India’s Pharmaceutical exports An Overview 21st June 2014

International Pharma Trade Scenario

(source: IMS)

2

Top 25 Global Generic Companies –June 2012

Top 25 Companies account for 28% of global generics market. 8 Indian Companies are among the Top 25 accounting for 4.8%

Source :BMI

Note: After merger of Sun & Ranbaxy, Sun becomes 5 th largest pharma.

The Indian Pharma Industry : The Flag Bearer India’s Exports of Pharmaceuticals during the last Five years (USD billion) 2008-09

2009-10

2010-11

2011-12

2012-13

CAGR%

8.8

8.95

10.7

13.3

14.6

13

India’s exports share in Global Generic Market is 3.3%.

India's Exports of Drugs, pharmaceuticals & fine chemicals (figs. in US$ Bn)

14.50 13.2

Over 55% exports of India are to highly regulated markets.

10.7 8.8

9.0

U.S.A the largest exports destination followed by UK Largest exporter of formulations in terms of volume during 2010 with 14% market share and 2nd after Germany in 2011. Source: UN COMTRADE

2008-09 2009-10 2010-11 2011-12 2012-13

4

India’s Pharmaceutical Contribution to Global HealthCare During 2012-13 Region

Values in USD million

% Contbn

North America

4000

27

EU

2635

18

Africa

2594

18

Middle East

1018

7

Asean

938

6

LAC

916

6

CIS

887

6

Asia (Excluding Middle East)

548

4

South Asia

523

4

Oceania

239

2

Other European Countries

153

1

Other America

86

1

Others

51

0

World

14,590

100

Source: DGCIS

Asia(Exclu Oceania ding South asia 2% 0% 0% 0% 0% Middle 4% east) 4% North CIS America 6% +Other LAC America 6% 28% Asean 6% Middle East 7% EU+Other Europe 19% Africa 18%

Indian Pharma in US Market Top 10 prescribed Generic Products in US Market (in million) and India’s Market authorizations (ANDAS) of the product Ra nk 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Products Hydrocodone/par acetamol levothyroxine sodium lisinopril Simvastatin Metoprolol Amlodipine Omeprazole Metformin Salbutamol Atorvastatin Azithromycin Amoxicillin Alprazolam Hydrochlorothiazi de Zolpidem Total Rxs Percentage of Top 15 Grand Total Prescriptions

ANDAs

No of companies

135.3

NIL

India Has No Presence

107.5

NIL

India Has No Presence

90.8 86.1 78.1 66 65.7 61.6 61.5 54.9 54.5 52 49.2

18 25 19 26 9 37 NIL 4 6 20 16

3 5 8 10 2 12 0 1 4 3 4

47.7

14

4

43.8 1054.7

8 8

4 4

2012

25.8% 4,078

Indian Pharma with European Market Authority

EUROPE

Name of Regulatory Agency

Nos.

Number of CEPs received (as of 31st Jan 2014)

1105

Number of companies with CEPs

155

Number of Molecules for which CEPs have been filed with EDQM

344

No of Sites approved by EDQM In India(As on 30th April 2013)

353

UK MHRA (Medicines Healthcare Regulatory Agency), Market authorizations as March 2013

1110

Number of CEPs with Irish Medicines Board

300

Number of companies registered in Irish Medicines Board

19

number of Authorisations with Sweden MPA (Läkemedelsverket)

209

Number of companies having MA`s with Sweden MPA (Läkemedelsverket)

14

Source: UN Comtrade

Top 10 formulations suppliers Top 10byformulations suppliers (excepting Israel) to US volumes

(excepting Israel) to US by volumes

Top ten countries exporting formulation to USA in Volumes (Metric Tonnes) Rank Countries 2012 %contbn India 74336 22.90 1 China 66274 20.42 2 3 Mexico 62925 19.39 Germany 18892 5.82 4 United Kingdom 16619 5.12 5 Belgium 8299 2.56 6 Austria 7407 2.28 7 Japan 7400 2.28 8 Italy 7147 2.20 9 France 6419 1.98 10 324542 100.00 USA's total imports

Values(USD mn) Actual 3021 963 400 9,278 6625 8234 566 752 1211 2485 61,934

S.No.

Company During 2012-13 Exporters %contbn

1.

DR REDDYS LABORATORIES LIMITED

2.

LUPIN LIMITED

3.

MYLAN LABORATORIS LIMITED

Top 5

25

4.

AUROBINDO PHARMA LIMITED

Top9

33

5.

CIPLA LIMITED

Top 23

50

6.

HETERO DRUGS LIMITED

75

7.

SUN PHARMACEUTICAL INDUSTRIES

8.

GLENMARK GENERICS LIMITED

Top 91 Total of 6945

9.

RANBAXY LABORATORIES

10.

SERUM INSTITUTE OF INDIA

100

India’s exports of Pharmaceuticals Value in USD million India’s exports During Last Five Years

Category

2009-10 2010-11

Gr%

2011-12

Gr%

2012-13

Gr%

2013-14

Gr%

Bulk drugs

3650

3972

8.8%

4704

18.4

4536

-3.6

3900

-14.02

Formulations

5183

6612

27.6

8388

26.8

9912

18.1%

10800

8.95

Herbals

120

142

6.1

176

16

232

-10.3%

200

-13.85

Total

8954

10725

19.8

13268

23.7

14681

10.6

14,900

1.49

2013-14 data is provisional.

India’s exports of Pharmaceuticals Value in Inr Cr India’s exports During Last Five Years

Category

2009-10 2010-11

Gr%

2011-12

Gr%

2012-13

Gr%

2013-14

Gr%

Bulk drugs

17307

18099 4.5

22557

24.7

24699

37.34

23171

-6.2

Formulations

24571

30130

23

49218

33.4

53973

34

65100

20.7

Herbals

571

646

13.1

845

16

1264

50

570

--55

Total

42449

48875

15.1

63620

30.2

79934

25

89,506

12

2013-14 data is provisional.

India’s exports of Pharmaceuticals - top ten countries

Value in USD million India's Pharma exports Top ten Destination Countries-Progress Country 2011-12 Gr% 2012-13 Gr% 2013-14 Gr% Deviation USA 3268 30.88 3729 14.10 3907 4.80 493 Russia 410 -10.04 572 39.52 559 -2.28 128 UK 491 25.56 513 4.48 519 1.12 124 Germany 463 27.95 467 0.95 467 -0.02 75 South Africa 383 12.25 441 15.04 497 12.76 62 Nigeria 310 38.41 341 9.83 378 10.86 59 Brazil 279 21.19 328 17.68 305 -7.12 59 Canada 258 68.60 286 10.60 254 -11.06 48 Kenya 230 25.72 252 9.65 246 -2.26 44 Netherlands 230 16.22 249 8.16 250 0.50 25 Total of top Ten Grand Total

6323 13268

2013-14 data is provisional.

25.80 23.71

7178 14681

13.60 7384 10.65 14,900

2.86 1.5

1590 Deviation

India’s exports of Pharmaceuticals Values in USD million

Estimated Actual value Deviation in Fy-14 Due to reduced Growth rates of some destinations Calculated Value Rank in Rank in Value in Gr% in Cagr last Four for 2013-14 Country 2012-13 2013-14 2012-13 2013-14 2013-14 Years applying CAGR Gr% Deviation USA 1 1 3729 3907 4.8 18 4400 493 Russia 2 2 572 559 -2.28 20 687 128 Singapore

14

27

187

123

-34.14

32

247

124

Canada Brazil Kenya

8 7 9

8 7 10

286 328 252

254 305 246

-11.06 -7.12 -2.26

15 12 21

329 367 305

75 62 59

Ghana

16

21

184

153

-17.12

15

212

59

Turkey Japan Spain Grand Total

12 18 19

17 19 19

200 179 174

170 176 163

-14.65 -2.01 -6.47

9 23 10

218 220 188

48 44 25

14680

14900

1.5

13

16490

1590

2013-14 data is provisional.

Estimated growth loss in 2013-14 is 9%

India’s exports of Pharmaceuticals - top ten countries

Values in million USD TOP 10 GLOBAL GENERIC DRUG MARKETS BY VALUE in the calendar year 2013 India's India’s Contribution By contribution by Country Generic market Value Percentage UNITED STATES 67000 3301 4.9 CHINA 55000 12 0.02 JAPAN 12500 63 0.5 GERMANY 12500 207 1.6 BRAZIL 10500 158 1.5 RUSSIA 9250 573 6.19

UNITED KINGDOM FRANCE SOUTH KOREA Canada

9000 7500 7000 5400

384 125 12 147

4.26 1.66 1.78 2.72

India’s contribution data is provisional. Generic market source : BMI/IMS, India’s contribution source : Pharmexcil

India’s exports of Pharmaceuticals USA: Mainly because USFDA’s reports of Indian manufacturing facilities citing non compliance of GMP/Data documentation. Some of the other Important Destination countries Like Russia, Brazil are pursuing their agenda of becoming self reliant swiftly.

Other important Destinations like Canada, Singapore and some others are seem to be influenced by USA’s import alerts. International price of some of the bulk Drugs/intermediates has dropped.

APIs are being employed for formulations exports.

Issues Sri Lanka : Quality Issues Vietnam : Quality Issues Ghana: Renewal of market authorizations and delayed registration process

India’s Pharmaceutical Regulatory Performance

USFDA Inpections and its Subsequent Actions of Indian Pharmaceutical Firms – Last 5 Years (ANDA approved only) YEAR

NAI

VAI

OAI

(No Action Indicated)

(Voluntary Action indicated)

(Official Action Indicated)

2009

(14/49)

29%

(34/49) 69%

(1/49) 2%

2010

(6/18)

33%

(9/18) 50%

(3/18) 17%

2011

(18/43)

42%

(24/43) 56%

(1/43) 2%

2012

(15/57)

26%

(40/57) 70%

(2/57) 4%

2013

(8/25)

32%

(13/25) 52%

(4/25) 16%

Sources: USFDA’s Inspection Classification Database Search. http://www.fda.gov/ICECI

USFDA Inspections and its subsequent actions indicated for US and Indian Firms – 2013 (ANDA approved only)

COUNTRY

TOTAL INSPECTIONS

ANDA APPROVED INSPECTIONS

INDIA

60

25

US

606

111

NAI

VAI

OAI

(8/25) 32%

(13/25) 52%

(4/25) 16%

(53/111) (53/111) 48% 48%

(5/111) 4%

State wise membership with Pharmexcil during 2012-13 State wise Membership with Pharmexcil During 2012-13 State Maharashtra Gujarat A.P. Delhi Tamil nau Karnataka Haryana U.P M.P West bengal Punjab Kerala Chandigarh Rajahstan Uttarnachal H.P Goa Bihar Jammu& Kashmir Orissa Chattisgarh Assam Total

Number Of Regns 1621 568 520 348 238 154 86 80 71 53 48 41 37 34 23 21 12 8 6 4 2 1 3976

FACT SHEET 2014 SHOW NAME

INTERNATIONAL EXHIBITION FOR PHARMA AND HEALTH CARE (iPHEX)

SHOW DESCRIPTION

The second edition of one of the largest showcase of Indian pharmaceutical products and technologies supported by the Ministry of Commerce & Industry, Government of India, and organised by PHARMEXCIL.

DATES

21-23rd May

FREQUENCY

Pharmacy of the World

VENUE

Hall 1, 2 Bombay Exhibition Centre, Mumbai

SHOW SIZE

Over 120,00 m 2 gross

EXHIBITORS

Over 300 companies show casing formulations, APIs, AYUSH and all related sector

FOREIGN DELEGATES

Over 400 hosted buyers including regulators from Africa, South America, Central America, ASEAN +2, CIS, Middle East, Europe & USA

International Exhibition for Pharma and Healthcare

21-23rd May 2014

Annual

Bombay Exhibition Center, Mumbai VISITORS

Over 5000 professional visitors from India and overseas