A brief history and description for the Genetic Modified Organisms Regulations in India

1. INDIAN STANDARDS FOR THE
RELEASE AND USE OF GENETICALLY
MODIFIED ORGANISMS
ROLL NO-12

2. What are GMO’s ????
GM organisms, or genetically modified organisms, are
living entities whose genetic material has been altered
using biotechnology to introduce specific traits or
characteristics not naturally present. This is achieved by
inserting foreign genes into their DNA. GM organisms can
include plants, animals, and microorganisms, and are often
created for agricultural, medical, or industrial purposes.
The technology has generated debates regarding safety,
ethics, and environmental impact!!!

3. Why are the organisms genetically
modified???
Agricultural plants are one of the most frequently cited examples of genetically modified organisms
(GMOs). Some benefits of genetic engineering in agriculture are increased crop yields, reduced
costs for food or drug production, reduced need for pesticides, enhanced nutrient
composition and food quality, resistance to pests and disease, greater food security, and
medical benefits to the world's growing population.
Advances have also been made in developing crops that mature faster and tolerate aluminum,
boron, salt, drought, frost, and other environmental stressors, allowing plants to grow in
conditions where they might not otherwise flourish
A number of animals have also been genetically engineered to
increase yield and decrease susceptibility to disease. For
example, salmon have been engineered to grow larger (Figure)
and mature faster, and cattle have been enhanced to exhibit
resistance to mad cow disease (United States Department of
Energy, 2007)

6. Where do you
find GMO’s.

8. Products made using
GMO’s or GE
In 2013, the USDA approved the import of a GM pineapple that is
pink in color and that "overexpresses" a gene derived
from tangerines and suppress other genes, increasing production
of lycopene
In February 2015 Arctic Apples were approved by the USDA
becoming the first genetically modified apple approved for sale in
the US. Gene silencing is used to reduce
the expression of polyphenol oxidase
(PPO), thus preventing the fruit
from browning.

9. Genetically modified food’s

10. Genetically modified food’s

11. Which nation is using this technology?
47%
24%
16%
8%
4%
1%
The worlds biggest GMO Lovers
USA Brazil Argentina Canada India Other countries
https://www.statista.com/statistics/271897/leading-
countries-by-acreage-of-genetically-modified-crops/

12. https://link.springer.com/chapter/10.1007/978-981-16-2339-4_13

13. What is the dark side of using GMO and
its derived products?
Multipole concerns against the GM or transgenic plants and
animals are prevalent even today these include
• Biosafety
• Human health
• Environment Protection
• Release of Biohazardous chemicals or mutants which are
resistant to antibiotic.
• Corporate control of industries
• World trade monopoly
• Trustworthiness of public institution
• Integrity of regulatory agencies
• And loss of individual choice Etc.

14. Therefore it is recommended that scientific research aim that risk analysis prediction and
prevention combined with adequate monitoring and stewardship must be done so that negative
impact from GM products if any may be kept minimum.
However it is also recognised that GM technology may initiate unintended risk and hazard and
so these safety concerns have led to formulation of safety guidelines and regulation in various
countries for research, testing, safe use, and handling of GMO’s and their products
The government of Bharat has also adopted a policy of careful assessment of benefits and risk
of GMO’s At various stages of their development and field release to ensure biosafety.
Nodal agencies responsible for biosafety purpous:
1. Ministry of environment and forest (MoEF)
2. Department of biotechnology (DBT)
3. Review committee of Genetic Manipulation (RCGM)
4. Indian Council for medical research (ICMR).

15. Rule 1989
Latest
updated in
2022
The MOEF notified the rules and procedure for the manufacture import use research and And release of
GMOS as well as products made by the use of such organism on December 5, 1989 under the environment
Protection Act (EPA) 1986 commonly referred as rule 1989.
It is one of the major rule and has six competent authorities to handle various issues related to rDNA
technology which are listed as follows.
The overall mechanism and Functional linkage among various committees and department concerned with
the approval of GMO’s for commercial release are summarised below:

16. The RDAC is constituted by DBT to make monitor in the development in
biotechnology at national level. It is set up and function in Department of
biotechnology with the role to.
I. Review development in biotechnology at National Level
II. shall recommend suitable and appropriate safety regulation for India in
recombinant research use and application from time to time.
III. Evolves long term policy for research and development in recombinant DNA
technology
A Recombinant DNA advisory committee

17. The committee shall function from DBT to monitor the safety related aspects in
respect of ongoing research project or activity involving hazardous
microorganisms, GE organism and cells and products of there.
The RCGM shall include representative of
a) Department of Biotechnology
b) Indian Council of Agricultural Research
c) Indian Council of medical research
d) Council of scientific and industrial research
e) And other experts in their individual capacity
The RCGM lays a down procedure restricting and prohibiting production, import,
and use of such hazardous microorganisms genetically engineered organisms
end cells
B Review committee on genetic manipulation (RCGM)

18. Any research project which is likely to have biohazard potential during the
execution stage or which involves the production of microorganisms or
biologically active molecules that may cause Biohazard should be notified to
IBSC.
Authorization for Interstate exchange of etidogic agent diagnostic specimen and
biological product are also done by IBSC
The manipulation of plant contaminants is performed under the regulatory
clearance of IBSC which has mendent to ensure the adherence of rDNA safety
guidelines
C Institutional biosafety committee (IBSC)

19. Formerly known as Genetic Engineering Approval Committee.
Responsible for approval of activity evolving large scale use of hazardous
microorganism and recombinant product in research and industrial production
from environmental point of view.
It also issues the permit for the use of GMO’s And the product here off for the
commercial application.
The appraisal proposal related to release of genetical engineered organism and
product into the environment including experimental field trial
D Genetic Engineering appraisal committee

20. In this monitoring committee at state level have power
• To inspect investigate and to take punishative action in case of violation of
statutory provision through State Pollution Control Board.
• To review. The safety and control measure established at various institutions
handling GE Organism
E State biotech Co-ordination Committee
F District level Committee
It works at District level and can induct representative from state
agencies to enable smooth functioning and inspection of installation with
a view to ensure the application of safety guidelines while handling gmos
under the Indian environmental policy 1986. The committee has power to
inspect investigate and report to SBCC or GEAC about complaint and of
rDNA guidelines or violation under the EPA rule 1986.

21. Other than that there are various Guidelines
and policies at state and national level
• Recombinant dna safety guidelines 01990; 1994
The guidelines issued the guideline for research and development activities on GMO’s
transgenic crop large scale production and deliberate release Of GMO’s plants
animals and product into the environment shipment and importation of GMO’s for lab
research
• Guidelines for research and transgenic plant 1998
The least guideline for research in transgenic plant includes guidelines for toxicity and
allergenicity of transgenic seed and plant and plant part to monitor over a period of
time the impact of transgenic plant on environment special MEC has been set up by
the RCGM details can be seen at www.dbt.biosafety.nic.in

22. • National Seed Policy 2002
It states that all genetically engineered crops or Varity have to be tested before their
commercial release as per the regulation and guidelines under EPA 1986. According
to this policy the seeds of transgenic plants will be imported only through National
Bruere of Plant Genetics Resource. The new commercialized seeds will be tested for
at least 2 season.
• Plant Quarantine Order
• Drug Policy, 2002
• Regulation for Import of GM products under foreign trade policy 2006-07
• National Biotechnology Development Strategy 2015-2020.

23. Salient features of Recombinant DNA Biosafety
guidelines revised guidelines for research in transgenic
plant and risk assessment.
A. Evaluation of Microorganism prior to introduction for hazard posed by their
properties, possible interaction with other disease causing agents and the
infected wild plant species.
B. Containment facilities for the ensuring safety and to prevent unwanted release in
environment.
C. Prelease test of GMO’s in agriculture application and field trials for 2 years, and
the viable test for the soil for count of viable cells in containment zone before
disposal in Env.
D. Biowaste from lab or industrial operation should be properly treated also
ensuring the proper disposal of microorganism.
E. Special facility for disposal of experimental animal.

24. Salient features of Recombinant DNA Biosafety
guidelines revised guidelines for research in transgenic
plant and risk assessment.
A. Evaluation of Microorganism prior to introduction for hazard posed by their
properties, possible interaction with other disease causing agents and the
infected wild plant species.
B. Containment facilities for the ensuring safety and to prevent unwanted release in
environment.
C. Prelease test of GMO’s in agriculture application and field trials for 2 years, and
the viable test for the soil for count of viable cells in containment zone before
disposal in Env.
D. Biowaste from lab or industrial operation should be properly treated also
ensuring the proper disposal of microorganism.
E. Special facility for disposal of experimental animal.

25. Handling of Pathogenic Microorganisms
For the assessment of potential risk in handling of pathogenic
organism the following scientific consideration are taken into
consideration
Characteristics of donor and recipient
i. Taxonomy, identity, source, culture
ii. Genetic characteristics and
iii. Pathogenic and physiological traits
Characteristics of modified host
i. Description of the modification
ii. Nature function and source of the inserted donor nucleic acid including the affecting
function of dna and the vector
iii. The methods by which the vector has been constructed
iv. methods for introducing the vector insert into the recipe and Organism for the selection of
modified organism
v. The structure and amount of any vector or donor nucleic acid remaining in the final
construction of the modified organism
vi. Characterization of sight of modification of the recipient genome

26. vii. Stability of insert DNA
viii. Frequency of mobilisation of insert vector and genetic transfer capabilities
Expression and properties of gene product
i. Rate and level of expression of induced genetic material
ii. Method and sensitivity of method
iii. Activity of the expressed protein
iv. Allergic hazard of the product and
v. Toxic hazard of the product

27. Containment
Containment is used to describe the safe methods for managing infectious agent belonging
to the four different bias safety levels in the laboratory environment where these are being
handled or maintained. The purpose of containment is to reduce exposure of laboratory
workers other persons and outside environment to potential hazardous agent.
At Laboratory level there are two different types of containment
1. Biological containment
2. Physical containment
Biological containment
In consideration of biological containment the vector (plasmid organelle or virus) for the
recombinant dna and the host (Bacterial plant or animal cell) In which the vector is
propagated in laboratory are considered together. Any containment of vector and host which
is provided biological containment Must be chosen or constructed as to limit the infectivity of
vector of specific host and to control the host.

28. Physical containment
The objective of physical containment is to confine pathogenic and recombinant organism
thereby preventing the exposure of the researcher and the environment to the harmful
agent. This is achieved by good laboratory practises safety equipment's and laboratory
design and facilities.
Based on these criteria’s there are two types of physical containment
1. Primary Containment- The protection of personal and immediate laboratory
environment from exposure to interfacial agent is provided by good microbiological
technique and is used of appropriate safety equipment’s.
2. Secondary Containment- The protection of environment external to the laboratory form
exposure of Infectious Material is provided by a combination of facility and operational
practices.

29. Physical containment
The objective of physical containment is to confine pathogenic and recombinant organism
thereby preventing the exposure of the researcher and the environment to the harmful
agent. This is achieved by good laboratory practises safety equipment's and laboratory
design and facilities.
Based on these criteria’s there are two types of physical containment
1. Primary Containment- The protection of personal and immediate laboratory
environment from exposure to interfacial agent is provided by good microbiological
technique and is used of appropriate safety equipment’s.
2. Secondary Containment- The protection of environment external to the laboratory form
exposure of Infectious Material is provided by a combination of facility and operational
practices.

30. Biosafety Levels
Biosafety is insured by the combination of laboratory practices and techniques, safety,
equipment's, and laboratory facilities appropriate for the operation performance in the
hazard post by the infectious agent. The guidelines for the microbial and biomedical
laboratories suggest four bio safety levels in increment order depending on the nature of
work. These four levels correspond to facility appropriate to four risk group assigned for
etological agent and categorised as PC1<PC2<PC3<PC4.
Biosafety Level-1
These practises safety equipment's and facilities are appropriate for undergraduate and
secondary educational training teaching laboratories and for other facilities in which work is
done with defined characterised stain of viable microorganism not known to causeway
disease in healthy adult humans. No special accommodation or equipment is required but
the laboratory personnel are required to have specific training to be supervised by a scientist
with general training in microbiology or related science

31. Biosafety Level-3
These practises safety equipments and facilities are applicable to clinical diagnostic
teaching research or production facilities in which work is done with indigenous or exotic
agents where the potential of infection by aerosol is real and the disease may have serious
or lethal consequences. Personals are required to have specific training. Specially designed
laboratories and precautions including the use of safety cabinets are prescribed. As an
additional safety measure, these laboratories must use controlled, or “directional,” air flow to
ensure that air flows from non-laboratory areas (such as the hallway) into laboratory areas.
Biosafety Level-2
These practises safety equipment's and facilities are applicable in clinical diagnostic
teaching and other facilities in which work is done with a broad spectrum of indigenous
moderate risk agent present in the community and associated with human disease.
Accommodation facilities include safety cabinets are prescribed, especially for handling
large volume and high risk contamination of agent when aerosols are likely to be created
moreover access to the laboratory is controlled.

32. Biosafety Level-4
Strict training and supervision are required and the work is done in special design laboratory
under stringent safety conditions including the use of safety cabinets and positive pressure
personal suits. Access is strictly limited. A special designed suit area may be provided in
facility and personnel who have entered in this area wear one piece positive pressure unit
that is ventilated by a life support system. Entry to this area is through a airlock philtre
airtight doors. A chemical shower is provided to decontaminate the surface of the suit before
the worker leaves the area the exhaust air from the suit area is filtered by two set of high
efficiency particulate air filter installed in a series. A duplicate filtration unit exhaust fan and
automatic starting emergency power source are provided the air pressure within the unit is
lower than that of any adjacent area emergency lights and communication system are
provided.

33. Recent Updates
Meeting of the review committee on genetic engineering RCGM held on the 29.11.2023
Proposal Considered
Application in related to Pharmaceuticals
The committee considered the application to import SARS-
CoV-2 virus strain (omicron B.A.5.2.1,Delta and Victoria).
Preclinical toxicity report on novel gene therapy product for
Haemophilia A.
Applications in the area of Agriculture
The committee considered the submission of records of
completion of Biosafety level 1st first year trial of GE potato,
complaints report for the ongoing event trial for GE brinjal lines

34. Refrences
• Genetic Engineering by Smita Rastogi and
Neelam Pathak
• Indian Biosafety Knowledge Portal
https://ibkp.dbtindia.gov.in/Content/AboutUs
• Review article from Natures.com
https://www.nature.com/scitable/topicpage/genetically-modified-
organisms-gmos-transgenic-crops-and-
732/#:~:text=Some%20benefits%20of%20genetic%20engineering,to%
20the%20world's%20growing%20population.

35. THANK YOU

36. WHAT IS THIS TOPIC ABOUT?
FORENSICS
Mercury is the closest
planet to the Sun and the
smallest one
DNA
Venus has a beautiful
name and is the second
planet from the Sun
FINGERPRINTING
Despite being red, Mars
is actually a cold place.
It’s full of iron oxide dust

37. —SOMEONE FAMOUS
“This is a quote, words full of wisdom
that someone important said and can
make the reader get inspired.”

38. A PICTURE
IS WORTH A
THOUSAND
WORDS

39. EXAMPLES OF DNA FINGERPRINTING
VENUS
Venus is the second
planet from the Sun
MERCURY
It’s the closest
planet to the Sun
MARS
Despite being red,
Mars is a cold place
3
2
1

40. EXAMPLE OF DNA PROFILES
STR LOCUS
EVIDENCE
SAMPLE
SUSPECT A SUSPECT B
SUSPECT B’S
GENOTYPE FREQUENCY
FGA 15, 17 17, 17 15, 17 0.13
D18S51 23, 27 14, 15 12, 13 0.31
D13S317 13, 13 9, 10 10, 11 0.29
TPOX 8, 11 11, 12 9.3, 9.3 0.38

41. Mars is actually a very
cold place, not hot
Neptune is the farthest
planet from the Sun
MARS
NEPTUNE
RECOMMENDATIONS
MERCURY
Mercury is the closest
planet to the Sun
VENUS
Venus is the second
planet from the Sun
JUPITER
Jupiter is the biggest
planet of them all
SATURN
It’s composed of
hydrogen and helium

42. THIS IS A MAP
MERCURY
Mercury is the smallest planet
70%
VENUS
Venus has a beautiful name
30%

43. 150,000
Big numbers catch your audience’s attention

44. 25%
Mercury is the closest
planet to the Sun
50%
Venus is the second
planet from the Sun
75%
Jupiter is the biggest
planet of them all

45. NATIONAL DNA DATABASE
Follow the link in the graph to modify its data and then paste the new one here. For more info, click here
MERCURY
Mercury is the closest
planet to the Sun
VENUS
Venus is the second
planet from the Sun

46. DNA FINGERPRINTING PROCESS
MERCURY
Mercury is the
smallest planet
JUPITER
Jupiter is the
biggest planet
VENUS
Venus is the
second planet from
the Sun
NEPTUNE
Neptune is far away
from Earth
MARS
Mars is actually a
very cold place
1 2 3 4 5

47. AWESOME
WORDS

48. PRACTICAL EXERCISE
Using the base Pairing Rule write the complementary base in the box
A C T G G A A C

49. THE SLIDE TITLE
GOES HERE!
Do you know what helps you make your
point clear?
Lists like this one:
● They’re simple
● You can organize your ideas clearly
● You’ll never forget to buy milk!
And the most important thing: the audience
won’t miss the point of your presentation

50. CREDITS: This presentation template was created
by Slidesgo, including icons by Flaticon,
infographics and images by Freepik
THANKS!
youremail@freepik.com
+91 620 421 838
yourcompany.com
Please keep this slide for attribution
Do you have any questions?

51. ICON PACK FINGERPRINTS

52. Here’s an assortment of alternative resources whose style fits the one of this template
ALTERNATIVE RESOURCES

53. PHOTOS
● Close-up hand pointing up
● Crop man pointing at camera
ICONS
● Icon Pack Fingerprints
VECTORS
● Group of scientists workers holding
tubes
● Scientists female and male working
together
● Person in different ages theme
● Person in different ages concept
RESOURCES
Did you like the resources on this template? Get them for free at our other websites:
Here is where your presentation begins

54. In order to use this template, you must credit Slidesgo by keeping the Thanks slide.
You are allowed to:
- Modify this template.
- Use it for both personal and commercial projects.
You are not allowed to:
- Sublicense, sell or rent any of Slidesgo Content (or a modified version of Slidesgo Content).
- Distribute Slidesgo Content unless it has been expressly authorized by Slidesgo.
- Include Slidesgo Content in an online or offline database or file.
- Offer Slidesgo templates (or modified versions of Slidesgo templates) for download.
- Acquire the copyright of Slidesgo Content.
For more information about editing slides, please read our FAQs or visit Slidesgo School:
https://slidesgo.com/faqs and https://slidesgo.com/slidesgo-school
Instructions for use

55. As a Premium user, you can use this template without attributing Slidesgo or keeping the "Thanks" slide.
You are allowed to:
● Modify this template.
● Use it for both personal and commercial purposes.
● Hide or delete the “Thanks” slide and the mention to Slidesgo in the credits.
● Share this template in an editable format with people who are not part of your team.
You are not allowed to:
● Sublicense, sell or rent this Slidesgo Template (or a modified version of this Slidesgo Template).
● Distribute this Slidesgo Template (or a modified version of this Slidesgo Template) or include it in a database or in
any other product or service that offers downloadable images, icons or presentations that may be subject to
distribution or resale.
● Use any of the elements that are part of this Slidesgo Template in an isolated and separated way from this
Template.
● Register any of the elements that are part of this template as a trademark or logo, or register it as a work in an
intellectual property registry or similar.
For more information about editing slides, please read our FAQs or visit Slidesgo School:
https://slidesgo.com/faqs and https://slidesgo.com/slidesgo-school
Instructions for use (premium users)

56. This presentation has been made using the following fonts:
Oswald
(https://fonts.google.com/specimen/Oswald)
Cambay
(https://fonts.google.com/specimen/Cambay)
#ffffff #fceee5 #f1d2ce #ffb1a8
#9dbdd3 #8989c9 #16004d #3c373d
#ff8e77
Fonts & colors used

57. Create your Story with our illustrated concepts. Choose the style you like the most, edit its colors, pick
the background and layers you want to show and bring them to life with the animator panel! It will boost
your presentation. Check out How it Works.
Pana Amico Bro Rafiki Cuate
Storyset

58. You can easily resize these resources without losing quality. To change the color, just ungroup the resource
and click on the object you want to change. Then, click on the paint bucket and select the color you want.
Group the resource again when you’re done. You can also look for more infographics on Slidesgo.
Use our editable graphic resources...

61. JANUARY FEBRUARY MARCH APRIL MAY JUNE
PHASE 1
PHASE 2
Task 1
Task 2
Task 1
Task 2
JANUARY FEBRUARY MARCH APRIL
PHASE 1
Task 1
Task 2

64. You can resize these icons without losing quality.
You can change the stroke and fill color; just select the icon and click on the paint bucket/pen.
In Google Slides, you can also use Flaticon’s extension, allowing you to customize and add even more icons.
...and our sets of editable icons

65. Educational Icons Medical Icons

66. Business Icons Teamwork Icons

67. Help & Support Icons Avatar Icons

68. Creative Process Icons Performing Arts Icons

69. Nature Icons

70. SEO & Marketing Icons