AN UPDATE ON

INDIAN BIOSAFETY

REGULATORY SYSTEM

Dr. Vibha Ahuja

Biotech Consortium India Limited

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

STRUCTURE OF PRESENTATION

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,1989

3. Applicable Rules deal collectively with hazardous

organisms with genetically engineered organisms

REGULATORY FRAMEWORK FOR GMOs

IN INDIA

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

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

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

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

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.

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

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

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.

Expected to meet every month but was not functional since last two years

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

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.

Ministry of Science

& Technology

Ministry of Environment

& Forests

DBT

IBSC RCGM

GEAC

REGULATION OF GMOs IN INDIA

Each major committee has sub-committees, comprising

experts in various fields drawn from various public institutions

State Governments

SBCC

DLC

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 Procedures (SOPs) for Confined

Field Trials of Regulated, Genetically Engineered Plants

Guideline for the Monitoring of Confined Field Trials of

Regulated, Genetically Engineered Plants

GUIDELINES Guidelines for the Safety Assessment of Foods

Derived from Genetically Engineered Plants - 2008

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

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 .

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

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 2006.

DGFT notification relating to inclusion of GM policy in

the Foreign Trade Policy (2006-09) by Ministry of

Commerce.

National Biotechnology Development Strategy, 2007

CONTD/-

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

.

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.

SWAMINATHAN COMMITTEE

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.

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

LEGAL FRAMEWORK

Setting up BRAI will require the

promulgation of new legislation,

namely the:

“Biotechnology Regulatory

Authority of India Act ” or the

BRAI Act.

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.

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.

ORGANIZATION STRUCTURE OF BRAI

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

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)

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.

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

ISSUES AND CHALLENGES

Influence of ongoing PIL, media reports

political scenario : Adhoc decisions

such as Involvement of states (NOC

from State Givernments)

ISSUES AND CHALLENGES

Need for enhancing operational

capacity in risk assessment :

committees vs dedicated secretariats

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