India,
preferred choice for clinical research
As global pharma companies re-visit their strategies by dovetailing
speed, cost of drug development and tapping high-growth pharma markets
in their business models, India is emerging as the preferred choice for
clinical research services. This prognosis is held out by a FICCI-Ernst
& Young (E&Y) paper on the compelling reasons for doing
clinical research in India.
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. India participates in 7% of global phase III and 3.2% of phase
II trials with industry-sponsored trials having grown at a spectacular
39% CAGR between 2004-08.
The FICCI-E&Y paper notes that the number of industry-sponsored
phase II-III sites in India has grown by 116% over the last 15 months
and India has moved up from rank 18 to 12 across the 60 most active
countries. India ranks second in Asia after Japan in its number of
industry-sponsored phase II-III clinical trial study sites and accounts
for nearly 20% of all Asian study sites.
Dr Surinder Kher, senior vice president, Vanthys Pharmaceutical
Development and chairman, Clinical Research Task Force, FICCI, said,
“The drug development scenario in India has
transformed in the last 10 years. This transformation has not only
brought India to the attention of the pharmaceutical world for clinical
research but many big pharma and biotechs have developed the so called
‘India Strategy’ as a part of their growth
strategies. This is the beginning of the road towards scientific
innovation including clinical research and the vision of
India being the drug development hub. India is
probably in the best situation than ever before to achieve this
vision with the complete commitment and partnerships between
the government, industry and the academia that we have been witnessing
especially in the last few years. This certainly is an exciting
time.”
As the world’s third-largest producer of drugs by volume,
with the third-largest drug research and development workforce, India
is a major player in the pharmaceutical industry. The most active 25
pharmaceutical companies worldwide, based on the number of study sites
registered, are also active sponsors of clinical studies in the country
The number of investigators in India has also grown the fastest among
Asian, Latin American and Eastern European countries with a 42% CAGR
between 2002–08. India has one of the fastest subject
recruitment rates globally (nearly three to five times the global
average), with screen failure and drop out rates lower by nearly
40–50%, as compared to global averages. As a result, India
contributes 15–30% of global enrollment in multi-centric
studies where it is a participant.
Data submissions from India in the recent past have been part of at
least 13 successful NDA approvals.
Not surprisingly, therefore, India is ranked third across all countries
after the US and China in terms of its overall attractiveness as a
clinical trial destination, according to a recent AT Kearney global
survey.