Biosafety Regulatory Framework in India by Fc7Y8yK3


									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
 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
   Deals with applications of gene technology
    and hazardous micro-organisms
   Includes:
     o Classification of micro-organisms or
       genetically engineered products
     o Scheme of approvals
     o Administrative mechanism
     o Punitive provisions
              …1989 Rules: MoEF
      A technique by
      which heritable       Import
   material generated       Export
   outside and inserted     Transport     Hazardous
        into a cell or      Manufacture   MO/GEO
    organism. Includes      Process
  combinations/ deletions   Use           Substances/
     of parts of genetic    Sell          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                 APPROVALS                ENFORCEMENT
  RDAC                     GEAC                      SBCC
                            RCGM                      DLCC
Serviced by DBT            IBSC                    SBCC
Reviews biotech           GEAC
developments                                    Powers to inspect,
                     Serviced by MoEF
Recommends                                      investigate and punish
                     Environmental clearance
safety regulations                               statutory violations
                      - Large scale use
                                                Post release
                      - Release into
                                                State nodal agency
                     Punitive powers
               Administrative Mechanism

       APPROVALS                                            ENFORCEMENT

   RCGM                         IBSC                         DLCC
   Manuals of guideline         Institute level              Monitors
   Approvals: RG III &          Approval role                 regulations in
    above research                  - R G I: Intimation        installations
   Approvals: contained            - R G II: Approval        Post release
    filed trials                                                monitoring
                                    - R G III
   Approvals: import for                                      Reports:
                                    & above: recommen-
    research                                                    SBCC, GEAC
   Monitors research
                                 Site emergency plan
    projects safety aspects
                                 Adherence of guidelines
   Advisory role
   Link: IBSC: GEAC             Nodal point for
 State Government’s Role
           Present Scenario
R&D    ENV. Release   Commercialization   Enforcement

 NIL         NIL               NIL        MAIN AGENCY

            Felt Difficulties
        ‘Navbharat’ case
        Illegal BT cotton mushrooming
        Differences over commercialization
        Constitutional framework
                 Identification of Gaps:
                  Basic Considerations

Societal needs                      Policy decisions
                     BALANCING      Science based
initiatives                         inputs




Identification of Gaps
   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   Procedural   Transparency   Involving
Revamping       Changes      .              the States
      …M S Swaminathan Task Force

Institutional Revamping             Procedural Changes

     Autonomous and                Shorter regulatory track for
      professional NBRA              released events
     State Biotechnology           Concurrent biosafety and
      Regulatory Board –             agronomic evaluations
      Liaisoning with NBRA          MEC reports direct to
     District Biotechnology         GEAC
      Risk Assessment and           Special AICRP for GM
      Communication Committee        crops
   …M S Swaminathan Task Force

Transparency                      Involving the States

      Transparent field         Standing Advisory
       evaluations                Committee - National
      Unfavorable results       SAUS: Lead role in
       highlighted                research priorities
      Evaluation mechanism      Information about large
       high credibility           scale trials
      Detailed record           Social mobilization and
       notebooks                  education
                                 Post releasing
                                  monitoring through
…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
   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

   Time lines
   Independent inspection facility
   Synergisation with PQO
   Standing Technical Advisory Committee on BT
   National Biotechnology Regulatory Authority
            Regulatory Scenario
 Pharmaceutical products derived from LMO’s

     (I)                               (II)
    EP– not LMO                   E P – LMO
                                  High Risk
RG III &      RG I &
above         II                   RCGM 
More Risk     Less Risk            GEAC 
RCGM         RCGM 
GEAC  yz     GEAC - Nil
              Regulatory Scenario
   Pharmaceutical products derived from LMO’s
(III)                                  (V)
 EP-LMO           EP-       (IV)     EP-
   FF             LMO                Not
                  Bulk               LMO
Less Risk
                More Risk          Least Risk
RCGM - Nil
GEAC  xy       RCGM              Outside
GEAC in         GEAC 
                                   of 1989
principle       GEAC in             Rules
approval        principle
for import      approval for
                import/ IBSC
               Regulatory Scenario
Pharmaceutical products derived from LMO’s
                 INDIGENOUS/ IMPORT

RCGM                         GEAC
A: Approval of preclinical   X: Prior approval for
   studies                      human clinical trials
B: Recommendation of         Y: Environmental
   human clinical trials
                             Z: Views about
C: Recommendation/
                                containment facility
   evaluation about
   containment facility

 EP-End Product
 FF- Finished Formulation
    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
Thank you

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