AN UPDATE ON INDIAN BIOSAFETY REGULATORY SYSTEM. Dr. Vibha Ahuja Biotech Consortium India Limited

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1 AN UPDATE ON INDIAN BIOSAFETY REGULATORY SYSTEM Dr. Vibha Ahuja Biotech Consortium India Limited

2 STRUCTURE OF PRESENTATION 1. Existing regulatory framework in India 2. New Acts/policies dealing with GM products 3. About Biotechnology Regulatory Authority of India 4. Issues and challenges

3 REGULATORY FRAMEWORK FOR GMOs IN INDIA 1. The Genetically Modified Organisms (GMOs) and products thereof are regulated articles in India in view of potential risks to human health and environment by indiscriminate use. 2. Regulatory framework notified under the Environment (Protection) Act, 1986 referred as Rules, Applicable Rules deal collectively with hazardous organisms with genetically engineered organisms

RULES, 1989 Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/ Genetically engineered organisms or cells, 1989 under the EPA (1986).

4 RULES, 1989 Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/ Genetically engineered organisms or cells, 1989 under the EPA (1986). Covers genetic engineering and new gene technologies; Also GMOs and products thereof including GM food Cover all activities including lab to release and also transboundary movement

5 IMPLEMENTION MECHANISM Ministry of Environment and Forests ( now renamed as Ministry of Environment, Forests and Climate Change is the lead ministry for implementation of Rules 1989 Jointly implemented with Department of Biotechnology, Ministry of Science & Technology State govts involved in monitoring activities

6 STATUTORY COMMITTEES 1. The Recombinant DNA Advisory Committee (RDAC). 2. Institutional Biosafety Committee (IBSC) 3. Review Committee on Genetic Manipulation (RCGM) 4. Genetic Engineering Approval Committee (GEAC) 5. State Biotechnology Coordination Committee (SBCC) 6. District Level Committee (DLC) Advisory Approval Monitoring

7 STATUTORY COMMITTEES 1. The Recombinant DNA Advisory Committee (RDAC). 2. Institutional Biosafety Committee (IBSC) 3. Review Committee on Genetic Manipulation (RCGM) 4. Genetic Engineering Approval Committee (GEAC) 5. State Biotechnology Coordination Committee (SBCC) 6. District Level Committee (DLC) Advisory Approval Monitoring

8 THE RECOMBINANT DNA ADVISORY COMMITTEE (RDAC) Set up by DBT Review developments in Biotechnology at National and International level and recommend suitable and appropriate safety regulations for India in r-dna research, use and applications Was set up in 1990 and prepared Recombinant DNA safety guidelines, 1990 Presently not in place Alternative mechanisms such as committees to prepare biotech policy etc.

9 INSTITUTIONAL BIOSAFETY COMMITTEE (IBSC) To be set up at each organization involved in rdna activities Responsible for ensuring compliance at institutional level and the nodal point for interaction with other regulatory committees Reports to RCGM Presently approx 500 IBSCs in place

10 REVIEW COMMITTEE ON GENETIC MANIPULATION (RCGM) Set by DBT Responsible for review of all research and controlled field experiments and preparation of guidelines/manuals etc. Members include experts from multiple disciplines and nominees of leading scientific agencies viz. CSIR,ICAR,ICMR,DCGI etc. Meets every month and more than 130 meetings held

11 Expected to meet every month but was not functional since last two years GENETIC ENGINEERING APPRAISAL(APPROVAL) COMMITTEE Operates in MOEF&CC and chaired by Special secretary/additional secretary Apex committee to permit/authorise the use of GMO and products thereof for large scale field trials and commercial applications The name changed to Appraisal committee in 2010 by the then Minister of Environment and Forests Has nominees from concerned ministries and agencies such as min of Agriculture, Min of Health, Min of Commerce and Industry, Min of External Affairs, Deptt of Atomic energy etc.

12 STATE BIOTECHNOLOGY COORDINATION COMMITTEE (SBCC) Responsible for inspection and monitoring of activities involving GMOs and also implement punitive actions To be set up in each state and headed by Chief Secretary with members from concerned departments Active in some states where there are significant activities involving GMOs underway

13 DISTRICT LEVEL COMMITTEES (DLC) Have powers to inspect, investigate and report to the SBCC or the GEAC about compliance or non compliance of r-dna guidelines or violations under EPA To be set up in each district and headed by district collector Were set up in a limited manner in some districts on need based Alternative monitoring mechanism in place for specific activities such as confined field trials, manufacturing units of healthcare products, seed certification deptts.

committee has sub-committees, comprising

14 REGULATION OF GMOs IN INDIA Ministry of Science & Technology Ministry of Environment & Forests State Governments DBT GEAC SBCC DLC IBSC RCGM Each major committee has sub-committees, comprising experts in various fields drawn from various public institutions

15 GUIDELINES Recombinant DNA Safety Guidelines, 1990 Revised guidelines for research in transgenic plants & guidelines for toxicity and allergenicity evaluation of transgenic seeds, plants and plant parts, 1998 Guidelines for generating preclinical and clinical data for rdna vaccines, diagnostics and other biologicals, 1999

GUIDELINES AND SOPs FOR GE CROPS Guidelines and Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered (GE) Plants - 2008 Standard Operating

16 GUIDELINES AND SOPs FOR GE CROPS Guidelines and Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered (GE) Plants Standard Operating Procedures (SOPs) for Confined Field Trials of Regulated, Genetically Engineered Plants Guideline for the Monitoring of Confined Field Trials of Regulated, Genetically Engineered Plants

17 GUIDELINES Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants Protocols for Food and Feed Safety Assessment of GE crops 2008 Guidelines and handbook for Institutional Biosafety Committees (IBSCs), 2011 Guidelines on Similar biologics: Regulatory requirements for Marketing Authorization in India, 2012

18 REGULATORY PROCESS : EXAMPLE CONFINED FIELD TRIALs OF GE CROPS The initial assessment of an application for confined field trial begins at the institutional level itself. Based on information generated by the applicant in lab /greenhouse and on preliminary phenotypic evaluation of event selection, an application is made to IBSC for one to a few events for further evaluation. If recommended by IBSC the applicant may submit an application to RCGM for biosafety assessment of the event along with necessary requirements.

19 REGULATORY PROCESS RCGM is the regulatory authority for Biosafety Research Level I (BRL I) trials. These trials are limited to no more than one acre per trial site location. Cumulative of 20 acres. GEAC is the regulatory authority for Biosafety Research Level II.(BRL II) trials. Size and number of trials will depend on case by case. Minimum of three seasons/ years BRL trials are required for approval of event by GEAC

20 IMPORTANT DEVELOPMENTS Release of first transgenic crop in 2002 National seed policy 2002 by Ministry of Agriculture India ratified Cartagena Protocol on Biosafety in 2003 National Environment Policy formulated by Ministry of Environment & Forests in 2006 Food Safety and Standards Act passed in DGFT notification relating to inclusion of GM policy in the Foreign Trade Policy ( ) by Ministry of Commerce. National Biotechnology Development Strategy, 2007 CONTD/-

21 Task Force/Committees report of the task force on Agriculture Biotechnology, 2004 constituted by Ministry of Agriculture. Report of the Task Force on Recombinant Pharma, 2005 constituted by Ministry of Environment & Forests Report of Mayee Committee on Bt cotton and related issues.

22 SWAMINATHAN COMMITTEE Task Force came to the conclusion that the existing system of approval of GM Varieties for cultivation needs review and rationalization. Recommended the establishment of an autonomous, statutory and professionally lead National Biotechnology Regulatory Authority with two separate wings for food and agricultural biotechnology and medical and pharmaceutical biotechnology. Recommended that NBRA is essential for generating the necessary public, political, professional and commercial confidence in the science based regulatory mechanism in place in the country.

23 MASHELKAR COMMITTEE Supported the establishment of NBRA Providing a professionally managed single window mechanism for giving various clearances including biosafety issues. Proposed NBRA model comprising of four wings namely: a) Agricultural products/transgenic Crops; b) Pharmaceutical/Drugs and Industry Products; c) Transgenic Foods/Feed and d) Transgenic Animals/Aquaculture. Alternate models may be examined.

24 NEED FOR NATIONAL BIOTECHNOLOGY REGULATORY AUTHORITY Biotechnology is a sunrise sector and expected to be the next key economic driver for the country after Information Technology. Extensive investment in R&D is leading to newer products & processes, driving the need for an efficient, effective and dedicated regulatory authority. Complexity of current and future biotechnology products/processes means careful attention is required to: Proactively address potential safety issues Facilitate trade by ensuring that regulatory benchmarks are state of the art and internationally recognised

25 LEGAL FRAMEWORK Setting up BRAI will require the promulgation of new legislation, namely the: Biotechnology Regulatory Authority of India Act or the BRAI Act.

26 SCOPE OF PROPOSED BRAI ACT The scope of the Act would extend to the manufacture, production, commercial release and import of genetically engineered organisms. Function as a safety net that ensures all biotech products and processes are regulated as regards their safety Some specific categories of GE products regulated by other ministries to be kept out of purview of NBRA e.g. processed foods that may contain GE ingredients and recombinant drugs.

27 PROPOSED MANAGEMENT STRUCTURE: REGULATORY BRANCHES Agriculture, Forest and Fisheries Branch (AFFB) to regulate GM plants, animals and micro-organisms used in agriculture, forestry or fisheries, including aquaculture. Human and Animal Health Branch (HAHB) to regulate genetically modified organisms with applications in human and veterinary health, such as assessing the potential environmental risks and benefits associated with the application of GMOs in pharmaceutical development or recombinant livestock vaccine production. Industrial and Environmental Applications Branch (IEAB) to regulate GMOs used in industrial manufacturing and in environmental applications, such as the use of GMOs for bioremediation of contaminated sites or oil spills.

28 ORGANIZATION STRUCTURE OF BRAI

29 CONSULTATIVE PROCESS FOR TAKING FORWARD BRAI BILL High level advisory committee Placing on the DBT s websites and advertisement in leading newspapers Consultation with state governments Six Consultation meetings (Delhi, Chennai, Hyderabad, Bangalore, Kolkata and Mumbai) with various stakeholders International consultation with regulators Interaction with the Ministry of Law and Justice Inter-ministerial consultation Incorporation of the comments and finalization of the documents Draft legislation introduced in the Parliament. Sent for review by Standing Parliamentary Connittee ; initiated consultative process

31 BIOTECH CROPS AND TRAITS IN INDIA Status 23 biotech crops being developed 67 biotech traits in different stages of development Developed by public and private sectors 39 traits by public sector 20 traits by private sector 8 traits by autonomous Institutes Variety of crops Rice (bacterial blight resistance, Bt, chitinase, osmotin) Millets (insect resistance) Vegetables (insect and fungal resistance, high protein) Sugarcane (fungal resistance) Pulses (insect resistance, viral tolerance)

32 ISSUES AND CHALLENGES More clarity needed in understanding scope of various regulations by implementing agencies and accordingly their role : FSSAI in place but has not initiated implementation of relevant clauses.

33 ISSUES AND CHALLENGES Address biosafety, not product efficacy or performance : Approvals of GM crops in all countries are event-based whereas these are approved on varietal basis in India

34 ISSUES AND CHALLENGES Influence of ongoing PIL, media reports political scenario : Adhoc decisions such as Involvement of states (NOC from State Givernments)

35 ISSUES AND CHALLENGES Need for enhancing operational capacity in risk assessment : committees vs dedicated secretariats

36 ISSUES AND CHALLENGES Need for clarity in regulatory requirements :updated guidance providing clarifying information to help both regulators and product developers in addressing biosafety ensuring decisions as per prescribed guidance

Strengthening biosafety compliance among public sector institutions in India: A SABP Initiative. Dr. Vibha Ahuja, Chief General Manager, BCIL

Strengthening biosafety compliance among public sector institutions in India: A SABP Initiative Dr. Vibha Ahuja, Chief General Manager, BCIL Structure of presentation Biosafety Regulations in India South