India's clinical trials and
tribulations By Indrajit Basu
KOLKATA - The potential is huge, multinationals
are willing and Indian companies are eager. Moreover, it
is a type of outsourcing that is not likely to draw the
protests of the anti-outsourcing brigade in rich
economies. Yet even as India increasingly emerges as a
preferred destination for outsourcing clinical trials -
testing of new drugs on humans - the country may also be
heading toward providing the greatest source of human
guinea pigs for the global drug industry.
A
spate of unfortunate events over the past few years has
brought to the fore the rampant practice of conducting
unethical and even illegal clinical trials in India,
which is fueling immense concerns culminating into a
huge public outcry over the regulatory authorities'
failure to check such practices, and even lawsuits.
For instance, in early March, the Supreme Court
of India hauled up two top biotech companies in India,
the Hyderabad-based Shanta Biotech and Bangalore-based
Biocon India, for "openly conducting illegal clinical
trials of new drugs on unsuspecting patients" after a
litigation filed by the Aadar Destitute and Old People's
Home, a Delhi-based social organization. This
non-governmental organization (NGO) alleged that the two
companies had conducted improper clinical trials of
Streptokinnese - a new clot-busting drug used in heart
attacks - last November without requisite permissions
(of the Genetic Engineering Approval Committee), as a
consequence of which eight people lost their lives.
Although the Streptokinnese case was a shocking
revelation, it wasn't an isolated one. According to
Monthly Index of Medical Specialities in India, an
independent pharmaceuticals journal, more than 400 women
who had been trying in vain to conceive were enrolled in
2003 without their knowledge or consent to take part in
clinical trials across India to see if a drug called
Letrozole induced ovulation. Letrozole used in India was
copied (with permission) by Sun Pharmaceuticals, a large
Indian generic drug company, from a patented product of
the same name of Novartis, which the multinational drug
maker introduced globally for solely treating breast
cancer and not for any other use in any country,
including India. A complaint on the Letrozole case, too,
was filed in the Supreme Court by yet another
Delhi-based NGO.
And in 2001, another trial that
made headlines involved the clinical trial of
nordihydroguairetic acid, a chemical with anti-cancer
properties that was tested by a regional
cancer-treatment center (RCC) in the Indian state of
Kerala for a US-based researcher then associated with
Johns Hopkins Hospital in the United States. The drug
was allegedly tried on 26 unsuspecting cancer patients,
two of whom died. Subsequently, a 60-year-old woman was
again included for a trial for which the RCC provided
five doses of the experimental drug, worth Rs10,000
(about US$200), free. The woman's condition turned
critical as well before the fifth dose, although she
escaped death.
These instances indicate that in
the absence of adequate regulations and proper laws, a
developing country eager to cash in on the opportunities
of globalization can be used for indulging in rash and
risky practices. A recent survey of 200 health
researchers globally that was commissioned by the former
US National Bioethics Advisory Commission and published
in February's edition of the Journal of Medical Ethics
revealed that a quarter of clinical trials conducted in
developing countries did not undergo ethical review.
However, in India particularly, unethical and
illegal clinical trials are most rampant and are
conducted without fear because, say critics, there is no
law to safeguard the interests of volunteers, while
regulatory authorities,"by design or default", fail to
take action against such trials.
The moot
question then is, why are multinational drug companies
increasingly preferring India to other poorer countries
to outsource their clinical research and trial needs?
Almost all top names, including Novo Nordisk, Aventis,
Novartis and GlaxoSmithKline, have started running
clinical drug trials in India lately, while some, such
as Eli Lilly and Pfizer, which started much earlier,
conduct tests on a number of their new drugs. Besides, a
variety of both India-based and global contract/clinical
research organizations that specialize in outsourced
clinical trials management are working to expand India's
clinical-trials business. These include Quintiles,
Omnicare, PharmaNet and Pharm-Olam (all US-based).
The simple answer is India's huge billion-plus
population and cheaper costs. According to a study by
Rabo India Finance, a subsidiary of the
Netherlands-based Rabo Bank, India's huge patient
population also offers vast genetic diversity, making
the country "an ideal site for clinical trials". For
example, India has the largest pool of diabetic
patients, with more than 20 million citizens suffering
from the ailment - small wonder that insulin is one of
the most researched drugs in the country. Moreover, many
in the country's large poor-patient population are
"treatment naive", which means they have never received
drugs for treatment - a fact that simplifies patient
enrollment and trial management. Besides this, the
country also offers other facilities, such as nearly
700,000 specialty hospital beds, 221 medical colleges
and skilled English-speaking medical personnel.
But obviously, India's most significant offering
is cost savings. "More than 40% of drug development
costs are incurred in clinical trials and India offers
immense savings on that aspect," says Alok Gupta,
country head for life sciences and biotechnology of Yes
Bank, adding, "and importantly the trials can get done
fast". Indeed, the cost-savings opportunity in the
country is irresistible. For instance, in the US, trials
for a standard drug can cost about $150 million, whereas
the Rabo Bank study estimates that drugs could be tested
in India for as little as 60% of that price.
Indian industry sources say that clinical-trials
outsourcing is a "tempting" opportunity for the
country's drug industry. In 2002, clinical trials were
reckoned to have generated $70 million in revenues for
the industry, which could grow to $200 million by 2007
and anywhere between $500 million and $1 billion by
2010. Globally, clinical research was estimated to be a
$5 billion to $6 billion market in 2002, and according
to Kiran Majumdar Shaw, chief executive officer of
Biocon, it is expected to touch $10 billion by 2005.
However, a study done in 2003 by Connecticut-based
Business Communications Co says US-based spending on
clinical trials is growing fast - at 12% per year - and
should generate $26.5 billion by 2007.
This is
why local industry sources feel that despite the ills,
India should embrace and encourage drug trials and
research in India. But there are better reasons as well.
Rajesh Jain, managing director of Panacea Biotec Ltd, a
prominent drug maker, says that for a country like
India, the potential benefits of clinical research are
far more than its hazards. "It brings in the best in
industry practices in clinical research for the benefit
of our population's health-care needs while exposing the
medical community to global processes and standards," he
says, adding: "If we are to benefit from the fruits of
modern research, we, too, should be willing to pay the
same price."
Nevertheless, rattled by the recent
deaths and the public outcry, India's regulators have
started sitting up. The Drug and Controller General of
India (DCGI) said last week that beginning in September,
it will put in place inspection systems to track the
progress of drug trials from beginning to end. There
will also be a new set of rules "to emphasize
incorporating good clinical-practices protocols", a DCGI
release said.
Industry critics are now hoping
that the DCGI efforts will be the first step in making
clinical trials more accountable in the country.
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