Transcript Science and Technology for Society

Biosafety Regulatory
Framework in India
Dr Veena Chhotray, IAS
Senior Fellow, TERI
7th February, 2006
 ‘BIOSAFETY’: Protecting human and animal
health and biodiversity from the possible adverse
effects of the products of modern biotechnology
 Biosafety Regulatory System essential for
biotechnology programme
 Broad outlines:
 Introductory
 EPA
 Statutory Rules
 State Government’s Role
 Identification of Gaps
 Streamlining Initiatives
Indian Biosafety Regulatory System
 Combination of existing and new
legislations
 Mix with non-statutory guidelines
 Shared responsibility
 Scope to evolve
The Indian Environment (Protection) Act 1986

Umbrella legislation
 ‘Hazardous substances’
 Central Government’s powers
 Legal provisions
• Search and seizures: CrPC
• Penalties
o 5-7 years imprisonment
o Rs.1 lakh fine
o Rs.5,000/day additional fine
‘Environment’ includes water, air and land and the
relationship which exists among and between water, air
and land and human beings, other living creatures, plants,
micro-organisms and property.
1989 Rules: MoEF

Objective: protect environment, nature and
health

Deals with applications of gene technology
and hazardous micro-organisms
Includes:

o
o
o
o
Classification of micro-organisms or
genetically engineered products
Scheme of approvals
Administrative mechanism
Punitive provisions
…1989 Rules: MoEF
GENETIC ENGINEERING
A technique by
which heritable
material generated
outside and inserted
into a cell or
organism. Includes
combinations/ deletions
of parts of genetic
material.
GEAC APPROVAL
Import
Export
Transport
Manufacture
Process
Use
Sell
Hazardous
MO/GEO
Substances/
Cells
Regulatory Mechanism
Ministry of Environment and Forests
Department of Biotechnology
Recombinant DNA Advisory Committee (RDAC)
Review Committee on Genetic Manipulations (RCGM)
Genetic Engineering Approval Committee (GEAC)
State Biosafety Coordination Committee (SBCC)
District Level Coordination Committee (DLCC)
Administrative Mechanism
ADVISORY
RDAC
Serviced by DBT
Reviews biotech
developments
Recommends
safety regulations
APPROVALS
ENFORCEMENT
GEAC
RCGM
IBSC
SBCC
DLCC
GEAC
Serviced by MoEF
Environmental clearance
- Large scale use
- Release into
environment
Supervises
implementation
Punitive powers
SBCC
Powers to inspect,
investigate and punish
statutory violations
Post release
monitoring
State nodal agency
Administrative Mechanism
APPROVALS
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RCGM
Manuals of guideline
Approvals: RG III &
above research
Approvals: contained
filed trials
Approvals: import for
research
Monitors research
projects safety aspects
Advisory role
Link: IBSC: GEAC
ENFORCEMENT
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IBSC
Institute level
Approval role
- R G I: Intimation
- R G II: Approval
- R G III
 & above: recommendation
Site emergency plan
Adherence of guidelines
Nodal point for
interaction
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DLCC
Monitors
safety
regulations in
installations
Post release
monitoring
Reports:
SBCC, GEAC
State Government’s Role
Present Scenario
R&D
NIL
ENV. Release
Commercialization
NIL
NIL
Enforcement
MAIN AGENCY
Felt Difficulties
 ‘Navbharat’ case
 Illegal BT cotton mushrooming
 Differences over commercialization
 Constitutional framework
Identification of Gaps:
Basic Considerations
Societal needs
Entrepreneurial
initiatives
BALANCING
Policy decisions
Science based
inputs
G U I D E L I N E S
ADAPTABILITY
ENFORCEABILITY
PREDICATABILITY
TRANSPARENCY
CLARITY
Identification of Gaps
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Broad Areas
Procedural streamlining
Institutional strengthening
Harmonization: National Legislations
Integration with federal structure
 International Legislation
o Identification of linkages and conflicts
o Assessment of national implications
M S Swaminathan Task Force
Institutional
Revamping
Procedural
Changes
Transparency
.
Involving
the States
…M S Swaminathan Task Force
Institutional Revamping
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Autonomous and
professional NBRA
State Biotechnology
Regulatory Board –
Liaisoning with NBRA
District Biotechnology
Risk Assessment and
Communication Committee
Procedural Changes
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Shorter regulatory track for
released events
Concurrent biosafety and
agronomic evaluations
MEC reports direct to
GEAC
Special AICRP for GM
crops
…M S Swaminathan Task Force
Transparency
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Transparent field
evaluations
Unfavorable results
highlighted
Evaluation mechanism
high credibility
Detailed record
notebooks
Involving the States
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Standing Advisory
Committee - National
SAUS: Lead role in
research priorities
Information about large
scale trials
Social mobilization and
education
Post releasing
monitoring through
SAUs
…M S Swaminathan Task Force
Involving the States
Not suggested:
o Nominees in IBSC/RCGM/GEAC
o Nominees in BCC/MEC
In view of the federal constitutional structure of
India need for greater involvement of state
governments in research priorities, policy
decisions & regulatory activities
Mashelkar task force on
Recombinant Pharma
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Objective: Streamline ambiguity: multiple
regulatory agencies
Objective: Reconcile biosafety: efficiency
GEAC-Role: Environmental regulations: large
scale use of LMOs
DCGI-Role: Product safety and efficiency:
clinical trials: market authorization
Synchronize regulatory process: degree of
environmental risk
Environmental risk: riskgroup of organisms,
extent of use of LMO; end product LMO?
Other Recommendations
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Time lines
Independent inspection facility
Synergisation with PQO
Standing Technical Advisory Committee on BT
Regulation
National Biotechnology Regulatory Authority
Regulatory Scenario
Pharmaceutical products derived from LMO’s
INDIGENOUS
(I)
(II)
EP– not LMO
RG III &
above
RG I &
II
More Risk
Less Risk
RCGM 
RCGM 
GEAC  yz
GEAC - Nil
E P – LMO
High Risk
RCGM 
GEAC 
Regulatory Scenario
Pharmaceutical products derived from LMO’s
(III)
EP-LMO
FF
Less Risk
RCGM - Nil
IMPORT
EPLMO
Bulk
(IV)
More Risk
GEAC  xy
RCGM 
GEAC in
principle
approval
for import
GEAC 
GEAC in
principle
approval for
import/ IBSC
(V)
EPNot
LMO
Least Risk
Outside
purview
of 1989
Rules
Regulatory Scenario
Pharmaceutical products derived from LMO’s
INDIGENOUS/ IMPORT
INDEX
RCGM
A: Approval of preclinical
studies
B: Recommendation of
human clinical trials
C: Recommendation/
evaluation about
containment facility
EP-End Product
FF- Finished Formulation
GEAC
X: Prior approval for
human clinical trials
Y: Environmental
clearance
Z: Views about
containment facility
Recommendations of Expert Committee
on GM foods
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Currently no appropriate regulatory mechanism
Need to incorporate regulatory provisions under PFA Rules 1955
Testing of processed food difficulties: for DNA and protein
Approval of GEAC necessary
Need for national preparedness
 Guidelines for regulators and analysts
 Development of DNA and protein based protocols
 Strengthening testing laboratories
 Experiments on bioimpact with approval of IBSC/ RCGM
 Independent research to establish safety of GM foods
 National Reference Centre for testing of GM foods
Compulsory labelling
 Indicate clearance status in country of origin
 Supporting documents
Thank you