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‘We
have to move towards the 3R concept in animal experimentation’
 The
effervescent Maneka Gandhi has taken up a Herculean task
it seems. At the helm of CPCSEA she has aroused the ill-will of
a large section of the scientific community. Latest in the list
is the war of words between herself and the Union Health Minister.
Maneka Gandhi in discussion with Jayashree Padmini on the
sidelines of the Seminar on the ‘State of Animal Houses’ conducted
recently in New Delhi. Excerpts:
Despite
their awareness on the international norms and practices on animal
research, do you feel that researchers here are unwilling to comply
with?
They
never do it, because there is no policing and no scientist has ever
been penalised for being non-productive. Our premier institutes
do not even document the researches conducted. If you take the example
of the National Institute of Virology (NIV), Pune, it neither has
a patent to its credit nor an experiment that can be reproduced.
In fact, the tenure of the NIV director was extended five times.
NIV at last, has been made to shut the shop.
So
do you think only penalising will do?
No,
penalising is only a part of the whole strategy to bring our research
institutes on par with international standards. It has to be a mix
and match of policing, monitoring and education.
When
I speak with researchers and institutes they point out fund constraint
and they are seeking more time to upgrade to match global standards.
This is not true. We had initially given two years time and are
still extending it. When NIV was spotted it was given ten months
time but they didn’t bother to move a single finger. The Indian
Institute of Science has been given two years time only to set up
rabbit runs, but they have not made them. Now we have given them
three more months to establish the set-up. On the funds front, most
of the money went into unproductive purposes. The roots of irresponsibility
lie in the fact that there is no system to ensure that the data
generated should be authentic.
We
need to ensure carefully planned research programme, avoid unnecessary
repetitive experimentation and opt for alternative models wherever
possible. Misappropriation of funds has become a norm in the country.
One of the laboratories was given approval to set up breeding facility.
Land worth rupees three crore was bought in Thane for this purpose.
They built the compound wall and kept a chowkidar, the expenses
on whom were put at almost Rs 48 lakhs. However, the facility was
never built. They got animals from the wild and pretended that those
were coming from the breeding facility. The CAG has caught them
and brought this to light.
Institutions
also complain that they face delays in getting their projects passed.
Reluctance on the part of the institutions to upgrade themselves
and meet the standards are the reasons, not CPCSEA or its guidelines.
Moreover, they undermine the authority of the nominees of the committee.
If delays are to be minimized there should be utter transparency
on both sides.
What
are the measures you are taking to ensure quality research in the
country?
On
the basis of the deliberations in the seminar on ‘The State
of Animal Houses in India’ we have set up three committees
to deal with different areas of animal experimentation and to take
the country to the global arena. The Committee on Alternatives &
Harmonization with Global Guidelines on Animal Houses would evolve
the strategy, and delineate tasks and sub-tasks for animal-based
research to move in the direction of the 3R concept, viz., replacement,
reduction & refinement. The second committee is on Norms for
Rehabilitation of Animals used in Experiments and this will be constituted
in three months time. The third is the Committee on Accreditation
of Laboratories that will grade the laboratories based on the agreed
norms and data presented by the labs to the committee.Could you
elaborate on the alternative methods you were talking?
We
have to update ourselves to the global changes in research, for
example, the world is moving towards the 3R concept viz., replacement,
reduction and refinement in animal experimentation. We have to start
with relative replacement, i.e., cell or tissue based and in-vitro
techniques until we completely shift to absolute replacement. We
need to evolve the right experimental design and sophisticated statistical
techniques to reduce the number of animals and still get valid results.
What
are the real problems we face?
Most
of the scientists in India live in vacuum. They do not get adequate
training and once they are on the job all training comes to an end.
Options for continuous education are neither available to them nor
do they avail of these. Someone who has received training in the
year 1955, would still continue to follow the 1955 practices.
The
Health Ministry has now retained the Delhi-based company, Biomedical
Research Team, to dig into the existing norms and tests for drugs
in the country, compare with the global scene and suggest the most
appropriate methodology. They have given the contract at Rs 10 lakh
last week and they are supposed to come out with the report in three-month’s
time.
We
face other complicated problems too. The Drug Controller General
of India is not an independent body, but a joint secretary with
the Department of Health, with no authority to make independent
decisions. DCGI has become a common bureaucrat without proper scientific
background and the Drug Pharmacopoeia that was formulated in 1930
is still in use.So are you suggesting amendments?
That
is right, and that is why we are coming out with this report. Actually
almost 50 per cent of the drugs do not need any more testing. Tests
for cosmetics, LD 50, testing syringe needles on rabbits, all these
unwanted tests that are part of the old pharmacopoeia should be
abandoned first. Globally they have adopted these changes and even
the domestic industry is seeking for it, but is yet to incorporate
in the pharmacopoeia.
It
is being suggested that drug research should be delinked from under
the purview of CPCSEA. Your comments.
The
roots of entire debate can be explained best as political reasons.
The Health Minister wants to put CPCSEA directly under him. But
when they had been handling it for over 40 years no guidelines or
standards were ever followed. The Indian National Science Academy
has formulated a guideline on animal experimentation in 1992, chalked
out by scientists themselves, but it was never ever implemented.
Otherwise, why should I take this step now? If everything went on
smoothly this would have been only a continuous process and India
would have obtained 2000 patents. Even Bangaldesh and Taiwan have
patents to their credit.What should be our immediate priorities?
We
need to ensure good laboratory practices. It is not that we do not
have the guidelines but we need to enforce these. I will give you
an example of one of the premier institutes in Delhi where we had
a recent inspection. We found 60 people working on 60 different
experiments and the animals used were not even labelled.
Some
of the institutes have been seeking permission to work on stray
animals which would only make the research meaningless. So how do
you ensure the health and genetics background of the animals used
for experimentation?
Start
breeding. That is the only solution. Unless we ensure GLP and work
on animals whose genetic and health background are known the data
generated would be unreliable and Indian research would never be
acceptable globally. We have decided to take on this strictly and
institutions that do not follow the norms will be shut down with
immediate effect.What is the monitoring mechanism that you are following?
We
are conducting inspection on a monthly basis in all institutions
and our inspectors are given continuous training. Moreover, we bring
experts to train laboratory assistants. In October we will be having
an international conference here on GLP conducted by the Department
of Biotechnology where all the best people across the world would
be coming. They would tell us how to implement good laboratory practices
by citing their global experience.
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