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

The Indian Environment (Protection) Act 1986 Umbrella legislation § ‘Hazardous substances’ § Central Government’s The Indian Environment (Protection) Act 1986 Umbrella legislation § ‘Hazardous substances’ § Central Government’s powers § Legal provisions • Search and seizures: Cr. PC • Penalties o 5 -7 years imprisonment o Rs. 1 lakh fine o Rs. 5, 000/day additional fine § ‘Environment’ includes water, air and land the relationship which exists among and between water, air and land human beings, other living creatures, plants, micro-organisms and property.

1989 Rules: Mo. EF Objective: protect environment, nature and health § Deals with applications 1989 Rules: Mo. EF 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: Mo. EF GENETIC ENGINEERING A technique by which heritable material generated … 1989 Rules: Mo. EF GENETIC ENGINEERING A technique by which heritable material generated outside and inserted into a cell or organism. Includes combinations/ deletions of parts of genetic material. GEAC APPROVAL §Import §Export §Transport §Manufacture §Process §Use §Sell Hazardous MO/GEO Substances/ Cells

Regulatory Mechanism §Ministry of Environment and Forests §Department of Biotechnology §Recombinant DNA Advisory Committee 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 §RDAC APPROVALS ENFORCEMENT §GEAC §RCGM §IBSC §SBCC §DLCC §Serviced by DBT Administrative Mechanism ADVISORY §RDAC APPROVALS ENFORCEMENT §GEAC §RCGM §IBSC §SBCC §DLCC §Serviced by DBT §Reviews biotech GEAC developments §Serviced by Mo. EF §Recommends §Environmental clearance safety regulations - Large scale use - Release into environment §Supervises implementation §Punitive powers SBC C §Powers to inspect, investigate and pun statutory violations §Post release monitoring §State nodal agency

Administrative Mechanism APPROVALS § § § § RCGM Manuals of guideline Approvals: RG III Administrative Mechanism APPROVALS § § § § 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 ENFORCEMENT § § § § § IBSC Institute level Approval role - R G I: Intimation - R G II: Approval - R G III § & above: recommendation Site emergency plan Adherence of guidelines Nodal point for interaction DLCC § Monitors safety regulations in installations § Post release monitoring § Reports: SBCC, GEAC §

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

Entrepreneurial initiatives BALANCING Integration Societal needs ederal framework F Multiple Agency Synergisation Identification of Entrepreneurial initiatives BALANCING Integration Societal needs ederal framework F Multiple Agency Synergisation Identification of Gaps: Basic Considerations Policy decision Science based inputs

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

Identification of Gaps § § § Broad Areas Procedural streamlining Institutional strengthening Harmonization: National 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 Revamping Procedural Changes Transparency. Involving the States M S Swaminathan Task Force Institutional Revamping Procedural Changes Transparency. Involving the States

…M S Swaminathan Task Force Institutional Revamping Autonomous and professional NBRA § State Biotechnology …M S Swaminathan Task Force Institutional Revamping Autonomous and professional NBRA § State Biotechnology Regulatory Board – Liaisoning with NBRA § District Biotechnology Risk Assessment and Communication Committee § Procedural Changes 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 Transparency Transparent field evaluations § Unfavorable results highlighted § …M S Swaminathan Task Force Transparency Transparent field evaluations § Unfavorable results highlighted § Evaluation mechanism high credibility § Detailed record notebooks § Involving the States § § § 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 Involving the States Not suggested: o Nominees in IBSC/RCGM/GEAC …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 &

Mashelkar task force on Recombinant Pharma § § § Objective: Streamline ambiguity: multiple regulatory 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 Other Recommendations § § § Time lines Independent inspection facility Synergisation with PQO Standing Technical Advisory Committee on BT Regulation National Biotechnology Regulatory Authority

Regulatory Scenario Pharmaceutical products derived from LMO’s INDIGENOUS (I ) EP– not LMO RG Regulatory Scenario Pharmaceutical products derived from LMO’s INDIGENOUS (I ) EP– not LMO RG III & above RG I & II More Risk Less Risk RCGM GEAC yz GEAC - Nil (II) E P – LMO High Risk RCGM GEAC

Regulatory Scenario Pharmaceutical products derived from LMO’s (III )EP-LMO FF Less Risk RCGM - Regulatory Scenario Pharmaceutical products derived from LMO’s (III )EP-LMO FF Less Risk RCGM - Nil IMPORT EPLMO Bulk (IV) More Risk GEAC xy RCGM GEAC in principle approval for import/ IBSC (V ) EP- Not LMO Least Risk Outside purview of 1989 Rules

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

Recommendations of Expert Committee on GM foods § § § Currently no appropriate regulatory 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

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