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The Exports Drugs, Pharmaceuticals & fine chemicals stood at Rs.39,537.66 crores
(US$8.61bn.) during the year 2008-09 growing at 28.54% (refer chart 1 & 2 below).
The exports grew at a compounded annual growth rate (CAGR) of 21.98% during the
five year period between 2004-05 to 2008-09.
Broadly, Asia is the largest importing region with a share of 30% of India's
pharmaceutical exports followed by Europe (24%) and North America (21%) (refer
chart 3& 4)
During 2008-09 United States of America is the top export destination with a share
of approx. 18% in India's pharmaceutical exports valued at US$1.55bn. followed by
Russia valued at US$0.33bn. with a share of 3.84%, Germany (US$.31bn. and
3.65%), Austria (US$0.31bn. and 3.58%) and UK (US$0.27bn. and 3.12%) (refer table 1).
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Table 1: Country-wise Exports of India's Drugs, Pharmceuticals & fine chemicals (figs. in Rs. Crores)
Rank Importing % Share Cumulative CAGR YoY Rank
(2008 Country 2008-09 2007-08 (2008-09) % Share(2008- (2004-05 Growth (2007
-09) 09) to 2008 (%) -08)
-09)
1 USA 7,103.27 5,839.35 17.97 17.97 27.18 21.64 1
2 Russia 1,519.20 1,243.81 3.84 21.81 18.37 22.14 3
3 Germany 1,441.87 1,448.01 3.65 25.46 193.90 1,172.37 58
5 UK 1,233.09 1,146.52 3.12 32.16 20.43 7.55 4
6 South Africa 1,126.75 684.27 2.85 35.01 51.02 64.67 8
7 Canada 1,090.43 789.15 2.76 37.77 21.81 38.18 6
8 Brazil 1,018.89 771.61 2.58 40.34 20.10 32.05 7
9 Nigeria 1,001.74 671.24 2.53 42.88 21.29 49.24 9
10 Ukraine 687.22 497.14 1.74 44.61 19.53 38.24 13
11 Israel 686.09 456.80 1.74 46.35 42.05 50.19 16
12 Netherlands 669.98 522.69 1.69 48.04 22.31 28.18 10
13 Spain 620.02 501.42 1.57 49.61 15.76 23.65 12
14 Turkey 614.20 502.10 1.55 51.17 26.64 22.32 11
15 China 561.53 879.42 1.42 52.59 0.76 -36.15 5
16 Kenya 543.86 366.60 1.38 53.96 43.65 48.35 23
17 Viet Nam 536.62 483.56 1.36 55.32 15.16 10.97 14
18 Belgium 520.90 273.28 1.32 56.64 36.19 90.61 33
19 Italy 507.85 471.28 1.28 57.92 13.66 7.76 15
20 Mexico 501.54 442.49 1.27 59.19 15.86 13.34 17
Source: DGCIS, Pharmexcil Research
Pharmaceutical exports occupy a share of 5.2% to 4.4% in India's total exports over
the last 5 years (refer table 2).
Table 2: Principal Commodity Exports of India (figs. In Rs. Crores)
Rank Commodity Name 2006-07 2007-08 2008-09 CAGR % Share Cumulative %
Share
1 Gems & jewellery 72,295.18 79,227.74 127,424.33 19.81 15.17 15.17
2 Petroleum & crude products 84,520.15 114,191.68 123,397.99 40.79 14.69 29.86
3 Transport equipment 22,398.22 28,282.06 51,246.30 41.69 6.10 35.96
4 Machinery & instruments 30,420.34 36,750.33 50,376.46 31.77 6.00 41.96
5 Drugs, pharmaceuticals & 26,895.18 30,759.64 39,537.66 21.98 4.71 46.67
fine chemicals
6 Readymade garments 31,289.51 30,335.79 38,521.06 14.18 4.59 51.25
cotton incl. accessories
7 Other commodities 13,919.72 16,146.56 35,208.23 36.42 4.19 55.44
8 Manufactures of metals 22,992.16 28,389.05 34,728.57 22.78 4.13 59.58
9 Electronic goods 12,914.31 13,532.16 31,227.70 39.57 3.72 63.30
10 Primary & semi-finished 19,813.73 16,723.63 21,773.14 8.32 2.59 65.89
iron & steel
Source: DGCIS, Pharmexcil Research
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2. India in Global Pharmaceutical Industry
The global pharmaceutical markets are estimated at US$773.1bn (2008) growing at
4.8% percent over the previous year (refer chart 7). Top Therapeutic Category-wise
Sales are also given at chart 8.
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As per the latest statistics available from United Nations 'Comtrade' the Global trade
in Bulk Drugs and Pharmaceuticals in the year 2008 stood at US$ 404.2bn growing
by 10.37 over the previous year. During that year, exports of Pharmaceuticals stood
at US$374.69bn. growing by 10.38%.
India is the 15th largest exporter of Bulk Drugs & Formulations in value terms with a
share of 1.44% during 2008. The country is 9th largest exporter of APIs/Bulk Drugs
valued at US$819.1mn. and the country ranked 8th in terms of export volumes. The
country also imported bulk drugs valued at US$968.27mn. during that year.
Germany is the top exporting country with exports valued at US$67.44bn. followed
by Belgium and Switzerland in that order (refer tables 4, 5 & 6). Bulk drugs have a
meager share of 7.3% in the total trade at US$29.5bn. Germany was the largest
exporter of formulations with exports valued at US$62.47bn. followed by Belgium
(US$48.69bn.) and Switzerland (US$40.09bn.). In quantity terms also Germany was
the largest exporting country followed by China and India. China was the largest
bulk drugs exporting country with exports at US$5.25bn. followed by Germany
(US$4.97bn.) and USA (US$4.11bn.).
Table 4: Top Exporting Countries of Bulk Drugs & Pharmaceuticals (figs. in US$mn.)
Rank Country 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
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Table 5: 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
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share at US$2.99bn. followed by Crude herbs and Essential Oils (refer Chart 1).
Country-wise top exporters and importers in each of the three segments are
provided at Table 5, 6, 7, 8, 9 & 10 respectively.
1. India's Strengths in Pharma R&D
India is a globally acknowledged source of high quality affordable generic medicine
with rich vendor base. India is not only an API and formulation manufacturing base,
the country is poised to become manufacturing hub for pharmaceutical industry of
the world and an emerging hub for Contract research, Bio-technology, Clinical trials
and Clinical data management. The country's pharmaceutical industry has shown
tremendous progress in terms of infrastructure development, technology base
creation and a wide range of production covering almost all therapeutic categories
and dosage forms.
The above fact is further firmly demonstrated by the trends in:
1. The number of product approvals received from various major regulatory
authorities of the world
2. The cost advantage India offers in comparison with developed markets and
3. Other technical strengths of our country in development and production of
pharmaceuticals.
The country has 814 WHO CGMP approved pharmaceutical plants (as on Apr. 2009
available in the website of DCGI). It has 153 European Directorate of Quality
Medicine (EDQM) approved pharmaceutical manufacturing facilities.
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These DMFs have been filed from 169 facilities by a total of 136 Indian companies.
India has 1,735 Type-II active DMFs filings with US FDA of all 6,482 DMFs filed which
is 26.76% as on Sep. 2008 (refer chart 9). India has DMFs for 462 products of the
total 1,117 products filed with U.S. FDA.
India, currently accounts for one out of every four Abbreviated New Drug
Applications (ANDAs) (Generic products approvals) in the years 2007 & 2008, more
than one fourth of total Drug Master Files (DMFs) (Active Pharmaceutical Ingredient
approvals) with US FDA, the largest share in registrations granted in the world
including USA. It also received 31% of all tentative approvals as at the end of
December 2008. The resilience can be seen in the number of approvals received in
both OTC & Prescription drugs as also in various therapeutic categories (refer chart
10 and Table 8).
Table 8: Therapeutic Category-wise Product Approvals of India (Prescription Products) in U.S.A (As on 12.11.2008)
Sl. No. Therapeutic Category Total % share
(Product-wise)
1. Anti-HIV 13 18.05
2. Anti-Microbial 274 14.77
3. CVS 254 11.12
4. Anti-Diabetic 37 10.57
5. CNS 247 10.27
6. Dermatological 9 10.22
7. GI Tract 60 9.88
8. Other Anti-Viral 12 9.09
9. Anti-Allergic 10 7.87
10. Analgesic 53 5.03
Source: U.S. FDA, Pharmexcil Research
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India's Exports of Medical, Surgical & Diagnostic Equipment and Diagnostic
Reagents
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