Indian transgenic scenario and the regulatory system in India is detailed.

1. 1. STEPS IN DEVELOPMENT OF TRANSGENIC
CROPS
2. REGULATORY APPROVAL SYSTEM OF
BIOTECH CROPS
Presentation by: Guru P N 2015-16
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2. What is a transgenic?
Transgene – the genetically engineered gene added to a species
Example: – modified EPSP synthase gene (encodes a
protein that functions even when plant is treated with
Roundup)
Transgenic – an organism containing a transgene introduced
by technological (not breeding) methods
Example:– Roundup Ready Crops
Concept Based on the Term Transgene
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3. We can develop organisms that express a “novel” trait
not normally found in the species
Why are transgenics important?
Extended shelf-life tomato (Flavr-Savr)
Herbicide resistant soybean (Roundup Ready)
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6. Insect resistant transgenics
Source: USDA
Insect resistant cotton – Bt toxin kills the
cotton boll worm
• transgene = Bt protein
Insect resistant corn – Bt toxin kills the
European corn borer
• transgene = Bt protein
Normal Transgenic
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7. Plant Transformation Methods
Physical Chemical Biological
Microinjection
Pressure
Biolistics - gene gun/
particle bombardment
Electroporation
Microinjection
Silica/carbon fibers
Lazer mediated
SAT
PEG
DEAE-dextran
Calcium phosphate
Artificial lipids
Proteins
Dendrimers
A. Tumefaciens
A. Rhizogenes
Virus-mediated
In planta
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8. Important Plant Improvement Methods
• Breeding
Crossing two individuals from the same species;
produces a new, improved variety;
not a biotechnology procedure
• Transformation
Adding a gene from another species; the
essential biotechnology procedure to produce
transgenics
Source: USDA
Source: USDA
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10. Introducing the Gene
or
Developing Transgenics
Steps
1. Create transformation cassette
2. Introduce and select for transformants
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11. Transformation Cassettes
Contains
1. Gene of interest
• The coding region and its controlling elements
2. Selectable marker
• Distinguishes transformed/untransformed plants
3. Insertion sequences
• Aids Agrobacterium insertion
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12. Transformation Steps
Prepare tissue for transformation
Introduce DNA
Culture plant tissue
• Develop shoots
• Root the shoots
Field test the plants
• Leaf, germinating seed, immature embryos
• Tissue must be capable of developing into normal plants
• Agrobacterium or gene gun
• Multiple sites, multiple years
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13. • Transformation cassettes are developed in the lab
• They are then introduced into a plant
• Two major delivery methods
Delivering the Gene
to the Plant
• Agrobacterium
• Gene Gun
Tissue culture
required to generate
transgenic plants
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14. The Lab Steps
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15. Production of transgenic plants
Isolate and clone gene of interest
Add DNA segments to initiate or enhance
gene expression
Add selectable markers
Introduce gene construct into plant cells
(transformation)
Select transformed cells or tissues
Regenerate whole plants
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16. 16

17. BIOTECHNOLOGY REGULATORY AUTHORITY OF
INDIA
ORGANOGRAM OF BRAI
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18. 18

19. Regulation of GM Foods in India
 Under Environment Protection Act (1986), MoEf rules
formulated in 1989 which created six competent authorities
namely RDAC, RCGM, GEAC, IBSC, SBCC, DLC;
 MEC for field trials under RCGM and GEAC
 Recombinant DNA Safety Guidelines 1990, modified 1994
 DBT Revised Guidelines for research on Transgenic Plants –
1998, also includes guidelines for Toxicity & Allergenecity
evaluation of transgenic seeds, plants & plant parts
 Safety assessment of GM Food Crops –2007, modified 2009
 Guidelines for the safety assessment of foods derived from
GE plants -2008
 Guidelines & SOPs for Confined Field Trials of Regulated
Genetically Engineered Plants –2008
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20. Indian Regulatory System
Aims to ensure that GM crops pose no risk to food safety,
environmental safety and agriculture productivity
To demonstrate potential benefits over the conventional
variety/hybrid in terms of economic benefit to the farmer and /or
the environment
To generate quantitative biological, ecological and agronomic
supportive data
Rules and guidelines formulated to achieve above objectives
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21. AGENDA
 Gene Stacking
 Crop Rotation
 Bt as part of IPM Agricultural practices to integrate
 GM crops
 SiRNA approach
 Minor Pests
 Marker-Free S
 stage-Specific Promoter
 Improved Nutrition & Abiotic Stress
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22. GOVERNMENT RULES FOR GMOs
 The regulatory framework for transgenic crops in India
consists of the following rules and guidelines.
 Rules and policies Rules 1989 under Environment Protection
Act (1986)
 Seed Policy 2002 Guidelines
 Recombinant DNA guidelines, 1990
 Guidelines for research in transgenic crops, 1998
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23. Rules, 1989
There are six competent authorities as per the rules:
Recombinant DNA Advisory Committee (RDAC)
Review Committee on Genetic Manipulation (RCGM)
Genetic Engineering Approval Committee (GEAC)
Institutional Biosafety Committees (IBSC)
State Biosafety Coordination Committees (SBCC)
District Level Committees (DLC).
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24. Out of these, the three agencies that are involved in approval
of new transgenic crops are:
IBSC set-up at each institution for monitoring institute level
research in genetically modified organ- isms.
RCGM functioning in the DBT to monitor ongoing research
activities in GMOs and small scale field trials.
GEAC functioning in the MoEF to authorize large-scale trials
and environmental release of GMOs.
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25. REGULATORY MECHANISMS
3 Tier System
•IBSC
•RCGM-MEC (Monitoring-cum- Evaluation)
•GEAC
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26. The approvals and prohibitions under Rules 1989 are summarized
below:
 No person shall import, export, transport, manufacture, process, use or
sell any GMOs, substances or cells except with the approval of the
GEAC.
 Use of pathogenic organisms or GMOs or cells for research purpose
shall be allowed under the Notification, 1989 of the EPA, 1986.
 Any person operating or using GMOs for scale up or pilot operations
shall have to obtain permission from GEAC.
 For purpose of education, experiments on GMOs IBSC can look after,
as per the guidelines of the Government of India.
 Deliberate or unintentional release of GMOs not allowed.
 Production in which GMOs are generated or used shall not be
commenced except with the approval of GEAC supervises the
implementation of rules and guidelines.
 GEAC carries out supervision through SBCC, DLC or any authorized
person.
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27.  If orders are not complied, SBCC/DLC may take suitable
measures at the expenses of the person who is responsible.
 In case of immediate interventions to prevent any damage,
SBCC and DLC can take suitable measures and the expenses
incurred will be recovered from the person responsible.
 All approvals shall be for a period of 4 years at fi rst instance
renewable for 2 years at a time. GEAC shall have powers to
revoke approvals in case of: Any new information on harmful
e ects of GMOs. GMOs cause such damage to theff
environment as could not be envisaged when approval was
given. Non-compliance of any conditions stipulated by GEAC.
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28. Genetic engineering experiments on plants have been grouped under three
categories.
Category I includes routine cloning of defined genes, defined non-coding
stretches of DNA and open reading frames in defined genes in E. coli or
other bacterial/fungal hosts which are generally considered as safe to human,
animals and plants.
Category II experiments include experiments carried out in lab and green
house/net house using defined DNA fragments non-pathogenic to human and
animals for genetic transformation of plants, both model species and crop
species.
Category III includes experiments having high risk where the escape of
transgenic traits into the open environment could cause significant alterations
in the biosphere, the ecosystem, plants and animals by dispersing new
genetic traits the e ects of which cannot be judged precisely. This alsoff
includes experiments having risks mentioned above conducted in green
houses and open field conditions. 28

29. OVERVIEW OF MINISTRIES AND
DEPARTMENTS INVOLVED IN REGULATION
OF GM FOOD
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30. 1. Ministry of Environment and Forest:
This ministry holds the Secretariat of the Genetic
Engineering Approval Committee, the apex body that gives approval for
manufacture, sale, import and export of all GMOs and products thereof
including foodstu , ingredients in foodstu and additives using geneticallyff ff
modifi ed (GM) organisms or cells.
2. Department of Biotechnology:
This department holds the Secretariat of the Review
Committee on Genetically Modifi cation that gives approval for research and
small scale fi eld trials involving GMOs and products thereof. It also interacts
with the Institutional Biosafety Committees (IBSCs) set up in all organizations
undertaking activities involves GMOs.
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31. 3. Department of Health in the Ministry of Health and Family
Welfare:
Department of Health is responsible for
implementation of the PFA Act under which the quality and safety of
food is regulated. The Directorate General of Health Services has also
been designed as the nodal Ministry with the Codex Alimentarious
Commission.
4. The Indian Council of Medical Research (ICMR)
It is the apex body in India for the formulation, coordination
and promotion of biomedical research under the Ministry of Health and Family
Welfare. ICMR acts as an advisory body for MoHFW on various issues
including GM foods.
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32. 5. Ministry of Agriculture:
Ministry of Agriculture is the nodal ministry for agriculture
growth in the country. It comprises of three Departments viz. Department of
Agriculture and Cooperation, Department of Agricultural Research &
Education/ Indian Council of Agricultural Research (ICAR) and Department of
Animal Husbandry & Dairying. Th e o cials from ICAR and Ministry offfi
Agriculture have an important role to play in the approval of GM crops as per
Seed Policy, 2002.
6. Ministry of Commerce and Industry:
This ministry is responsible for the formulation of the
Export and Import (EXIM) Policy in the country. It implements a legislation
prescribing a system of quality control and inspection for both export/import.
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33. 7. Ministry of Food Processing Industries:
This ministry is responsible for the formulation of policy for
the healthy growth of the food processing industries and provides
developmental support to these industries. It encourages research and
developmental activities and assists the industries in active participation in the
laying down of food standards as well as their harmonization with inter-
national standards. Th is ministry is also the licensing authority for processed
fruits and vegetable industries.
LABELLING ISSUES
India, along with a number of other countries, has supported the
mandatory labeling of GM food by Codex.
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34. Limitations of the Regulatory System in India
I.Lack of adequate standards for risk assessment
II.The procedure and information required for a full environment
risk assessment and appropriate safety and emergency responses not
laid down.
III.Instructions and conditions for use on labeling and packaging of
products containing GMOs yet to be specified.
IV.Detailed safeguards as embodied in the Cartagena Protocol yet to
be incorporated.
V.Lack of infrastructure for risk assessment.
VI.Shortage of skilled personnel from laboratory researchers to
extension service officers. 34

35. (vii) Although food safety studies are fairly rigorous as prescribed
by the RCGM, there are always uncertainties in the risk
assessment process because this is a novel technology. Also
there needs to be special considerations when the food forms a
major portion of the diet (for e.g. cereals) and the special
sociocultural habits of the population need the consumption of
parts of the plant which are unconventional for other
civilisations (e.g mustard leaves). In such a scenario special
studies may have to be undertaken even on human volunteers.
Limitations contd…
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36. Presentation by: Guru P N 36