Required Report - public distribution

**Date:** 7/18/2006

**GAIN Report Number:** IN6060

IN6060

**India**

**Biotechnology**

**Annual**

**2006**

**Approved by:**

![](media/image1.wmf)Michael Riedel

U.S. Embassy, New Delhi

**Prepared by:**

Deepa Dhankhar

**Report Highlights:**

The Government of India recently announced two new regulations that
could adversely impact trade in agricultural biotechnology products. The
current legal troubles in India regarding the pricing of Bt cottonseed
could have serious implications for future technology transfer and
foreign direct investment in India's biotechnology sector. Continuing
its efforts to improve the regulatory mechanism for bio-engineered
crops, the Ministry of Environment and Forests recently decided to
simplify the clearance system for biotechnology crops by replacing the
"case-by-case" approval process by an "event-based" approval system.
Area coverage under Bt cotton, the only commercially-released
biotechnology crop in the country, continues to grow. All sections of
this report were updated on 07/15/06.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

New Delhi \[IN1\]

\[IN\]

**Table of Contents**

[**SECTION I: EXECUTIVE SUMMARY 3**](#section-i-executive-summary)

[SECTION II: BIOTECH TRADE AND PRODUCTION
3](#section-ii-biotech-trade-and-production)

[SECTION III: BIOTECH POLICY 4](#section-iii-biotech-policy)

[SECTION IV: MARKETING ISSUES 6](#section-iv-marketing-issues)

[SECTION V: CAPACITY BUILDING AND OUTREACH
6](#section-v-capacity-building-and-outreach)

[ANNEX I: Bt Cotton Hybrids approved to-date
8](#annex-i-bt-cotton-hybrids-approved-to-date)

[ANNEX II: Transgenic crops approved for contained, limited field
trials, including multi-locational field trials, during 2005
9](#annex-ii-transgenic-crops-approved-for-contained-limited-field-trials-including-multi-locational-field-trials-during-2005)

[ANNEX III: Application formats for imports of biotech products
10](#annex-iii-application-formats-for-imports-of-biotech-products)

[(R&D/contained use, intentional release & biotech food)
10](#rdcontained-use-intentional-release-biotech-food)

[ANNEX IV: Steps involved in processing a transgenic event into a
commercial variety
11](#annex-iv-steps-involved-in-processing-a-transgenic-event-into-a-commercial-variety)

[ANNEX V: Composition and Functions of Indian Biotech Regulatory
Authorities
12](#annex-v-composition-and-functions-of-indian-biotech-regulatory-authorities)

[ANNEX VI: Procedure for Approval of Biotech Crops in India
14](#annex-vi-procedure-for-approval-of-biotech-crops-in-india)

[ANNEX VII: Present Status of India's Compliance and Capacity Building
Needs for Various parts of the Cartagena Protocol
15](#annex-vii-present-status-of-indias-compliance-and-capacity-building-needs-for-various-parts-of-the-cartagena-protocol)

# SECTION I: EXECUTIVE SUMMARY

The biotechnology sector in India is evolving, and the regulatory
authorities are trying to streamline the regulatory process for biotech
crops. However, the biotechnology community in India still feels that
further reforms are needed for faster growth in their sector. The
Government of India (GOI) recently announced two new regulations that
could adversely impact trade in agricultural biotechnology products
(GAIN reports IN6024 and IN6030). The current legal troubles in India
regarding the pricing of Bt cottonseed could have ramifications on
future technology transfer and foreign direct investment in India's
biotechnology sector. Bt cotton remains the only transgenic crop
approved for commercial cultivation in India. A number of other biotech
crops are under development by private seed companies and public sector
institutes. The next biotech crop in the pipeline for commercial release
is expected to be Bt brinjal (eggplant) in 2007/08. Other transgenic
crops approved for contained and limited field trials are cabbage,
cauliflower, corn, cotton, peanut, mustard, okra, pigeon pea, rice, and
tomato, for traits such as nutritional enhancement, pest resistance, and
increased yields.

# SECTION II: BIOTECH TRADE AND PRODUCTION

Bt cotton remains the only biotech crop released for commercial
cultivation in India, spanning the country's major cotton growing
regions. The crop itself has been a main focus for biotech research,
with the number of approved biotech hybrids/varieties growing from three
in 2002 to 59 in 2006, covering four events and involving 16 major seed
companies. Details on the zonal spread of approved Bt cotton hybrids are
in Annex I. Out of the 59 hybrids, 55 are from Monsanto technology. For
specifics regarding India's cultivation of Bt cotton, please see Section
III of Post's recent "Cotton Annual Report" (GAIN IN6040).

Bt brinjal is expected to be commercially released by 2007 or 2008.
Other biotech crops approved for multi-location trials include cabbage,
cauliflower, corn, peanut, mustard/rapeseed, okra, pigeon pea, rice, and
tomato, and details are in Annex II.

The GOI recently announced two new regulations that could adversely
impact trade in agricultural biotech products, both of which refer to
existing GOI statutes (the 1989 Rules framed under the Environmental
Protection Act of 1986). The Ministry of Commerce and Industry, on April
7, 2006, announced a supplement to the GOI's Foreign Trade Policy
(2004-2009), which requires all imports containing products of modern
biotechnology to receive prior approval via the Genetic Engineering
Approval Committee (GEAC), as well as mandating a declaration stating
that the product is "genetically modified." Importers would be
responsible for providing this declaration, and likewise would be liable
if the declaration is incorrect. Punitive action in a case where the
consignment does not carry the correct declaration could be up to five
times the value of the consignment. However, it is not clear how
enforcement will be handled, since India does not have the ability to
test products for bioengineering at its ports of entry. Inquiries
regarding these new measures and their potential impact on trade have
focused primarily on vegetable oil shipments, since India is the world's
largest importer of vegetable oils. The impact on imports of everything
from bulk corn for feed (which is not currently being traded due to a
restrictive TRQ regime) to processed food products could be significant.
Government sources tell Post that this regulation has come into force
with effect from July 8, 2006.

On March 10, 2006, the Ministry of Health and Family Welfare (MHFW)
published a proposed amendment to the "Prevention of Food Adulteration
Rules," which pertains to the labeling and sale of foods derived from
biotechnology. This amendment would require the labeling of "genetically
modified foods." For additional details, please refer to the "Marketing
Issues" Section.

![](media/image2.wmf)

Source: Biospectrum-ABLE survey, June, 2006

During the Indian Fiscal year (IFY) 2005-06, the agricultural biotech
sector is reported to be the third largest contributor among the
different sectors of the biotech industry, with total revenues of more
than \$130 million. It is also the fastest growing sector in the biotech
industry, registering a revenue growth of 81% from IFY 2004-05 to
2005-06. The revenue figures for exports and the domestic market were
around \$8 million and \$122 million, respectively.

# SECTION III: BIOTECH POLICY

The regulatory framework for biotech crops and products in India is
governed by the "Rules for the manufacture, use/import/export and
storage of hazardous microorganisms/genetically engineered organisms or
cells, 1989" under the Environmental Protection Act, 1986. These Rules
cover the gamut of activities relating to research, development, use,
and imports of biotech organisms and their products. Guidelines were
first issued in 1990, and were updated in 1994 and 1998. The EPA Act of
1986, 1989 Rules, and all Guidelines are available online at
[www.dbtindia.nic.in/thanks/biosafetymain.html](http://www.dbtindia.nic.in/thanks/biosafetymain.html).

The Format for filing clearance applications for imports of biotech
products are detailed in Annex III. The Steps involved in
commercializing a transgenic event are provided in Annex IV.

A plethora of committees constituted under the 1989 Rules govern the
commercialization of biotech crops (Annex V). The procedure for
government approval of biotechnology crops in India is shown in Annex
VI.

The Review Committee on Genetically Modified Crops (RCGM), one of the
regulatory bodies, was "reconstituted" in January 2006 in order to
broaden its membership by involving expert members from relevant
backgrounds and organizations. See
[http://dbtindia.nic.in/biosafety/New%20RCGM%20OM.doc](http://dbtindia.nic.in/biosafety/New RCGM OM.doc)
for more details.

In a similar development, the Genetic Engineering Approval Committee
(GEAC) was reshuffled in March 2006. A list of members of the new
committee is available at
[www.envfor.nic.in/divisions/csurv/geac/comp.doc](http://www.envfor.nic.in/divisions/csurv/geac/comp.doc).

India ratified the Cartagena Protocol on Biosafety on January 17, 2003
(see Annex VII). A Biosafety Clearing-House (BCH) exists within the
Ministry of Environment and Forests to facilitate the exchange of
scientific, technical, environmental and legal information on living
modified organisms (LMOs). The BCH facilitates the protocol
implementation by functioning as an internet-based system.

On June 30, 2006, the Ministry of Environment and Forests (MOEF)
simplified and shortened the clearance system for biotech crops. This
decision was based on a GEAC-approved report by one of its
subcommittees. According to the new modus operandi, the "case-by-case"
approval process previously followed by the GEAC will be replaced by an
"event-based" approval system, designed specifically to speed up the
approval process for Bt cotton hybrids. Under the old system, a biotech
hybrid or variety had to endure a minimum of three years of extensive
trials in order to qualify for approval. Now, any seed with the Cry 1Ac
gene should require only one year of trials to gain GEAC clearance,
mainly to test the agronomic trait value of hybrids and to confirm the
presence of the gene. The Indian Council of Agricultural Research (ICAR)
trials for Bt cotton (with the Cry 1Ac gene and the Mon 531 event) have
been made optional. The roles of state agricultural universities (SAUs)
and state agricultural departments have been enhanced by making them
responsible for the pre-release field monitoring of biotech crops. The
responsibilities have been transferred to the SAUs, because agriculture
is considered to be a state subject.

The Seed Policy, 2002, which is non-binding, includes issues related to
transgenic crops. Accordingly, all biotech crops and varieties should be
tested for environmental- and bio-safety before their commercial
release, in line with the regulations and guidelines of the EPA, 1986.
The National Bureau of Plant Genetic Resources (NBPGR) is the designated
agency to import biotech seeds for research purposes. The Seed Policy
also advocates "protection," which remains undefined, of transgenic
varieties under the Plant Variety Protection (PVP) legislation.

Considering perceived flaws in the present seed legislation (Seed Act,
1966), a new Seed Bill was introduced in Parliament in 2004. Clause 15
of the draft Bill covers specific provisions for the registration of
transgenic varieties.

Other major highlights of the draft are import and export regulations of
seeds, and an exemption for farmers to save, use, exchange, share, or
sell their seed without registration. The full text of the draft Seed
Bill is available at: <http://agricoop.nic.in/seeds/seeds_bill.htm>.

The Food Safety and Standards Bill, 2005, was introduced by the Ministry
of Food Processing Industries with the basic aim of integrating the
existing multitude of food laws in the country. Existing acts or orders
like the Prevention of Food Adulteration (PFA) and the sections related
to food under the EPA, 1986, and the Environment Protection Rules, 1989,
will be moot once the Bill becomes functional. The Bill has a provision
to address biotech-related issues through a separate scientific panel,
which will be composed of independent scientific experts. The provisions
prohibit the manufacture, processing, export, import or sale of biotech
food products that are not in compliance with the Act's regulations.

The import of biotech seeds is regulated by the "Plant Quarantine
(Regulation of Import into India) Order, 2003," which came into force in
January 2004. The PQO regulates the import of germplasm/bioengineered
organisms/transgenic plant material for research purposes. The NBPGR
will be authorized to issue import permits. The complete text of the
order is available at <http://agricoop.nic.in/gazette/gazette2003.htm>.

The MOEF issued the "Draft National Environment Policy, 2004," which
reviews the regulatory processes for Living Modified Organisms (LMOs) in
order to address any health, ecological, and economic concerns.
([www.envfor.nic.in/nep/nep.pdf](../www.envfor.nic.in/nep/nep.pdf))

A draft "National Biotechnology Strategy, 2005," prepared by the
Department of Biotechnology, Ministry of Science and Technology,
enumerates various amendments being made to policies, procedures, and
protocols by the departments regulating biotech products and processes.
Another aspect of the strategy attempts to resolve various conflicting
issues related to the regulation of biotech activities in research and
development, import, export, commercial releases etc. See:
<http://dbtindia.nic.in/biotechstrategy.htm>

# SECTION IV: MARKETING ISSUES

Current marketing issues relating to biotech crops are confined mainly
to Bt cotton, the only biotechnology crop commercially released so far
in India. This may change, however, depending on the ultimate outcome of
the regulations discussed below. Monsanto, the pioneer of Bt cotton seed
technology in India, is having legal problems regarding the pricing of
its Bt cotton seed.

A biotech declaration has been made mandatory for imported food, feed,
bioengineered organisms, or LMOs, via a notification issued by the
Director General of Foreign Trade, Ministry of Commerce and Industry, on
April 7, 2006 (<http://164.100.9.245/exim/2000/not/not06/not0206.htm>).
Ministry of Commerce sources state that this regulation was implemented
on July 8, 2006. For additional details, please refer to the "Trade and
Production" section of this report.

The Ministry of Health and Family Welfare (MHFW) issued a draft
amendment on the labeling of biotech foods via a notification published
in the Official Gazette of India on March 10, 2006. The amendment
proposes to add two rules (37-E and 48-F) to the PFA Rules, 1955, and
seeks compulsory labeling of foods derived from biotechnology (to
include those obtained by primary or secondary processing, any
ingredient of food, food additives), whether produced domestically or
imported. It also mandates specifying that such categories of products
have been subjected to genetic manipulation. Additionally, the
proposition requires the food label of biotech foods to specify that the
product has been cleared for marketing and use in its country of origin.
The new rule also restricts the sale, manufacture, import, transport,
storage, and distribution of biotech foods without the approval and
fulfillment of the criteria imposed by the GEAC, whatever those are at
that moment. The MHFW has constituted an expert group to review comments
received from various stakeholders; this group is expected to meet in
late July or early August 2006, after which it will likely take at least
six months to implement the amendment. The draft amendment can be
accessed at <http://mohfw.nic.in/152.pdf>.

# SECTION V: CAPACITY BUILDING AND OUTREACH

Biotechnology is one of the prime focus areas under the US-India
Agricultural Knowledge Initiative (AKI). Post, with active support from
the FAS/Biotech team, the Cochran program, and many others, is deeply
involved in these activities. Representatives from various
agriculturally-oriented private and public organizations are currently
being processed for training in agricultural biotechnology in the United
States. Conferences, workshops, and other events are also planned.
Please see
[www.fas.usda.gov/icd/india_knowl_init/india_knowl_init.asp](http://www.fas.usda.gov/icd/india_knowl_init/india_knowl_init.asp)

for more information on the AKI.

A conference between US and Indian regulatory officials was conducted in
February 2005 to help both sides share and learn from each other's
regulatory experiences. USAID-India is working closely with various
public and private sector research organizations to develop and
commercialize biotech crops that may be commercially "unattractive," but
which would have a significant stakeholder impact (example: Bt Brinjal;
resistant to fruit borer). In 2003/2004, the State Department funded and
coordinated two Speakers' tours, which were aimed at developing
confidence in biotechnology among consumers and other stakeholders.
Additionally, the State Department's Senior Advisor for Agricultural
Biotechnology visited with key stakeholders in India in early 2006.
USDA/FAS' Director of Biotechnology Group visited India in May 2006.

Capacity building and outreach activities undertaken by USG agencies
have focused on streamlining the Indian regulatory mechanism and
spreading the message regarding the safety of biotech foods.

A USAID-sponsored South Asia Biosafety Program (SABP) was initiated in
early 2004 to support capacity building in safety issues related to
biotech food crops. SABP is an ongoing program that aims to work with
Indian partners to respond to the training needs for food, feed, and
environmental safety assessments.

The Agricultural Biotechnology Support Project (ABSP)-II was initiated
in October 2002, and focuses on South Asia to aid the development of
expertise in agricultural biotechnology, with the aim of reducing hunger
and poverty. The prime areas that are targeted include research, policy
development, licensing, and outreach. Details on the program can be
accessed at
[www.absp2.cornell.edu/aboutabsp2/index.cfm](http://www.absp2.cornell.edu/aboutabsp2/index.cfm).

##  

# ANNEX I: Bt Cotton Hybrids approved to-date

+-----------+------+------+------+----------------+-------------------+
|           | **20 | **20 | **20 | **2005**       | **2006**          |
|           | 02** | 03** | 04** |                |                   |
+-----------+------+------+------+----------------+-------------------+
| **NORTH** | *    | *    | *    | **6 hybrids**  | **7 hybrids**     |
|           | * ** | * ** | * ** |                |                   |
| **ZONE    |      |      |      |                |                   |
| (23%)\*** |      |      |      |                |                   |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      |                |                   |
+-----------+------+------+------+----------------+-------------------+
| Haryana   |      |      |      | RCH 134, RCH   | MRC 6026, MRC     |
|           |      |      |      | 317,           | 6029,             |
+-----------+------+------+------+----------------+-------------------+
| Punjab    |      |      |      | MRC 6304       | NCS-913, NCS-138, |
+-----------+------+------+------+----------------+-------------------+
| Rajasthan |      |      |      | MRC 6301,      | NCE               |
|           |      |      |      | Ankur 651,     | H-6RCH-308RCH-314 |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      | Ankur 2534     |                   |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      |                |                   |
+-----------+------+------+------+----------------+-------------------+
| **        | **3  | **3  | **4  | **12 hybrids** | **11 hybrids**    |
| CENTRAL** | h    | h    | h    |                |                   |
|           | yb** | yb** | yb** |                |                   |
| **ZONE    |      |      |      |                |                   |
| (58%)**   |      |      |      |                |                   |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      |                |                   |
+-----------+------+------+------+----------------+-------------------+
| Gujarat   | Mech | Mech | Mech | Mech 12, Mech  | ACH-33-1, ACH     |
|           | 12   | 12   | 12   | 162,           | 155-1,            |
+-----------+------+------+------+----------------+-------------------+
| Madhya    | Mech | Mech | Mech | Mech 184, RCH  | Brahma Bt, GK 205 |
| Pradesh   | 162  | 162  | 162  | 2,             |                   |
+-----------+------+------+------+----------------+-------------------+
| Ma        | Mech | Mech | Mech | RCH 118, RCH   | NCEH-2, PRCH-102, |
| harashtra | 184  | 184  | 184  | 138,           |                   |
+-----------+------+------+------+----------------+-------------------+
|           |      |      | RCH  | RCH144, Ankur  | RCH 377,          |
|           |      |      | 2    | 09,            | Tulasi-4, VICH-5  |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      | Ankur 651, MRC | VICH-9, VICH-111  |
|           |      |      |      | 6301           |                   |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      | NCS-145 Bunny, |                   |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      | NCS-207        |                   |
|           |      |      |      | Mallika        |                   |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      |                |                   |
+-----------+------+------+------+----------------+-------------------+
| **SOUTH** | **3  | **3  | **4  | **9 hybrids**  | **15 hybrids**    |
|           | h    | h    | h    |                |                   |
| **ZONE    | yb** | yb** | yb** |                |                   |
| (19%)**   |      |      |      |                |                   |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      |                |                   |
+-----------+------+------+------+----------------+-------------------+
| Andhra    | Mech | Mech | Mech | Mech 162, Mech | ACH-33-1, Brahma  |
| Pradesh   | 12   | 12   | 12   | 184,           | Bt, GK            |
+-----------+------+------+------+----------------+-------------------+
| Karnataka | Mech | Mech | Mech | RCH 2,         | 207, GK 209,      |
|           | 162  | 162  | 162  |                | KDCHH-            |
+-----------+------+------+------+----------------+-------------------+
| Tamil     | Mech | Mech | Mech | RCH 20, RCH    | 9632, NCS-913,    |
| Nadu      | 184  | 184  | 184  | 368,           | NCEH-3,           |
+-----------+------+------+------+----------------+-------------------+
|           |      |      | RCH  | MRC 6322,      | RPCH-2270,        |
|           |      |      | 2    |                | PRCH-102,         |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      | MRC 6918       | PRCH-103,         |
|           |      |      |      |                | RCH-111,          |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      | NCS-145 Bunny  | RCH-371,          |
|           |      |      |      |                | RCHB-708,         |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      | NCS-207        | VICH-5, VICH-9    |
|           |      |      |      | Mallika        |                   |
+-----------+------+------+------+----------------+-------------------+
|           |      |      |      |                |                   |
+-----------+------+------+------+----------------+-------------------+
| **TOTAL** | *    | *    | *    | **20**         | **25**            |
|           | *3** | *3** | *4** |                |                   |
+-----------+------+------+------+----------------+-------------------+

\*Figures given in percentage denote the contribution of each zone in
the development of new hybrids

Source: ISAAA via Monsanto India

# ANNEX II: Transgenic crops approved for contained, limited field trials, including multi-locational field trials, during 2005

## 

+----+-----------+----------------------------------+-----------------+
| *  | **CROP**  | **INSTITUTE/INDUSTRY**           | **EVENT**       |
| *S |           |                                  |                 |
| L. |           |                                  |                 |
| ** |           |                                  |                 |
|    |           |                                  |                 |
| *  |           |                                  |                 |
| *N |           |                                  |                 |
| o. |           |                                  |                 |
| ** |           |                                  |                 |
+----+-----------+----------------------------------+-----------------+
| 1  | Brinjal   | Mahyco, Mumbai                   | cry1Ac          |
| \. |           |                                  |                 |
|    |           | Sungro Seeds Ltd., New Delhi     | cry1Ac          |
|    |           |                                  |                 |
|    |           | IARI, New Delhi                  | cry1F           |
+----+-----------+----------------------------------+-----------------+
| 2  | Cabbage   | Sungro Seeds Ltd., New Delhi     | cry1Ac          |
| \. |           |                                  |                 |
+----+-----------+----------------------------------+-----------------+
| 3  | Ca        | Sungro Seeds Ltd, New Delhi      | cry1Ac          |
| \. | uliflower |                                  |                 |
+----+-----------+----------------------------------+-----------------+
| 4  | Corn      | Monsanto, Mumbai                 | cry1Ab          |
| \. |           |                                  |                 |
|    |           | Metahelix Life Sciences,         |                 |
|    |           | Bangalore                        |                 |
|    |           |                                  |                 |
|    |           | Modified Mu-element (Turbo-Mu)   |                 |
+----+-----------+----------------------------------+-----------------+
| 5  | Cotton    | Ajeet Seeds, Aurangabad          | cry1Ac, cryX    |
| \. |           |                                  |                 |
|    |           | Ankur Seeds P. Ltd., Nagpur      | cry1Ac, cryX    |
|    |           |                                  |                 |
|    |           | M/s Bioseed Research India Pvt.  | cry1Ac, cryX    |
|    |           | Ltd., Hyd                        |                 |
|    |           |                                  | cry1Ac, cryX    |
|    |           | M/s Emergent Genetics India P.   |                 |
|    |           | Ltd., Hyd                        | cry1Ac          |
|    |           |                                  |                 |
|    |           | Ganga Kaveri Seeds Ltd.,         | GFM cry1A       |
|    |           | Hyderabad                        |                 |
|    |           |                                  | cry1Ac          |
|    |           | Green Gold Seeds Ltd.,           |                 |
|    |           | Aurangabad                       | cry1Ac          |
|    |           |                                  |                 |
|    |           | JK Agri Genetics, Hyderabad      | cry1Ac, cryX    |
|    |           |                                  |                 |
|    |           | M/s Kaveri Seeds Co. P. Ltd,     | cryX            |
|    |           | S'bad                            |                 |
|    |           |                                  | cry1Ac          |
|    |           | Krishidhan Seeds, Jalna          |                 |
|    |           |                                  | cry1Ac          |
|    |           | Mahyco, Mumbai                   |                 |
|    |           |                                  | cry1Ac          |
|    |           | Metahelix Life Sciences,         |                 |
|    |           | Bangalore                        | GFM cry1A       |
|    |           |                                  |                 |
|    |           | Nandi Seeds, Aurangabad          | cry1Ac, cryX    |
|    |           |                                  |                 |
|    |           | Namdhari Seeds Pvt. Ltd.,        | cry1Ac          |
|    |           | Bangalore                        |                 |
|    |           |                                  | cry1Ac          |
|    |           | Nath Seeds, Aurangabad           |                 |
|    |           |                                  | cry1Ac          |
|    |           | Nuziveedu Seeds, Hyderabad       |                 |
|    |           |                                  | cryX            |
|    |           | Prabhat Agri Biotech Ltd.,       |                 |
|    |           | Hyderabad                        | Vip-3A          |
|    |           |                                  |                 |
|    |           | Pravardhan Seeds Pvt. Ltd,       | cry1Ac, cryX    |
|    |           | Hyderabad                        |                 |
|    |           |                                  | cry1Ac          |
|    |           | Proagro Seeds Co. Ltd.,          |                 |
|    |           | Hyderabad                        | cry1Ac          |
|    |           |                                  |                 |
|    |           | Rasi Seeds Ltd., Attur           | cry1Ac          |
|    |           |                                  |                 |
|    |           | Syngenta India Ltd., Pune        | cry1Ac          |
|    |           |                                  |                 |
|    |           | Tulsi Seeds, Guntur              | GFM cry1A       |
|    |           |                                  |                 |
|    |           | UAS, Dharwad                     |                 |
|    |           |                                  |                 |
|    |           | Vibha Agrotech Ltd., Hyderabad   |                 |
|    |           |                                  |                 |
|    |           | Vikki's Agrotech, Hyderabad      |                 |
|    |           |                                  |                 |
|    |           | Vikram Seeds Ltd., Ahmedabad     |                 |
|    |           |                                  |                 |
|    |           | Zuari Seeds Ltd., Bangalore      |                 |
+----+-----------+----------------------------------+-----------------+
| 6  | Groundnut | ICRISAT, Hyderabad               | Coat protein of |
| \. |           |                                  | IPCV            |
|    |           |                                  |                 |
|    |           |                                  | Nucleo Capsid   |
|    |           |                                  | Protein of PBNV |
+----+-----------+----------------------------------+-----------------+
| 7  | Mustard   | UDSC, New Delhi                  | Barnase &       |
| \. |           |                                  | barstar         |
+----+-----------+----------------------------------+-----------------+
| 8  | Okra      | Mahyco, Mumbai                   | cry1Ac          |
| \. |           |                                  |                 |
+----+-----------+----------------------------------+-----------------+
| 9  | Pigeonpea | ICRISAT, Hyderabad               | cry1Ac          |
| \. |           |                                  |                 |
+----+-----------+----------------------------------+-----------------+
| 10 | Rice      | IARI, New Delhi                  | cry1Ac,         |
| \. |           |                                  | cry1Aa + cry1B  |
|    |           | Mahyco, Mumbai                   |                 |
|    |           |                                  | cry1Ac          |
|    |           | Metahelix Life Sciences,         |                 |
|    |           | Bangalore                        | NHX gene        |
+----+-----------+----------------------------------+-----------------+
| 11 | Tomato    | IARI, New Delhi                  | Antisense       |
| \. |           |                                  | replicase gene  |
|    |           | Mahyco, Mumbai                   | of tomato leaf  |
|    |           |                                  | curl virus      |
|    |           |                                  |                 |
|    |           |                                  | Cry1Ac          |
+----+-----------+----------------------------------+-----------------+

Source: Department of Biotechnology Annual Report 2005-06

# ANNEX III: Application formats for imports of biotech products 

#  (R&D/contained use, intentional release & biotech food)

+-------+--------+------------------+----+----------------------------+
| A     | AP     | GOVERNING        | FO | LINKS FOR                  |
| GENDA | PROVAL |                  | RM |                            |
|       |        | RULES            |    | DOWNLOADING                |
|       | ACC    |                  | N  |                            |
|       | ORDING |                  | O. |                            |
|       |        |                  |    |                            |
|       | AGENCY |                  |    |                            |
+-------+--------+------------------+----+----------------------------+
| I     | IBSC   | Rules 1989;      | I  | [www.envfor.ni             |
| mport | /RCGM/ |                  |    | c.in/divisions/csurv/geac/ |
| of    |        | Plant Quarantine |    | geacform-I.doc](http://www |
| GMOs  | NBPGR  | (Regulation of   |    | .envfor.nic.in/divisions/c |
| /     |        | Imports into     |    | surv/geac/geacform-I.doc), |
| LMOs  |        | India) -- Order, |    |                            |
| for R |        | 2004 issued by   |    | [http://dbtindia.nic.in]   |
| & D   |        | NBPGR;           |    | (http://dbtindia.nic.in/), |
|       |        |                  |    |                            |
|       |        | Recombinant DNA  |    | http://nbpgr.delhi.nic.in  |
|       |        | safety           |    |                            |
|       |        | guidelines,1990; |    |                            |
|       |        |                  |    |                            |
|       |        | Revised          |    |                            |
|       |        | guidelines for   |    |                            |
|       |        | research in      |    |                            |
|       |        | transgenic       |    |                            |
|       |        | seeds, plant &   |    |                            |
|       |        | plant            |    |                            |
|       |        | parts,1998, &    |    |                            |
|       |        |                  |    |                            |
|       |        | Guidelines for   |    |                            |
|       |        | import of        |    |                            |
|       |        | germplasm, 2004  |    |                            |
|       |        | by NBPGR         |    |                            |
+-------+--------+------------------+----+----------------------------+
| I     | IBSC   | Rules 1989,      | II | [www.envfor.nic.in/di      |
| mport | /RCGM/ |                  | B  | visions/csurv/geac/geac_fo |
| of    |        | Biosafety        |    | rm-II-B.doc](http://www.en |
| GMOs  | GEAC   | guidelines of    |    | vfor.nic.in/divisions/csur |
| /     | /ICAR  | 1990 & 1998      |    | v/geac/geac_form-II-B.doc) |
| LMOs  |        |                  |    |                            |
| for   |        |                  |    |                            |
| i     |        |                  |    |                            |
| ntent |        |                  |    |                            |
| ional |        |                  |    |                            |
| re    |        |                  |    |                            |
| lease |        |                  |    |                            |
| (incl |        |                  |    |                            |
| uding |        |                  |    |                            |
| field |        |                  |    |                            |
| tr    |        |                  |    |                            |
| ials) |        |                  |    |                            |
+-------+--------+------------------+----+----------------------------+
| I     | GEAC   | Biosafety & Food | I  | [www.envfor.nic.in/        |
| mport |        | safety studies,  | II | divisions/csurv/geac/geac_ |
| of GM |        | Compliance with  |    | form-III.doc](http://www.e |
| food  |        | the Biosafety    |    | nvfor.nic.in/divisions/csu |
| /     |        | protocol         |    | rv/geac/geac_form-III.doc) |
| feed  |        |                  |    |                            |
| as    |        |                  |    |                            |
| LMOs  |        |                  |    |                            |
| per   |        |                  |    |                            |
| se    |        |                  |    |                            |
+-------+--------+------------------+----+----------------------------+
| I     | GEAC   | One time         | IV | [www.envfor.nic.i          |
| mport | to     | approval         |    | n/divisions/csurv/geac/gea |
| of GM | follow | required &       |    | c_form-IV.doc](http://www. |
| proc  | "Event | following        |    | envfor.nic.in/divisions/cs |
| essed | based  | information      |    | urv/geac/geac_form-IV.doc) |
| food  | app    | needs to be      |    |                            |
| de    | roval" | furnished --     |    |                            |
| rived | in a   |                  |    |                            |
| from  | given  | List of          |    |                            |
| LMOs  | crop   | genes/events     |    |                            |
|       |        | approved in the  |    |                            |
|       |        | crop species for |    |                            |
|       |        | commercial       |    |                            |
|       |        | production in    |    |                            |
|       |        | the country of   |    |                            |
|       |        | export/country   |    |                            |
|       |        | of origin;       |    |                            |
|       |        |                  |    |                            |
|       |        | Approval of      |    |                            |
|       |        | product for      |    |                            |
|       |        | consumption in   |    |                            |
|       |        | countries other  |    |                            |
|       |        | than producing   |    |                            |
|       |        | countries;       |    |                            |
|       |        |                  |    |                            |
|       |        | Food safety      |    |                            |
|       |        | study conducted  |    |                            |
|       |        | in the country   |    |                            |
|       |        | of origin;       |    |                            |
|       |        |                  |    |                            |
|       |        | Analytic         |    |                            |
|       |        | al/compositional |    |                            |
|       |        | report from the  |    |                            |
|       |        | country of       |    |                            |
|       |        | export/origin;   |    |                            |
|       |        |                  |    |                            |
|       |        | Details on       |    |                            |
|       |        | further          |    |                            |
|       |        | processing       |    |                            |
|       |        | envisaged after  |    |                            |
|       |        | import;          |    |                            |
|       |        |                  |    |                            |
|       |        | Details on       |    |                            |
|       |        | commercial       |    |                            |
|       |        | production,      |    |                            |
|       |        | marketing and    |    |                            |
|       |        | use for          |    |                            |
|       |        | feed/food in the |    |                            |
|       |        | country of       |    |                            |
|       |        | export/origin;   |    |                            |
|       |        |                  |    |                            |
|       |        | Details on the   |    |                            |
|       |        | approval of      |    |                            |
|       |        | genes / events   |    |                            |
|       |        | from which the   |    |                            |
|       |        | product is       |    |                            |
|       |        | derived          |    |                            |
+-------+--------+------------------+----+----------------------------+

Source: MOEF Website

# ANNEX IV: Steps involved in processing a transgenic event into a commercial variety

![](media/image3.jpeg){width="4.5in" height="6.0in"}

#   {#section-2 .unnumbered}

# 

# ANNEX V: Composition and Functions of Indian Biotech Regulatory Authorities

+-------------+------------------------------+-------------------------+
| Committee   | Members                      | Functions               |
+-------------+------------------------------+-------------------------+
| In          | Head of the Biotech Research | Training GM project     |
| stitutional | Project                      | personnel for safety.   |
| Biosafety   |                              |                         |
| Committee   | Scientists                   | Help the applicant to   |
|             |                              | prepare an on-site      |
| (IBC)       | Medical Expert               | emergency plan.         |
|             |                              |                         |
|             | Nominee of the Department of | Coordinate with         |
|             | Biotechnology                | district and state      |
|             |                              | level biotechnology     |
|             |                              | committees.             |
|             |                              |                         |
|             |                              | Instituting health      |
|             |                              | monitoring program for  |
|             |                              | lab personnel.          |
|             |                              |                         |
|             |                              | Carry out periodical    |
|             |                              | medical checks on lab   |
|             |                              | personnel.              |
+-------------+------------------------------+-------------------------+
| Review      | Representatives from:        | Review all ongoing GM   |
| Committee   |                              | research projects.      |
| on Genetic  | Department of Biotechnology  |                         |
| M           | (DBT)                        | Undertake visits to     |
| anipulation |                              | trial sites to ensure   |
| (RCGM)      | Indian Council of Medical    | adequate security       |
|             | Research (ICMR)              | measures.               |
|             |                              |                         |
|             | Indian Council of            | Issue clearance for     |
|             | Agricultural Research (ICAR) | import of raw materials |
|             |                              | needed in GM research   |
|             | Council of Scientific and    | projects.               |
|             | Industrial Research (CSIR)   |                         |
|             |                              | Scrutinize applications |
|             | Other experts in their       | made to the GEAC for    |
|             | individual capacity.         | import of bioengineered |
|             |                              | products.               |
|             |                              |                         |
|             |                              | Form Monitoring and     |
|             |                              | Evaluation Committee    |
|             |                              | for bio-engineered crop |
|             |                              | research projects.      |
|             |                              |                         |
|             |                              | Appoint sub-groups as   |
|             |                              | and when required in    |
|             |                              | topics of interest to   |
|             |                              | the committee.          |
+-------------+------------------------------+-------------------------+
| Genetic     | Chairman-Additional          | Approve activities      |
| Engineering | Secretary, Ministry of       | involving large-scale   |
| Approval    | Environment and Forests      | use of potential        |
| Committee   | (MOEF)                       | hazardous               |
|             |                              | micro-organisms and     |
| (GEAC)      | Co-Chairman - Nominee of     | recombinants in         |
|             | Department of Bio-technology | research and industrial |
|             |                              | production from the     |
|             | Members: Representatives of  | point of view of        |
|             | concerned agencies and       | environmental safety.   |
|             | departments namely Ministry  |                         |
|             | of Industrial Development,   | Approve proposals       |
|             | Department of Biotechnology, | relating to release of  |
|             | and the Department of Atomic | genetically engineered  |
|             | Energy                       | organisms and products  |
|             |                              | into the environment,   |
|             | Expert members: Director     | including field trials. |
|             | General-ICAR, Director       |                         |
|             | General-ICMR; Director       | Take punitive actions   |
|             | General-CSIR; Director       | on those found          |
|             | General of Health Services;  | violating the GM rules  |
|             | Plant Protection Adviser;    | under EPA, 1986.        |
|             | Directorate of Plant         |                         |
|             | Protection; Quarantine and   | Consult RCGM on         |
|             | storage; Chairman, Central   | technical matters       |
|             | Pollution Control Board; and | relating to clearance   |
|             | three outside experts in     | of bioengineered        |
|             | individual capacity.         | crops/products.         |
|             |                              |                         |
|             | Member Secretary: An         | Approve bioengineered   |
|             | official from the MOEF       | foods for commercial    |
|             |                              | sales/distribution.     |
+-------------+------------------------------+-------------------------+
| Recombinant | Scientists of Department of  | Take note of            |
| DNA         | Biotechnology                | developments in         |
| Advisory    |                              | biotechnology at        |
| Committee   |                              | national and            |
|             |                              | international level.    |
| (RDAC)      |                              |                         |
|             |                              | Prepare suitable        |
|             |                              | guidelines for safety   |
|             |                              | in research and         |
|             |                              | applications of GMOs.   |
|             |                              |                         |
|             |                              | Prepare other           |
|             |                              | guidelines as may be    |
|             |                              | required by the GEAC.   |
+-------------+------------------------------+-------------------------+
| State       | Chief Secretary, State       | Periodically review     |
| Bi          | Government; Secretaries,     | safety and control      |
| otechnology | Departments of Environment,  | measures in             |
| C           | Health, Agriculture,         | institutions in         |
| oordination | Commerce, Forests, Public    | handling biotech        |
| committee   | Works, Public Health;        | products.               |
| (SBCC)      | Chairman, State Pollution    |                         |
|             | Control Board; State         | Inspect and take        |
| (in states  | microbiologists and          | punitive action through |
| where       | pathologists; Other experts. | the State Pollution     |
| biotech     |                              | Control Boards or the   |
| research    |                              | Directorate of Health   |
| occurs)     |                              | in case of violations.  |
|             |                              |                         |
|             |                              | Take on-site control    |
|             |                              | measures.               |
+-------------+------------------------------+-------------------------+
| Dis         | District Collector; Factory  | To monitor safety       |
| trict-Level | Inspector; Pollution Control | regulations in research |
| Committee   | Board Representative; Chief  | and production          |
| (DLC)       | Medical Officer; District    | installations           |
|             | Agricultural Officer, Public |                         |
|             | Health Department            | Investigate compliance  |
|             | Representative; District     | with rDNA guidelines    |
|             | M                            | and report violations   |
|             | icrobiologists/Pathologists; | to                      |
|             | Municipal Corporation        |                         |
|             | Commissioner; other experts. | SBCC or GEAC.           |
+-------------+------------------------------+-------------------------+

Source: Environmental Protection Act, 1989.

# ANNEX VI: Procedure for Approval of Biotech Crops in India

Source: Department of Biotechnology, GOI

# ANNEX VII: Present Status of India's Compliance and Capacity Building Needs for Various parts of the Cartagena Protocol

  ------------- ------------------ -------------- ------------------- ---------------------
  **Article**   **Provisions**     **Present      **Capacity Building **Stakeholders**
                                   Status**       Needs**             

  Article 7     Application of the Competent      Customs and border  Scientists,
                Advanced Informed  authority      control procedures, regulators, customs
                Agreement          notified.      mainly for          and border control
                procedure prior to Border control import/export of    officials, traders
                the first          through NBPGR  LMOs for food, feed (importers,
                transboundary      only for       and processing;     exporters), food/feed
                movement of LMOs   contained use. documentation and   processing industry.
                intended for       Projects       inspection systems  
                direct use as food initiated to   for LMO shipments;  
                or feed, or for    strengthen DBT development of      
                processing         and MOEF's     methods and systems 
                                   capabilities   of identification   
                                   to identify    of LMOs.            
                                   LMOs.                              

  Article 8     Notification --    Rules 1989 and Harmonization of    Regulators, border
                The Party of       competent      rules with the      control officials,
                export shall       authorities in requirements of the industry,
                notify, or require place.         protocol.           importers/exporters
                the exporters to                  Incorporating the   
                ensure                            information         
                notification to,                  requirements for    
                in writing, the                   regulating status   
                competent                         of LMOs/GMOs in the 
                authority of the                  documentation for   
                Party of import                   export/import       
                prior to the                      Training            
                intentional                       customs/port        
                transboundary                     officials, such as  
                movement of LMOs                  plant quarantine,   
                that falls within                 etc. to review the  
                the scope of                      information         
                Article 7                         requirements.       

  Article 9     Acknowledgement of Point of       Strengthening of    Regulators (Members
                receipt of         contact        domestic regulatory of GEAC and other
                notification-The   notified, the  framework to meet   officials working in
                Party of import    regulatory     the timelines and   the relevant
                shall acknowledge  body, i.e.     access to data      ministries)
                receipt of the     GEAC, in place requirements.       
                notification, in                                      
                writing to the                                        
                notifier                                              
  ------------- ------------------ -------------- ------------------- ---------------------

  ------------- -------------------- ------------- -------------------------- --------------------
  **Article**   **Provisions**       **Present     **Capacity Building        **Stakeholders**
                                     Status**      Needs**                    

  Article 10    Decision             Regulatory    Strengthening of the       Regulators and
                Procedure-Decision   body, GEAC,   decision-making procedures associated
                taken by the Party   is in place   including access to        scientists,
                of import shall be                 databases (in terms of     Information
                in accordance with                 enforcement, inspection,   Technology managers
                Article 15                         and risk assessment)       

  Article 11    Procedure for LMOs   1989 Rules,   Capacity building for      Regulators, officers
                intended for direct  procedures to methods and systems of     from concerned
                use as food or feed, be detailed   detection of LMOs          ministries, i.e.
                or for processing                                             Ministry of Health,
                                                                              Ministry of Commerce
                                                                              etc.;
                                                                              importers/traders;
                                                                              researchers and
                                                                              technicians

  Article 13    Simplified Procedure 1989 rules    No information available   No information
                to ensure the safe                                            available
                intentional                                                   
                transboundary                                                 
                movement of LMOs                                              

  Article 14    Bilateral, regional  No            Regional harmonization of  No information
                and multilateral     information   biosafety-related sectoral available
                agreements and       available     laws/policies, and         
                arrangements                       synchronizing with other   
                                                   international agreements   
                                                   such as WTO and IPPC.      

  Article 15    Risk assessment      DBT           Laws/guidelines/policies   Policy makers,
                                     Guidelines    to be developed for        regulators,
                                     for research  biotech food/feed and      scientists, industry
                                     in plants     products thereof.          
                                                   Environmental risk         
                                                   assessment procedures to   
                                                   be streamlined, including  
                                                   baseline information.      

  Article 16    Risk Management      DBT           Laws/guidelines to be      Policy makers,
                                     Guidelines    developed, particularly    regulators,
                                     for research  for food/feed crops;       scientists, industry
                                                   harmonization with the     
                                                   existing procedures.       
  ------------- -------------------- ------------- -------------------------- --------------------

  ------------- ---------------- ------------- ---------------------- ------------------
  **Article**   **Provisions**   **Present     **Capacity Building    **Stakeholders**
                                 Status**      Needs**                

  Article 17    Unintentional    1989 rules    Detection, testing and Scientists,
                transboundary                  quantitative analysis  technicians, and
                movements and                  of LMOs; Border        custom and port
                emergency                      control and inspection officials
                measures                       facilities;            
                                               development of         
                                               emergency plans.       

  Article 18    Handling,        Detailed      Customs and border     Scientists,
                transport,       guidelines to control procedures,    technicians, and
                packaging and    be developed  Documentation and      custom and port
                identification                 inspection systems for officials
                                               LMO shipment, Methods  
                                               and systems of         
                                               identification of      
                                               LMOs, including        
                                               traceability and       
                                               technologies for safe  
                                               handling, packaging    
                                               and transporting of    
                                               LMO shipments.         

  Article 20    Information      Biosafety     Web based databases;   IT managers,
                sharing and the  Clearing      Non-internet based     scientists
                Biosafety        House (BCH)   electronic exchange    
                Clearing House   in place. A   material (e.g. CD      
                                 separate      ROMS, etc),            
                                 website on    publications and       
                                 capacity      documents; handbooks;  
                                 building      newsletters etc.       
                                 activities                           
                                 hosted by                            
                                 MoEF.                                

  Article 21    Confidential     No            Harmonization with     Regulators
                information      information   Right to Information   
                                 available     Act                    

  Article 22    Capacity         Ongoing,      Institutional capacity All stakeholders,
                building         including     building (including    including interest
                                 Global        national regulatory    groups such as
                                 Environment   frameworks), Human     farmers and
                                 Facility      resources development  consumers industry
                                 (GEF)-World   and training, Public   associations.
                                 Bank funded   awareness, education   
                                 Capacity      and participation,     
                                 Building      information exchange   
                                 project       and data management    

  Article 23    Public awareness Ongoing,      Biosafety awareness    All stakeholders
                and              including     activities (workshops, 
                participation    GEF-World     seminars, training     
                                 Bank funded   programmes, etc.) and  
                                 Capacity      materials (newsletter, 
                                 Building      bulletins, newspapers  
                                 Project       etc.), Risk            
                                               communication skills   
                                               and strategies         
  ------------- ---------------- ------------- ---------------------- ------------------

  ------------- ---------------- --------------- ---------------------- ------------------
  **Article**   **Provisions**   **Present       **Capacity Building    **Stakeholders**
                                 Status**        Needs**                

  Article 24    Non-Parties      1989 rules in   No information         No information
                (transboundary   place for all   available              available
                movements of     import and                             
                LMOs between     export                                 
                Parties and                                             
                non-Parties)                                            

  Article 25    Illegal          No information  Methods and mechanisms No information
                transboundary    available       for detecting          available
                movements                        unintentional or       
                                                 illegal LMO movement,  
                                                 border control and     
                                                 inspection facilities, 
                                                 compliance mechanisms  
                                                 to be strengthened.    

  Article 26    Socio-economic   Socioeconomic   Mechanism to determine Regulators,
                considerations   analysis is an  added value to         economists, NGOs,
                                 integral part   specific               social groups
                                 of decision     socio-economic         
                                 making          groups/sectors;        
                                                 Mechanism to review    
                                                 case-by case cost      
                                                 benefit analysis       

  Article 27    Liability and    National        Deliberations on       Regulators and
                redress          Consultation    approach for Article   legal experts,
                                 initiated and   27 negotiations.       particularly on
                                 ongoing                                international law.
  ------------- ---------------- --------------- ---------------------- ------------------

Source: Report on Capacity Building on Biosafety: Training Needs
Assessment, Project Coordination and Monitoring Unit, Ministry of
Environment and Forests, January 2006.