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India Emerges as New Drug Proving Ground
By Joanna Slater
1,340 words
19 February 2004
The Wall Street Journal
B1
English
(Copyright (c) 2004, Dow Jones & Company, Inc.)
Bangalore, India -- WESTERN DRUG companies are bringing a new form of
outsourcing to India: clinical trials on the country's more than one billion
potential patients.
India's huge population allows new-drug studies to be completed much faster,
says A.S. Arvind, chief operating officer of Clinigene International Ltd., a
four-year-old clinical-trial concern outside Bangalore that is hoping to cash in
on the trend. When a U.S. biotechnology company needed 400 diabetics for a
study, Clinigene began by heading to a nearby hospital specializing in diabetes,
where a dozen new patients arrive every day and more than 40,000 are in its
records.
Beyond the sheer size of the population, India offers clinical researchers other
distinct advantages: Costs are lower. The population is genetically diverse.
Every disease, from tropical maladies to "lifestyle" ailments, is present. There
are also plenty of English-speaking physicians and nurses, some of whom are
familiar with international clinical-trial practice.
The result is that India is emerging on the radar screen of Western companies
looking to contain rising research-and-development costs for new drugs, says
Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development
in Boston. For U.S.-approved drugs, such costs averaged $900 million per drug in
the 1990s, according to an analysis by the center last year.
Shepherding a novel drug through the phases of clinical research, from initial
study to post-launch follow-up, eats up an enormous chunk of the total
development cost, 40% by some industry estimates. To control those expenses,
drug companies are actively looking beyond the U.S., Europe, and Japan -- places
where new drugs traditionally have been tested -- to the world's two most
populous countries, China and India, as well as to Eastern Europe and Brazil.
India does pose some challenges. While the country has as many as 500,000
physicians, only a tiny fraction of them have the expertise to supervise
clinical trials according to globally recognized standards, medical experts say.
And Indian health officials -- sensitive to the suggestion that the nation's
population is being used as guinea pigs -- don't allow companies to conduct the
very first phase of clinical studies, in which drugs are tested for basic
safety. Meanwhile, ethics committees at Indian hospitals, which approve drug
trials, can fall short in some respects, executives involved in studies say.
Nevertheless, India is actively pursuing a bigger slice of the global business.
Its small but fast-growing clinical-trials industry is made up of local firms
such as Clinigene, large international research organizations such as Quintiles
Transnational Corp., of Research Triangle Park, N.C., and Indian subsidiaries of
Pfizer Inc., Eli Lilly & Co. and other pharmaceutical giants.
Last fall, the Indian government added to the allure by removing a regulatory
barrier to performing more clinical trials here. And next year, India will adopt
a stricter, Western-style patent regime, long a demand of large global
pharmaceutical companies. Big drug companies see the existing weak patent law
for drugs as an invitation for generic rivals to copy their branded medicines.
Indians who volunteer to take part in clinical trials aren't paid, as per
international practice, which dictates that patients receive no remuneration,
with the exception of a first-stage trial. But Indian patients sometimes benefit
in other ways: They may get free medicines as part of a study or more-diligent
medical attention.
Dr. Sanjeev Shah, a Bombay doctor and diabetes specialist, says patients in
trials he has supervised have received free insulin and syringes, for example,
when a company was testing a different form of the staple treatment. In a
typical arrangement, if patients in a trial suffer complications as a result of
taking a drug, the pharmaceutical company is responsible for paying for their
care. If negligence on the part of the physician supervising the study caused
harm, then he or she is responsible. Giving groups placebos in the place of
drugs is infrequent, says Dr. Shah, because hospital ethics committees often
reject the practice.
Some foreign drugmakers are already reaping the gains from clinical research
performed in India. Germany's Mucos Pharma GmbH, a niche drug company that
produces compounds made from plant and animal enzymes, is a case in point. Mucos
asked Bombay-based Siro Clinpharm to find 650 of a total of 750 volunteers for
the trial of a drug to treat patients suffering from head and neck cancer.
Clinpharm went to five hospitals and found the volunteers within 18 months, says
company general manager Chetan Tamhankar.
"We would never have been able to achieve this in Western Europe," says Wilfried
Schiess, head of clinical research at Mucos in Germany. Finding the 100
remaining volunteers in Europe took nearly double the time and involved 22
different hospitals.
India also has a large population of what are known as "treatment naive"
patients, or people who haven't taken other drugs to treat their condition,
something that can influence study results. One U.S. company approached
Clinpharm looking to test a breast cancer drug when it couldn't find a single
patient in the U.S. who hadn't already received tamoxifen, the standard first
treatment for the disease in the U.S.
Clinpharm found the right patients and recently formed a partnership to perform
trials on behalf of Covance, Inc., of Princeton, N.J., one of the world's
largest clinical trials companies.
Testing in India isn't entirely new. Global drug giants have long performed some
form of clinical-trial work in India, largely to satisfy the requirements of
health regulators in order to sell medicines developed elsewhere. But now their
Indian subsidiaries are also involved in contributing patient data to global
clinical trials, and in increasingly significant proportions.
"The problem with the West is you can't get enough numbers -- and the cost is
high," says Ramananda S. Nadig, medical director at Eli Lilly's Indian arm.
"India is going to get a bigger chunk of the business, especially in certain
therapeutic areas where we have expertise."
Questions can arise concerning issues of ethics and informed consent. Sometimes
the ethics committees at Indian hospitals are less than thorough: Their
procedures aren't standardized, and their deliberations aren't sufficiently
documented, says Clinpharm's Mr. Tamhankar. One U.S. drug firm testing a
compound in India made sure also to have an independent ethics committee in the
U.S. approve the study.
Indian doctors also enjoy exceptionally high social status, and patients
generally do what they're told -- raising questions of how well they understand
the risks that may be involved in a trial. "Patients have implicit faith in
their physicians," says Dr. Nadig of Eli Lilly, who adds that malpractice suits
are rare.
Isabel Baptista, a 56-year-old teacher and diabetic in one of Dr. Shah's
studies, says she decided to participate on the basis of her doctor's advice.
"I'm feeling much better," she says, adding that she was amazed at the number of
blood tests necessary and the requirement that she document her blood sugar six
times a day.
To address concerns that patients may not be fully informed, research groups in
India say they make sure all materials and consent forms are translated into
local languages and that staff workers are trained in giving clear explanations
to potential patients.
---
Tests for Less
The cost of clinical trials in India vs. the U.S.
STUDY: Phase I (normally tests on small groups of healthy humans)
AVERAGE U.S. COST (IN MILLIONS): $20
INDIA COST: 50% less than the U.S.
STUDY: Phase II (tests on individuals afflicted with the condition for
which the drug was developed)
AVERAGE U.S. COST (IN MILLIONS): $50
INDIA COST: 60% less than the U.S.
STUDY: Phase III (tests on large groups of afflicted patients)
AVERAGE U.S. COST (IN MILLIONS): $100
INDIA COST: 60% less than the U.S.
Source: Rabo India Finance
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