biosafety regulatory framework in india
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Biosafety Regulatory Framework in India. Dr Veena Chhotray, IAS Senior Fellow, TERI 7 th February, 2006. ‘ BIOSAFETY’: Protecting human and animal health and biodiversity from the possible adverse effects of the products of modern biotechnology - PowerPoint PPT PresentationTRANSCRIPT
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
Combination of existing and new legislations
Mix with non-statutory guidelines Shared responsibility Scope to evolve
Indian Biosafety Regulatory System
Umbrella legislation ‘Hazardous substances’ Central Government’s powers Legal provisions
• Search and seizures: CrPC• Penalties
o 5-7 years imprisonmento Rs.1 lakh fineo Rs.5,000/day additional fine
The Indian Environment (Protection) Act 1986
‘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.
Objective: protect environment, nature and health
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
…1989 Rules: MoEF
A technique by which heritable
material generated outside and inserted
into a cell ororganism. Includes
combinations/ deletionsof parts of genetic
material.
GENETIC ENGINEERING
ImportExportTransport HazardousManufacture MO/GEOProcessUse Substances/Sell Cells
GEAC APPROVAL
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 ENFORCEMENTRDAC GEAC
RCGMIBSC
SBCCDLCC
Serviced by DBTReviews biotech developmentsRecommends safety regulations
Serviced by MoEFEnvironmental clearance - Large scale use - Release into environmentSupervises implementationPunitive powers
GEAC Powers to inspect, investigate and punish statutory violationsPost release monitoringState nodal agency
SBCC
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
Administrative Mechanism
APPROVALS ENFORCEMENT
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
State Government’s Role
R & D Commercialization
Enforcement
ENV. Release
NIL NIL NIL MAIN AGENCY
Present Scenario
Felt Difficulties ‘Navbharat’ case Illegal BT cotton mushrooming Differences over commercialization Constitutional framework
Identification of Gaps: Basic Considerations
BALANCING
Mul
tiple
Ag
ency
Syne
rgisa
tion
Fede
ral
fram
ewor
kIn
tegr
atio
n
Societal needsEntrepreneurial initiatives
Policy decisionsScience based inputs
G U I D E L I N E S
TR
AN
SP
AR
EN
CY
CL
AR
ITY
PR
ED
ICA
TA
BIL
ITY
EN
FO
RC
EA
BIL
ITY
AD
AP
TA
BIL
ITY
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
Identification of Gaps
M S Swaminathan Task Force
Institutional Revamping
Procedural Changes
Transparency .
Involving the States
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
…M S Swaminathan Task Force
Institutional Revamping
Procedural Changes
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
…M S Swaminathan Task Force
Transparency Involving the States
Not suggested:o Nominees in IBSC/RCGM/GEACo 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
…M S Swaminathan Task Force
Involving the States
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?
Mashelkar task force on Recombinant Pharma
Other Recommendations
Time lines Independent inspection facility Synergisation with PQO Standing Technical Advisory Committee on BT
Regulation National Biotechnology Regulatory Authority
Regulatory ScenarioPharmaceutical products derived from LMO’s
EP– not LMO
INDIGENOUS
RG III & above
RG I & II
More Risk
Less Risk
RCGM
GEAC yz
RCGM
GEAC - Nil
E P – LMO
High Risk
RCGM
GEAC
(I) (II)
Regulatory ScenarioPharmaceutical products derived from LMO’s
IMPORT
EP-LMO FF
EP-LMO Bulk
EP-Not
LMO Less Risk More
RiskLeast Risk
Outside
purview of 1989 Rules
RCGM - Nil
GEAC xy
GEAC in principle approval for import
RCGM
GEAC
GEAC in principle approval for import/ IBSC
(III)(IV)
(V)
RCGM
A: Approval of preclinical
studies
B: Recommendation of
human clinical trials
C: Recommendation/
evaluation about
containment facility
GEACX: Prior approval for
human clinical trials Y: Environmental
clearanceZ: Views about
containment facility
Regulatory ScenarioPharmaceutical products derived from LMO’s
EP-End ProductFF- Finished Formulation
INDIGENOUS/ IMPORTINDEX
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