WILL INDIA SAVE THE PHARMA INDUSTRY FROM COLLAPSE?

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WILL INDIA SAVE THE PHARMA INDUSTRY FROM COLLAPSE?

" GM WATCH " <info

 

Sun, 10 Oct 2004 15:51:24 +0100

 

WILL INDIA SAVE THE PHARMA INDUSTRY FROM COLLAPSE?

http://www.gmwatch.org

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There are some striking parallels here between the way that the Indian

political and business elite are apparently falling over themselves to

line up their citizenry as cost-cutting guinea-pigs in pharma clinical

trials, and the way pharma and other GM crops are being pushed for

testing in the developing world - for instance, the plans to test

European-developed pharma crops in South Africa with its lax biosafety

regime.

 

Even in the US pharma crops are being blocked by food industry and

consumer concerns but governments in some countries, like India,

appear to

be hell-bent on reducing biosafety/regulatory hurdles just as the US is

under pressure to increase its own.

 

Similarly, Monsanto's only hope of survival, given its multi-million

dollar losses as its herbicide sales comes under increasing pressure and

its GM seed sales are almost non-existent in lucrative markets like

Europe and Australia, lies in pushing GM seeds into countries like India

and Brazil which have now become its lifeline.

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Article

 

 

WILL INDIA SAVE THE PHARMA INDUSTRY FROM COLLAPSE?

With the promise of ethical treatments for cancer, parkinsons, ms, and

diabetes, still lightyears away- is rapid testing in India a blessing

in disguise?

Medscaper, October 25, 2003

http://www.alwayson-network.com/comments.php?id=6345_0_5_0_C

 

India emerges as new drug trial hot spot

 

Biotech entrepreneurs see Indian clinical trials – which can cut costs

by 60 percent – as the difference between success and slow death.

 

Boosted by key changes in the drug regulatory system, India is poised

to become an important player in the rapidly growing global clinical

trials business. While some Western critics have charged that moving part

of the U.S. Food and Drug Administration's (FDA) mandated clinical

trials is a kind of " medical imperialism, " Indian industry leaders are

cutting costs and saving time in new drug testing.

 

Leveraging its unique combination of English speaking medical

personnel, an experienced pharmaceutical industry, expertise in

medical data

processing, and a vast and motivated patient pool, India's small but fast

growing clinical trials industry has the potential to significantly

lower drug development costs for U.S. and global companies. Drug

trials in

India may also mean the difference between life and death for startup

companies in the biotech and medical device fields.

 

The business of pharmaceutical and medical device clinical trials is a

$15 billion per year business in the U.S., and $35 to $40 billion

globally, according to the industry group Pharma Research. A recent

industry

study from Business Communications Company of Norwalk, Connecticut,

says that U.S.-based spending on clinical trials is growing fast – at

a 12

percent per year pace that should generate $26.5 billion by 2007.

 

The cost of new drug development is enormous. Boston's Tufts Center for

the Study of Drug Development, the leading research center of new drug

regulation economics, calculates that total pre- and post-approval

research including clinical trials averages $897 million per drug. But

the

time required for the trials process – which may take 10 years – is

both a major factor in costs and an impediment to releasing beneficial

new

drugs. Some of the promising startups, which have created what might be

highly beneficial new drugs, are strangled by both the amount of money

and time needed to pass FDA-certified trials, as well as the FDA

approval process itself. Last month, for example, a Santa Monica-based

company, Balance Pharmaceuticals which had been working for 11 years on a

promising drug for use against both breast cancer and fibroids, simply

ran

out of money and was unable to raise the $50 million necessary to

finish clinical trials according to a report in the Los Angeles Times.

 

" The cost of drug development needs urgent attention, " says Kiran

Mazumdar-Shaw, founder of the clinical research organization (CRO)

Clinigene, based in Bangalore. " Those that cost-effectively develop

drugs in

lower-cost countries like India will certainly gain a significant

advantage over those that do not. "

 

With a widespread base of highly trained scientists, doctors,

technicians, support workers, and in some areas, robust IT systems

(originally

built to handle record and data management outsourcing for U.S. health

care organizations), the cost of testing drugs is significantly lower in

India. India can apply its healthcare infrastructure for the intensive

record keeping and report filing required by clinical trials. A recent

study by Rabo India Finance, a subsidiary of Rabobank, Netherlands,

estimates cost savings of 50 to 60 percent, with the higher savings for

the most-expensive Phase III trials, which can cost $100 million or more

and take several years to complete in the U.S.

 

Multinational drug companies like Pfizer, Eli Lilly, Novo Nordisk,

Aventis, Novartis and GlaxoSmithKline have been running Phase II and III

clinical drug trials in India. Eli Lilly alone is conducting tests on 20

new drugs in India, and will include India in global testing next year

with its important new inhaler insulin drug, Oralin. Pfizer has been

conducting limited clinical trials in India for seven years, and is

testing drugs for the treatment of schizophrenia, menopause and breast

cancer. A variety of both India-based and global CRO firms that

specialize

in outsourced clinical trials management are working to expand India's

clinical trials business. Until this year's important regulatory

changes, they had not been able to expand beyond one percent of the

global

market.

 

There are more than 2,500 FDA clinical trials underway in the U.S. for

new drugs. Because Phase II trials often use up to several hundred

people and Phase III trials often require several thousand people, the

need

for a very large 'patient market' with a particular disease is

enormous. The problem for biotech, pharmaceutical, and medical device

companies

is that it is increasingly difficult and expensive to find the large

pools of people needed to thoroughly test new drugs and devices.

 

But cost saving is not India's only advantage. Genetically and

culturally, India is perhaps the most diverse country on the face of

the earth,

argues biologist Madhav Gadgil, who teaches at Bangalore's Indian

Institute of Science. Genetic diversity is an important asset in

testing new

drugs because people with different genetic make-ups may respond to

drugs in different ways, he notes.

 

Until last April's regulatory changes, companies running clinical

trials could only conduct such tests in India after the FDA had signed

off

on earlier Phase II and III trials already run in the U.S. or elsewhere.

Trials could be conducted in India, but not efficiently.

 

 

 

 

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