(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

Pharmexcil is the designated authority for drugs &

pharmaceutical sector dealing in the following products/
services from India:
Bulk drugs (APIs)

Drug formulations
Biological products

Drug intermediates
Biotechnology
Veterinary Drugs

Herbal products
Nutraceuticals & Phytochemicals
Homeopathy
Medicinal plants
Diagnostics

Contract research
Clinical research

Surgical dressings
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

Indias bilateral trade in pharmaceuticals

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

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

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.

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 Indias 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.
1.
2.
3.
4.
5.
6.
7.

COUNTRY
China
Germany
USA
Canada
India
HongKong SAR
Others

VALUEUS $ Millions
418.24
23.6
107.00
7.0
114.00
6.8
90.51
6.7
80.00
5.9
67.22
4.9
35.60

SHARE %

Top World Herbal Importers 2007

S.No.
1.
2.
3.
4.
5.
6.

COUNTRY
VALUEUS $ Millions
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
Others
48.70

SITC

SHARE %

Indian Export of Crude Drugs

Top 10 Products
Rs in Crs.
S. No. COMMODITY 2007-2008
1
2
3
4
5
6
7
8
9
10

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

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
Regulatory

Regulatory Non-

American Region
14
Eastern Mediterranean Region
European Region (selected)
CIS & others
15
South East Asia
WesternPacific Region
10
African Region

4
11
20

5
1
2

12
12

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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
Homeopathy450 species
Modern medicine- 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

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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].

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
Homeopathy450 species
Modern medicine- 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

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.
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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

Focus LAC

Focus Africa
(including WANA
countries)

Focus CIS

4
5

Maximum Financial ceiling

per event

Trade Fair /
Exhibition
Rs.in lakhs
1.80

Trade
delegation
Rs.in lakhs
1.00

1.50

0.70

1.50

0.70

Focus ASEAN + 2

1.50

0.70

General

0.80

Nil

Total visits

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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
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 @ 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:

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

25

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
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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

 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 :

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

Pharmexcils 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

3. Bankers Certificate
5. PAN
Fees :
New

Renewals

For details visit our Website

www.pharmexcil.com

2. SSI Certificate
4. Drug License,

Rs

SSM
6000

ME
9000

LSM
28500

Rs

4500

6500

21000

Our Website www.pharmexcil.com

34

THANK YOU

35