1、Biosafety Regulatory Framework in India,Dr Veena Chhotray, IAS Senior Fellow, TERI7th February, 2006,BIOSAFETY: Protecting human and animal health and biodiversity from the possible adverse effects of the products of modern biotechnologyBiosafety Regulatory System essential for biotechnology program
2、meBroad outlines: Introductory EPA Statutory Rules State Governments 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 Hazar
3、dous substances Central Governments powers Legal provisions Search and seizures: CrPC Penalties 5-7 years imprisonment Rs.1 lakh fine 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
4、 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: Classification of micro-organisms or genetically engineered produc
5、ts Scheme of approvals Administrative mechanism Punitive provisions,1989 Rules: MoEF,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 Trans
6、port Hazardous Manufacture MO/GEO Process Use 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 (G
7、EAC) State Biosafety Coordination Committee (SBCC) District Level Coordination Committee (DLCC),Administrative Mechanism,ADVISORY,APPROVALS,ENFORCEMENT,RDAC,GEAC RCGM IBSC,SBCC DLCC,Serviced by DBT Reviews biotech developments Recommends safety regulations,Serviced by MoEF Environmental clearance- L
8、arge scale use- Release into environment Supervises implementation Punitive powers,GEAC,Powers to inspect,investigate and punishstatutory violations Post release monitoring State nodal agency,SBCC,RCGM Manuals of guideline Approvals: RG III & above research Approvals: contained filed trials Approval
9、s: 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:
10、Approval- R G III & above: recommen-dation Site emergency plan Adherence of guidelines Nodal point for interaction,State Governments Role,R & D,Commercialization,Enforcement,ENV. Release,NIL,NIL,NIL,MAIN AGENCY,Present Scenario,Felt Difficulties,Navbharat case Illegal BT cotton mushrooming Differenc
11、es over commercialization Constitutional framework,Identification of Gaps: Basic Considerations,BALANCING,Multiple Agency,Synergisation,Federal framework,Integration,Societal needs,Entrepreneurial initiatives,Policy decisions,Science based inputs,G U I D E L I N E S,TRANSPARENCY,CLARITY,PREDICATABIL
12、ITY,ENFORCEABILITY,ADAPTABILITY,Broad Areas Procedural streamlining Institutional strengthening Harmonization: National Legislations Integration with federal structure International Legislation Identification of linkages and conflicts Assessment of national implications,Identification of Gaps,M S Sw
13、aminathan 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 even
14、ts 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,
15、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: Nominees in IBSC/RCGM/GEAC Nominees
16、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 Objecti
17、ve: 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
18、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 Scenario Pharmaceutical products deri
19、ved from LMOs,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 Scenario Pharmaceutical products derived from LMOs,IMPORT,EP-LMO FF,EP-LMO Bulk,EP-Not LMO,Less Risk,More Risk,Least Risk,Outside purview of
20、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 preclinicalstudies B: Recommendation ofhuman clinical trials C: Recommendation/evaluation aboutcontainment facility,GEAC X: Prior approval forh
21、uman clinical trials Y: Environmentalclearance Z: Views aboutcontainment facility,Regulatory Scenario Pharmaceutical products derived from LMOs,EP-End Product FF- Finished Formulation,INDIGENOUS/ IMPORT INDEX,Recommendations of Expert Committee on GM foods,Currently no appropriate regulatory mechani
22、sm 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,
