(PHARMACEUTICALS EXPORT PROMOTION COUNCIL)
Set up by Ministry of Commerce and Industry
GOVERNMENT OF INDIA
Export Opportunities for Pharma & Herbal
Industry
Presentation by:
G.Vijay Kumar
Consultant Advisor
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
2
Pharmexcil is the designated authority for drugs &
pharmaceutical sector dealing in the following products/
services from India:
 Drug formulations
 Biological products
 Drug intermediates
 Biotechnology
 Veterinary Drugs
 Herbal products
 Homeopathy
Nutraceuticals & Phytochemicals
 Medicinal plants
 Diagnostics
 Surgical dressings
 Bulk drugs (APIs)


Contract research
Clinical research
 Contract manufacturing
 Collaborative research
 Pharma industry related services
 Technologies/consultancy
3
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
India’s bilateral trade in pharmaceuticals
4

Dissemination of India’s 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
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
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 105+65+40+35+35 etc
Break-up of Pharmexcil Membership
Small Scale
Manufactur
ers, 1270,
44%
Large Scale
Manufactur
ers, 297,
10%
State-wise Composition of Pharmaceutical
Members
Others,
314.00, 11%
Karnataka,
109.00, 4%
Tamil Nadu,
164.00, 6%
Merchant
Exporters,
1302, 46%
Maharashtra,
1,173.00, 43%
Delhi, 246.00,
9%
Gujarat,
352.00, 13%
Andhra
Pradesh,
385.00, 14%
6

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.
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.
8
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

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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 R&D infrastructure Low cost of
production & Low R&D 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.
Global Pharma Markets
Year
2000
2001
2002
2003
2004
2005
2006
2007
2008
Total Countries (229)
Source Data : Intracen/ims health
Value
US $ Billions
106.51
131.75
163.80
199.39
239.27
348.62
502.65
712.00
773.00
% Growth
23.68
24.33
21.73
20.00
45.70
44.12
41.65
08.00
2008 India’s Contribution 7.3 (1% Share)
Indian Pharma Export Performance
Total Pharma
2003-04:
2004-05:
2005-06:
2006-07:
2007-08:
2008-09:
Herbal + Medica(me)nts (ayush)
Rs. 15213.24 Crs.
Rs. 17857.80 Crs.
Rs. 21578.96 Crs.
Rs. 26895.00 Crs.
Rs. 29140.00 Crs.
Rs. 35402.50 Crs.
511.20
693.46
540.55
636.55
792.17
808.17
(upto Feb 2009)
(upto Jan 2009)
Ranks 4th in Exports “Principal Commodity” wise with 4.74% Contribution
Top World Herbal Exporters 2007
Plants & pts of plants (used in pharma,perf,insect etc)
S.No. COUNTRY
1.
China
2.
Germany
3.
USA
4.
Canada
5.
India
6.
HongKong SAR
7.
Others
VALUEUS $ Millions
418.24
107.00
114.00
90.51
80.00
67.22
SHARE %
23.6
7.0
6.8
6.7
5.9
4.9
35.60
Top World Herbal Importers 2007
S.No. COUNTRY
1.
USA
2.
China. HongKong SAR
3.
Germany
4.
Japan
5.
France
6.
Others
SITC
VALUEUS $ Millions
247.60
SHARE %
16.30
179.05
11.80
154.25
118.00
80.01
10.20
7.80
5.30
48.70
Indian Export of Crude Drugs
Top 10 Products Rs in Crs.
S. No.
1
2
3
4
5
6
7
8
9
10
COMMODITY
Gaur gum
CastorOil – Fractions
Psyllium Husk (Isobgul)
Gaurgum Refined
Peppermint Oils - Mentha
Hydrogenated oils
Pepper Oleoresins
Capsicum Oleoresins
Turmeric Oleoresins
Others Senna
Total Exports (40 Items)
2007-2008
931.00
543.50
255.00
193.00
174.00
87.00
80.00
50.00
42.00
40.00
2882
SHARE %
35.30
20.60
10.00
7.30
6.60
3.30
3.00
1.90
1.60
1.40
100.00
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
9.06
2.1
430.66
100
10 Netherlands
Total
includes menthol exports, Value million U.S.$
Herbal Medicines & Regulatory Status – Region
Wise
Region
American Region
Eastern Mediterranean Region
European Region (selected)
CIS & others
South East Asia
WesternPacific Region
African Region
Regulatory
14
11
20
15
7
12
12
Non-Regulatory
4
5
1
2
3
10
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India’s 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 –
SiddhaUnaniHomeopathyModern medicine-
7000 species
600 species
700 species
450 species
30 species
Provides > 35 million workdays of employment a year.
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
17
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‘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].
India’s 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 –
SiddhaUnaniHomeopathyModern medicine-
7000 species
600 species
700 species
450 species
30 species
Provides > 35 million workdays of employment a year.
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
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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.
20

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
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
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
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
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
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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.
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MAI SCHEME

Market Access Initiatives (MAI) Scheme is an Export
Promotion Scheme envisaged to act as a catalyst to promote
India’s 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 @ 50% and upto
Rs 50 Lacs pa
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Eligible activities for financial assistance under MAI are as under:
1. Marketing Projects abroad:
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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
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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, R&D projects for select export markets, hiring of consultants
in the buyer country only
26

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.
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For other schemes visit the sites of
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AYUSH
NMPB
APEDA
Vishesh Krishi Upaj Yojana
Backward Regions Grant Fund

Deptt of Ayush
Centrally Sponsored Scheme of QC of Ayurveda, Siddha, Unani
and Homeopathy
Scheme No: 4
Rs 30 lakhs or 30% of expenditure for in house QC Lab
or
Scheme 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


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 Lacs
Cultivation 20% - 75% (depending on the species of cultivation
selected)
Post Harvestment Management 5 Lacs (50%-100%)
Processing & Value addition 10- 50 lacs @ 25- 50%
Further 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 Value
Backward 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 ideas:www.tdb.gov.in –
Provides for Reimbursement of R&D Innovative activities.
Activities for 2009-10
Delegations/BSM to Abroad :

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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:

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

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
Pharmexcil’s other activities / services
Patents Facilitation Center
services to the members:




at Hyderabad offers following
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
Offices of Pharmexcil
Head Office:
Pharmexcil
101, Aditya Trade Centre
Ameerpet
Hyderabad – 500 034.
Phone: 91 – 40 – 23735462/66
Fax: 91 – 40 – 23735464
Email: info@pharmexcil.com
Regional Office, Mumbai
Pharmexcil
T.V. Industrial Estate, Unit No.
211
2nd Floor,
248-A, S.K. Ahire Marg
Worli, Mumbai - 400 030.
Phone: 91 - 22 - 24938750 / 51
Fax: 91 - 22 - 24938822
Email:
romumbai@pharmexcil.com
Regional Office, Delhi
Pharmexcil
305, Padma Tower II
22, Rajendra Place
New Delhi - 110008
Phone: 91 - 11 - 41536654 /
45062550
Fax: 91 - 11 - 41536658
Email: rodelhi@pharmexcil.com
32
Requirements for Membership:



1. Import Export Code Number 2. SSI Certificate
3. Bankers Certificate
4. Drug License,
5. PAN

Fees :
New

Renewals

For details visit our Website
www.pharmexcil.com

Rs
SSM
6000
ME
9000
LSM
28500
Rs
4500
6500
21000
Our Website - www.pharmexcil.com
34
THANK YOU
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