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SCIENCE:
BIOTECHNOLOGY
New
Money Plant
Biotechnology
is the next big thing happening to India-for big bucks and big breakthroughs
By Supriya
Bezbaruah
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| COMING
TO LIFE: Scientists peering at genes under ultra- violet light. The
biotech market in India is estimated to reach Rs 11,500 crore by the
year end |
For
25 million Indians with diabetes, the freedom to submit without fear to
a simple craving for chocolate borders on the utopian. Indian scientists
may be on the verge of a breakthrough that could put an end to their misery.
Hunched
over computers, scanning through thousands of genes from the human genome
database, calculating
complex data from computerised models of enzyme functions, Indian scientists
are on the hunt for candidate genes that predispose one to diabetes. At
GenoMed, an alliance of the Mumbai-based pharmaceutical company Nicholas
Piramal and the Centre for Biochemical Technology (CBT), Delhi, and one
of the front-runners in the search. The idea: if you knew where the problem
lay you could ultimately find a way of treating it.
Nicholas
Piramal is one of the many Indian companies investing heavily in the science
that is redefining the frontiers of life. "India is on the threshold
of a biotechnology revolution" says its Chief Scientific Officer
Swati Piramal. She is in good company. The Confederation of Indian Industry
(CII) in its latest report on biotechnology in India says the market has
increased fivefold since 1997 with an estimated market of $2.5 billion
(Rs 11,500 crore) in 2001. By 2010 the market is estimated to reach $4.5
billion. A survey conducted in February 2000 found approximately 850 biotech
units (many of them tiny ones) that employ 10,000 people, but employment
is expected to double by 2001-end. We may be minnows yet compared to the
US (biotech turnover in 2000: $20 billion) but India is finally on the
fast track. Already the slew of Indian companies are working on a range
of areas that may provide both big breakthroughs and big bucks. A sampling:
- Indian
companies are working on transgenic crops that triple crop yields and
use less pesticides and fertilisers.
- Others
are working on DNA-based vaccines that could provide cheaper and more
effective measures to prevent diseases like cholera, hepatitis and rabies.
- As exciting
is work on genetically modified rice and potatoes with higher levels
of iron and vitamins that could eliminate diseases like anaemia.
- They are
also looking at data from the genes of large close-knit families and
communities that may reveal how some major diseases are transmitted.
-
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| GENE
POWER: The virtues of pest-resistant genes-the leaf on the right
has them |
Fuelling
the boom for India are discoveries from the international Human Genome
Project. The real challenge now for scientists across the world is unravelling
the gene functions to understand how life works. Sophisticated software
is needed to distinguish the 1,00,000 genes from "junk", pick
out the disease-causing ones, and predict their myriad functions and interactions
that make us human-no mean task.
But Indian
institutions are already making it happen. At CBT recently scientists
identified a potential gene for schizophrenia, which affects one in 100
people. Biochemists zoomed in on the molecules that were either missing
or overly expressed in a large number of schizophrenic patients. They
mined through billions of bytes of human genome data to dig out genes
that have been associated with the possibility of schizophrenia, then
fed the information for another worldwide database search to match the
genes isolated with the behaviour of the molecules. At least one gene
that could lead to schizophrenia has been isolated.
Similar
techniques are being used at the Centre for DNA Fingerprinting and Diagnostics
(CDFD) at Hyderabad to pick out the genetic pieces of the bug responsible
for gastric ulcers and gastric cancers, and the minute genetic mismatches
behind multi-drug resistant forms of tuberculosis. Says Syed Hasnain,
director of CDFD: "With the development of an excellent biocomputing
environment coupled with high class molecular biology, India has a lead
role to play in this area."
Large joint
families and hospital blood banks are some of the unlikely genetic treasure
troves that could catapult India to the big league in the biotech race.
Sheer numbers, strong traditions and tremendous ethnic diversity preserve
rare genetic disorders which would otherwise be lost, says Professor Samir
Brahmachari, head of the functional genomics unit at the CBT. The accumulation
of occasional inadvertent molecular errors are largely responsible for
the differences between individuals and communities-the reason, for example,
behind why codeine does not work for your migraine but does wonders for
your colleague across the room. Scientists are using hospital resources
to identify the differences in such errors in ethnic groups in a human
body protein that helps to metabolise frequently used drugs. Correlating
how easily the drug is assimilated and the severity of side effects to
the genetic errors will provide an idea of how the gene variations affect
drug uptake-so the future could hold "designer drugs" without
side effects for a specific individual.
Research
is where huge opportunities lie for India. Biotechnology, like it, is
knowledge-intensive. India has a very good pool of scientific talent available
at a significantly low cost. An English-speaking population is the other
advantage that both it and BT have over other developing countries like
China. In the West, a biotech-based therapeutic product costs $500 million
to $1 billion and 10-15 years to reach the market. In India, the cost
is estimated at $250 million or lower. Besides, there's synergy: biotech
requires good IT infrastructure and knowledge which is available in India.
As a result, multinationals looking for ways to reduce research costs
through outsourcing are seriously considering India as an option. US pharmaceutical
major Pfizer was cleared by the government in 1998 to manufacture drugs
from the research stage by investing $1 million through a wholly-owned
subsidiary.
Indian contract
research organisations (CROs) for research, manufacture and clinical trials
are on the rise, and they often find foreign partners. For example, Dr
Reddy's Labs has teamed up with Novo of Denmark; Biocon already has Syngene
Inc as a functional CRO, as does Nicholas Piramal with Wellcrest.
It
is domestic demand that has fuelled the biotechnology growth in India
so far. In medicine, the vaccines market, for example, has been growing
at 20 per cent annually, and the success of firms like Shantha Biotech
and Bharat Biotech lay in exploiting this demand and producing cheaper
vaccines. India's first genetically engineered vaccine, Shantha Biotech's
Shanvac against Hepatitis B, costs Rs 190-less than half the price of
similar vaccines marketed by multinationals. According to the CII report,
a huge unmet demand for vaccines exists for rabies, typhoid and other
common diseases. A DNA vaccine for rabies is currently being developed
and tested and could be marketed next year.
Diagnostics
is another growing field for biotechnology products. More than half the
diagnostic kits in this country are imported, expensive and often ineffective
as they are not designed for Indian climatic conditions or variant Indian
strains of microbes. According to Purnima Sharma, general manager of the
Biotechnology Consortium of India Limited, the immuno-diagnostic market
is expected to increase four to five times by 2005. Diagnostics for malaria
is expected to increase by more than 50 per cent. Another big growth area
where biotechnology will impact daily Indian lives most is agriculture.
According to Kailash Bansal, principal scientist at the Indian Agricultural
Research Institute, Delhi, scientists are working on enhancing the nutritional
qualities of everyday foods such as rice, potatoes and mustard oil by
inserting genes that will increase levels of vitamin A, iron, antioxidants
such as vitamin E.
At Delhi's
Jawaharlal Nehru University (JNU), Vice-Chancellor Asis Dutta's laboratory
has isolated a gene for a protein, Ama1, which has all the eight amino
acids the World Health Organisation (WHO) recommends. Expression of this
gene in different foods would go a long way towards eliminating protein
deficiency. Increasing the shelf life of fruits and vegetables is another
boom area. This also makes much economic sense in the country that is
the world's largest fruit producer and second largest vegetable producer,
but has only 1 per cent of the export market due to post-harvest handling
losses of more than $2 billion.
Agricultural
biotechnology companies like Monsanto and Pro Agro are focusing on increasing
yields through genetically modified crops with increased pest and weed-resistance.
Monsanto's pest-resistant BT-cotton plants are now undergoing large-scale
field trials, and if approved for safety, could soon be in the market.
Pro Agro has a whole array of pest-resistant vegetables in various stages
of trials, while it is modifying the mustard plant to grow in dry areas.
"The idea is to develop vegetable oil sustainability to help marginal
farmers," says Pro Agro Managing Director Arvind Kumar.
With so
many advantages, why is India not yet a power to be reckoned with in BT?
Purnima Sharma blames the poor commercial instincts of scientists. But
this could soon change. Recently the Council for Scientific and Industrial
Research (CSIR) announced that it had entered into "knowledge alliances"
with various pharmaceutical units to develop genomic medicine. GenoMed
is the first such alliance. The Department of Biotechnology (DBT) reports
more than 30 technologies transferred to industry in the past few years
in medicine and agriculture.
Funding
is another key factor in biotechnology. Says Biocon CEO Kiran Shaw Mazumdar:
"Biotechnology is highly dependant on research and development. Indians
are not attuned to long-term rewards." In the US, the biotech industry
spent $9.9 billion in 1998 in research and development. In India, venture
capital (VC) and angel fund investments in the IT sector have grown from
Rs 70 crore in 1996 to Rs 3,200 crore in 2000. In contrast, VC funding
for biotechnology is negligible. Shantha Biotechnics and Bharat Biotech
have received funding for various projects from The Technology Development
Board (TDB), a public body under the Ministry of Science and Technology,
but the total amount is less than $8 million. Lack of awareness is the
issue, according to Chandra Prakash, executive member of the All India
Biotech Association, so venture capitalists have a poor understanding
and high risk perception of biotechnology ventures.
In
true Indian tradition, however, the biggest block to a biotechnology boom
is bureaucracy. "Speed," sums Piramal, "is the greatest
barrier." Drugs, for example, are still monitored by a pre-independence
1945 law on drugs and cosmetics. The law is simply not adequate, says
Prakash, to deal with developments in genetically engineered products.
For a drug to reach the market, it has to go through three phases of clinical
trials. In the US, permission from the monitoring authority, the FDA,
is required only at the beginning. In India the Drug Controller of India
is required to separately give permission for each stage of the trials.
All genetically modified products have to be cleared through four tiers
of regulatory committees for safety.
While this
is essential for public safety, (UK has nine safety committees) Kapur
laments that most committee members are there on the basis of official
designations alone. Bureaucrats without science backgrounds often can't
grasp technical details or scientific consequences of the issues at stake.
The committee members should be appointed, adds Prakash, on the basis
of their backgrounds, and not the office they hold. The regulatory committees
are also under two departments - DBT and the Ministry of Forests and Environment.
Coordination between them can slow the process further, say frustrated
industry leaders. Monsanto's BT-cotton, with an anti-pest gene, took 10
years for approval and has still not been cleared for the market. But
a quicker "single window system" will soon come into operation,
says A. Vinayak, adviser, Department of Biotechnology.
The IT industry,
on the other hand, has very few regulations, and the existing ones help
rather than hinder the industry. Yet if the Government gets its act together,
biotechnology in India could well be the new money plant.
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While
FIIs have been rushing to buy Indian tech stocks like Infosys, Zee and
or NIIT, why have our desi brethren been rushing to sell? India Today
Associate Editor V. Shankar Aiyar provides answers in
METRO TODAY