1. EXPORT OPPORTUNITIES AND MDA/MAI SCHEMES
Interactive Session
06th May, 2011
Presentation by:
Abhay Kumar Sinha, Assistant Regional Director
PHARMACEUTICALS EXPORT PROMOTION COUNCIL
(Set up by Ministry of Commerce, Govt., of India)
Regional Office, 305 Padma Tower-II, 22, Rajendra Place, New Delhi-8 1

2. Global Pharmaceutical Industry – Overview
AGENDA 1
Global Pharmaceutical Industry – Overview 2
Indian Pharmaceutical Industry – Overview 3
Opportunities for Indian Pharma Industry 4
MDA/MAI Schemes of Department of Commerce 5
Role of Pharmexcil 2 2

3. Global Pharmaceutical Industry – Overview1
Global Pharmaceutical Industry – Overview
The global pharmaceutical markets are estimated at US$773.1bn (2008) growing at 4.8% percent over the previous year.
As per the latest statistics available from United Nations ‘Comtrade’ the Global exports of Bulk Drugs and Pharmaceuticals in the year 2008 stood at US$ 404.2bn growing by over the previous year.
Global Exports of Pharmaceuticals stood at US$374.69bn. growing by 10.38%.
Bulk drugs have a meager share of 7.3% in the total trade at US$29.5bn.

4. Top Exporting Countries of Bulk Drugs & Pharmaceuticals
(figs. in US$mn.)
Rank
Country (Exports)
2007
2008
% share 1
Germany
55,520.78
67,438.88
16.68 2
Belgium
47,377.79
50,665.56
12.53 3
Switzerland
36,232.92
44,145.34
10.92 4
USA
33,379.84
38,076.67
9.42 5
France
28,291.37
33,189.47
8.21 6
United Kingdom
28,975.58
31,342.25
7.75 7
Ireland
18,749.69
22,546.15
5.58 8
Netherlands
15,361.05
17,231.52
4.26 9
Italy
15,646.15
16,595.01
4.11 10
Sweden
8,719.60
9,167.87
2.27 11
China
6,093.35
8,117.00
2.01 12
Denmark
7,237.12
8,076.41
2.00 13
Austria
6,303.99
7,382.23
1.83 14
Canada
6,188.93
6,191.10
1.53 15
India
4,475.95
5,822.45
1.44
Source: UN trade database ‘Comtrade’, Pharmexcil

5. Source: UN trade database ‘Comtrade’, Pharmexcil
Top Importing Countries of Bulk Drugs & Pharmaceuticals (figs. in US$mn.)
Rank
Country
2007
2008
% share 1
USA
53,954.01
59,868.18
15.38 2
Germany
40,934.01
46,669.00
11.99 3
Belgium
41,602.36
44,332.86
11.39 4
France
22,068.56
24,820.57
6.37 5
United Kingdom
20,418.65
20,658.26
5.31 6
Italy
18,176.71
19,974.99
5.13 7
Switzerland
16,693.44
17,777.67
4.57 8
Netherlands
16,353.47
12,981.00
3.33 9
Japan
9,145.98
10,998.52
2.82 10
Canada
10,315.06
10,770.32
2.77
Source: UN trade database ‘Comtrade’, Pharmexcil 5

6. Region-wise Imports of Formulations (figs in US$ mn.)
2004
2005
2006
2007
2008
CAGR
( to )
% Share EU
136,646.37
150,930.08
165,865.34
198,076.04
219,722.57
12.61%
57.82%
North America
38,148.73
43,075.37
51,539.68
58,999.89
63,054.17
13.39%
16.59%
Other European Countries
12,919.97
14,291.89
16,394.10
18,889.73
20,317.85
11.98%
5.35%
Asia (Excluding Middle East)
10,075.43
11,803.01
13,293.29
15,869.83
19,442.41
17.86%
5.12%
LAC
7,829.30
9,220.21
10,909.13
16,137.70
15,711.52
19.02%
4.13%
CIS
4,374.39
6,330.61
8,768.74
10,129.35
13,229.05
31.87%
3.48%
Middle East
7,129.95
8,384.63
8,490.05
11,104.89
9,383.53
7.11%
2.47%
Oceania
5,137.06
5,931.11
5,963.17
7,195.15
7,704.82
10.67%
2.03%
Africa
3,677.62
4,191.28
4,737.33
5,712.55
4,964.89
7.79%
1.31%
Asean
2,730.36
3,455.16
4,183.43
4,692.09
4,511.31
13.38%
1.19%
South Asia
659.90
822.85
1,058.40
1,395.46
1,526.66
23.33%
0.40%
Other America
256.11
321.87
331.55
365.76
443.91
14.74%
0.12%
Grand Total
229,585.17
258,758.09
291,534.21
348,568.44
380,012.71
13.43%
100.00%
Source: UN Trade Statistics Database ‘Comtrade’
Notes on Infrastructure – GLP Labs, GCP Hospitals, Data Management Centers, Toxicity Centres, Pharma SEZs, etc 6 6

7. Region-wise Imports of Bulk Drugs (figs in US$ mn.)
Rank
Region
2004
2005
2006
2007
2008
CAGR
% Share 1 EU
8,417.18
9,059.21
9,598.95
10,631.82
10,942.03
6.78%
47.76% 2
North America
2,981.26
3,125.03
2,926.99
3,155.24
3,822.54
6.41%
16.68% 3
Asia (Excluding Middle East)
1,518.39
1,600.15
1,659.63
1,818.84
2,193.67
9.63%
9.57% 4
LAC
984.74
1,021.29
1,108.10
1,201.14
1,599.77
12.90%
6.98% 5
South Asia
498.70
646.90
711.38
1,005.66
999.85
18.99%
4.36% 6
Asean
715.29
979.91
881.89
1,112.83
995.17
8.61%
4.34% 7
Other European Countries
810.22
791.49
707.29
675.53
854.27
1.33%
3.73% 8
Middle East
665.67
710.41
580.70
730.07
636.15
-1.13%
2.78% 9
Africa
195.79
228.04
232.50
292.86
336.65
14.51%
1.47% 10
Oceania
327.89
320.37
267.51
271.55
294.37
-2.66%
1.28% 11
CIS
125.49
144.41
176.68
212.79
231.95
16.60%
1.01% 12
Other America
3.33
4.12
3.15
3.29
4.13
5.54%
0.02%
Grand Total
17,243.97
18,631.35
18,854.79
21,111.62
22,910.57
7.36%
100.00%
Source: UN Trade Statistics Database ‘Comtrade’
Notes on Infrastructure – GLP Labs, GCP Hospitals, Data Management Centers, Toxicity Centres, Pharma SEZs, etc 7 7

8. 2
Indian Pharmaceutical Industry – Overview
The Indian domestic pharmaceutical market size is estimated at US$12.2bn (Rs.55,454 crores) in the year 2008 growing by health 10%. (Source: IMS)
India’s Healthcare Expenditure in the year 2008 is estimated at US$68.6bn (as per Espicom Reports).
Pharmaceuticals expenditure occupies a share 17.78% in health care expenditure and 0.8% in GDP.
The per capita Pharmaceutical expenditure in the country is approximately US$10 (compared with US$1,154 of USA). 8

9. Indian pharmaceutical industry is among the world’s largest and most developed.
15th largest exporter of Bulk Drugs & Formulations in value terms with a share of 1.44% during 2008.
It ranked 14th in value terms and 3rd in volume terms.
The country is 9th largest exporter of APIs/Bulk Drugs and
Ranked 8th in terms of export volumes. 9

10. Exports for the year 2009-10 are estimated at US$8.88bn.
EXPORTS FROM INDIA
Exports for the year are estimated at US$8.88bn.
CAGR ( to ) was 17.46%
Pharmaceutical exports occupied a share of around 5% in India’s total exports over the last 5 years. 10

11. 11

12. Country-wise Exports of India’s Drugs, Pharmaceuticals & fine chemicals (figs. in Rs. Crores)
Rank
Importing Country
CAGR
YoY Growth Rate
% Share
Cumulative % Share 1
USA
5,839.35
7,177.06
9,121.25
30.26%
27.09%
21.67% 2 UK
1,146.52
1,235.83
1,636.70
18.45%
32.44%
3.89%
25.56% 3
Germany
1,448.01
1,530.49
1,502.44
7.61%
-1.83%
3.57%
29.13% 4
Russia
1,243.81
1,529.60
1,301.64
4.89%
-14.90%
3.09%
32.22% 5
South Africa
684.27
1,127.38
1,164.32
27.02%
3.28%
2.77%
34.99% 6
Brazil
771.61
1,167.64
987.58
12.27%
-15.42%
2.35%
37.33% 7
Nigeria
671.24
1,040.75
904.17
14.53%
-13.12%
2.15%
39.48% 8
Canada
789.15
1,096.04
767.06
9.94%
-30.02%
1.82%
41.30% 9
Viet Nam
483.56
536.73
707.84
14.62%
31.88%
1.68%
42.98% 10
Netherlands
522.69
683.28
685.15
14.35%
0.27%
1.63%
44.61% 11
Turkey
502.10
627.99
661.42
10.63%
5.32%
1.57%
46.18% 12
China
879.42
564.81
643.20
-4.83%
13.88%
1.53%
47.71% 13
UAE
426.11
478.14
577.79
13.26%
20.84%
1.37%
49.08% 14
Thailand
352.48
461.08
573.12
24.95%
24.30%
1.36%
50.45% 15
Ukraine
497.14
687.45
569.13
7.37%
-17.21%
1.35%
51.80% 16
Spain
501.42
622.89
564.36
12.64%
-9.40%
1.34%
53.14% 17
Italy
471.28
633.87
563.21
7.47%
-11.15%
54.48% 18
Kenya
366.60
544.08
551.26
30.69%
1.32%
1.31%
55.79% 19
Iran
379.11
485.64
532.23
15.31%
9.59%
1.26%
57.05% 20
Ghana
296.44
332.22
522.03
34.46%
57.13%
1.24%
58.29%

13. Current Status of India in Global Pharma Markets1
Global Pharmacy for Generic Medicines 2
Manufacturing Hub of the World 3
Emerging Flagship Industry of India
Finished generics supplied from India account for 20% of the global generics market.
Source: PricewaterhouseCoopers, The changing dynamics of pharma outsourcing in Asia 1
More Than 90% of WHO Prequalified API [ARVs, Anti-tubercular & Anti-malarials ] are sourced from India. 2
It is estimated that 70% of the patients belonging to 87 developing countries received medicine procured from India by
The United Nations Children’s Fund (UNICEF)
International Dispensary Association (IDA)
the Global Fund and
the Clinton Foundation. 3
Medicine Sans Frontiers also purchases 80% of its ARVs, for its projects in over 30 countries, from India.
Source: Ellen F.M. ’t Hoen, LL.M., The Global Politics of Pharmaceutical Monopoly Power, AMB 2009 4 5
Indian generic ARVs approved by the US Food and Drug Administration (US FDA) also resulted in cost- savings of an over 90% of the ARVs for PEPFAR.

14. The largest number of US FDA approved facilities outside US are in India.
1/3rd of all DMFs & 30% of all approved ANDAs in US are from India, ranking next only to USA.

15. India’s Competence 1. USA*
India’s Presence in Regulated Markets
1. USA*
Over 30% of DMFs, ANDAs, Tentative Approvals in USA are from India
India accounts for one out of every four Abbreviated New Drug Application (ANDA) approvals in the years 2007 & 2008
Ranks first in total Type II active Drug Master Files (DMFs) with U.S. FDA
Received 31% of all tentative approvals (as on ).
The country currently has 1,735 Type-II active DMFs filings with US FDA of all 6,482 DMFs filed which is 26.76% of all DMFs filed with that country.
- Source: U.S. FDA, Pharmexcil Research
* All figs. as at the end of Sep. 08 15

16. India has 539 CEPs (21.47%) of the total 2,511 granted by EDQM.
2. Europe*
Highest number of Certificate of Suitability (CEPs) is granted to India.
India has 539 CEPs (21.47%) of the total 2,511 granted by EDQM.
The country has 153 EDQM approved facilities for 195 molecules out of the total 693 molecules approved by EDQM.
* Source: European Directorate of Quality Medicine EDQM) (As on July, 2009)
Notes on Infrastructure – GLP Labs, GCP Hospitals, Data Management Centers, Toxicity Centres, Pharma SEZs, etc

17. Name of Regulatory Agency No. of Companies Approved from India
Registration Summary
Table 5: Approvals Received by Indian Pharma Companies from Various Regulatory Agencies of the World (As on Sep. 2009)
Name of Regulatory Agency
No. of Companies Approved from India
DMFs filed with U.S. FDA (companies)
136
DMFs filed with U.S. FDA (facilities)
169
Number of molecules filed for which DMFs have been filed
464
Formulation Plants approved by U.S. FDA 23
EDQM (European Directorate of Quality Medicine) (Bulk drug facilities)
153
Number of CEPs received
539
Number of Molecules for which CEPs have been filed with EDQM
195
WHO GMP Certified Plants
Over 1,000
DACA (Drug Administration and Control Authority), Ethiopia 50
(TFDA) Tanzania Food and Drugs Authority 75
Source: FDA sites of respective countries, Pharmexcil Research
Notes on Infrastructure – GLP Labs, GCP Hospitals, Data Management Centers, Toxicity Centres, Pharma SEZs, etc

18. Opportunities for Indian Pharma Industry3
Opportunities for Indian Pharma Industry
Generic Opportunity: 450 molecules worth US$350 bn are going off patent in the coming years 1
The contract manufacturing opportunity of prescription drugs is estimated to increase from a value of $26.2 billion to $43.9 bn. in the next 5years. 2
There are many important categories such as monoclonal antibodies, Peptides, biotech, etc., which are not filed by India forgoing a global opportunity of approx. US$ 90bn. 3
Several technologies such as sustained release/controlled /modified release Lyophilized Pharmaceuticals, bio-pharmaceuticals, Specialty generics, Drug Intermediates, NIP based APIs/Formulations, regulatory compliant infrastructure are not attempted in India. There are more than 285 drug in this category with an opportunity of US$50bn. 4
In the drug research value chain, there are certain key strengths such as:
Significant valid population to participate in clinical trials
Significant capabilities in medical skills, hospital beds and IT. 5
There exists an opportunity to capture the market share in global clinical R&D market such as clinical trials, data management, testing, etc. 6
By 2012, nearly half of all newly approved prescription drug products will be biologics 4 7
By the end of 2010, patents will expire on brand biologics with $15bn in annual sales.
Source: GPhA. 4 8

19. MDA/MAI Schemes of Department of Commerce4
MDA/MAI Schemes of Department of Commerce
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 19

20. MDA SCHEMES
The Objectives of the MDA Scheme is basically to assist the SMEs to promote exports of their products
Explore new markets for their product
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
Exporting companies with an FOB value of exports of up to Rs 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).

22. MDA Amount Ceilings & Visits in each areas permitted
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.
MDA Amount Ceilings & Visits in each areas permitted
S. No.
Area / Sector
No. of Visits
Maximum financial Ceiling per event 1
Focus LAC
Rs.1,80,000 2
Focus Africa (including WANA Countries)
Rs.1,50,000 3
Focus CIS 4
Focus ASEAN + 2 5
General Areas
Rs. 80,000
Total Visits
The participation of individual companies in the above activities shall be
subject to the following conditions:
For EPC etc. led Trade Delegations/BSMs only air-fare by Economy Excursion class upto a maximum of Rs. 70,000 (Rs. 1,00,000 in case of Focus LAC) shall be permissible.

23. (2) Maximum number of permissible participations shall be five in a
financial year as indicated in above table (No travel grant is \
permissible for visit to General Areas).
(3) Assistance shall be permissible to one regular employee/director/
partner/proprietor of the company. Assistance would not be
available to exporter of foreign nationality or holding foreign
passport.

24. After completion of the activity, the exporters have to file their claims with Pharmexcil along with the following simple documents:
Claim form as per Annexure – VII (downloadable from our website) duly signed by the Chartered Account
Claims must be filed immediately upon return to India after completion of activity but positively within 45 days from their return to India.

25. 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 / 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.

26. Marketing Projects abroad: Level of Assistance
Leasing/rental charges of Showroom/warehouses
75%, 50% and 33% in the first, second and third year respectively
Ceiling of Rs lakhs for each market/product per annum.
In cases of multi product showroom/warehouse-Rs lakhs
Participation & Organising Trade Festival of India etc abroad
Ceiling of Rs lakhs.
65% of the total expenses towards venue, publicity, catalogues, translation and interpreter and any other component as approved by EC.
Displays in International Departmental store
50% of rental charges subject to a ceiling of Rs lakhs per annum/each product
Publication of World class Catalogues
50% for a particular market subject to a ceiling of Rs lakhs per market per annum. Can be again considered after 3 years for updation.
Publicity Campaign and Brand Promotion
50% for two years subject to a ceiling of Rs lakhs per annum per market
Research and Product Development
65%. Ceiling Rs.100 lakhs for each product.
Industrial Clusters
75% subject to ceiling of Rs.100 lakhs.
RBSM
65% of total expenses. 100% of the travel cost(economy) of foreign delegates. Hotel charges – up to Rs75000/-. Rs 1lakhs in case of American continent

27. Capacity Building Level of Assistance Imparting training
65% subject to ceiling of Rs.10 lakhs. (study material, venue cost, faculty charges, organising expenses
Upto 90% of the cost of developing study material for trainers and exporters subject to ceiling of Rs.25 lakhs may be considered.
Up-gradation of lab, universities, Research institutions, national level institutions for fulfilling SPS measures, related testing
75% of the approved expenditure subject to ceiling of Rs.50 lakhs per organisation, for creating hardware and software neaded for creating these facilities
Capacity building for up gradation of quality
66% subject to a ceiling of Rs.25 lakhs per annum towards organising training prog for skill imrovement for quality up-gradation, product improvement etc.
Developing Common facility centres, packaging etc.
65% subject to a ceiling of Rs. 50 lakhs.
Funds may be provided for engaging experts/consultants. ( Amount up to10 lakhs in each case)
Hiring of consultants in the prospective/buyer country
65% subject to a condition that an exporter can apply for maximum two reimbursements in a year and the total ceiling for each exporter would be Rs.5 lakhs per annum.

28. Statutory Compliances Level of Assistance
Charges/expenses for fulfilling statutory requirements in the buyer country including product Registration charges
50% subject to ceiling of Rs.50 lakhs per annum for each exporter.
Anti-dumping, Anti money laundering and other investigations/ compliances
Support up to 50% of the actual expenditure subject to a celing of Rs. 200 lakhs in each case. Nature of litigation and extent of support shall be decided by EC on case to case basis

29. Studies Level of Assistance Market Study
75% subject to a ceiling of Rs. 100 lakhs per study. 100% in case of studies assigned by Department of Commerce for the cause of export promotion.
Ceiling of Rs lakhs for each market/product per annum.
Export Potential survey of the states
The organisation of state government would be the co-ordinating agency for the survey.
65% of the cost of survey subject to a ceiling of Rs 100 lakhs.
Project/Study which further the objective of the scheme
Financial assistance to any project/study.
65% subject to ceiling of Rs. 50 lakhs.
Studies on WTO related matters and JSG/FTA/RTA
Assistance may also be provided for preparation of projects through reputed professional institutions.
Upto 100% of the cost.

30. Miscellaneous Level of Assistance Developing Foreign Trade Portal
100% upto a maximum of Rs 2 crore.

31. Reimbursement of 50% of registration charges R & D projects
Out of the above, individual exporters are eligible to apply for the following incentives:
Reimbursement of 50% of registration charges
R & D projects
Hiring of Consultants at abroad
Litigation expenses in the buyer country on anti dumping duties etc
Reimbursement of Product Registration Charges overseas
50% of registration fees upto Rs 50 lacs( subject to MAI Guidelines) 31

32. 5
Role of Pharmexcil
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

33. 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  Herbal products
 Medicinal plants  Homeopathy
 Diagnostics  Nutraceuticals & Phytochemicals
 Contract research  Contract manufacturing
 Clinical research  Surgical dressings
 Collaborative research  Pharma industry related services
 Technologies/consultancy 33

34. 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
Dissemination of India’s pharmaceutical trade statistics
Preparing technical publications, exporters’ directory, etc. 34

35. Resolving grievances of pharmaceutical importers and exporters
Organizing national & international seminars on areas related to pharmaceutical industry.
Certificate of origin 35

36. Other services from Pharmexcil:
Country reports
World Pharma Reports
Patents Facilitation Center
Separate Cell for Ayush products 36

37. Offices of Pharmexcil Head Office: Pharmexcil 101, Aditya Trade Centre
Ameerpet
Hyderabad –
Phone: 91 – 40 – /66
Fax: 91 – 40 –
Regional Office, Mumbai
T.V. Industrial Estate, Unit No. 211
1st Floor, 248-A, S.K. Ahire Marg Worli, Mumbai
Phone:    / 51 Fax:     
Regional Office, Delhi
305, Padma Tower II 22, Rajendra Place
New Delhi
Phone:   / Fax:  

38. THANK YOU