Biosafety Regulatory Framework in India

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Biosafety Regulatory Framework in India

• Dr Veena Chhotray, IAS
• Senior Fellow, TERI
• 7th February, 2006

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• 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 Governments Role
• Identification of Gaps
• Streamlining Initiatives

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Indian Biosafety Regulatory System

• Combination of existing and new legislations
• Mix with non-statutory guidelines
• Shared responsibility
• Scope to evolve

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The Indian Environment (Protection) Act 1986

• Umbrella legislation
• Hazardous substances
• Central Governments powers
• Legal provisions
• Search and seizures CrPC
• Penalties
• 5-7 years imprisonment
• Rs.1 lakh fine
• 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.
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1989 Rules MoEF

• Objective protect environment, nature and health
• Deals with applications of gene technology and
  hazardous micro-organisms
• Includes
• Classification of micro-organisms or genetically
  engineered products
• Scheme of approvals
• Administrative mechanism
• Punitive provisions

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1989 Rules MoEF
GEAC APPROVAL
GENETIC ENGINEERING

• Import
• Export
• Transport Hazardous
• Manufacture MO/GEO
• Process
• Use Substances/
• Sell Cells

A technique by which heritable material
generated outside and inserted into a cell
or organism. Includes combinations/ deletions of
parts of genetic material.
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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)

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Administrative Mechanism
ADVISORY
APPROVALS
ENFORCEMENT

• RDAC

• GEAC
• RCGM
• IBSC

• SBCC
• DLCC

• Serviced by DBT
• Reviews biotech
• developments
• Recommends
• safety regulations

• Powers to inspect,
• investigate and punish
• statutory violations
• Post release
• monitoring
• State nodal agency

SBCC

• Serviced by MoEF
• Environmental clearance
• - Large scale use
• - Release into
• environment
• Supervises
• implementation
• Punitive powers

GEAC
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Administrative Mechanism
APPROVALS
ENFORCEMENT

• 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

• DLCC
• Monitors safety regulations in installations
• Post release monitoring
• Reports SBCC, GEAC

• IBSC
• Institute level
• Approval role
• - R G I Intimation
• - R G II Approval
• - R G III
• above recommen-
• dation
• Site emergency plan
• Adherence of guidelines
• Nodal point for interaction

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State Governments Role
Present Scenario
Commercialization
Enforcement
R D
ENV. Release
NIL
NIL
NIL
MAIN AGENCY
Felt Difficulties

• Navbharat case
• Illegal BT cotton mushrooming
• Differences over commercialization
• Constitutional framework

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Identification of Gaps
Basic Considerations
Multiple Agency
Synergisation
Societal needs
Policy decisions
BALANCING
Science based inputs
Entrepreneurial initiatives
Federal framework
Integration
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TRANSPARENCY
CLARITY
PREDICATABILITY
ENFORCEABILITY
ADAPTABILITY
G U I D E L I N E S
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Identification of Gaps

• Broad Areas
• Procedural streamlining
• Institutional strengthening
• Harmonization National Legislations
• Integration with federal structure
• International Legislation
• Identification of linkages and conflicts
• Assessment of national implications

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M S Swaminathan Task Force
Institutional Revamping
Procedural Changes
Involving the States
Transparency .
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M S Swaminathan Task Force
Institutional Revamping
Procedural Changes

• Autonomous and professional NBRA
• State Biotechnology Regulatory Board Liaisoning
  with NBRA
• District Biotechnology Risk Assessment and
  Communication Committee

• Shorter regulatory track for released events
• Concurrent biosafety and agronomic evaluations
• MEC reports direct to GEAC
• Special AICRP for GM crops

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M S Swaminathan Task Force
Transparency
Involving the States

• Transparent field evaluations
• Unfavorable results highlighted
• Evaluation mechanism high credibility
• Detailed record notebooks

• Standing Advisory Committee - National
• SAUS Lead role in research priorities
• Information about large scale trials
• Social mobilization and education
• Post releasing monitoring through SAUs

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M S Swaminathan Task Force
Involving the States

• Not suggested
• Nominees in IBSC/RCGM/GEAC
• 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
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Mashelkar task force on Recombinant Pharma

• 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?

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Other Recommendations

• Time lines
• Independent inspection facility
• Synergisation with PQO
• Standing Technical Advisory Committee on BT
  Regulation
• National Biotechnology Regulatory Authority

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Regulatory ScenarioPharmaceutical products
derived from LMOs
INDIGENOUS
(I)
(II)
EP not LMO
E P LMO
High Risk
RG III above
RG I II
RCGM ? GEAC ?
Less Risk
More Risk
RCGM ? GEAC - Nil
RCGM ? GEAC ? yz
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Regulatory ScenarioPharmaceutical products
derived from LMOs
IMPORT
(III)
(V)
(IV)
EP-LMO FF
EP-LMO Bulk
EP-Not LMO
Less Risk
More Risk
Least Risk
RCGM - Nil GEAC ? xy GEAC in principle approval
for import
RCGM ? GEAC ? GEAC in principle approval for
import/ IBSC
Outside purview of 1989 Rules
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Regulatory ScenarioPharmaceutical products
derived from LMOs
INDIGENOUS/ IMPORT INDEX

• RCGM
• A Approval of preclinical
• studies
• B Recommendation of
• human clinical trials
• C Recommendation/
• evaluation about
• containment facility

GEAC X Prior approval for human clinical
trials Y Environmental clearance Z Views
about containment facility
EP-End Product FF- Finished Formulation
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Recommendations of Expert Committee
on GM foods

• 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

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Thank you