cover story
none of the companies was really
offering these services, so these
areas need a lot of investment.
The fields of data management
and medical writing have seen a
significant increase in the
country. There is a trend of
significant amount of work
related to data services going to
the BPO sector of big IT
companies. The CROs were
approached for end-to-end study
and program management rather
than sponsors outsourcing
individual activities to different
CRO players.
With low confidence in their own
habitat, the homegrown CROs
were also seen aggressively
looking at expanding to other
markets. Apart from looking at
South East Asian countries to
expand their operations, East
European nations were also
considered for the purpose as
well. The main focus areas
included oncology, diabetes, CNS
and respiratory as their key
therapeutic segments. The Indian
arms of global CROs too started
their business consolidation.
Siro Clinpharm, in early 2011,
launched operations in Malaysia.
Veeda Clinical Research too has
commissioned its CRC Veeda
phase I unit at Ampang Hospital
in Kuala Lumpur, Malaysia.
Having established its presence in
Thailand, Synchron Research is
looking at tapping the growing
South East Asian market With the
start of its full fledge 30 bedded
facility called Bio-Innova
Synchron Research at Bangkok,
Thailand. The JSS Research India
which was formerly called the
Max Neeman International
(earlier acquired by JSS Research,
US), has also expanded its
footprint into lot many
neighbouring countries. The
16
BioVoiceNews | July 2016
“
I urge all clinical research stakeholders
to reiterate their commitment to patient
safety, ethics and quality
and to work together to
ensure we address our
growing disease burden
effectively and efficiently.
Dr G N Singh, Drug Controller General of India
(DCGI)
Vietnam and Sri Lanka are among
the hot destinations for clinical
research due to low labour cost
and supportive environment.
Challenges can’t be wished
away until tackled!
Although there has been positive
signals from the government on
the revival of the industry, the fact
remains that the clinical trials
over the past four years has
shown negative or slow growth.
The experts familiar with Indian
system say that the sponsors can
experience unpredictable delays
during regulatory approval and
multiple queries after dossier
submission, compensation pay
out issues, approval and rejection
queries on documents, which
required only notification as per
current guidelines like approval of
Investigator Brochure (IB),
addition of sites, etc.
While the Modi government in
India has taken few steps such
as coming up with compensation
formula and the amendments in
overall regulatory guidelines,
the challenges are deep rooted.
Lot many CROs are still
dissatisfied with the way system
operates in India and want a
much clear roadmap.
There is a need to sensitize the
government officials, politicians
and the activists about the clinical
trials and their importance. If
government and official bodies
don’t take serious steps, there is a
danger of relying over imports for
life saving drugs which would cost
our patients 30 to 40 times higher
than the cost available in India.
“India has some of the highest
brain power in the world and
should benefit more from
conducting larger number of
clinical trials of new drugs under
development,” commented the
Dutch expert Prof Meir Perez
Pugatch while presenting the
global trends on BioPharma at the
Ministerial meeting of the
International Council of Biotech
Associations (ICBA) meeting
during the BIO International
conference here in San Francisco
on June 6, 2016.
Prof Pugatch opined that clinical
trials accounted for nearly 70 per
cent of the global research and
development (R&D) spends of
pharmaceutical companies. And
clinical trials are a fundamental
and crucial component of the
BioPharma innovation system
globally. According to the global
data prepared by the Pugatch
Consilium, of the nearly 150,000
clinical trials currently going in