clinical research industry needs next?
-Dr Anand Bidarkar,
The author is a well-known expert in clinical research in India and is
a vice president with a leading clinical research organization. The
views expressed are in his personal capacity.
The real growth in the clinical research industry in India started with
the country amending the Patent Act in the year 2005 to
include product patent in pharma and agrochemicals. The industry has
grown rapidly since then. According to an estimate conducted in 2009
the industry in India is between $350–400 million. It is
nowhere near the projected value of over $1 billion by 2010.
Many small and mid-sized Indian Clinical Research Organizations (CROs)
are now in a precarious situation because of the after effects of
global recession. As a result of this, a large numbers of students who
paid lakhs of rupees for fancy clinical research degrees find
themselves without employment options. The CRO companies and captive
units of multinational companies (MNCs) that have the business and the
ability to expand find themselves constrained due to various factors.
We are in the midst of a strange paradox. The fundamental factors that
made India attractive to clinical research have not changed. However,
more and more people opine that conducting clinical research in India
has becoming increasingly challenging. That is the bad news. The good
news is that the situation can be easily remedied. The following is a
five-step road map for the speedy growth of the clinical research
sector in India
The first and urgent initiative is to exponentially increase the number
of sites and investigators in India. An overwhelming majority of the
investigators are in metro cities and are running multiple trials.
Overload of trials at the same few centers is impacting recruitment
rates and quality of deliverables. Due to competing demands on their
services many of the leading investigators have hiked their fees or
grant expectations to unrealistic levels.
There is a huge potential business opportunity for training institutes
and Site Management Organizations (SMOs). At this stage, the industry
needs large SMOs with regional or even national presence with at least
200-300 centers under their belt.
The clinical research industry in India lacks the strength and the
financial muscle of a unified representative body like the National
Association of Software and Services Companies (NASSCOM), which was
instrumental in the promotion of India’s IT industry abroad.
The Indian Society for Clinical Research (ISCR) is doing good work but
is largely underfunded to take up high level promotional activity on
behalf of the industry.
An emerging concern is the number of substandard institutes mushrooming
across the country, offering fancy degrees and diplomas in clinical
research. The ISCR or the government can start an accreditation program
for clinical research training institutes as well as work with them to
design a syllabus relevant to the industry’s needs.
The next important issue is the positioning of India in terms of the
quality of data generated and Good Clinical Practices (GCP) compliance.
As the industry in India is fairly nascent we have to invest more
resources and time in adequate training including regular refresher
The regulatory authorities in India have been largely supportive of
clinical trials. There are however multiple issues that are needed to
be resolved to ensure growth of the industry in India. The approval
process has to be more time bound, transparent and consultative.
The last but not the least is to educate the media and the masses about
the need for clinical research and the process of conducting the
research. The Indian media, especially the mass media is to a large
extent a victim of the ‘guinea pig syndrome’ and
tends to report everything about clinical trials through this lens.
Reactions to alleged problems in clinical trials in the past have
resulted in sharp reactions from the political class including threats
to suspend all clinical trial activity in India. The issues were
however professionally investigated and were found to be compliant with
The industry needs to invest significant time and effort in educating
the masses and other stakeholders like the media and political class.
This is essential to ensure that the perception of exploitation
associated with clinical trials in India does not interfere with the
rational conduct of clinical research