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9-Misc: India to unveil new biotech policy

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TITLE:  India to unveil new biotech policy
SOURCE: IANS / Kerala News, India
DATE:   11 Jul 2004

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India to unveil new biotech policy

Bangalore, July 11 (IANS) : India will unveil a new national
biotechnology policy within six months to boost the sunrise sector. The
ministry of science and technology's department of biotechnology will set
up a committee by month-end to frame the new policy, Biotechnology
Secretary M.K. Bhan said here Sunday. He was addressing an international
conference on 'Biotechnology for a billion people', being held as part of
the three-day Bangalore Bio 2004 event. Delivering the keynote address at
the inaugural session of the conference, Bhan told about 300 delegates
from India and abroad the new policy would provide the framework for the
functioning of research and business institutions. It will also spell out
trade and investment guidelines for the emerging sector. "A group of
experts will also be set up to suggest models for public-private
partnerships in the biotech sector. The biotechnology department will
invest in the creation of innovation centres within the existing academic
and research institutions," Bhan said. Delhi University will be the first
centre to receive the funding. Five such centres will be established
across the country in as many years. Outlining the department's strategy
for the biotech sector's growth, Bhan said the government would allocate
its resources in a targeted manner, selecting the areas that had built up
competence levels. Besides Bangalore, the department will focus on other
cities such as Hyderabad, Pune, Chennai, Ahmedabad and Lucknow for
uniform development of the biotech sector. "We will invest in those
states and cities where the ingredients of the biotechnology enterprise
are present," Bhan stated. Inaugurating the conference, Thailand's
Science and Technology Minister Korn Thapparansi said Indian scientific
and business institutions should explore collaborations with his country
in the biotech sector. "They can identify organic and herbal products
besides the traditional medicine as areas of collaboration," he pointed
out. Sharing his country's vision to transform into a knowledge-based
economy in the southeast Asian region this decade, Thapparansi said
Thailand had launched a campaign to be the "kitchen of the world" as part
of its strategic focus on the food sector. "Biotechnology will help us
diversify the range of crops, improve yields and enhance quality," he said.

                                  PART II
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TITLE:  Biotech Sector Wants GEAC Wings Clipped
SOURCE: The Financial Express, India by Ashok B. Sharma
DATE:   16 Jul 2004 

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Biotech Sector Wants GEAC Wings Clipped

NEW DELHI: The biotech industry has favoured curtailing Genetic
Engineering Approval Committee's (GEAC) powers by seeking changes in
rules relating to production and handling of micro-organisms, cells and
genetically modified organisms (GMOs).

They have alleged that the 'rules for manufacture, use, import, export
and storage of hazardous micro-organisms, genetically engineered
organisms or cells, 1989' (EPA-Rules 1989), framed under the Environment
Protection Act, 1986, have given unnecessary powers to GEAC to intervene,
which is hindering the growth of the biotech industry.

Apart from the rules being "protectionist in nature," it prima facia
"wrongly" reflects that any micro-organism, whether naturally occuring or
genetically modified, is risky and hazardous. The industry has suggested
that EPA-Rules 1989 can be amended by a government notification instead
of seeking ratification by the Parliament.

In a memorandum to the union environment ministry and the RA Mashelkar
panel on recombinant pharma sector, the biotech division of the
Federation of Indian Chambers of Commerce and Industry (Ficci) has
suggested that micro-organisms listed in risk category-1 under EPA-Rules
1989 should be exempted from regulations. Biosafety and risk assessments
of micro-organisms, GMOs and biologicals should be done as per guidelines
issued by WHO and US Food and Drug Agency (FDA).

All drugs, whether recombinant or not, should be treated under Indian

Calling for a change in the approval regime for imports of micro-
organisms and GMOs, the memorandum suggested that academic institutions
and the biotech industry should be permitted to import less risk
organisms with the approval of their in-house institutional biosafety
committee (IBSC) and after intimation to the union environment ministry,
department of biotechnology (DBT), Indian Council of Medical Research
(ICMR) and Indian Council of Agricultural Research (ICAR). It also said
that the import licence should be given by the Drugs Controller General
of India (DCGI). However, high-risk organisms should be imported with a
short approval process by the enivornment ministry and not by the GEAC.

The research and development (R&D) labs approved by the Council for
Scientific and Industrial Research (CSIR), should be allowed to import
biologicals with the approval of their in-house bioethics committee and
through a system of self-regulation. There should be a common approval
for export, import and transportation of GMOs.

Ficci's biotech division has alleged that GEAC is not the competent
authority for assessing clinical trials involving both humans and animal
studies. It says that the approval for clinical trials should be given by
DCGI, while GEAC can only fix specific timeframes for inspections and
approvals. In case of new applicants seeking approval for the already
approved products, the process of approval should be simplified.

The memorandum also said that the use of products derived from GMOs and
micro-organisms should be exempted from regulations, while the GMOs used
as a product may be covered under the regulations. Instead of case by
case approval, a positive list of GM ingredients for foods should be
evolved, based on scientific method with discussions with stakeholders.

The grant of approvals under rules 8 to 11 under the existing EPA-Rules
1989 should be extended for a period of 7 to 10 years, in lieu of the
existing 2 year period.

The memorandum said that the definition of micro-organism should be made
consistent with that adopted under Drugs and Cosmetics Act, Indian
Patents Act and the Plant Quarantine (Regulation of Import into India)
Order, 2004. Micro-organism cultures used as references while testing
food or samples for environment safety in labs should not be covered
under regulations.

The memorandum also called for intellectual property protection, simple
benefit sharing model for use of community-owned bioresources,
standardisation of protocols, simple mechanism for transfer of
agricultural biotechnology from public sector R&D institutes to the
industry, and acceptance of credible regulatory data from US and other
countries on biomedical research.

It said that the industry should not be made accountable for its
financial disclosures to the GEAC, and there should be clarity in "what
consitutes a violation of the rule and nature of penalties."

The Rules-1989 should also unveil the details of the Appellate Authority.


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