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Clinical Research Industry has grown around the world at an unparalleled rate in the past few years. It has opened up new vistas of employment for a large number of people. The Clinical Trials market worldwide is worth over US$ 45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK and they form one third of the total Research & Development staff. These large numbers can be attributed to the fact that this industry offers lucrative employment opportunities. The average nominal annual salary growth across all the positions is 4% as against less than 1% for other segments.
 

Salaries of Clinical Research Professionals in US

Clinical Research Organizational Chart


Position

Annual Gross Salary (in US$)

Growth in Salary
(in %)

1999

2001

CRA I

45,000

46,000

2.22

CRA II

50,000

52,000

0.40

CRA III

59,000

68,000

1.50

Senior CRA

63,000

72,000

1.40

Regional CRA

58,000

65,000

1.20

Project Manager

71,000

74,000

4.20

Regulatory Affairs

70,000

73,000

4.28

Data Management

59,000

65,000

10.10

Medical Writing

50,000

58,000

16.00

Medical Affairs

81,000

84,000

3.70

Business Development

83,000

90,000

8.43

Clinical Research Co-ordinator

34,000

40,000

17.64

   

Indian Pharmaceutical Industry


India is home to more than one billion people, including 30 million with cardiovascular diseases, 25 million with type-2 diabetes, and 10 million with major psychiatric disorders. Large, extended families also still live in proximity to one another, making them attractive recruits for genetic linkage studies. And India's pharmaceutical market is the second largest in Asia, growing by more than 9% annually. The Indian pharmaceutical industry is estimated at US$ 5.40 billion and projected to grow up to US$ 7.40 billion.
 

R & D Expenditure in 2003-04 & 2002-03


COMPANY

TOTAL TURNOVER TOTAL R & D EXPENSES    % TO TURNOVER
2003-04 2002-03 2003-04 2002-03 2003-04 2002-03

Dr Reddy's Lab

1,742.37 1,575.06 226.05 163.49 12.99 9.92

Ranbaxy Lab

3,782.47 2,969.05 276.13 192.17 7.30 6.47

Nicholas Piramal

1,293.38 1,017.22 55.86 18.50 4.32 1.82

Lupin

1,195.05 959.86 45.99 36.00 3.90 3.49

Orchid Chemicals

695.13 529.96 39.65 27.84 5.56 5.13

Cadilla Healthcare

1,172.00 1,028.00 88.20 38.30 7.52 3.72

Wockhardt

767.12 743.29 60.41 46.18 7.89 6.23

Sun Pharma

1,055.34 873.20 107.68 65.77 10.20 7.50

Aurobindo Pharma

1,318.30 1,157.46 48.68 22.05 3.57 1.82

Biocon

540.60 257.40 51.40 11.40 10.00 4.48

Unichem Laboratories

354.67 295.50 8.42 8.66 2.19 2.69

Divi's Lab

317.28 259.72 7.59 6.87 2.51 2.79

JB Chemicals

312.76 287.70 6.87 4.99 2.20 1.73

Shasun Chemicals

269.03 240.41 10.84 11.09 4.23 4.74

Alembic

569.04 516.10 19.58 19.67 3.19 3.47

TOTAL

15,384.54 12,709.93 1,053.35 672.98 6.85 5.29

 

Clinical Research Industry - An Indian Perspective

Clinical Research - The Future

India has become a signatory to TRIPS. Consequently, a new patent law has come into effect from January 2005. The new keyword for the pharmaceutical industry is innovation and to introduce new drugs, clinical trials are mandatory. They are to be conducted as per ICH GCP norms. The clinical trials that have been conducted in India till date have gone well. For majority of the studies, patient enrollment is a key advantage. This helps compress the development timeline and data quality is excellent.
Numerous audits in India are a testimony to level of quality. And data from clinical study in India have been successfully filled with international regulatory agencies. The potential realized at present is a fraction of the possible in India. Consistent with WTO guidelines effective from 2005, India will also offer 10-year tax concessions on revenue to companies making Research & Development (R&D) investments here. These incentives are expected to substantially increase R&D activities of both multinational and domestic biopharmaceutical companies.
Analysts are projecting that total Clinical Research spending in India will increase by more than 30% annually through 2010.


India is increasingly being recognized as a hub for global clinical trials as it has several prized attributes:
Large and diverse patients' pool for conducting clinical trials
Availability of Medical, Pharmacy and Science graduates
Excellent infrastructure facilities
Comparative cost advantage
Changes in the Patent Laws
 

The Clinical Research industry in India has grown from Rs 20 crores to Rs 100 crores in the last three years. As per a recent McKinsey report, it is expected to touch Rs 5,000 crores by 2010 and will employ 50,000 people in the next five years.
There will be a huge demand for qualified and trained Clinical Research Professionals.
Many pharmaceutical organizations and Clinical Research organizations have already come forward to unlock the vast potential that India has, and are conducting Clinical Trials in India.
 

Pharmaceutical Companies and CROs Operating in India
Asian Clinical Trials Apothecaries Clininvent Covance
Aventis Astra Zeneca Dr Reddy's Lab Eli Lilly & Co
Clinigene Clintec International Glaxo Smithkline Igate
Periclinical Pharmanet Icon Jubilant Clinsys Ltd
Panacea Biotec Quintiles Kendle Lotus Labs
Ranbaxy Laboratories Reliance Crs Lambada Niman
Sun Well Quest Novartis Novo Nordisk
Siroclinpharm PPD Omnicare Pfizer
 
    Various Types of Clinical Trials being conducted in India

 
Trials are on for drug which is indicated for reduction of mortality in adult patients and can be used for sepsis. Clinical Trials have already been held on more than 600 patients for human insulin and insulin. Clinical Trials are being conducted on oncology and developing a new molecule for lung cancer.
Clinical trials are on 300 patients on a new malaria 'cocktail' drug that combines chloroquine (to which Indian malarial strains have developed resistance) and azithromycin, an antibiotic. Clinical Trials are also being conducted for drugs to treat osteoporosis, breast cancer and schizophrenia.
Global trials are on in India for treatment of a particular variant of lung cancer. One of the reasons for considering India is that it has a vast patient population infected by this type of lung cancer, which is primarily triggered by use of tobacco products. India is also being considered a prospective site for future clinical trials involving new drugs and therapies for treatment of different variants of blood cancer and colorectal diseases.
The trials in India are mostly in different areas like oncology, endocrinology, traumatology, sports medicine, pulmonary diseases, pediatric diseases, and infectious diseases.
The largest Clinical Trial outside US for a drug delivery device has been conducted in India.

Major Players in Clinical Research

India has numerous Clinical Research players with a global standard infrastructure and manpower. They are ready to support the drug development initiatives of several pharma companies and entrepreneurs. As the number of studies carried out by these major players is on the rise, the career prospects for Clinical Research professionals look positive. The number of players in the Clinical Research industry in India has risen to over hundred from less than eight, three years ago.

 

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