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

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ICA

TA

BIL

ITY

EN

FO

RC

EA

BIL

ITY

AD

AP

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BIL

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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

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