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HEALTH: DIAGNOSTIC KITS
India's New Detectives
Inexpensive and reliable, indigenous test kits are
good news not just for medicine but business too
By Supriya Bezbaruah
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DROP OF CLUES: A pink dot or a black
band make the difference between life and death
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Asplash of pink.
That's all it took to shatter 10-year-old Abhay Gupta's life. Two years
ago, Delhi-based Abhay was diagnosed with hepatitis B-the pink that showed
in a laboratory test indicated the potentially fatal virus infection.
Abhay promptly lapsed into a whirl of anxiety
and confusion. Taunted by friends, his depression began to affect his
studies. But when the supposedly ailing child showed no symptoms, his
suspicious doctor ordered a retest. It was negative. The previous test
had been a false alarm, but Abhay's nightmare persists.
For the magnitude of trauma that wrong diagnoses
can unleash and for a country condemned with the world's largest diseased
populace, India has been surprisingly bereft of a healthy stock of diagnostic
kits. Relying heavily on expensive imported kits, people have had to contend
with unreliable prognoses primarily because these kits are not suited
to hot and dusty Indian conditions. Now, however, things are changing.
A new range of India-specific diagnostic kits developed by Indian companies
through indigenous research promise reliable results at a cheaper price.
Last year, nine technological procedures were transferred from the Department
of Biotechnology (DBT)-funded laboratories to Indian industries to be
developed. Another 12 are on the way.
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NEVA HIV: By Cadila. Five minutes
to conduct a test with no special equipment. Cost: Rs 39 per test.
HEPC: By XCyton. Hepatitis C and HIV kits
with India-specific designs. Cost: Rs 35-40 per test.

HIV TRI-DOT: By J. Mitra & Sons.
Result in three minutes. WHO approved. Cost: Rs 50 per test.

HCV TRI-DOT: By J. Mitra & Sons.
Similar to HIV kit and as accurate. Cost: Rs 50 per test.
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"The business potential is enormous for
India," says Purnima Sharma, managing director, Biotechnology Consortium
India Limited (BCIL). This is because the industry is largely import driven
and companies either market finished products or import reagents in bulk
and repackage them here. The present Indian market is estimated at Rs
500 crore and is growing at a rate of 25-30 per cent every year, according
to a BCIL study.
Besides the business, it is the medicinal benefits
that promise to be immense. In a hospital, overworked doctors with minimal
equipment often have seconds to find out what ailment the patient suffers
from. "The patient provides only one sample and there is no room
for errors," says V.K. Vinayak, dynamic adviser, medical biotechnology,
DBT. Equally important is the purity of blood available in blood banks,
where each sample has to be checked for a range of infections like HIV,
hepatitis and malaria.
Diseases, like people, may be the same the world
over but have distinctive faces in different parts of the globe. To detect
them beyond doubt one needs to recognise their local characteristics.
European and American kits undergo stringent quality tests but could occasionally
miss out on a particularly desi version of a bacterium or virus. Which
is why indigenously designed kits are vital. AIDS, for instance, is a
global disease, but hiv-1, the culprit in most cases, has various subtypes
in several countries. In India, 95 per cent of HIV cases are of the hiv-1C
type, whereas hiv-1A and B are predominant in western countries.
The range is even wider in hepatitis. "Hepatitis
C has as many as 11 genotypes. In India, C-1 is universal while there
are a significant number of C-2 and C-3 cases," points out B.V. Ravi
Kumar, former Astra-Zeneca scientist who made his fortune with an Indian
version of the HIV kit in 1997 and now heads the Bangalore-based XCyton
Diagnostics Limited. In May this year, his company launched a hepatitis
C test kit that incorporates key pieces from all the three Indian versions
of the virus which will be distributed to blood banks all across the country.
Similarly, Delhi-based J. Mitra & Sons brought out a specific hiv-1C
confirmatory kit earlier this year, while the Ahmedabad-based Cadila Health
Products introduced a two-minute preliminary HIV test kit. Hepatitis A
kits are expected to be launched by Bharat Biotech by December. Cadila
Zydus is also close to launching a diagnostic kit for Japanese encephalitis
(JE) for which there was no reliable test till now. To outsmart the antibiotic-resistant
desi versions of tuberculosis, Delhi-based doctor-turned-entrepreneur
Nimrat Bawa's team at Auroprobe Labs has fine-tuned a sensitive technique
called polymerase chain reaction.
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