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9-Misc: Draft Indian national biotechnology development strategy released



                                  PART I
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TITLE:  Draft biotech policy draws criticism from NGOs
SOURCE: The Financial Express, India, by Ashok B Sharma
        http://www.financialexpress.com/fe_full_story.php?content_id=86986
DATE:   3 Apr 2005

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Draft biotech policy draws criticism from NGOs

NEW DELHI, APRIL 3: The Centre's draft National Biotechnology Development
Strategy has begun attracting criticisms from several civil society
organisations for identifying development of 18 genetically modified (GM)
crops and for not emphasising on adequate risk evaluation.

Incidentally, such criticisms have come from the member of the drafting
committee Dr Suman Sahai, who is the sole representative in the panel
from the NGO sector. The Centre has invited suggestions from the public
on the draft by May 16. After reviewing these suggestions, the draft is
slated to be finalised for implementation.

The draft document has called for development of transgenics in rice,
wheat, maize, sorghum, pigeonpea, chickpea, moong bean (green gram),
groundnut, mustard, soybean, cotton, sugarcane, potato, tomato, cole
crops, banana, papaya and citrus. It said that priority target traits in
crop plants would be yield increase, pest and disease resistance, abiotic
stress tolerance, enhanced quality and shelf life, engineering male
sterility and development of apomixis.

In case of hybrids, research on the introduction of genetic factors for
apomixis would be supported so that resource-poor farmers can derive
benefits from hybrid vigour without having to buy expensive seeds, every
cropping season. The draft document has also proposed development of
transgenic animals, aquaculture and genetically modified foods.

In this context, Dr Suman Sahai of Gene Campaign speaking from Paris
said: "This policy has included practically all the suggestions of the
industry and has ignored many areas of public concern. I had suggested
that there should be crop specific strategies for developing transgenics,
taking into account the export factor, environmental and health aspects.
The need for keeping out biodiversity rich regions from the influence of
transgenics should be emphasised."

She alleged that in the last February meeting it was decided that the
minutes of the meeting would be discussed again before the release. "This
did not happen," she alleged. She said that she had suggested to co-op
other representatives from the civil society in the panel. But instead of
doing so the panel preferred to hold a consultation with some NGOs
through one its sub-committee.

However, the draft has suggested active involvement of civic society in
decision-making process relating to transgenic crops. It said: "In
general biopharmaceutical products seem to be better accepted than
transgenic crops...hence there is a need to work actively and
transparently to inform and engage the civic society in decision-making
and to maintain a relationship of trust and confidence. The Centre and
the industry must actively promote access to information on the benefits
and risks in a balanced manner."

Realising that development of transgenics in agriculture is a contentious
issue, the draft admitted "insufficient dialogue between scientists,
industry, policymakers, regulators, consumers, civil society
organisations and the mass media and lack of sufficiently proactive
administrative machinery." As a matter of new strategey, the draft
suggested involvement of local village bodies in the process of analysis
and understanding the risks and benefits associated with GMOs.

The draft called for setting up of a training school for the judiciary
with the help of the Centre for DNA Fingerprinting and Diagnostics,
Hyderabad and imparting training through the National Law Schools and
other similar institutes.

The draft contains several other contentious issues which has invited the
ire of the civil society, particularly those provision relating to
regulations. It said: An event (construct) that has already undergone
extensive biosafety tests should not be treated as a new event if it is
in a changed background....Where adequate evidence is available that the
recurrent parent genetic background of a notified/registered genotype is
nearly restored (through field data/molecular data), only the agronomic
performance and the level and stability of the transgene expression may
be analysed by two-year trial data by the Indian Council of Agricultural
Research (ICAR)."

Even in case of a structurally altered transgene with no significant
modifications in protien conformation, the toxicity and allergenicity
tests need not be carried out provided the predicted antigenic epitope
remains the same and the level of expression of the transgene is within
the defined limits, it added.

The draft proposed implementations of the recommendations of the MS
Swaminathan panel on agri-biotech and RA Mashelkar panel on recombinant
pharma. Accordingly it has proposed setting of "a competent single
National Biotechnology Regulatory Authority with separate divisions for
transgenic crops, recombinant drugs and industrial products, transgenic
food and feed, transgenic animals and aquaculture."

Pending setting up of the new regulatory authority, the draft document
suggested setting up of an inter-ministerial group in 2005 chaired by a
reputed scientist to address anomalies and issues that arise in
regulation from time to time. The promoter agency, department of
biotechnology, will provide administrative support to this inter-
ministerial body.

The draft document noted: "Majority of the genes under use - about 40% -
are currently held by multinational companies and have been received
under material transfer agreements for R&D purpose without clarity on the
potential for commercialisation." It proposed that at least 30% of the
government funded programmes must invite a private sector to
commercialise its R&D efforts.


                                  PART II
-------------------------------- GENET-news -------------------------------

TITLE:  Draft national biotechnology development strategy released
SOURCE: The Hindu, India
        http://www.hindu.com/2005/04/01/stories/2005040107711200.htm
DATE:   31 Mar 2005

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Draft national biotechnology development strategy released

NEW DELHI, MARCH 31. The Union Science and Technology Minister, Kapil
Sibal, today released a draft national biotechnology development strategy
that envisages the establishment of a single high-powered regulatory
authority and changes in the rules to provide for a faster and more
efficient clearance for all biotechnology products.

The highlights of the draft document includes a proposal to exempt all
biotech units from the requirement of compulsory licensing and allow 100
per cent Foreign Direct Investment through the automatic route. It
proposes to fund biotech parks promoted by a private industry or through
public-private partnership in the form of a grant up to 30 per cent of
the total cost or up to 49 per cent in the form of equity. It plans to
continue all existing fiscal incentives for the industry up to 2010 and a
scheme to facilitate the flow of incentives applicable to Export Oriented
Units to units in the biotech parks.

Addressing a press conference, Mr. Sibal said the draft would be kept in
the public domain for the next six weeks to get suggestions from
different sections of society before it was finalised.

The document is being placed on the website of the Department of
Biotechnology (http://dbtindia.nic.in/biotechstrategy.htm). Once
finalised, the document would have a detailed time-table for the
implementation of the various provisions. It would have a clear mention
of the financial aspects at that time.


                                  PART III
-------------------------------- GENET-news -------------------------------

TITLE:  Draft biotech strategy moots 100% FDI via automatic route
SOURCE: The Financial Express, India
        http://www.financialexpress.com/fe_full_story.php?content_id=86689
DATE:   31 Mar 2005

------------------- archive: http://www.genet-info.org/ -------------------


Draft biotech strategy moots 100% FDI via automatic route

NEW DELHI, MARCH 31: The draft national biotechnology development
strategy has proposed attracting 100% foreign direct investment (FDI) in
the sector through automatic approval. It has suggested exempting biotech
industries from compulsory licencing and urged for continuance of all
fiscal incentives till 2010.

Ten more biotech parks are proposed to be set up by 2010. The draft
document proposed upscaling investments in R&D and biotech education. The
strategies are designed to help Indian biotech industry generate a $5
billion revenue annually and create one million jobs by 2010. The
government has invited public comments within six weeks for finalising
this draft.

The draft policy document which was released by minister for science and
technology Kapil Sibal on Thursday, proposed setting up "a competent
single national biotechnology regulatory authority with separate
divisions for transgenic crops, recombinant drugs and industrial
products, transgenic food and feed, transgenic animals and aquaculture."
It suggested implementation of the recommendations of MS Swaminathan
panel on agri-biotech and RA Mashelkar panel on recombinant pharma from
the year 2005.

Pending setting up of the new regulatory authority, the draft suggested
setting up of an inter-ministerial group in 2005 chaired by a reputed
scientist to address anomalies and issues that arise in regulation from
time to time. The department of biotechnology, will provide
administrative support to this inter-ministerial body.


--


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European NGO Network on Genetic Engineering

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