ISSN 0975 – 8542

Journal of Global Pharma Technology

Available Online at www.jgpt.co.in

REVIEW ARTICLE

RECENT EMERGING HUB FOR GLOBAL CLINICAL RESEARCH IN INDIA

Debjit Bhowmik*a, Chiranjib, Biswajita, Jyoti Jaiswala, K.K.Tripathia, Durgesha & K.P.Sampath Kumarb
a
Rajiv Gandhi college of Pharmacy, Nautanwa, Maharajganj,Uttar Pradesh, India
b
Department of Pharmaceutical sciences, Coimbatore medical college, Coimbatore,
Tamilnadu, India

For correspondence: Email- margretchandira@yahoo.com

Abstract: The economic environment of a country has a very strong impact on the economic system in
which its industries and business firms operate. As far as economic environment of India is concerned,
India's is a mixed economy. A simple mixed economic system is characterized by existence of both private
and public sectors. In present the clinical trial market in India looks very lucrative. The country promises to
be one of the hottest destinations for conducting global clinical trials, owing to a huge patient pool
representing both chronic and infectious diseases, easy recruitment of patients, and high cost savings.
Moreover, the market is getting boost from improved IPR protection with changed rules and also from
reduced taxes and duties. According to our new research study on the sector called “Booming Clinical
Trials Market in India”, the clinical trial outsourced market in India is forecasted to grow at a compound
annual growth rate( CAGR) of around 31% during 2010-2012. Presently, the market is characterized by the
dominance of phase III and phase II trials, which currently hold more than 80% of the market. India has the
largest pool of patients in many diseases, including cancer and diabetes. The study also points out that
India’s biggest advantage is its low cost. For instance, trials for a standard drug in the US can cost up to
$150 million. A similar drug could be tested in India for less than half that amount. Center Watch has
predicted that by 2010, the industry will spend around $250-300 million on clinical trials in India. Mc
Kinsey estimates a much higher figure of $1-1.5 billion. This scenario is expected to remain intact in future
as well. With detailed description of the regulatory environment and cost factors promoting the market. It
also highlights several emerging market trends like clinical data management, pathology and diagnostic
market, etc. The research study offers detailed statistical and analytical review on demographics,
macroeconomic indicators, disease profile, clinical service market, key drivers and restraints. It contains all
the requisite information that will help clients to draw up market strategies and assess opportunity areas in
India’s clinical trial market.Clinical trials in India is 44% less expensive than US trials.

Key Words: Clinical trial, disease, global, regulatory, phase

INTRODUCTION treatment. Advances in medicine and

Clinical research is a scientific study of the
effects, risks, efficacy and benefits of a
medicinal product. These are carried out
prior to the release of the medicine in the
market. These trials are undertaken at
various stages and studies are conducted
after the launch of a new product to
monitor safety and side effects during
large-scale use.Clinical trials are designed
to help us find out how to give a new
treatment safely and effectively to people.
All patients who participate in a clinical
trial provide information on the
effectiveness and risks of the new
science are the result of new ideas and
approaches developed through research.
New treatments must prove to be safe and
effective in scientific studies with a certain
number of patients before they can be
made available to all patients. Clinical
trials show that which therapies are more
effective than others. This is the best way
to identify an effective new treatment.
New therapies are designed to take
advantage of what has worked in the past
and to improve on this base. There are
certain steps and protocols which needed
to be followed while carrying out the

© 2009, JGPT. All Rights Reserved. 30

 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
actual clinical trials. Pre-clinical
Testing .The sponsor of the clinical trial
needs to gather data regarding safety of a
new drug in small-scale clinical studies
before it is studied in humans. Animal
studies provide data regarding the
absorption, distribution, metabolism and
excretion of a new drug. Data regarding
the short-term toxicity of the drug in
animals is also obtained. Short-term
studies in animals can range from 2 weeks
to 3 months depending on the proposed
action of the new drug.
PHASES OF CLINICAL TRIAL [1,2,4]
Testing of a new therapy or treatment,
trial progresses in an orderly manner
which is known as phases. Which make
researchers able to ask and answer
questions in a way that results in reliable
information about the drug and the
patients? Clinical trials are usually
classified into four phases.
PHASE I:
This is the first and foremost stage of
any clinical trial. In this stage the drug
gets tested on human beings. For this
phase only a small no of people, usually
20-80 , are taken. The people involved
in the trial are the people who volunteer
themselves for the study and are healthy.
In this phase, safety, acceptability
Absorption, Distribution, Metabolism
and Excretion of a drug is administered.
These trials are generally conducted in
the clinics with the inpatient facility so
that the subject or the volunteer, who
has been given the drug, could be under
round the clock observation. In this
phase usually only healthy volunteers
are taken but in some special cases like
cancer and HIV, drug trials are only
done on the patients suffering from
these diseases.
PHASE II
As soon as the initial safety of the drug
is ensured in phase I trials, Phase II
trials are initiated. Phase II trials take a
© 2009, JGPT. All Rights Reserved.
larger group on which the drug has to be
administered. The group usually consists
of 20-300 volunteers. Phase II mainly
assesses the drug on the basis of its
performance in the previous phase or in
phase I. The development process
failure for a new drug, usually takes
place during Phase II when the drug is
discovered to not work as planned, or
have toxic effects.
PHASE III
These trials are initiated on comparatively
a very large group of people or patient
groups. Group size consists usually of
300-3000 patients but can increase as per
the requirement. As opposed to Phase I
trials, Phase III trials are performed in
more then one centre or clinic. The major
advantages of trials conducted in various
centers include a larger number of
participants, different geographic locations
and the possibility of including of a wider
range of population groups which
enhances the ability to compare results
among centers. The more varied results are
obtained, the more beneficial they prove
for the study.
PHASE IV
This phase initiates after the drug is
allowed to be sold in the market or is made
available for the general public. These
trials are carried out mainly by the
sponsors of the drug to find a new market
for the drug, or for many other reasons like
can this drug be administered with any
other drugs or how well it interacts with
the different types of drugs.
CLINICAL TRIAL IN INDIA [4,5,6]
Clinical trial is a research study,
comprising human volunteers, to test the
effectiveness of a new drug. In other
words, clinical trials are carried out to find
out if proposed treatments work on human
beings. A clinical trial for a specific drug
takes nearly 9 to 10 years to reach the
completion stage. The global clinical trials
market is expected to be worth USD16
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 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
billion by 2008, up from USD10 billion in
2005 and is growing at 15-18%. The
clinical research industry in India touched
USD140 million in 2006, up from USD70-
80 million in 2001-02 and has been
estimated to touch USD200 million by
2007 and USD500-600m by 2010. A
clinical trial is a long-drawn out process,
globally costing anywhere between
USD350 and USD500 million. Not
surprisingly, a significant share (30%) of
clinical trials is now outsourced to
Contract Research Organizations (CROs).
At a given time, over 3,500 drugs are
under development and about 4,000
clinical trial projects are in progress for
new drug applications. The report presents
Global and Indian scenario for the clinical
trials market in terms of recent trends,
major diseases, pre-clinical trails,
regulatory developments etc. The report
covers the market scenario in terms of
R&D expenditure, drug withdrawals,
research on drug price controls etc.
The report profiles listed and unlisted
major players with an introduction, clinical
trials expertise, regulatory approvals
& recognitions, collaborations,
financial details etc. This clinical trials
report presents information on technology
aspects in the industry such as drug design,
biochemistry of drugs etc. The clinical
trials report has highlighted the major
growth drivers in the industry along with
critical success factors. It provides
information on the regulatory issues in
India and presents the information on the
issues & challenges in the industry.
Finally, it presents the future outlook of
the clinical trials industry. According to
McKinsey report the clinical research
industry will witness a business of Rs
10,000 crores creating a demand of 50,000
professionals in the next five years.
Analysts’ project that by 2008 up to 30
percent of global clinical trials will take
place outside US and Western Europe and
India would emerge a favorable
destination. India is witnessing this
positive trend which is reflected by
© 2009, JGPT. All Rights Reserved.
growing numbers of players - global and
local CROs, currently providing a
spectrum of clinical development services
at different stages of drug development,
viz. project management, clinical trial
monitoring, medical affairs, regulatory,
clinical trial supplies, quality assurance,
data management and statistical analysis.
Most companies acknowledge that
knowledge process outsourcing to India
not only minimizes the cost, but also
propels the growth of the organization.
With this growth in knowledge process
outsourcing, there is a constant demand of
human resources in India.
There is no dearth of knowledgeable and
educated professionals in India. But the
sudden skewed growth in this segment of
CRO business has put lot of demand for
skilled professionals, which are not
existent in sufficient numbers in Indian
market. The available pool of human
resources mainly comprises of pharmacy
graduates or graduates in biological
sciences, post - graduates and/or
doctorates, medical doctors, statisticians
and software engineers. Depending upon
their qualification and experience they are
assigned the job responsibilities.
Every clinical project taken up by the
employee is a learning experience through
which one gets to learn about the activities
performed by the other functional groups
during the conduct of the trial. If an
individual has put in years in the clinical
operation department, is highly
experienced and is aware of the
regulations and standards, then that
individual through experience can gain
knowledge of regulatory affairs, clinical
trial supplies management, quality
assurance and data management and hence
can also perform cross-functional tasks.
However, freshers, who desire to join this
industry, wish to start their careers through
clinical operations. The craving for clinical
operations is because of huge demand for
Clinical Research Associates (CRAs) in
the market today. But looking at the
current business expansion, the industry
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 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
may demand professionals for other
service offerings like QA,
pharmacovigilance and regulatory affairs
as well.
Indian clinical trials market in 2006 was
US$ 140m and is growing at a CAGR of
40% for the last 3 years. India is fast
emerging as a favored destination for
clinical trials outsourcing, in view of the
country’s advantages like large pool of
patients, faster patient recruitment, well
trained English speaking Physicians and
IPR protection, besides lower costs. Over
100 pharmaceutical companies, including
Fortune 100 companies such as Pfizer and
Merck, are currently outsourcing clinical
trials in the country. Also, there is an
increased awareness regarding ICH–GCP
(International Conference on
Harmonization-Good Clinical Practice)
guidelines for conduct of clinical research.
Besides, India’s inherent advantage in IT
skills helped in outsourcing of high-end
activities like data management. All these
advantages will drive the growth of
Clinical Trial Outsourcing industry to
scale up to US$ 600m by 2010.This report
discusses in detail the nature of the Indian
clinical trials market, its size, costs
incurred and Indian advantages and future
outlook for the industry. The report also
examines overview of the Indian clinical
trials market scenario and is compared
with the global industry size. This report
also analyses the critical success factors
driving the industry and issues relating to
infrastructure constraints and technical
expertise. This report profiles thirty two
major Indian companies covering aspects
like services offered, key people, clinical
phases and financials for the last two years.
Issues Relating to Government regulations,
governing clinical trials, along with details
on Good Clinical Practices and ICH
Regulations have been covered The report
talks about future outlook, outsourcing
opportunities, industry dynamics and also
growth and change in the industry.
A clinical research is a scientific study of
the effects, risks, efficacy and benefits of a
© 2009, JGPT. All Rights Reserved.
medicinal product. These are carried out
prior to the release of the medicine in the
market. These trials are undertaken at
various stages and studies are conducted
after the launch of a new product to
monitor safety and side effects during
large-scale use. Clinical trials are
conducted by pharmaceutical companies
or contract research organizations (CRO's)
on their behalf. It is this sector that is
driving the growth in clinical research in
India.
CLINICAL RESEARCH - A FAST
GROWING INDUSTRY [7,9]
A multinational and multidisciplinary
industry, Clinical Research is the
systematic scientific study to understand
the effects, side effects, and risks of a new
drug on humans. In India alone, the
industry is about to reach the staggering
size of Rs 5,000 crores by 2010 which
outlines the vast potential and job
prospects it offers over the next few years.
The field of clinical trials and research in
India gained attention from major players
all over the world because of its over 1
billion population size with a large ratio of
patient population that are seen as
potential subjects by the scientists for
various studies. Moreover, India also
offers a large talent pool of English-
speaking trained doctors and certified
professionals in all the related fields as
well as world-class infrastructure in its
hospitals and research laboratories at very
economical rates. Clinical trials are usually
conducted in four phases. In the initial
stage, drugs are tested on healthy and
informed volunteers to study behavior of
the medicine, followed by trials on
informed patients to test its effects and
side effects. In the third phase, a large
number of volunteers are administered the
drug and kept under close supervision to
generate statistics and data for regulatory
and licensing authorities.
Phase IV trials are conducted by the
company after its limited commercial
launch to monitor how thousands of
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 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
patients, prescribed the drug by their
doctor, are reacting to the medicine and
study any unforeseen situations that might
occur. The strong growth shown by
pharmaceutical companies in India and
abroad and the technological and scientific
advancements has given unprecedented
rise to expenditure on research and
development of new drugs.
The processes too have quickened up and
the industry is in need of trained and
qualified personnel who are well aware of
latest trends in the industry, and can design,
handle and monitor all drug development
and clinical trial projects with ease. The
need for professionals, who understand the
stringent rules and regulations outlined by
the government and regulatory authorities
and also ensure safety of human subjects
and volunteers, is also on a steep rise.
Asia’s second biggest player in the field,
India offers easy patient enrollment and
high quality data analysis that have made a
great contribution in the discovery of
innovative drugs at a global level. It has
also cemented its position as a global hub
for clinical trials and research.
Thus, the field has emerged as an
attractive career option for life science,
biotechnology, medicine or computer
science graduates and postgraduates.
Clinical Research Industry offers packages
ranging from Rs 15,000 to Rs 40,000 per
month to a fresher, depending on his or her
qualification and post.
An exponential rise on an annual basis has
also been noticed in the salary of Clinical
Research professionals globally,
depending on their performance and years
of experience in the industry. Whether you
want to join as a project manager,
pharmacovigilance supervisor or clinical
data manager, specific certificate and
diploma courses in the industry from a
good and reputed institute will multiply
your chances of landing a suitable job soon.
© 2009, JGPT. All Rights Reserved.
CURRENT & FUTURE SCENARIO
FOR CLINICAL TRIALS IN INDIA
[4,9,10]
The market for clinical trials has been
expanding rapidly in recent years, with
impressive revenue growth and important
trends. One regional market expanded by
65% in 2008. From the perspectives of
various pharma stakeholders, the
expanding clinical research market
represents opportunities for revenue
growth and cost savings. Our latest report -
Clinical Trials: World Market 2009-2024 -
considers perspectives of pharma
companies and CROs in particular. We
comprehensively analyze the market’s
strengths, weaknesses and revenue trends
from 2009 to 2024.A career in clinical
research begins at the clinical research
associate (CRA) level and there are quite a
few institutes claiming to train industry-
ready CRAs. A few pointers to choosing a
good clinical research course and institute.
The pharmaceutical industry is one of the
most powerful and steadily growing of all
industries. Presently pegged at $ 643
billion, the industry is growing at seven
percent. The single country that consumes
the largest amount of pharma products (by
value) is the US, and the ICH countries
account for 55 percent of the world
consumption of pharmaceuticals. One of
the important growth drivers for this
industry is innovation and the development
of new drugs. Initially, new drugs came
from the plant world, later chemistry took
over and presently the largest number of
drugs in the pipeline is from
Biotechnology. Irrespective of the source,
every new drug has to undergo a series of
tests: in vitro, in vivo, both in animals and
man. Before a medication can be sold in
the open market it must undergo rigorous
testing. The process by which new
medications are tested in human beings so
they can ultimately be marketed to treat
various diseases is called clinical research.
A molecule has to undergo various stages
of testing before it can be labeled as drug.
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 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44

These stages include the following: NDA, the company can market the drug to
the public. Additional testing (post-
1. Preclinical phase: It can be further marketing or late phase III/phase IV) to
subdivide in to: look at the rare adverse effects continues.
Development of a compound: Chemists
in a laboratory develop thousands of CAREERS IN CLINICAL RESEARCH
chemical compounds with a certain One needs to have the right educational
chemical structure that the scientists background to enter this industry. A life
believe may have biological activity in science degree (especially pharmacology,
humans to alleviate certain symptoms in a pharmacy, biochemistry, biology,
disease, or perhaps cure some diseases. immunology, physiology, or
Pre-clinical testing: The next stage of biotechnology) or a medical, dental or an
testing is called the pre-clinical stage. To alternative medicine degree is one of the
prove that the compound works as is requirements to become a clinical research
hypothesized and does not produce any professional. A computer or IT degree will
unwanted side effects, it is first thoroughly be an asset to start career as a clinical data
tested in two to three species of animals manager.
(such as, mice, rats, dogs and monkeys).
The purpose of these animal studies is to
prove that the drug is relatively safe, is not
carcinogenic (causes cancer), mutagenic
(causes mutations), or teratogenic (causes
foetal malformations), and to understand
how the drug is absorbed, metabolized and
excreted. Once a pharma company proves
that the compound appears to be safe, and
possibly effective in animals, the company
then provides this information to DCGI in
India or FDA in the US or TPD in Canada
and requests approval to begin testing the
compound (experimental drug) in humans
via an Investigational New Drug (IND)
Clinical research Associate
application.
A Clinical Research Associate (CRA) is a
2. Clinical testing
professional who monitors the
Clinical trials/Studies in humans:The
administration and progress of a clinical
clinical testing of experimental drugs in
trial on behalf of a sponsor. A clinical trial
humans is normally done in three phases
is a scientific study of the effects, risks and
(Phase I, II and III) starting with normal
benefits of a medicinal product, including
healthy volunteers and then testing the
new drug substances and currently
new drug on more and more patients,
marketed drugs. A CRA is also called a
included in each subsequent phase. Before
clinical research (or trials) monitor,
moving to the next phase of development
executive, scientist or coordinator,
the data are carefully analyzed to ensure
depending on the company. Typical work
the experimental drug is at least safe and
activities include: locating and briefing
well tolerated. After successful completion
suitable doctors/consultants (investigators)
of Phase III testing, a company will submit
to conduct the trial; setting up the study
the results of all of the studies to the Drug
centers — ensuring each center has the
Controller General India (DCGI) or FDA
trial materials and checking that the
to obtain a New Drug Approval (NDA).
investigator knows exactly what has to be
Once the regulatory authorities grant an
done; monitoring the trial throughout its

© 2009, JGPT. All Rights Reserved. 35

 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
duration which involves visiting the study
centers on a regular basis to check the
patient data in the case report forms
(CRFs) and to sort out any problems which
may arise; validating and collecting
completed CRFs from hospitals; closing
down study centers on completion of the
trial; discussing results with the statistician.
Writing technical reports on the trial is
usually carried out by a medical writer.
The job of a CRA can vary tremendously
from company to company. In some
companies, the candidate would be
involved in the whole process - from
sitting down with the doctor who has the
idea for a trial, and actually working out a
protocol, to writing up reports after the
analysis has been done. In other companies
it would be the medical adviser who
initiated the trial and the CRA could just
be involved in collecting data once the trial
has been set up. The CRA will need to
work extra hours regularly, generally, a
limited amount of time is spent in the
office. The work is mainly on the road
visiting trial centers, general practitioners
(GPs) or hospitals; dealing with doctors
and research nurses.
CURRENT DEVELOPMENTS IN
CLINICAL RESEARCH IN INDIA
[12,13,14]
India emerged as a global hub for clinical
research. According to a report by Mc
Kinsey the global Clinical trial outsourcing
opportunity in India in the pharmaceutical
industry is estimated to be around $2
billion by 2010 and there will be the
demand for more than 10,000 investigators
trained in Good Clinical Practice (GCP)
and 50,000 clinical research professionals.
Analysts project that by 2008 an estimated
30 % of global clinical trials are being
undertaken in developing countries. In
India alone the clinical trial market of
$300 million is expected to grow to nearby
$2 billion 2012. In terms of cost efficiency
India is better, as the cost of conducting a
trial here is lower by 50-60% than in the
United States or the European Union.
© 2009, JGPT. All Rights Reserved.
More importantly due to the large naïve
patient pool the recruitment rate can be
greatly accelerated which in turn leads to
shorter study duration.
This provides as major advantage in terms
of shortening the time to launch a new
drug in the market. Based on these
advantages, the number of clinical trials in
India is expected to grow exponentially
over the next five to ten years. According
to official reports “In 2005 around 100
clinical trials had been approved in the
country by the Drug Controller of India
(DCI). In 2006, it increased to around 150
and to 240 in 2007.In the current year
around 450 have already been approved”
Joint Drugs Controller of India, A.B
Ramteke said on the sidelines of a
conference in Mumbai. Certain recent
changes in regulatory affairs encourage
clinical trials in India. In 2005, Schedule Y
of the Drugs and Cosmetics Act was
amended. Earlier foreign drugs trials could
be conducted only at one phase below the
highest phase of testing abroad. Now,
parallel global clinical trials are possible in
India. Permission is granted for
concomitant phase 2 and Phase 3 trials.
There is a need at the present time for a
strong centralized regulatory regime which
can give high quality development of
ethical capacity, with extra vigilance but
with an informed understanding of
acceptable risk. The increase in clinical
trials also has challenges like regulatory
uncertainties about time to approval of
biotech products and for processing
import/export licenses and several other
factors are hurdles in planning a clinical
trial. Lack of potential investigators with
fundamental knowledge of regulatory,
ethical, GCP guidelines to conduct clinical
trials. While India is in its own stand in
Clinical research most of the medical
schools lack a formal course in training for
clinical research, so there is a shortage of
trained manpower. India has 500 to 1000
investigators in the country as compared to
50,000 in the United States. In a country,
which boasts a large medical fraternity,
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 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
only 400-500 investigators sites have taken
part in global GCP trials. The efforts of
government and industry to create
awareness through GCP workshops and to
provide training to the investigators and
ethics committees go a long way towards
creating a culture of global GCP quality
trials. Despite all these issues most
pharmaceutical companies are conducting
multicentre studies in India with the
establishment of small Clinical research
departments in the country. This team
coordinates with its global project
management or outsourcing partner. The
outsourcing decision for these global
studies are mostly made in US and Europe;
however, as India becomes major hub and
contributes further to subject recruitment
in clinical studies, Indians will play a
much larger role in the outsourcing
process. But this calls for the development
of its capacities and capabilities in terms of
infrastructure, Regulatory structure and
formulation of a specialized pool of
research investigators.
Increasingly, a need is being felt for the
development of institutes that may provide
training and education in the clinical
research segment and meet the growing
demands of skilled manpower by the
industry. Clinical research industry is
growing exponentially in the past few
years. It has opened large number of career
opportunities to medical, pharma and all
interdisciplinary fields. Global clinical
trials market is worth of over USD 45
billion and India has good potential to tap
the clinical research pie. India is one of the
favored destinations for clinical research
by MNC's. The Indian Pharma market is
about $8 billion today and overall Indian
Pharma market is growing at 8-10%.
Indian Pharmaceutical industry has
immense opportunities in contract research
activities, clinical research, New drug
delivery system, drug discovery,
outsourcing for IT needs, Custom
synthesis, manufacturing etc.Worldwide,
the average cost of developing one
molecule costs about $282 million and
© 2009, JGPT. All Rights Reserved.
takes about seven years to complete.
According to industry estimates, the cost
of phase I trial is 50% cheaper in India and
for phase II it is 60% less.
BOOMING CLINICAL TRIALS
MARKET IN INDIA [1,4,13]
India has implemented product patents
since 2005, which will lead to widening of
the market for indigenous (say, Ayurvedic
products) as they will have the authenticity
of internationally recognized product
patents. Product patent protection will
encourage multinational companies to
import technology into India to develop
new products. These developments will
open up increased opportunities for the
clinical trials of bio-tech and medicinal
products. Clinical research is losing its
attractiveness in the US due to the shortage
of investigators. By 2005, there will not be
enough clinical investigators to handle the
number of drugs in clinical development.
Center Watch estimates that against a 2005
demand for 56,000 investigators, only
48,000 will be available, a shortfall of 15
percent. According to industry sources,
India has about 500 investigators. India
has over 572,000 doctors, 43,322 hospitals
and dispensaries and about 8.7 lakhs beds
including both private and public.
Majority of the doctors are graduates with
little or no knowledge about clinical trials
and hence would not qualify as
investigators for complex international
clinical trials. The situation requires
tremendous efforts to attract the medical
professionals/specialists to clinical
research. Identifying and attracting
potential investigators is the biggest
challenge, requiring innovative approaches.
The current efforts at training are
fragmented. The training focus of sponsors
and CROs is on the investigators involved
in their trials and their own monitors and
other professionals. The enormous
challenge of large number of quality
professionals in medical and clinical
research can only be met by cooperative
and collaborative efforts between industry,
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 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
academia and government. Besides the
manpower efforts, the training activity will
need financial support. In the US, the
industry spends over $300 million on
training.
The funding has to come from all
stakeholders, with majority share coming
from the major beneficiary, the pharma
industry. Around 25 contract research
organizations (CROs) and almost all
multinational pharmaceuticals companies
have started full-fledged clinical trials in
India since last three years. Further, the
amendment to Schedule Y of the Drugs
and Cosmetics Act in February, now
allows MNC s to conduct simultaneous
trails in India and abroad MNCs like Pfizer,
Eli Lilly, GlaxoSmithKline, Sanofi-
Aventis and Roche have already started
phase-I and II trails in India. There are
many independent CROs in the fray too,
which are consolidating their base and
expanding operations.
Mumbai-based CRO, Metropolis Health
Services which conducts clinical trials in
various therapeutic segments and offers a
spectrum of clinical development services,
is in the process of offering site
management services to various pharma
firms and other CROs. It offers trials in 16
therapeutic segments like anti-
inflammatory, allergic disorders,
cardiovascular, central nervous system and
oncology. Ahmedabad -based CRO,
Synchron Research offers services like
rapid pharmacokinetic (PK) analysis,
qualitative and quantitative medical
imaging and silico drug metabolism
studies. It has conducted over 200 bio-
availability studies. Bangalore-based Lotus
Labs has also completed more than 450
bio-studies and is conducting several phase
III trials.
It has set up research facilities in
Bangalore and Chennai and has recently
tied up with St John’s National Academy
of Health Sciences, Bangalore, for
conducting phase I trials. Mumbai-based
Clin Invest Research focuses on all phases
of clinical trials mainly in the areas of
© 2009, JGPT. All Rights Reserved.
oncology, neuro-psychiatry, cardiology
and diabetes drugs. Clingene International,
a Biocon subsidiary, concentrates on bio-
analytical, bio-statistical and data
management services to its clients
Quintiles Spectral (India), a subsidiary of
Quintiles Transnational, the clinical
services segment, conducts studies in
oncology, psychiatry, neurology and anti-
infective. The company has conducted
over 90 clinical studies on 13,000 patients.
In fact, many new CROs have outlined
plans to tap India’s large pool of patients
suffering from cancer, diabetes and other
diseases for various drug developments.
Belgium-based CRO Trainor and Partners
(T&P) has decided to launch its Indian
operations soon. Pharma giant Pfizer has
already chosen a city in one of the
northeast part of India to conduct clinical
trials on 300 patients for a new malaria
drug that combines chloroquine (to which
several Indian malarial strains have
developed resistance) and azithromycin, an
antibiotic. It is also carrying out clinical
trials for drugs to treat osteoporosis, breast
cancer and schizophrenia. According to
industry sources, Pfizer’s cumulative
investment on clinical research in India is
believed to be $13 million.
NEW OPPORTUNITIES &
CHALLAGES OF CLINICAL TRIAL
[13,14]
At present, Pfizer is conducting around 20
clinical trials. It has independently
conducted more than 40 good clinical
practices (GCP) workshops and has trained
more than 2,000 investigators. The
company has also contributed to research
infrastructure development at various
institutes through clinical trials that have
already been conducted. For instance, it
has contributed dual energy X-ray
absorptiometry (DeXA) machines, costing
over $600,000, to develop osteoporosis
centers at leading hospitals in the India.
According to industry sources, the pace at
which drug trials are being instituted in the
country is so fast that the Clinical Data
38
 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
Interchange Standards Consortium
(CDISC), USA, a non-profit organization
committed to the development of clinical
research organizations’ standards the
world over, is looking at setting up a
chapter in India. Eli Lilly has over 17 large
and small clinical research projects
running in 40 hospitals across India. The
company has already held clinical trials
involving more than 600 patients for
human insulin and insulin lispro. It is also
conducting trials on oncology besides
developing a new molecule for lung cancer.
GlaxoSmithKline (GSK) Plc has started
seven simultaneous clinical trials of its
vaccine and pharma molecules. The
company has tied up with a series of
hospitals in India to do the trials. Aventis
Company sources say it will conduct
clinical trials in the cardiovascular,
diabetes and oncology segments and is
presently setting up trial infrastructure in
India. Roche, the Swiss pharma major, has
set up clinical trial sites in India as part of
its global trials of a new drug for a
particular variant of lung cancer. India,
also, has a vast patient population afflicted
by this type of lung cancer, primarily
triggered by the sustained use of tobacco
products. The company is also considering
India as a prospective site for its future
clinical trials involving new drugs and
therapies for variants of blood cancer.
Gujarat, a prime exporter of
pharmaceuticals drugs and formulations,
has taken several steps to increase clinical
trials in the state.
The state pharma industry offers expertise
in conducting phase I to phase IV trials in
bio-equivalence and bio-availability
studies and data management for almost
all therapeutic drugs. Many Gujarat-based
CROs have tied-up with leading research
institutes across the country to develop
new methodologies in clinical trials.
Pharma experts feel that Gujarat can be the
prime location for conducting clinical
trials in the country because of
multispeciality hospitals, availability of
subjects and high literacy rate. In fact, the
© 2009, JGPT. All Rights Reserved.
presence of many pharma MNCs in the
state gives it an extra edge in R&D.
Companies like Zydus Cadila and Torrent
offer exciting prospects in this field. The
facility of Zydus Research Center has been
approved by ANVISA, a Brazilian
regulatory agency, and complies with
international standards and practices in the
field of pharma research. Much of the
research is directed towards development
of new molecular entities. Similarly,
Torrent Pharmaceutical Ltd has six
projects in the pipeline. One of them, the
New Safer Anti-Arrhythmic Agents, is
ready for phase II clinical trials. Till date,
the company has filed 120 patents
worldwide and the US and Indian patent
offices have granted patents to four New
Chemical Entities (NCEs). The Gujarat
government is also taking steps to promote
clinical trials in the state.
At the Vibrant Gujarat Investor’s meet last
December, it proposed to invest Rs 30
crore in setting up an animal testing lab for
toxicology. This involves creating an
environment-controlled animal house
under strict quality-control. The facility
will be used for phase I clinical trials that
will facilitate bio-medical research activity.
The state has also proposed to set up a
USFDA approved kilo quantity
manufacturing plant at an investment of Rs
20 crore for manufacturing chemical
solutions for clinical trials. IT city
Bangalore, known for its biotech ventures,
is home for many clinical research
organizations (CROs). Many big hospitals
are also contributing plenty of patients to
the clinical trials done by these companies.
While Sagar Apollo hospital has a tie-up
with Clinigene, Lotus Labs has signed an
MOU with St John’s Medical College for
multiple phase clinical studies and has also
set up a clinical research facility in the
medical college campus. Lotus Labs has
an association with around 20 hospitals in
the country for these studies and so do
other CROs.
At the human ethic end, the CROs claim to
strictly monitor the volunteers that trials
39
 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
are done only after obtaining written
consent. Volunteering, especially for phase
I trials and bio equivalence studies which
require healthy volunteers, is seen as a
lucrative assignment by many unemployed
youth according to industry sources.
According to USFDA and ICH guidelines,
no volunteers can participate in more than
one study per quarter. However, there are
instances when people tried to violate this
with forged documents, forcing many of
the CROs to develop a bar-coding system
which would identify the finger print of
the volunteer. Despite the regulatory
hassles, foreign firms are interested in
conducting clinical trials in India due to
the availability of patients, volunteers and
cost-effectiveness. A volunteer earns
anything between Rs 3,000 and Rs 15,000
based on the requirement of the study and
could take part in three studies in a year.
IDEAL DISTINATION OF CLINICAL
TRIAL IN INDIA SCENARIO [3,15,16]
Being the world’s third largest producer of
drugs by volume and the third largest drug
research and development workforce,
India is fast becoming the most preferred
destination for contract research and
clinical trials, says a study by an industry
lobby.
A joint study by the Federation of Indian
Chamber of Commerce and Industry
(Ficci) and Ernst and Young found clinical
trials in India cost 50-60 percent cheaper
than in the developed markets.
“The Indian market is growing by leaps
and bounds and is gearing itself to
becoming one of the fastest growing
clinical research destinations with a
growth rate that is two and a half times the
overall market growth,” the industry study
said. The country has a booming domestic
pharma market that is growing at a rate of
12-14 percent annually. “The number of
investigators in India has also grown the
fastest among Asian, Latin American and
Eastern European countries with a 42
percent compound annual growth rate
(CAGR) between 2002-2008,” the study
© 2009, JGPT. All Rights Reserved.
added. Additionally, the fact that India has
840,000 hospital beds in urban areas, over
600,000 English-speaking physicians and
nearly 100,000 specialists, with many of
them having been trained in the best global
institutes, also adds to India’s
competitiveness. The study said this was
also a prime reason that nine of the top 15
global pharmaceutical and biotech
companies have set up captive clinical
research centers in the country. India
constitutes 16 percent of the global
population with 20 percent of the global
disease burden.At present India appears to
be beating China in the race for Asia's top
clinical spot, according to new figures
published by india´s Planning Commission.
According to a report released by the
Commission´s deputy chairperson Montek
Singh Ahluwalia, 139 trials were recently
outsourced to India by global pharma
companies, compared with only 98 to
China.
Data provided by the Indian
Pharmaceutical Alliance revealed that drug
giants GlaxoSmithKline (GSK) and
Johnson and Johnson are currently the
most prominant sponsors outsourcing
clinical research to India, both with 22
studies, followed by Eli Lily and Bristol-
Myers Squibb (BMS) with 17 each, Pfizer
with 16, Sanofi Aventis with 15, Astra
Zeneac on 10, Novartis with nine, Merck
with eight and Roche on five. As it
continues to attract new business from
large pharma players, the market value of
India´s clinical research organisation
(CRO) industry is blossoming - currently
estimated at $300m and projected to rocket
to $1.5bn-$2bn by 2010. The Planning
Commission data ties in with a newly-
released study published by researchers
from the Massachusetts Institute of
Technology (MIT), who charted the recent
trends in the globalisation of clinical trials.
India ranked 16th in a tally of the most
popular clinical outsourcing destinations
with China in only 23rd place behind
Brazil, Sweden, Mexico, Hungary, South
Africa and Austria. At the same time
40
 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
though, both India and China, along with
other countries in emerging regions
(Eastern Europe, Latin America, Asia,
Middle East and Africa) are still small
players when analysed individually, each
with less than 2 per cent global share, the
data revealed. Eastern Europe and Latin
America generally currently host more
sites than Asia, although India and China
have "grown rapidly from an almost
negligible base in just several years" and
their high average relative annual growth
rates, coupled with their very low density
of trials and current levels of investment in
clinical research infrastructure, suggest
that they have potential to grow into
"major players" in the future, the
researchers wrote. At present India appears
to be winning the race in Asia.
Commenting on the Planning
Commission’s report, chairman of india´s
Institute of Clinical Research S R Dugal
said several factors had contributed to
India's advancement in the field of clinical
trials. "India has a vibrant pharmaceutical
market and with patient protection in
place since 2005", and this effectively
means that companies can introduce drugs
in India at the same time as other countries,
he said, adding that compared with China,
India "strictly follows" ethical guidelines.
In addition, "India has a larger number of
doctors with a far better reputation than
their Chinese counterparts," he said.
However, according to the report, although
the "prospects for outsourcing of clinical
research by global pharmaceutical
companies look bright; there are a number
of problems that need attention". The main
dark cloud hanging over India´s clinical
industry is a shortage in trained and
experienced staff. "There is a looming
shortage of clinical research personnel,
estimated at 30,000 to 50,000", the report
said. "We need more trial investigators,
auditors, personnel to serve on Ethics
Committees, Data Safety Management
Boards and personnel in other categories".
Dugal quantified this, stating that at
present, clinical trials is taught as a subject
© 2009, JGPT. All Rights Reserved.
by 40 institutes in India, producing 5,000
graduates annually. However, the indistry
already needs 11,000 graduates a year to
fill present demand and by 2010, will
require 50,000 staff specialising in clinical
trials. Indeed this problem is already
evident on the ground in India. In an
earlier interview with Outsourcing-
pharma.com, Dr Vasudeo Ginde, president
of Indian-based CRO iGATE clinical
research said that "by far the biggest
problem (in India´s CRO industry) is staff
recruitment and retention, and the situation
is only getting worse." All the major
pharmaceutical and biotech players as well
as major CROs are making India their base
for conducting global clinical trials
outsourcing market in India is forecasted
to grow at a CAGR of over 30% during
2010-2012 to around US$ 600 million by
2012, says new report by RNCOS. India
will become one of the highest growing
clinical trial destinations in the world, with
this kind of growth, according to the study
titled “Booming Clinical Trials Market in
India”. India is becoming a major hub for
clinical studies because all the major
pharmaceutical and biotech players as well
as major CROs are making India their base
for conducting global clinical trials.
Finding and recruiting patients – the most
crucial part of the clinical research — who
can qualify for a clinical trial, is relatively
much easier in India as compared to the
Western countries. Increasing prevalence
of diseases and low cost of clinical trials
are other factors promoting this market.
Syngene and Quintiles are right on top in
terms of market share in a market which is
rather crowd with more than 100 firms
working in India in the clinical trial market.
However, weak IPR protection, lack of
trained staff, etc., which are blocking the
proper growth of the market. So, in order
to ensure proper growth of the industry,
these issues need to be addressed
efficiently. The Indian government needs
to take several initiatives to ensure an easy
approval system for promoting foreign
investments, the report said. In June,
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 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
Indian government has made registration
of all clinical trials conducted in the
country mandatory from 15th June 2009.
The new registration norm will be
applicable to the clinical trials started after
15th June 2009, stated the notification
from the Central Drugs Standard Control
Organization (CDSCO) –the DCGI’s
office. Registration of clinical trials in the
registry has not been held compulsory in
India so far, even though India has become
a sought-after destination for outsourcing
clinical studies for drug makers across the
world. Currently, a total 987 clinical
studies are being run at various centers in
India, according to ClinicalTrials.gov, a
service by US National Institutes of Health.
As of now, only less than 25 of the nearly
thousand ongoing clinical studies are
registered in India with the Clinical Trials
Registry because such registration
formalities were voluntary for the
companies.
Dr Surinder Singh, DCGI, has been
reiterating the need for making the
registration of clinical studies mandatory
for sometime now. Recently, Dr Singh
announced in press gathering that clinical
trials registration, along with their auditing,
would be made compulsory in India, as
part of his efforts to bring in more
accountability and transparency into the
controversial clinical trail industry.
“Registration of clinical trials in a publicly
accessible registry is very important as it
improves the accountability of the stake-
holders and also ensures that key
information is made available to the
public,’’ stated the notification dated 1st of
June, 2009.The Clinical Trials Registry-
India (CTRI) has been set up by the
ICMR’s National Institute of Medical
Statistics (NIMS) and is funded by the
Department of Science and Technology
(DST) through the Indian Council of
Medical Research (ICMR).The idea
behind setting up of the Clinical Trials
Registry-India (CTRI) is to encourage all
clinical trials conducted in India to be
prospectively registered before the
© 2009, JGPT. All Rights Reserved.
enrollment of the first participant and to
disclose details of the 20 mandatory items
of the WHO International Clinical Trials
Registry Platform (ICTRP) dataset. The
CTRI dataset is meant to: 1) improve
transparency and accountability, 2)
improve the internal validity (details of the
methods of the trial that produce reliable
results, primarily the method of random
sequence generation, concealment of
allocation, blinding of participants and
investigators, and inclusion of all
participants results) of trials right from the
design, through conduct and reporting, 3)
conform to accepted ethical standards and
4) lead to reporting of all relevant results
of all clinical trials in India and the region.
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.
CLINICAL RESEARCH COLLEGES
IN INDIA [16,17]
Training is a continuous process. Every
organization should be prepared to develop
human resources. If trained resources are
scarce, it's the duty of the organization to
recruit and train candidates as per
organizational requirements. Till recently,
there were no structured formal training
courses focusing only on clinical research.
But now with growing awareness of
clinical research, there have been many
clinical research courses introduced in
India. To name a few there are; Academia
of Clinical Excellence (ACE), Catalyst
Clinical Services, Institute of Clinical
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 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
Research India (ICRI),(
www.icriindia.com) Kriger Research
Institute, Kundnani College of Pharmacy,
Bioinformatics Centre, University of Pune
and Bioinformatics Institute of India.
Syanapse in Delhi and Watsallya Institute
Banglore offer Post Graduate diploma
course. The duration of these courses vary
from 6 months to 1 year and the cost also
ranges between Rs 40000 to Rs 200000.
ACE and ICRI, and Bioinformatics Centre
offers post-graduate courses in clinical
research management and data
management. Whereas Bioinformatics
Institute of India
(www.bioinformaticscentre.org) conducts
industry program in clinical trialr Research
and administration.
Clinwell Kriger Training & Research
Institute is a training and research
institution of Clinical Research, Agra,
India (www.cktri.com). It’s a First
Institution in India providing various
training programmes of Clinical Research
in collaboration with Clinwell Research
Inc. & Kriger Research Center (KRC),
USA. CREMA(clinical research education
management and academy)
(www.cremaindia.org )was founded in
pursuit of strong desire to fulfill industry
demand for skilled clinical research
professionals, with management acumen
through state-of-the art training and
education in campuses located at Mumbai,
Bangalore, New Delhi and Hyderabad.
CREMA will have five pillars of growth
on the basis of teaching methodology,
international collaboration, learning series,
industry association & industry endorsed
courses. Bilcare Research Academy
(www.bilcareacademy.com), Pune.
CONCLUSION
India clearly provides an opportunity in
terms of availability of large patient
populations, highly educated talent, wide
spectrum of disease, lower cost of
operations and favourable economic and
IP environment etc. With full efforts being
made on the part of Government and
© 2009, JGPT. All Rights Reserved.
cooperation from Indian CRO industry to
meet the challenges in this field, India is
set to become the "Global hub of Clinical
Research."
The overall time and cost advantage in
bringing a drug to the market by
leveraging India could be as high as 200
million USD. This is evident by steadily
increasing number of global studies in
India over past two years. A Mckinsey
report projects the potential clinical
research outsourcing opportunity to be
around 1.5-2 billion USD by the year 2010.
Contract Research Organizations (CRO)
are fast gaining importance because of
their global presence, specialized local
expertise as well as competitive pricing
strategies and a significant number of new
CROs have set up their operations in India
over the past couple of years. Clinical
trials are the mainstay for bringing out new
drugs to the market and constitute
approximately 70 per cent of the total time
and money spent in drug development.
Typically it takes approximately 12 years
and 800 million USD to bring one new
drug from conception to market. 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 increase the
productivity. I
ndia 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.
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 Debjit Bhowmik et al., Journal of Global Pharma Technology. 2010; 2(1): 30-44
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