Biosafety Regulatory Framework in India

1. Biosafety Regulatory Framework in India Dr Veena Chhotray, IAS Senior Fellow, TERI 7th 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. Indian Biosafety Regulatory System • Combination of existing and new legislations • Mix with non-statutory guidelines • Shared responsibility • Scope to evolve

4. The Indian Environment (Protection) Act 1986 • Umbrella legislation • ‘Hazardous substances’ • Central Government’s 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.

5. 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

6. …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.

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 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

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

10. State Government’s 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

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

12. TRANSPARENCY CLARITY ENFORCEABILITY ADAPTABILITY PREDICATABILITY G U I D E L I N E S

13. 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

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

15. …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

16. …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

17. …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

18. 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?

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

20. Regulatory ScenarioPharmaceutical products derived from LMO’s 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

21. Regulatory ScenarioPharmaceutical products derived from LMO’s 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

22. RCGM A: Approval of preclinical studies B: Recommendation of human clinical trials C: Recommendation/ evaluation about containment facility Regulatory ScenarioPharmaceutical products derived from LMO’s INDIGENOUS/ IMPORT INDEX GEAC X: Prior approval for human clinical trials Y: Environmental clearance Z: Views about containment facility EP-End Product FF- Finished Formulation

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