Professional Documents
Culture Documents
Manish Sharma
M. Pharm. Sem-II
Pharmaceutical Management & regulatory affairs
Contents
Introduction
Definitions
Regulation of Access to Biological Diversity
National Biodiversity Authority
Functions and Powers of The National
Biodiversity Authority
State Biodiversity Board
Duties of The Central and The State
Governments
Biodiversity Management Committees
Forms
Significance/ Role in Pharmaceutical
Industry
Nagoya Protocol
Conclusion
References
Introduction
Developed countries use the biogenetic
resources accessed from the developing
countries. It results in beginning of the
unprotected flow of genetic information from the
developing countries to the capital-rich west,
and a protected flow in the reverse direction
mainly through patents and Plant Breeders
Rights (PBR)
The Biological Diversity Act 2002 was born out of
India's attempt to realise the objectives
enshrined in the United Nations Convention on
Biological Diversity (CBD) 1992 which
recognizes the sovereign rights of states to use
their own Biological Resources
The Biodiversity Act, 2002
Definitions
biological diversity means the variability
among living organisms from all sources and
the ecological complexes of which they are
part and includes diversity within species or
between species and of eco-systems;
biological resources means plants,
animals and micro-organisms or parts
thereof, their genetic material and byproducts (excluding value added products)
with actual or potential use or value, but
does not include human genetic material;
The Biodiversity Act, 2002
10
11
12
Members
ex-officio
(10)
non-official
(5)
The Biodiversity Act, 2002
13
ex-officio
(10)
Ministry of
Tribal Affairs
(1)
Ministry of
Agriculture
Research
and
Education
(1)
Ministry
of
Biotechno
logy (1)
Indian Systems
of Medicine and
Homeopathy
(1)
Ministry
of Ocean
Develop
ment (1)
Science and
Technology
(1)
The Biodiversity Act, 2002
Ministry of
Agriculture and
Cooperation
(1)
Scientific and
Industrial
Research (1)
14
non-official
(5)
sustainable
use of
biological
resources
conservation
of biological
diversity
specialists and
scientists having
special knowledge
of, or experience in
representatives
of industry
Conservers,
creators &
knowledge-holders
of biological
resources
The Biodiversity Act, 2002
equitable
sharing of
benefits
15
Sec. 11.
The Central Government may remove any member
from NBA who has
adjudged
as an
insolvent
Offence of
moral
turpitude
Removal
of
member
from NBA
physically
or
mentally
incapable
abusing
position
financial or
other interest
The Biodiversity Act, 2002
16
17
18
a Chairperson
five ex-officio members
five members from among the experts in matters
relating to conservation of biological diversity,
sustainable use of biological resources and equitable
sharing of benefits arising out of the use of biological
resources.
The Biodiversity Act, 2002
19
Sec. 23.
The functions of the State Biodiversity
Board shall be to
(a) advise the State Government, on matters
relating to the conservation of
biodiversity, sustainable use of its
components and equitable sharing of the
benefits arising out of the utilization of
biological resources;
(b) regulate by granting of approvals or
otherwise requests for commercial
utilization or bio-survey and bio-utilization
of any biological resource by Indians;
The Biodiversity Act, 2002
20
21
22
Sec.39
Powers of Central Govt. to designate
Repositories:
(1) Designate institutions as repositories for
different categories of biological
resources.
(2) To keep safe custody of the biological
material including voucher specimens.
(3) To keep safe custody of any new taxon
discovered by any person.
23
24
25
Forms
I
10,000
II
5000
III
500
IV
10,000
Within 30-45
days
VI
VII
Form of notice
The Biodiversity Act, 2002
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27
28
Nagoya Protocol
The Nagoya Protocol is a supplementary
agreement to the Convention on Biological
Diversity . To access genetic resources and
the fair and equitable sharing of benefits
arising from their utilization to the
Convention on Biological Diversity.
The Nagoya Protocol will create greater
legal certainty and transparency for both
providers and users of genetic resources by:
Establishing more predictable conditions for
access to genetic resources.
Helping to ensure benefit-sharing when genetic
resources leave the contracting party providing
the genetic resources
The Biodiversity Act, 2002
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