Bt cotton is currently the only commercially approved biotech crop in India.
THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY
USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT
Required Report - public distribution
GAIN Report Number: IN2098
Agricultural Biotechnology Annual
Bt cotton is currently the only commercially approved biotech crop in India. Over the last ten years, six
events and more than 1100 Bt hybrids have been approved for commercial cultivation. As a result,
India has emerged as the second largest producer and exporter of cotton in the world. In 2010, the
Government of India (GOI) announced a moratorium on the approval process for Bt brinjal (eggplant).
Since then there has been no movement in resuming the approval process. Research has also been
hampered by a new Genetic Engineering Appraisal Committee directive which requires applicants to
obtain a “No Objection Certificate (NOC)” from the relevant state authority before commencing biotech
field crop trials. On May 10, 2012, the Supreme Court of India instituted a six-member Technical
Expert Committee to review and recommend biosafety risk assessment studies for genetically modified
Section I. Executive Summary:
Agricultural trade between the United States and India reached $3.4 billion in calendar year (CY) 2011.
U.S. exports to India amounted to $723 million, while U.S. imports from India reached $2.68 billion,
skewing the agricultural trade balance nearly 4 to 1 in India’s favor. India’s agricultural exports to the
U.S. include guar gum, shrimp, cashew nuts, spices, tea, essential oils, rice, vegetable oil and processed
fruits & vegetables. U.S. agricultural exports to India include tree nuts, soybean oil, fresh fruits, cotton,
pulses and forest products.
The 1986 Environmental Protection Act (EPA) lays the foundation for India’s biotechnology regulatory
framework (see Annex 1). The Indian biotech regulatory system adopts a precautionary approach for
the biosafety assessment of food and agricultural products. Annex 2 of the EPA outlines the procedures
for importing biotech products, including products used for research.
Under current Indian regulations, all biotech food/agricultural products or products derived from biotech
plants/organisms must receive formal approval from the Genetic Engineering Appraisal Committee
prior to commercialization or imports (the GEAC is India’s apex biotech regulatory body). Soybean oil
derived from Round-up Ready soybeans is the only biotech food/agricultural product currently
approved for import. In CY 2010, U.S. soybean oil exports to India were estimated at a record $132
million, but declined sharply in CY 2011 to $94,000 due to market conditions.
In November 2007, the Government of India (GOI) introduced a National Biotech Development
Strategy, outlining a plan to set up an independent and autonomous national biotech regulatory authority
that would provide a single window mechanism for biosafety clearance of genetically engineered
products and processes. The Department of Biotechnology (DBT) under the Ministry of Science and
Technology (MST) has the responsibility to establish and operationalize the new Biotechnology
Regulatory Authority of India (BRAI). After a consultative process involving interdisciplinary and
inter-ministerial experts, state governments and other stakeholders, the DBT submitted a draft BRAI bill
2012 for parliamentary approval. Pending action by the Indian Parliament, the existing regulatory
framework will continue to oversee biotechnology regulation.
Bt cotton is the only biotech crop currently approved for commercial cultivation in India. Since 2002,
the GOI has approved six Bt cotton events and more than 1100 Bt cotton hybrids for commercial
cultivation. In October 2009, the GEAC recommended the approval of commercial cultivation of Bt
brinjal (eggplant). However, on February 9, 2010, following a series of public consultations, the
Ministry of Environment and Forest (MoEF) announced a moratorium on the approval of Bt eggplant
until the regulatory system could ensure food and environmental safety. More than two years have
passed since the moratorium announcement, but there has been little progress on either biosafety
assessment or approval of Bt eggplant.
On July 6, 2011, the GEAC introduced new procedures for authorizing biotech crop field trials,
requiring applicants (technology developers) to obtain a “no objection certificate (NOC)” from the
relevant state government. The GEAC decision has hampered ongoing field trials as only a few states
have issued NOCs.
On May 10, 2012, the Supreme Court of India instituted a six-member Technical Expert Committee to
review and recommend biosafety risk assessment studies for genetically modified (GM) crops. The
Technical Expert Committee was given two months to develop recommendations that may affect the
current/existing biotech regulatory system/processes.
Section II. Plant Biotechnology Trade and Production:
Based solely on the success of Bt cotton, agricultural biotechnology is one of the fastest growing
segments of the Indian biotech industry. With approximately 64 seed companies selling Bt cotton
hybrid seeds across various agro-climatic zones, agricultural biotechnology is the third largest
component in India’s domestic biotech industry, accounting for 15 percent of the industry’s total
revenues of Rs. 30.5 billion ($545 million) in FY 2011/12 (April-March). While over the past five
years the revenue share of agricultural biotechnology has grown from less than five percent to 15
percent, this growth rate is slowing due to an overdependence on Bt cotton. With close to 90 percent of
cotton farmers already having adopted Bt cotton, there is limited scope for growth in coming years.
Since its introduction in 2002, India’s Bt cotton area has grown to over 90 percent of the total cotton
area, accounting for over 95 percent of cotton production in 2011. As a result, India has emerged as the
second largest producer and exporter of cotton in the world. To date, the GOI has approved six cotton
events and more than 1100 hybrids for cultivation in different agro-climatic zones. Most of the
approved Bt cotton hybrids are produced from two Monsanto events (Mon 531 and Mon 15985). Other
approved events include the GFM event (developed by Nath Seeds) sourced from China and the locally
developed Event 1 (J.K. AgriGenetics), Event MLS-9124 (Metahelix Life Sciences) and Event BNLA-
601 (Central Institute of Cotton Research and University of Agriculture Sciences).
In addition to cotton, several Indian seed companies and public sector research institutions are working
on the development of various biotech crops, mainly for pest resistance, herbicide tolerance, nutritional
enhancement, drought tolerance and yield enhancement. The crops currently being developed by public
sector institutions include banana, cabbage, cassava, cauliflower, chickpea, cotton, eggplant,
rapeseed/mustard, papaya, pigeon pea, potato, rice, tomato, watermelon and wheat. Indian seed
companies are also focusing on cabbage, cauliflower, corn, rapeseed/mustard, okra, pigeon pea, rice and
tomato, and next generation technologies (stacked events) for cotton. In 2011, field trials were
conducted for castor bean, cotton, corn, rice, mustard, peanut, potato, and sorghum.
On October 14, 2009, the GEAC recommended the approval of commercial cultivation of Bt brinjal
(eggplant), which was forwarded to the MoEF for a final decision. The Ministry of Environment and
Forest (MoEF) subsequently held a series of public consultations on the approval of Bt eggplant, and on
February 9, 2010, announced a moratorium on the approval until the government regulatory system
could ensure human and environmental safety through long term studies. On April 27, 2011, the GEAC
held a consultation with experts and scientists on the regulatory process for genetically modified crops.
The GEAC has, however, deferred its decision, and as a result more than two years have now passed
without a clear indication of next steps or additional studies that need to be undertaken for the approval
of Bt egg plant.
The only biotech food product currently authorized for import into India is soybean oil derived from
glyphosate-tolerant soybeans. India has imported soybean oil from several countries, including Brazil,
Argentina and the United States. India exports biotech cotton and cottonseed meal, but does not export
any significant quantity of cotton or cottonseed meal to the United States.
Section III. Plant Biotechnology Policy:
The regulatory framework for biotech crops, animals and products in India is governed by the
Environmental Protection Act of 1986 and the “Rules for the Manufacture, Use/Import/Export and
Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989.” These rules
govern research, development, large-scale use, and import of biotech organisms and their products. The
rules identify six competent authorities (see Annex 1).
Role of Various Ministries/State Governments:
In 1990, the Department of Biotechnology (DBT), in the Ministry of Science and Technology
developed Recombinant DNA Guidelines, which were subsequently amended in 1994. In 1998, the
DBT issued separate guidelines for biotech plant research, including the import and shipment of biotech
plants for research use. In 2008, the GEAC adopted “Guidelines and Standard Operating Procedures
for the Conduct of Confined Field Trials.” The GEAC also adopted new “Guidelines for Safety
Assessment of Foods derived from Genetically Engineered Plants” All guidelines and protocols,
including the EPA Act of 1986 and the 1989 Rules are available online at http://dbtbiosafety.nic.in/.
Status of the Proposed Biotechnology Regulatory Authority
On November 13, 2007, the Ministry of Science and Technology unveiled a “National Biotechnology
Strategy” to strengthen the regulatory framework, instituting a National Biotech Regulatory Authority
(NBRA) that would provide a single window mechanism for biosafety clearance. In 2008, the DBT
issued a draft “National Biotechnology Regulatory Bill,” together with a draft “Establishment Plan for
Setting up the National Biotechnology Regulatory Authority.” Following inter-ministerial
consultations with different stakeholders, the DBT subsequently drafted a revised “Biotechnology
Regulatory Authority of India Bill 2012” (BRAI), which has now been submitted to the Parliament of
India for approval. Pending parliamentary approval of the BRAI, India’s regulatory mechanisms
continue to be governed by the EPA 1986 and the Rules of 1989.
Field Testing of Biotech Crops
The GEAC is ultimately responsible for approving all field trials. In 2008, the GEAC adopted an “event
based” approval system, reviewing the efficacy of the event/trait, and focusing on biosafety, particularly
on environmental and health safety. Before any biotech event can be approved for commercial use, it
must undergo extensive agronomic evaluation through field trials under the supervision of an Indian
Council of Agricultural Research (ICAR) institution or a state agriculture university (SAU) for at least
two crop seasons. Product developers can also conduct agronomic trials in conjunction with the
biosafety trials, or can also do so separately after the GEAC recommends environmental clearance and
the GOI gives final authorization. For approval purposes, a stacked event, even if consisting of already
approved events, is essentially treated as a new event.
The GOI does not have any specific regulations on coexistence between biotech and non-biotech
crops. On January 10, 2007, the GEAC decided against allowing multi-location biotech field trials in
basmati rice growing areas, particularly in the states of Punjab, Haryana and Uttaranchal.
In early 2011, some state governments objected to authorization of biotech crop field trials without state
permission. On July 6, 2011, the GEAC amended the procedures for field trial authorization, which
now require the applicant (the technology developer) to obtain a “no objection certificate (NOC)” from
the relevant state government. Applications that had previously received approval from the GEAC now
also require an NOC from the state government before commencing the field trials. Industry sources
report that only a few states (Punjab, Haryana, Gujarat and Andhra Pradesh-cotton only) have issued
NOCs for biotech field trials. As a result, a number of field trials already approved by the GEAC could
not be conducted in 2011. A few states (Maharashtra, Rajasthan, and Delhi National Capital Region)
are in the process of developing their own approval system, and could still be in a position to issue
NOCs for the 2012 kharif season planting.
Once an event is approved for commercial use, the applicant can register and market seeds in various
states according to the provisions of the 2002 National Seed Policy and other relevant seed regulations
specific to each state. Following the commercial release of a biotech crop, the the Ministry of
Agriculture, together with the various state departments of agriculture, monitor field performance for 3-
Supreme Court Appoints Technical Committee To Review Biosafety Assessment
On May 10, 2012, the Supreme Court of India appointed a six-member Technical Expert Committee to
review and recommend risk assessment studies (for health and environmental safety) for all
bioengineered crops before they can be released for open field trials. The Supreme Court has given the
Technical Expert Committee three months to submit a report, which will be discussed in the next case
hearing on August 6, 2012. The Supreme Court action is in response to a petition filed in 2005 which
alleged that field trials of GM crops were being allowed without proper scientific evaluation of bio-
safety concerns. [For more information on the 2005 Supreme Court case, please refer to GAIN report
IN8077, page 7].
India’s seed policy, developed by the Ministry of Agriculture in 2002, notes that all biotech crops must
be tested for environmental and bio-safety concerns prior to commercial release, per the regulations and
guidelines of the EPA 1986. The National Bureau of Plant Genetic Resources (NBPGR) is the
designated agency responsible for reviewing and approving the import of biotech seeds for research
purposes. Biotech crops must be tested by the Indian Council of Agricultural Research (ICAR) for at
least two seasons to determine the agronomic potential. India’s seed policy advocates “protection” of
transgenic varieties under the Protection of Plant Variety and Farmers Right Rules, 2003.
The Seeds Act of 1966, regulates the quality of certified seeds, while the 1983 Seeds Control Order
regulates and licenses the sale of seed, including transgenic seeds. A new seed bill
(http://agricoop.nic.in/seeds/seeds_bill.htm) was introduced in December 2004, but the proposed
legislation has not received final parliamentary approval.
In 2001, India enacted the Protection of Plant Varieties and Farmers’ Rights Act to protect new plant
varieties, including transgenic plants. The Protection of Plant Varieties and Farmers’ Right Authority
(PPVFRA) was established in 2005, and to date has notified 57 crops species for registration. The
PPVFRA is planning to gradually expand the list of crop species to be notified for registration.
Cotton Seed Pricing/Technology Fee
India does not regulate seed pricing or set technology fees. Seed companies are free to fix seed prices,
and a technology provider can set its own technology fees. Nevertheless, several biotech companies
have faced seed pricing and technology fee challenges with individual state governments.
In January 2006, the State Government of Andhra Pradesh filed a complaint with the Monopolies and
Restrictive Trade Practices Commission (MRTPC) contending that the technology fees were too high.
The MRTPC asked the technology provider to review technology fees, and urged a more modest pricing
structure for sales to farmers. Following the MRTPC order, the Andhra state government issued a
directive to all biotech seed companies not to price Bt cotton seeds above Rs. 750 per packet (450 gm Bt
seeds and 150 gm non-Bt seeds). Subsequently, several other state governments issued similar orders.
The pricing order directives have been challenged in the Supreme Court, and these cases are still
On August 24, 2006, the GOI enacted an integrated food law, namely the “Food Safety and Standards
Act of 2006”, which has specific provisions to regulate genetically engineered food products, including
processed foods. Under the Act, the Food Safety and Standard Authority of India (FSSAI) has been
entrusted as the single authority responsible for establishing and implementing science-based standards
for food, and align these with international standards.
On August 23, 2007, the MoEF issued a notification stating that processed food products derived from
genetically engineered products (where the end-product is not an LMO - a living modified organism) do
not require approval from GEAC for production, marketing, import and use in India. As processed food
products are not replicated in the environment, they are not considered to be an environmental safety
concern under the 1989 EPA. However, imports of products that are LMOs continue to be under the
purview of GEAC and the 1986 EPA.
As FSSAI does not have specific regulations for biotech food products, the Ministry of Health and
Family Welfare (MHFW) has requested that the GEAC continue to regulate processed food products
(containing biotech ingredients) under the 1989 Rules. Thus, the MoEF notification on processed food
products has been deferred and the GEAC continues to regulate imports of processed biotech food
products. On May 21, 2010, the FSSAI circulated a “Draft on Operationalizing the Regulation of
Genetically Modified Foods in India.” Stakeholders have been invited to comment. (See GAIN report
IN1044). However until new regulations are in place, the 1986 EPA remains cornerstone of India’s
biotech regulatory system.
In March 2006, the Ministry of Health and Family Welfare issued a draft amendment to the 1955
Prevention of Food Adulteration (PFA) Rules, extending a labeling requirement to “Genetically
Modified foods” (For more information on the proposed regulation, refer to GAIN reports IN6024 and
IN6060). While the draft amendment has not been finalized, the FSSAI has been consulting with
various stakeholders to consider options under the new Food Safety and Standard Act.
On June 5, 2012, the Department of Consumer Affairs (DCA), Ministry of Consumer Affairs, Food and
Public Distribution, issued notification G.S.R. 427 (E) amending the Legal Metrology (Packaged
Commodities) Rules, 2011, effective January 1, 2013, which stipulates “every package containing
genetically modified food shall bear at the top of its principal display panel the word “GM.” Sources
report that the DCA did not conduct prior consultations with other government agencies or domestic
stakeholders before introducing the notification. As the FSSAI is still in the process of establishing
labeling regulations for GM foods, the future status of the DCA GM labeling regulation remains
uncertain (see GAIN report IN2078).
Cartagena Protocol and Other International Agreements
On January 17, 2003, India ratified the Cartagena Protocol on Biosafety, and has since established rules
for implementing the provisions of the articles (see Annex 3). A Biosafety Clearing-House (BCH) has
been set up within the MOEF to facilitate the exchange of scientific, technical, environmental and legal
information on living modified organisms (LMOs). The GEAC has the responsibility of approving
trade of biotech products, including seed and food products. India has traditionally advocated strict
liability and redress to the trans-boundary movement of LMOs, a position that could complicate the
movement of Bt cotton seed to neighboring countries.
In Codex Alimentarius discussions, India has supported mandatory labeling of GM foods, requiring a
clear declaration whenever food and food ingredients contain genetically modified organisms.
In 2006, the MOEF published the Procedure for GEAC Clearance for Imports of GM Products. The
specific procedure for filing an import application for a biotech product is found in Annex 2 of this
On July 8, 2006, the Ministry of Commerce and Industries issued a notification specifying that all
imports containing biotech products must have prior approval from the GEAC. This directive requires a
biotech declaration at the time of import. On June 22, 2007, the GEAC gave a permanent approval for
importation of soybean oil derived from glyphosate-tolerant soybeans for consumption after refining.
No other biotech food products, bulk grain, semi-processed or processed food are authorized for
The import of biotech seeds and planting material is also regulated by the 2003 “Plant Quarantine Order
(PQO Regulation of Import into India),” which came into force in January 2004. The PQO regulates the
import of germplasm/bioengineered organisms/transgenic plant material for research purposes. NBPGR
is the authorizing authority for issuing import permits. A complete text of this order is available at
Section IV. Plant Biotechnology Marketing Issues:
Bt cotton is currently the only biotech crop authorized for marketing in India. There are no restrictions
in marketing domestically produced biotech cottonseed oil and meal. Imported soybean oil is also
authorized for domestic marketing without any restrictions or labeling requirements.
Section VI. Animal Biotechnology:
Animal biotechnology is very much at an infancy stage in India. Most of the research work focuses on
the genomics of important livestock, poultry and fish species, which can be subsequently adopted into
breeding programs for important traits - production (milk/meat), reproductive, drought/heat tolerance
and pest/disease resistance. Research is generally conducted by public sector research organizations
like ICAR institutions, Council of Scientific and Industrial Research (CSIR) institutions, SAUs, and
other research organizations supported by DBT.
Currently, no animal products derived from genetically engineered animals are in commercial
production, nor has there been any request for regulatory approval for commercial production. The
EPA 1986 governs the development, commercial use and /or import of genetically engineered animals
Section VII. Author Defined:
Annex 1: Existing Biotech Regulatory Authorities – Function/Composition
Committee Members Functions
Genetic Engineering Chairman-Additional Secretary, Ministry of Environment Review and recommend the use of
Appraisal Committee and Forests (MOEF) bio-engineered products for
(GEAC); functions under Co-Chairman - Nominee of Department of Biotechnology commercial applications.
Ministry of Environment (DBT) Approve activities involving large-
and Forests (MOEF). Members: Representatives of concerned agencies and scale use of bio-engineered
departments namely Ministry of Industrial Development, organisms and recombinants in
DBT, and the Department of Atomic Energy research and industrial production
Expert members: Director General-ICAR, Director General- from an environmental safety angle.
ICMR; Director General-CSIR; Director General of Health Consult RCGM on technical matters
Services; Plant Protection Adviser; Directorate of Plant relating to clearance of bio-
Protection; Quarantine and storage; Chairman, Central engineered crops/products.
Pollution Control Board; and few outside experts in Approve imports of bio-engineered
individual capacity. food/feed or processed product
Member Secretary: An official from the MOEF derived thereof.
Take punitive actions on those found
violating GM rules under EPA, 1986.
Review Committee on Representatives from: Develop guidelines for the regulatory
Genetic Manipulation DBT, Indian Council of Medical Research (ICMR), Indian process for research and use of bio-
(RCGM); function under Council of Agricultural Research (ICAR), Council of engineered products from a bio-safety
Department of Scientific and Industrial Research (CSIR) angle.
Biotechnology (DBT). Other experts in their individual capacity. Monitor and review all ongoing GM
research projects up to the multi
location restricted field trial stage.
Undertake visits to trial sites to
ensure adequate security measures.
Issue clearance for the import of raw
materials needed in GM research
Scrutinize applications made to the
GEAC for the import of
Form Monitoring and Evaluation
Committee for biotech crop research
Appoint sub-groups when required in
topics of interest to the committee.
Recombinant DNA Scientists from DBT and other public sector research Take note of developments in
Advisory Committee institutions biotechnology at the national and
(RDAC); function under international level.
DBT Prepare suitable guidelines for safety
in research and applications of
Prepare other guidelines as may be
required by the GEAC.
Monitoring Cum Experts from ICAR institutes, State Agricultural Universities Monitor and evaluates trial sites,
Evaluation Committee (SAUs) and other agricultural/crop research institutions and analyze data, inspect facilities and
(MEC) representatives from DBT. recommend safe and agronomically
viable transgenic crops/plants for
approval to RCGM/GEAC
Institutional Biosafety Head of the Institution, Scientists engaged in biotech work, Develop a manual of guidelines for
Committee Medical Expert, and Nominee of the Department of the regulatory process on bio-
(IBC); functions at Biotechnology engineered organisms in research, use
research institution/ and application to ensure
Organization level. environmental safety.
Authorize and monitor all ongoing
biotech projects to the controlled
multi location field stage.
Authorize imports of bio-engineered
organisms/transgenic for research
Coordinate with district and state
level biotechnology committees.
State Biotechnology Chief Secretary, State Government; Secretaries, Departments Periodically reviews the safety and
Coordination Committee of Environment, Health, Agriculture, Commerce, Forests, control measures of institutions
(SBCC); functions under Public Works, Public Health; Chairman, State Pollution handling bio-engineered products.
the state government Control Board; State microbiologists and pathologists; Other Inspect and take punitive action
where biotech research experts. through the State Pollution Control
occurs. Boards or the Directorate of Health in
case of violations.
Nodal agency at the state level to
assess damage, if any, due to release
of bio-engineered organisms and take
on-site control measures.
District-Level Committee District Collector; Factory Inspector; Pollution Control Monitor safety regulations in research
(DLC); functions under the Board Representative; Chief Medical Officer; District and production installations.
district administration Agricultural Officer, Public Health Department Investigate compliance with rDNA
where biotech research Representative; District Microbiologists/Pathologists; guidelines and report violations to
occurs. Municipal Corporation Commissioner; other experts. SBCC or GEAC.
Nodal agency at district level to
assess damage, if any, due to release
of bio-engineered organisms and take
on-site control measures.
Source: Department of Biotechnology (DBT) and Ministry of Environment and Forest (MOEF), GOI.
Annex 2: Procedure and Application Formats for Import of Biotech Products
Item APPROVAL GOVERNING FORM LINKS FOR
ACCORDING RULES NO. DOWNLOADING
GMOs / IBSC/RCGM/ Rules 1989; Biosafety guidelines of 1990 and I GEAC Form I
LMOs for NBPGR 1998; Plant Quarantine (Regulation of Imports
R&D into India) – Order, 2004 issued by NBPGR;
and Guidelines for the import of germplasm,
2004 by NBPGR
GMOs / IBSC/RCGM/ Rules 1989; II B GEAC Form II
LMOs for GEAC /ICAR Biosafety guidelines of 1990 & 1998 B
GM food GEAC Provide biosafety & food safety studies, III GEAC Form III
/feed as Compliance with the Rules 1989 and Biosafety
LMOs per se guidelines of 1990 & 1998
GM processed GEAC One time “event based” approval given based IV GEAC Form IV
food derived on importer providing the following
from LMOs information:
i. List of genes/events approved in the crop
species for commercial production in the
country of export/country of origin;
ii. Approval of the product for consumption in
countries other than producing countries;
iii. Food safety study conducted in the country
iv. Analytical/compositional report from the
country of export/origin;
v. Details on further processing envisaged after
vi. Details on commercial production,
marketing and use for feed/food in the country
vii. Details on the approval of genes / events
from which the product is derived
Processed GEAC If the processed food contains any ingredient IV , if GEAC Form IV
food derived from category 2 and 3 mentioned required B
containing above, and if the LMO / product thereof has
ingredients been approved by the GEAC, no further
derived from approval is required except for declaration at
GMO the port of entry. In case it does not have the
approval of GEAC, the procedure mentioned in
category 3 above to be complied.
Source: MOEF Website http://www.envfor.nic.in/divisions/csurv/geac/gmo_lmo.htm
Annex 3: India’s Compliance with Various Articles of the Cartagena Protocol
Article Provisions Present Status
Article 7 Application of the Advanced Informed Agreement procedure Competent authority (GEAC) notified. Border control
prior to the first transboundary movement of LMOs intended through NBPGR only for contained use. Projects
for direct use as food or feed, or for processing. initiated to strengthen DBT and MOEF’s capabilities to
Article 8 Notification – The Party of export shall notify, or require the Rules 1989 and competent authorities in place.
exporters to ensure notification to, in writing, the competent
authority of the Party of import prior to the intentional
transboundary movement of LMOs that falls within the
scope of Article 7
Article 9 Acknowledgement of receipt of notification-The Party of Point of contact notified, the regulatory body (GEAC)
import shall acknowledge receipt of the notification, in in place
writing to the notifier
Article Decision Procedure-Decision taken by the Party of import Regulatory body (GEAC) in place
10 shall be in accordance with Article 15
Article Procedure for LMOs intended for direct use as food or feed, 1989 Rules  , DGFT Notification No. 2(RE-2006) /
11 o r for processing 2004-2009
Article Simplified Procedure to ensure the safe intentional 1989 rules
13 transboundary movement of LMOs
Article Bilateral, regional and multilateral agreements and --
Article Risk assessment DBT Biosafety Guidelines for research in plants,
15 guidelines for confined field trials guidelines for safety
assessment of foods derived from GE plants.
Article Risk Management DBT Guidelines for research
Article Unintentional transboundary movements and emergency 1989 rules
Article Handling, transport, packaging and identification 1989 Rules, guidelines to be developed
Article Competent National Authorities and National Focal Point Ministry of Environment and Forests designated as
19 competent authority and national focal point
Article Information sharing and the Biosafety Clearing House Biosafety Clearing House (http://www.indbch.nic.in)
20 has been set up.
Article Confidential information --
Article Capacity building Ongoing capacity building activities by DBT, MOEF,
22 USTDA and USAID-sponsored SABP
Article Public awareness and participation Ongoing, MOEF and DBT have specific websites on
23 biotech developments and regulatory system including
website of IGMORIS  , GEAC  , DBT Biosafety 
Article Non-Parties (transboundary movements of LMOs between 1989 rules in place for all import and export
24 Parties and non-Parties)
Article Illegal transboundary movements --
Article Socio-economic considerations Socioeconomic analysis is an integral part of decision
Article Liability and redress National Consultation ongoing
Source: MOEF and Industry Sources.
 See Annex 2