Financial performance of the Indian drug and pharmaceutical industry, Imports and Exports
Global Pharma market size in the calendar year 2015 is estimated at $1060 billion as per IMS with a very marginal growth rate of 1-2%. India’s total export of pharmaceuticals( APIs, Generics and Alternative system of medicine) during 2015-16 was $16.89 billion with a growth of 9.44%. India’s exports in INR terms has recorded a growth of 17% and was valued at 11 0,52 2crore during Fy-15
A Global generic market is estimated to be of size $ 294 billion. The market grew 2015 approximately by 4% as Per IMS (World renowned market audit agency) data. India, a predominant player in the Generic market has docked $ 12.6 billion of &ports out of this $ 294 a growth of 12.8% during the year 2015-16.
Following table shows the progress of India’s exports of Pharmaceuticals during the last
three years.
|
India’s Exports of Pharmaceuticals Category wise in $ mn
|
|||
|
Category
|
Fy-1 5
|
Fy-1 6
|
Grtfc
|
|
Ayush
|
118.46
|
108.76
|
-8.19
|
|
Bulk Drugs & Drug Intermediates
|
3564.57
|
3585.05
|
0.57
|
|
Drug Formulations & BiologicaIs
|
11214.16
|
12645.51
|
12.76
|
|
Herbal Products
|
236.41
|
249.84
|
5.68
|
|
Surgical s
|
299.46
|
300.02
|
0.19
|
|
Grand Total
|
1 5433.06
|
16889.18
|
9.44
|
|
Source: DGCIS
|
|||
India has a market share of almost 80% of a Generic market size of Africa. A region of North American as contributed over 33%to India’s pharmaceutical exports and has grown by a 26% in Fy-l6 which is highest when the data is plotted by regions as shown in Table-2.
| Region wise Performance in the April- March | ||||
|
Row Labels
|
Fy-1 5 | Fy-16 | Gr% | Contb% |
|
North America
|
4517.94
|
5704.07
|
26.25
|
33.77
|
|
Africa
|
3089.03
|
3348.55
|
8.40
|
19.83
|
|
EU
|
2445.49
|
2549.31
|
4.25
|
15.09
|
|
LAC
|
1076.99
|
1032.68
|
-4.11
|
6.11
|
|
Asean
|
1055.62
|
1031.09
|
-2.32
|
6.11
|
|
Middle East
|
956.12
|
978.51
|
2.34
|
5.79
|
|
India’s exports to top 25 countries during 2015-16 in $ mn
|
|||||||
|
Rank
|
Country
|
Fy-15
$mn |
Fy-16
$mn |
Growth*
|
Contb*
|
cum
contbn* |
Change in Value
|
|
1
|
USA
|
4309.72
|
5502.96
|
27.69
|
32.58
|
3258
|
119324
|
|
2
|
SOUTH AFRICA
|
511.36
|
60620
|
18.67
|
3.59
|
3618
|
95.45
|
|
3
|
UK
|
54a 24
|
56429
|
328
|
324
|
32 S2
|
21.05
|
|
4
|
NIGERIA
|
420.50
|
43726
|
3.98
|
2.59
|
4211
|
16.76
|
|
5
|
RUSSIA
|
42480
|
374.02
|
-11.95
|
221
|
4432
|
-50.78
|
|
6
|
GERMANY
|
37267
|
347.53
|
-6.75
|
2.06
|
4638
|
-25.14
|
|
7
|
KENYA
|
28420
|
33321
|
1724
|
1.97
|
48.35
|
49.00
|
|
8
|
BRAZIL
|
37619
|
32522
|
-13.55
|
1.93
|
5028
|
-50.98
|
|
9
|
NETHER LAND
|
24243
|
243.49
|
0.00
|
1.44
|
51.72
|
0.01
|
|
10
|
AUSTRALIA
|
20620
|
23325
|
13.12
|
128
|
5210
|
27.05
|
|
11
|
FRANCE
|
209.00
|
232.16
|
11.08
|
127
|
5447
|
23.17
|
|
12
|
VIETNAM SOC REP
|
23245
|
22123
|
-523
|
121
|
5678
|
-1222
|
|
13
|
SRI LANKADSR
|
17116
|
206.14
|
18.47
|
121
|
57.00
|
31.99
|
|
14
|
CANADA
|
208.22
|
201.11
|
-3.42
|
1.19
|
5819
|
-7.11
|
|
15
|
PHILIPPINES
|
155.99
|
193.25
|
2388
|
1.14
|
59.33
|
3726
|
|
16
|
BELGIUM
|
154.01
|
192.15
|
24.77
|
1.14
|
60.47
|
38.14
|
|
17
|
IRAN
|
17480
|
179.53
|
2.71
|
1.06
|
61.53
|
4.73
|
|
18
|
TANZANIA REP
|
187.44
|
178.51
|
-4.76
|
1.06
|
6299
|
-8.93
|
|
19
|
NEPAL
|
169.17
|
170.14
|
0.57
|
1.01
|
6160
|
0.97
|
|
20
|
UGANDA
|
15828
|
160.25
|
6.94
|
1.00
|
6460
|
10.98
|
|
21
|
EGYPT A RP
|
11695
|
161.85
|
3889
|
0.96
|
6656
|
44.90
|
|
22
|
MEXICO
|
12664
|
1 60.25
|
26.54
|
0.95
|
6651
|
33.61
|
|
23
|
TURKEY
|
147.77
|
199.92
|
822
|
0.95
|
67.45
|
12.15
|
|
24
|
MYANMAR
|
17251
|
154.40
|
-10.50
|
0.91
|
6837
|
-18.11
|
|
25
|
THAILAND
|
157.37
|
147.71
|
-6.14
|
087
|
69.24
|
-9.66
|
|
Total of the above
|
1023712
|
11694.64
|
1424
|
6924
|
69.24
|
1457.52
|
|
|
Grand Total
|
1543106
|
16889.18
|
9.44
|
100
|
1456.12
|
||
India’s Pharmaceutical industry has filed the highest number of DMFS with US FDA and by the end of 2015, of fillings stands at 3820. India’s totaling 3470 by Feb 2016 ATCs.
Following Table gives an overview of India’s Accreditations.
|
Authority |
Name of Regulatory Agency |
Nos. |
| USA |
DMFs filed with U.S. FDA (companies) (As on 31st march 2015)
|
238
|
|
No: of Sites(Bulk drugs + Formulations) Registered with US FDA (as on 15th april20l 5)
|
605
|
|
|
Total No Of DMFs (Type II Active) filed from India (as on 31 St Dec 2019
|
3820
|
|
|
ANDAs(Ason Feb2016)
|
3470
|
|
| EUROPE |
Formulation companies withUSFDA approvals.
|
53
|
|
Number of CEPs received (as of February 201 6)
|
1354
|
|
|
Number of companies with CEPs
|
220
|
|
|
Number of Molecules for which CEPs have been filed with EDQM
|
382
|
|
|
No of Sites with EU GMP Compliance as on 15thFebruary 2016
|
631
|
|
|
UK MHRA (Medicines Healthcare Regulatory Agency), Market authorizations as on March 2015
|
1559
|
|
|
Number of CEPs with Irish Medicines Board
|
300
|
|
|
Number of companies registered in Irish Medicines Board
|
19
|
|
|
Number of Authorisations with Sweden MPA (Lakemedelsverket)
|
209
|
|
|
Number of companies having MA s with Sweden MPA (Lafcemedelsverket)
|
14
|
|
|
WHOGMP
|
WHO GMP Certified Plants (as per Drug Controller General of India)
|
1400
|
|
Ethiopia
|
DACA (Drug Administration and Control Authority), Ethiopia (companies)
|
50
|
|
Tanzania
|
(TFDA) Tanzania Food and Drugs Authority (companies)
|
1373
|