India provides a number of advantages for the outsourcing of clinical
trials because it offers a large patient population that facilitates
faster recruitment, low trial cost per patient, a highly qualified
professional medical community, plus global quality hospitals and
clinical research facilities. Also, there is a highly developed IT and
data collection capability with no language barrier. This has opened up
many opportunities for CROs in India. At the same time they are facing
challenges due to overcrowding of the industry.
The challenges that India faces for expansion of its clinical research
market, are non-availability of sufficient number of hospital sites,
trained personnel matching the International Conference on
Harmonisation of Technical Requirements for Human Use-Good Clinical
Practice (ICH-GCP) norms; equipments at hospitals/sites for conducting
trials not always on par with trial sites in Western countries, besides
bureaucratic hurdles for regulatory approvals for global clinical
Chairman of the Institute of Clinical Research India (ICRI), Mr Shiv
Raman Duggal says, “Approval time in India for phase I studies which is
restricted to Indian molecules, is around 90 days, whereas for the same
in Western countries, it is about 30 days. Also, lack of protection for
the data generated in these trials is a matter of concern. There have
also been concerns over ethical issues in patient recruitment and
conduct of trial, along with lack of sufficient infrastructure for
central laboratory services.”
The key issues of CRO market, Mr Duggal says, are consistent high
quality, credibility, reliability, offering a range of services, broad
and focused therapeutic expertise, timeliness, GLOCAL approach (Global
Reach Local Expertise) and expertise in developing Novel Drug Delivery
System (NDDS) packages.
Dr Anand Bidarkar, vice president, Business Development, Siro
Clinpharm, points out that it is the image of India that is portrayed
to the global community. We have been portrayed as a country which uses
patients as guinea pigs and that is not so, because some patients need
those medicines and clinical trials become very useful. In cancer, for
instance, altogether, there are 5000 trials being conducted in the
world, out of which only 92 trials are taking place in India. Instead,
we should compare the number of clinical trial deaths against the total
number of trials that are conducted in all.
According to Mr Murali Mohan, business development manager, Ecron
Acunova, the Indian CROs are facing two distinct challenges today, one
is immediate and the second is strategic. The immediate challenge:
Operational Delivery. Until the CRO’s “potential” revenue is converted
into “kinetic” profit, it is still at risk, and can be pulled at any
time. Therefore, finding enough patients, sites and staff to
operationally deliver on their growing backlog is a major challenge.
The strategic challenge: Service Differentiation. In a growing,
crowded, and competitive market, companies have to differentiate
themselves or face commoditization. CROs are close to painting
themselves into the commodity corner.
The challenge for CROs, Mr Murali Mohan, says, in this market is to
differentiate at a speed faster than commoditization is gaining on
To overcome many of the challenges, the CROs need to adopt both
short and long term strategies to beat the competition and look for a
deaths on rise
|The number of death
occurrences in clinical trials in India has
increased with each passing year. According to the official sources in
Ministry of Health, Government of India, there were 132 deaths in
2007, 288 deaths in 2008, 637 deaths in 2009 and 462 deaths up to June,
2010. The report says death may occur during clinical trials for
various reasons. These could be terminal disease-related deaths like
cancer, or administration to critical or terminally ill patients or
side effects of unrelated cause. Such deaths are investigated for
causal relationship by investigator and by medical experts of sponsor.
challenges: Uncertainty of regulatory processes and time
lines, quality of documentation at Indian sites, lack of sites for
early phase trials, increasing requirements from ethics committees,
shortage of GCP trained investigators and sites.
Difficulties in identifying sponsors due to alliances/ mergers,
increased costs due to inflation, acceptance of potential new
sites/hospitals by sponsors/ CROs, small start up CROs and mushrooming
of Site Management Organizations (SMOs).
Human resources: Shortage of managerial manpower, retention of
personnel, lack of stable and qualified CRAs, training.
Commoditization: Competition between big CROs and big IT companies,
lack of having global capabilities, price reduction due to short
sighted policies of competitors, offering services in niche areas
instead of offering basket full of services.
Patient recruitment: Lack of patient pool in some therapeutic area,