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India leads in clinical
trials
By Kunal Kumar Kundu
MUMBAI - Globally, clinical research - the
business of testing new medications for safety and
efficacy in human patients to gain required
government approvals - was estimated to be a
US$5-6 billion market in 2002, and is expected to
reach $10 billion by the end of this year.
According to a 2003 study by Connecticut-based
Business Communications Co (BCC), US-based
spending on clinical trials is growing at 12% per
year - and should generate $26.5 billion by 2007.
The reason the business is growing so rapidly is
that the pharmaceutical industry is required by
government regulations to conduct human trials
before marketing new drugs.
Bearing in
mind a looming March 1, 2005, deadline, when all
countries had to adopt patent rules in line with
WTO rules, pharma companies worldwide have been
concentrating on new drug development. It is
estimated that the number of drugs developed has
gone up from 4,194 in 1997 to 7,067 in 2002, which
underlines the necessity for increased demand for
Clinical Research Organization (CRO) services.
An independent CRO provides committed
resources for clinical studies. This helps to
maintain the high standards set by the industry,
such as strict adherence to protocols, excellent
clinical practices and complete and accurate
documentation. The personal attention to detail
given by CROs and their ability to provide timely
and proficient trials speed up the process of
clinical studies.
India is increasingly
emerging as a preferred destination for the
outsourcing of clinical trials. Currently, about
80 government and privately owned Indian hospitals
are engaged in global and local clinical trials.
Advantages of conducting trials in
India
A large pool of patients, from multiethnic and
multiracial backgrounds
Rapid patient recruitment, which significantly
reduces the clinical development process
Wide spectrum of diseases. Multidrug-resistant
pneumonia, Hepatitis B, diabetes, and some cancers
are far more prevalent in India than in the West
Drug companies can save 30%-50% by conducting
trials in India as compared to the West
Data generated in India is accepted by all
major conferences and journals
Investigators are mostly trained in the West
All hospitals and private institutions store
comprehensive source data, mostly in English
Subject recruitment is the most common
rate-limiting step in the drug development
process. Sponsors normally cannot reduce study
timelines without sacrificing quality and
incurring increased costs. India offers sponsors
the opportunity to recruit subjects quickly while
maintaining a high level of quality. The relative
cost savings result not only from shorter
timelines but also from the low cost of performing
studies in India.
Due to the high
population density of urban areas and the
relatively small number of hospitals, recruiting a
large number of subjects within a short time frame
is not difficult. Also, the accessibility of these
hospitals allows for cost-effective monitoring of
studies. Subject compliance is an important aspect
of clinical trials. Subjects recruited in the
studies performed in India are not only
treatment-naive but also recognize that study
participation can offer access to quality health
care and medicines that may not be otherwise
affordable. As result, subjects are compliant and
keenly attend all study visits. An independent
study by a global CRO concluded that India has one
of the best subject return rates in the world.
India is today identified as a major
resource center for conducting clinical trials and
data management services. With its large patient
population, well-trained and enthusiastic
investigators and trial costs considerably lower
than those in developed nations, India has gained
wide recognition as a nation capable of offering
unique opportunities for conducting clinical
trials. Its increased regulatory control and
acceptance of the International Conference on
Harmonization (ICH) guideline for good clinical
practice further enhances India's reputation as an
ideal location to conduct clinical trials.
Regulations pertaining to clinical trials
in India are governed by Schedule "Y" of the Drug
and Cosmetic Act. It deals with regulations
relating to clinical trial requirements for the
import, manufacture and obtaining marketing
approval for a new drug in India. The procedure
for applying for marketing approval depends on the
status of the new drug, which can be broadly
classified into three categories: new drug
substances discovered that are already
approved/marketed in other countries; new drug
substances discovered that are not
approved/marketed in other countries; and new drug
substances discovered in India.
In case of
the first category, it is sufficient if
confirmatory trials (phase III) are conducted to
obtain data about the efficacy and safety of the
drug in a large number of patients (minimum 100,
in 3-4 centers), generally in comparison with a
standard drug or a placebo, to confirm efficacy
and safety claims made in the product monograph.
For the second category, permission for
clinical trials is given with a "phase lag". Phase
I of a new drug substance, for example, is allowed
only if the drug has completed phase I and moved
to phase II in other countries; similarly phase II
is allowed in India only after completion of phase
II in other countries and phase III has commenced.
Phase I trials cannot be initiated in India for
new drug substances discovered in other countries
unless phase I data from other countries is
available. In the case of new drug substances
discovered in India, clinical trials have to be
carried out as human/clinical pharmacology trials
(phase I). The phase I trials are carried out on
healthy human volunteers (minimum two at each dose
level) to determine the maximum tolerated dose in
humans, adverse reactions, etc.
Exploratory trials, or phase II trials,
are carried out on limited number of patients
(normally 10-12 at each dose level) to determine
therapeutic uses, effective dose range and further
evaluation. Confirmatory trials, or phase III
trials, are conducted to obtain sufficient data
about the efficacy and safety of the drug in a
larger number of patients (minimum 100 in 3-4
centers), again in comparison with a standard drug
or a placebo, to confirm efficacy and safety
claims made in the product monograph. If the new
drug substance is not marketed in any other
country, phase III trials should be conducted on a
minimum of 500 patients spread across 10-15
centers.
In the case of new drug
substances discovered that are not approved or
marketed in other countries, Schedule Y would
previously put India back by a step as compared to
other countries due to the phase lag that needed
to be adhered to. This has been recently revised,
and now allows clinical trials to be carried out
in India concurrently with trials abroad.
Some, however, have raised fears that
India still lacks appropriate provisions to ensure
that human subjects used for the trials are
volunteers and not people compelled by poverty to
offer themselves as "guinea pigs". Since India
does not have high literacy levels, it might also
be possible that volunteers would not be
adequately informed about the risks they are
undertaking. However, the ills associated with
clinical trials in India are now said to be a
thing of the past. Compliance to International
Conference on Harmonization-Good Clinical Practice
(ICH-GCP) norms, trained investigators, a growing
population of experienced monitors and exposure to
international protocols have enabled the industry
in India to offer a viable alternative to the
hugely expensive sites in the West.
As
things stand today, CROs are still in their
infancy in India. Even though a handful of
international CROs have a presence in India,
either on their own or via local partners, the
industry remains on the threshold of a major
expansion. The total market value of clinical
research performed in India in 2001-02 was about
$70-80 million. The firm increase in CRO
activities can be attributed to large subject
pools in most major therapeutic areas, improved
medical infrastructure, and increased awareness of
the ICH Guideline for Good Clinical Practice and
formation of specialized researchers.
Backed by the recent government
notification amending Schedule Y, multinationals
like Pfizer, Eli Lilly, GlaxoSmithKline and
Aventis have kickstarted simultaneous and
stand-alone clinical trials in various therapeutic
segments. Many new CROs have also outlined plans
to tap India's large pool of patients suffering
from cancer, diabetes and other maladies. Pfizer,
which has invested $13 million on clinical
research in India, has already earmarked a city in
North-east India to conduct clinical trials on 300
patients. The trial will test a new malaria
cocktail drug that combines chloroquine (to which
Indian malarial strains have developed resistance)
and azithromycin - an antibiotic.
Other
MNCs are close to setting up shop in India. A case
in point is that of Belgium-based CRO Trainor and
Partners (T&P). Bullish on India, it is now
scouting for partners to start a franchise. The
optimism stems from the fact that a huge drug
trials market is emerging in India. Global
consultancy major McKinsey estimates that by 2010,
global pharma majors would invest $1-1.5 billion
in the Indian market.
The pace of drug
trials in the country has forced US-based Clinical
Data Interchange Standards Consortium (CDISC), a
non-profit organization, to look at setting up a
chapter here. Eli Lilly has over 17 large and
small clinical research projects running in 40
hospitals across India, while GSK Plc has started
seven simultaneous clinical trials of its vaccines
and drugs. The Schedule Y booster shot is clearly
working.
Kunal Kumar Kundu is a
senior economist with a leading bilateral Chamber
of Commerce in India. He has a Masters in
Economics from the University of Calcutta.
(Copyright 2005 Asia Times Online Ltd. All
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