1. Biosafety Regulatory Framework in India Dr Veena Chhotray, IAS Senior Fellow, TERI 7 th February, 2006

2.  ‘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

3.  Combination of existing and new legislations  Mix with non-statutory guidelines  Shared responsibility  Scope to evolve Indian Biosafety Regulatory System

4.  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 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.

5.  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

6. …1989 Rules: MoEF A technique by which heritable material generated outside and inserted into a cell or organism. Includes combinations/ deletions of parts of genetic material. GENETIC ENGINEERING  Import  Export  Transport Hazardous  Manufacture MO/GEO  Process  UseSubstances/  SellCells GEAC APPROVAL

7. 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)

8. Administrative Mechanism ADVISORYAPPROVALSENFORCEMENT  RDAC  GEAC  RCGM  IBSC  SBCC  DLCC  Serviced by DBT  Reviews biotech developments  Recommends safety regulations  Serviced by MoEF  Environmental clearance - Large scale use - Release into environment  Supervises implementation  Punitive powers GEAC  Powers to inspect, investigate and punish statutory violations  Post release monitoring  State nodal agency SBCC

9.  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

10. State Government’s Role R & D CommercializationEnforcement ENV. Release NIL MAIN AGENCY Present Scenario Felt Difficulties  ‘Navbharat’ case  Illegal BT cotton mushrooming  Differences over commercialization  Constitutional framework

11. Identification of Gaps: Basic Considerations BALANCING Multiple Agency Synergisation Federal framework Integration Societal needs Entrepreneurial initiatives Policy decisions Science based inputs

12. G U I D E L I N E S TRANSPARENCY CLARITY PREDICATABILITYENFORCEABILITYADAPTABILITY

13.  Broad Areas  Procedural streamlining  Institutional strengthening  Harmonization: National Legislations  Integration with federal structure  International Legislation oIdentification of linkages and conflicts oAssessment of national implications Identification of Gaps

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

15.  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

16.  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

17. 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 …M S Swaminathan Task Force Involving the States

18.  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

19. Other Recommendations  Time lines  Independent inspection facility  Synergisation with PQO  Standing Technical Advisory Committee on BT Regulation  National Biotechnology Regulatory Authority

20. Regulatory Scenario Pharmaceutical 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)

21. Regulatory Scenario Pharmaceutical products derived from LMO’s IMPORT EP-LMO FF EP- LMO Bulk EP- Not LMO Less Risk More Risk Least 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)

22. 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 Regulatory Scenario Pharmaceutical products derived from LMO’s EP-End Product FF- Finished Formulation INDIGENOUS/ IMPORT INDEX

23. 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

24. Thank you