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Global Scenario

Although the origins of the modern pharmaceuticals industry can be traced back to the late 19th century, the real development started in 1960s due to some new and innovative discovery with permanent protection. Next couple of decades saw tightening of regulatory control in the sector all across the world. It was during this period that drugs got laws for patent protection, leading to the appearance of generic drugs.

The introduction of generics was very beneficial for society as the valuable medicines became extremely cheap. 1980s and 1990s saw the introduction of venture capital in the pharma and biotech industries. Due to worldwide reforms in the healthcare sector, several regulations were passed to control the pricing of the drugs and deliverance of genuine product innovation. By the turn of the century, all the leading drug companies were spending reasonable amount of their revenue in research and development (R&D).

Today, the global pharmaceuticals industry is more than USD 550 billion and has grown at a compound annual growth rate of more than 6% in last 5 years. Geographically, north America is the biggest pharmaceuticals market with a share of almost 50%, followed by Europe 30% and Japan 9%. Around 20% of all retail prescriptions filled today are related to Medicare. Of those only 31% are for branded drugs and rest are filled generics. 

At present there are over 1,000 drugs under development, with companies diverting increasingly large proportions of their revenue streams into R&D, the primary driver of competitiveness in the industry.

Having traditionally enjoyed strong growth rates, the industry's operating environment is becomingly increasingly complex. Volume growth is, currently, negligible, the primary driver of industry value being rising per-unit values, whilst the rise of generics is eroding sales growth. Under these circumstances, the global pharmaceutical market is expected to show slightly slower growth in coming years and is predicted to be in the range of USD712 billion to USD 745 billion by the end of 2008 which is depicted below. In recent years, pharmaceutical companies in Asia, particularly in China, South Korea and India, have been a success due to their ability to retain their cost advantage while matching the quality standards of the west. Despite an impressive growth, foreign drug makers are particularly concerned with issues on corruption, governmental bureaucracy and intellectual property (IP) protection in these countries. These issues are important particularly when growing drug counterfeiting activities pose a major global public health risk as well as a financial and reputation threat to pharmaceutical manufacturers. Drug pricing pressures are challenging the pharmaceutical industry like never before, with governments resorting to drug price controls and other measures to manage spiraling pharmaceutical costs.

 
National Scenario
 
Overall
A highly organized sector, the Indian pharmaceutical industry is estimated to be worth $5-10 billion and growing at the rate of 8-9% annually. It ranks very high in the third world in terms of technology, quality and ranges of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine in now made indigenously. Its plays a key role in promoting sustainable development in the vital field of medicine. Indian pharmaceutical industry boasts of quality producers and many units are approved by regulatory authorities in USA and UK. The Indian pharmaceuticals sector is highly fragmented with more than 20,000 registered units. It is an extremely fragmented market with severe price competition and government price control. The Indian industry meets around 70% of the country's demand in bulk drugs, drugs intermediates, pharmaceuticals formulation, chemicals tablets, capsules, orals and injectables. There are 250 large units and about 8000 small scale units which form the core of pharmaceutical industry in India (including 5 central sector units). These units produce the complete ranges of pharmaceuticals formulations i.e., medicines ready for consumption by patients and about 350 bulk drugs, i.e. chemicals having therapeutic value and used for production of pharmaceuticals formulation The pharmaceutical sector is distributed through various pharmaceuticals clusters in the country. The Details of Pharmaceutical Clusters in India (Turnovers & Employment) are as follows:
S.No. State Production value per
annum (Rs in Crores)
Estimated Employment
1 Maharashtra (Mumbai ,Pune and Aurangabad) 12000 - 15000  65000
2 Gujarat (Ahmedabad and Baroda) 10000 – 12000 55000
3 Delhi , UP and Haryana 5000 25000
4 MP ( Indore Cluster) 2500 15000
5 Uttarakhand (Dehradun Cluster) 2000 20000
6 AP(Hyderabad cluster) 8186 20000
 
The Pharmaceuticals sector has been able to attract FDI amounting to USD 1401.60 million in the sector during 2000-01 to 2008-09 (up to September). In so far as domestic industrial proposals between August 1991-March 2008 are concerned, total IEMs[2] filed including LOI[3] & DIL[4] add up to Rs. 31257 crores in Drugs & Pharmaceutical Sector.

The Pharmaceutical sector is estimated to have created 2.20 lakh employment opportunities Indian exports rising from a negligible amount in early 1990s to US$ 11183.49 million by 2007-08. The exports of drugs, pharmaceuticals, & fine chemicals from India grew at a compounded annual growth rate (CAGR) of 17.8% during the five year period 2003-04 to 2007-08.  (In USD Million)
S.No Importer

2003

2004

2005

2006

2007

2008

1

USA

455.66

492.27

603.93

715.54

989.27

1,375.42

2

Germany

161.68

211.17

206.52

253.01

296.78

337.41

3

Russia

107.17

140.05

172.15

242.84

291.88

297.97

4

UK

89.05

109.10

130.41

187.75

199.12

267.82

5

China

92.96

102.33

121.21

177.04

151.62

203.40

6

Brazil

76.07

87.09

108.96

140.39

171.60

187.03

7

Canada

52.94

90.09

110.20

118.56

124.22

183.41

8

South Africa

25.29

38.26

48.19

101.02

110.77

161.62

9

Nigeria

76.00

82.78

102.99

118.69

139.09

160.06

10

Other countries

2986.84

3857.01

4669.76

5788.92

6824.73

8009.35

Total

4123.66

5210.15

6274.32

7843.76

9299.08

11183.49

(Source: Pharmexcil, Hyderabad)
 
 
 
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