This document discusses India's guidelines and policies around biotechnology and genetically modified organisms (GMOs). It outlines the Recombinant DNA Guidelines from 1990 that classified research into three categories based on risk level. The guidelines were revised in 1998 to specifically address transgenic plant research. The policies also discuss seed policy from 2002 and the Food Safety and Standards Act, which aims to consolidate food laws and establish a food safety authority to regulate genetically modified food and other standards.

1. UNIT-I
IPR
(INTELLECTUAL PROPERTY RIGHT)
Shubham Maurya

2. • There were various research were initiated
in the department of the biotech in our
countries by various Indian institution
industries.
• Biotech department had formulated the
recombinant DNA guide lines 1990.
• It includes the guide lines for R&D activities
on the GMO’s transgenic groups large scale
production, plant animal.
• During the forming of the guide lines issue
related to the G.E has no been considerd.
RECOMBINANT DNA GUIDE LINES-

3. The research categories have been classified in to
the three category base on the level of associated
risk-
I. It involves the self-cloning using the strain &also interspecies
cloning belonging to the organism.
II. It require the prior information of the contempt authority&
including the experiment failing the under the contaminant.
III.It requires the review& approval of the competent authority before
commencement include the experiment involving the toxic cloning.
• Cloning of the gene for the vaccine production & other experiment
as merited in the guide lines.
• The level of the risk &classification of organism within this
category have defines in this guide lines.
• The guide line enumerates the physical &biological contaminant
&principle of the good laboratory practices.
• The guide lines provide the message to the large scale practices.

4. REVISE GUIDE LINES FOR
RESEARCH IN TRANSGENIC PLANT-
• In 1998 DBT brought out separate guide
lines for carrying the research in transgenic
plant.
• It includes the guide lines for toxicity&
allergencity of transgenic seeds.
• It covers the area of the research &field
evaluation.
• It deals with import &shipment of
genetically modified plant.

5. The genetic engineering experiment plant have
been grouped in to three categories-
• Category-I
• Category-II
• Category-III
Category-I
It include the routine cloning of the defined
gene, defined no of non-coding DNA
,&ORF,defined gene of the E.coli& other
bacterial DNA which are generally considerd
as the safe human.

6. Category-II
• In this category experiment carried out in lab& green
housing using defined DNA fragment non-pathogenic to
the human &animal for genetic transformation as the
plants.
Category-III-
• It includes the experiment having the risk where escape of the
transgenic plant in the open environment.
• The ecosystem plant &animal by dispersing new genetic traits the
effect of which can’t be judged.
• To monitor the transgenic plant in the environment as especially
monitory evaluation committee has been set up the RCGM.
• The committee also collects the agronomic advantage of transgenic
plant.

7. SEED POLICY-2002-
• It separates the section of the transgenic plants.
• It states the all transgenic plant will be tested for environmentally
&biosafety before commercially release.
• See of the transgenic plant would be imported for the research
purposes.
• Transgenic crop verities will be tested to check their agronomic
values.
• One the transgenic verities is commercially released, its seed will
be registered & marked in the country per provision of the seed
act.
• It will be monitored less than 3-5 years of state of the agriculture
department.
• It has been maintained transgenic verities can be protected under
the plant verities former rights protection legislation in the same

8. FOOD SAFETY &STANDERD ACT-
The ministry of the food industry has been
included-
• It seeks the consolidate law relating to food &establish food
safety &standard authority of the India.
• The fact is that eight ministers can view food law in the
diverse way.
• It facilitates the scientific Standerd for food article &regulates
their manufacture storage, distribution, sales &import.
• The authority will consist of members from the various
ministers &representative from the state govt.
• Food safety not only incorporates the provision of prevention
of food adulteration but also based on the international
legislation.
• .

9. • Food authority will regulate the limits on usage of food activities, crop
contamination pesticide residue, and heavy metals mycotoxin.
• It will formulate the mechanism &guidelines for the accreditation of bodies
• It will formulate the mechanism &guidelines for the accreditation of bodies.
• It will also setup the labeling standards including claim on health, nutrition
&special dietary uses.
• This act seeks to regulate nutreceuticals & delivery supplements.
• No person shall be allowed to import usage misbranded or substandard food
&impurities.
• Genetically modified food –which is produced through the technical in which
genetic material have been altered.
• Special mid carrier training program may be conducted group with special
responsibilities.
• It is proposed to prepare & implement at strategy for enhancing the
environmental awareness among the general public& special group.
• The production as well as dissemination, may involve public, private&voluntery
agencies.