500 21000
• For details visit our Website www.pharmexcil.com

34
Our Website - www.pharmexcil.com
35
THANK YOU