(Note: When this piece started out as a prospective op-ed article, the H1N1 death-count was around 650. Today - 18Mar15 - it has crossed 1800)
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Your child
has developed a fever. Could it be Swine Flu? Perhaps it is Bird Flu or Monkey
Flu?
It is difficult not to panic when
you have been getting bombarded with daily reports on skyrocketing infections, a
rising death toll, shortages of diagnostic kits and medicines.
Unfortunately,
our nationwide response to the spread of H1N1 Swine Flu has been just that - reactive
rather than proactive. There has been a sudden rush to procure diagnostic kits;
an increase the number of ‘authorised outlets’ selling drugs; A DGCI letter to
requesting states to ensure that
diagnostic kits and drugs are available at the “right price”, and an awareness
campaign that leaves you with more questions than answers.
Meanwhile,
the number of deaths has climbed to 1537, and the number of confirmed cases has
shot up to over 27,000. The list now includes film stars, top bureaucrats, and
senior politicians.
Accurate Diagnosis is the Key
Accurate
diagnosis is the first and most critical step in disease control.
For many known
diseases the diagnosis and treatment protocols are centred on something called
Antigen-Antibody Reactions. Antigens and antibodies are molecules with unique
shapes that tend to lock into one another. Antibodies act like policemen in our
blood-stream, waiting to ‘handcuff’ any foreign antigens that slip in. Most
vaccines contain antigens that provoke our immune systems to produce more
antibodies, in case of a real attack. Diseases like measles, for instance, have
only one antigenic-type, and this makes the vaccines relatively easy to make,
and are therefore quite affordable.
Indian
vaccine manufacturers are quite strong in this area. They supply 90 per cent of
all measles vaccines worldwide, as well as half of WHO’s requirement for DPT
and BCG vaccines against tuberculosis.
Influenza or
Flu is caused a much smarter virus. It keeps changing its cell-surface proteins
so frequently that detecting it accurately and then formulating drugs to
counter them becomes rather difficult. According
to the US Centre for Disease Control there are now more than 800 different
influenza viruses. This flu season, the annual influenza vaccine in USA proved
only 23% effective. Last year, it was about 60% effective.
When it
comes to diagnosis, the only reliable way identifying the flu virus comes from
a method called Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
Why is RT-PCR Test so Expensive?
RT-PCR is a
technique that amplifies genetic material to get a detectable signal. Its
accuracy and reliability has made it the cornerstone of modern molecular
biology.
The starting
point for this test is Deoxyribonucleic acid (DNA), a molecule that encodes the
genetic instructions used in the development and functioning of all known
living organisms and many viruses.
Despite its
unwieldy name, the RT-PCR machine is essentially a hi-tech heater. It ‘melts’
DNA strands at high temperatures and re-joins them again at lower temperatures
using special enzymes called polymerases.
Every
organism has certain nucleotide sequences which are unique to it. These
‘signature sequences’ are first carefully identified and recreated as “primers”.
Detection of H1N1 Swine Flu usually begins with the DNA extracted from a sample
of body fluids of an infected person. It
is mixed with H1N1 primers and probes are introduced into a RT-PCR machine. If the primer finds a match, the machine
creates multiple copies of it. Over time – usually 24 hours – there is enough
of the genetic material that can be detected by running it through a device
called gel chromatograph.
Most of the
RT-PCR machines used in India are imported. Apart from the high cost of these
machines, the cost of critical consumables - imported primers, probes, enzymes
and assays - continue to drive the high cost of accurate diagnosis. So even the minimum cost for a test comes to
about Rs.4,500.
We also have
home-grown pioneers like Molbio (Goa) and RAS LifeSciences (Hyderabd) who have
developed indigenous, portable PCR kits that lower the cost of the tests to Rs.
800. Despite getting clearances from DCGI and ICMR, the state governments
prefer to procure imported kits.
This state
of affairs in not unique to diagnostic devices. According to a KPMG report
(2011), even though there are about 700 medical device makers in the country,
India imports approximately 75 percent of devices.
Is There a Better Way Forward?
Coming soon
after the Ebola scare, our tardy response to the H1N1 influenza ought to set
the alarm bells ringing.
As the
number of nationwide flu-related deaths crosses 1600, we need to ask ourselves
if we are sufficiently prepared to tackle the new cohorts of emerging drug-resistant
diseases.
We already
have world class facilities for manufacture of vaccines and pharmaceuticals. Will
the ongoing Budget Session of Parliament introduce the much needed amendments
to the Drugs and Cosmetics Act, 1940 – especially with respect to medical
devices? Can the on-going ‘Make in India’ initiative pull together the key
players in the Government and the private sector, to create the right policy
environment for reducing our dependence on expensive, imported diagnostic kits?
Unless we get
our act together, we are bound to lurch helplessly from one round of infections
and pandemics, to another.
REFERENCES
·
DGCI Notice to states - H1N1 / SwineFlu
Diagnostic Kits being sold at exhorbitant prices -- http://cdsco.nic.in/writereaddata/swine%20flue.pdf
·
National Centre for Disease Control (NCDC) -- http://www.ncdc.gov.in/
- Procurement of RT-PCR kits -- (11,12) -- http://www.ncdc.gov.in/writereaddata/tenders/160.pdf
·
Dr. Path Labs – List of Molecular Diagnostic
Tests - http://www.lalpathlabs.com/genetics.aspx
·
(28Feb15) -
http://indianexpress.com/article/india/india-others/swine-flu-deaths-breach-1000-mark-40-more-succumb-to-virus/
·
(9Mar15) -- Molbio develops first SwineFlu
diagnostic -- http://articles.economictimes.indiatimes.com/2015-03-03/news/59725551_1_swine-flu-swiss-firm-roche-diagnostics-flu-tests
·
(9Mar15) - DRDO-RAS diagnostic for SwineFlu -- http://www.thenewsminute.com/news_sections/3181
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