Shiv Raman Dugal,
board of directors, Institute of Clinical Research, New Delhi
Dugal is the chairman of the board of directors at the Institute of
Clinical Research (ICRI), the first and the world’s largest institute
in clinical research education. He has been responsible for raising the
organization’s delivery capability to world-class standards. With over
30 years of experience, Dugal has been a part of the ICRI since its
inception in 2003. He is an active member of many industry associations
and societies, and has served these bodies in various capacities, in
implementing their programs
Clinical research industry has been growing exponentially
in the past few years. It has opened up a large number of career
opportunities to medical, pharma and all interdisciplinary fields.
In Asia, the major destinations for clinical research are Singapore and
India – estimated to be worth
crore ($2.5 billion ) by 2010. Currently 2,50,000 positions in clinical
research are said to be available worldwide; with 50,000 job openings
in India, within next 3-5 years.
Singapore is already a hub in the APAC for biopharma firms and contract
research organizations (CROs) to conduct their regional clinical
development activities. Growth of global clinical research.
Clinical research industry has grown around the world at an unparallel
rate in the past few years. It has opened up new vistas of employment
for a large number of people.
Currently, the worldwide clinical research market is worth over
crore ($52 billion), 70 percent of the business is generated within the
US, employing an estimated 210,000 individuals. UK is considered as the
hub for clinical trials in Europe with over 70,000 individuals in the
Clinical research in India
India is increasingly recognized as the most promising hub for global
clinical research. The clinical trial outsourced market in India is
forecasted to grow at a CAGR of around 31 percent during 2010-12.
“Registered clinical trials in India have gone up from 221 in 2007 to
around 1,300 in 2009. Eighty Indian hospitals are presently involved in
clinical trials. This figure is likely to go up to 14,000; and will
mean involvement of five-lakh doctors, seven-lakh beds, 17,000 medical
graduates in 160 medical colleges.
India is fast emerging as a favored destination for clinical trials in
new products by multinational pharmaceutical companies. Two major
reasons for its popularity can be attributed as easy access, and
availability of a large, diverse and therapy-näive population,
with vast gene pool and a lower cost of technical services;
resulting into lowest per patient trial cost.
According to an analysis done last year by Rabo India Finance,
conducting a clinical trial in a low-cost destination such as India,
can cost up to 60 percent less than in the US. Cost savings are a
significant dream for many pharma companies when deciding to outsource
clinical research to countries in emerging markets such as India.
Unlike the US, India has favorable government regulations and approval
Trials and tribulations
The challenges India faces for expansion of its clinical research
market are: insufficient number of hospital sites and trained personnel
meeting international conference on harmonisation-good clinical
practice (ICH-GCP) norms, equipments at hospitals/ sites for conducting
trials not always on par with trial sites in western countries, apart
from bureaucratic hurdles for regulatory approvals for global clinical
Phase I trial is not allowed in India unless the molecule is developed
in India, the industry is looking forward to this being allowed. Phase
II and III studies take 45 to 90 days to get approval. Also the lack of
protection for the data generated in these trials is the matter of
There have been concerns over ethical issues in patient recruitment and
conduct of trial, along with the lack of sufficient infrastructure for
central laboratory services.
The key expectations from CRO market are consistent high quality,
credibility, reliability, offering a range of services, broad and
focused therapeutic expertise, timeliness, global reach local expertise
approach and expertise in developing newer drug delivery systems (NDDS)
To meet the challenges and address the key issues, India need to devise
policies and insure implementation in legislative, IPR structure and
regulatory issues. India also needs to help develop CROs with adequate
capacity and competency in carrying out clinical research activities in
compliance with ICH/GCP guidelines.
Clinical research to boost industry.
According to McKinsey report, India is emerging ‘as hub for global
clinical research’. The global clinical trial outsourcing opportunity
in India is estimated to be around Rs 5,000 crore by 2010, and there
will be a requirement of approximately 50,000 clinical research
Today, there are more than 2,50,000 positions vacant worldwide. And
salaries vary from a minimum of
lakh ($40,000) per annum for a clinical research coordinator, to
lakh ($10,000) per annum for a business development manager. What this
means is that clinical research is definitely the next big career.
India, at present, has a requisite of clinical research professionals
and personnel in allied services; such as data management,
biostatistics and medical welfare.
But the current numbers of skilled professionals are only 2,000 and
3,000. The clinical trial market is growing at the rate of 30 percent
It takes about
crore ($1 billion) and some eight to 10 years for a new drug discovery.
But if clinical trials were to be conducted in countries like India,
the cost could come down to as much as 60 percent. In terms of career,
a fresher could get jobs in clinical research segment with a pay packet
lakh annually which eventually goes higher to
– 6 lakh annually.
Some of the career options available are clinical research associate,
clinical research coordinator, clinical data management executive,
pharmacovigilance executive, clinical trial analysts, medical writer,
drug reviewer and many more.
ICRI addresses the need for qualified and trained clinical research
professionals by offering various programs in clinical research at its
centre of excellence campuses in New Delhi, Mumbai, Ahmedabad,
Dehradun, Hyderabad and Bangalore.
ICRI is India’s first and only clinical research institute dedicated to
promoting ethical research and high-quality clinical research education
The courses offered by ICRI are in collaboration with Cranfield
University, UK. ICRI is the only institute in India offering courses at
multiple campuses throughout the country, thus giving the courses a
Quality in clinical research is of paramount importance. Ethical and
social considerations should be kept in mind while conducting a
clinical trial. All clinical trials performed in the country should
meet the specifications laid down in ICH-GCP guidelines.
For this our country needs skilled professionals having in-depth
knowledge and understanding of the basic principles that are considered
as prerequisites for conducting clinical trials.
India has various systems of medicines like homeopathy, unani, ayurveda
and other traditional systems that offer a wide scope for clinical
trials. These practices need to be integrated in traditional products
to generate superior knowledge-based products.
As the drug development is a high-risk investment global pharmaceutical
companies under pressure from stakeholders are trying to find ways for
cost-containment and to increase the productivity. India with its
intellectual powerhouse, patient population, world-class scientific and
technical skills and discipline is an attractive destination for global
players, for cost and time containment. This is the reason why MNCs are
outsourcing clinical research and trials to India.
With government initiatives in full swing, a favorable environment is
being created not only for the conduct of outsourced clinical research
but also for the growth of local pharmaceutical industry at a rapid
pace. With full efforts from the government and cooperation from Indian
CRO industry to meet the challenges in this field, India is set to
become the ‘global hub of clinical research’.