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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102647
Status
Published
Date of creation
2011-10-31 19:40 UTC (andrew.bowers@cbd.int)
Date of last update
2012-01-24 19:51 UTC (andrew.bowers@cbd.int)
Date of publication
2012-01-24 19:51 UTC (andrew.bowers@cbd.int)

Origin of report
Country
  • India
Contact officer for report
Coordinates
Mr. Hem Pande
Joint Secretary
Ministry of Environment & Forests
Paryavaran Bhawan, CGO Complex, Lodi Road
New Delhi
India, 110 003
Phone:+91 11 24362551
Fax:+91 11 24360894
Email:hempande@nic.in
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
The process of preparation of the second national report included collection of information from various relevant documents and discussions with subject specific expert and representatives from concerned ministries/departments and institutions.

Copy of the draft report was circulated to various stakeholders including ministries/departments, enforcement agencies, academic institutions involved in biotechnology research, industry, industry associations, civil societies, farmers associations, NGOs etc. Technical and legal experts were consulted at various stages during the preparation and validation process.Important line ministries and agencies whose inputs were critical to the preparation of the second national report included Department of Agriculture & Cooperation, Department of Agricultural Research and Education, Department of Biotechnology, Customs departments, National Biodiversity Authority, National Bureau of Plant Genetic Resources etc. , participated actively during the process.

The draft report was validated by organizing a series of consultations with stakeholders and reveiew by an expert group. 

  
Submission
10. Date of submission
2011-10-31
11. Time period covered by this report
Start date
2008-03-01
Time period covered by this report
End date
2011-10-31
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
  • Other laws, regulations or guidelines that indirectly apply to biosafety
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country:
The Government of India has created a comprehensive framework for ensuring safety while dealing with transboundary movements of GMOs/LMOs.
MoEF has notified the "Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/ Genetically Engineered Organisms or Cells  through Notification No. 621 in Official Gazette of Govt. of India on December 5, 1989 under the provisions of the Environment Protection Act,1986 (EPA)  with a view ensure sound application of biotechnology making it possible to accrue benefits arising from modern biotechnology while minimizing the risks to environment and human health. These rules and regulations commonly referred as 'Rules 1989' cover areas of research as well as production,manufacture, storage, export and import of genetically engineered cells or organisms and products thereof including drugs, pharmaceuticals and food stuffs.
The other relevant regulations and guidelines involving the manufacture, use, export, import and storage of LMOs include the following:
1.Protection of Plant Varieties and Farmers Rights Act,2001
2. Biological Diversity Act, 2002
3.Plant Quarantine (Regulation of Imports into India) - Order, 2003
4.Biological Diversity Rules, 2004
5.Food Safety & Standards Act, 2006
6.DGFT Notification relating to Inclusion of GM Policy in the  Foreign Trade Policy (2006-09)
7.National Green Tribunal Act, 2010
8. Recombinant DNA Safety Guidelines, 1990
9. Revised guidelines for research in transgenic plants, 1998
10. Guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics and other biologicals, 1999
11. Guidelines & SOPs for conduct of confined field trials of regulated, GE Plants, 2008
12. Guidelines & Protocols for the safety assessment of foods derived from GE Plants, 2008
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • Yes
23. If you answered Yes to question 22, has this information been submitted to the BCH?
  • Yes
24. Here you may provide further details on the implementation of Article 5 in your country:
Regulation of recombinant drugs and pharmaceuticals in India are guided by the following laws, guidelines and policy documents:
1. Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms/ Genetically Engineered Organisms or Cells, 1989 issued under EPA, 1986.
2. Recombinant DNA Safety Guidelines, 1990
3. Drugs and Cosmetics Rules (8th Amendment), 1988
4. Guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics and other biologicals, 1999.
5. Gazette Notification No. GSR 616(E) dated 4th October, 2006 exempting certain categories of recombinant pharma from the purview of Rules, 1989.
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • No
26. Does your country regulate the contained use of LMOs?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
28. Here you may provide further details on the implementation of Article 6 in your country:
The import and use of LMOs for the purpose of research in contained condition are regulated under the provisions of Rules, 1989 and the Plant Quarantine Order, 2003.
In respect of import of LMOs for the purpose of contained use, rDNA Biosafety Guidelines, 1990 stipulate detailed procedure for import including the type of containment, packaging, labelling, contact point and documents to accompany shipment. National Bureau of Plant Genetic Resources (NBPGR) is the nodal institute for import of LMOs (transgenic plant materials) for research purpose. Technical  clearance for import of transgenic plant material, for research purposes is issued by the Review Committee on Genetic Manipulation (RCGM) under Rules, 1989 based on the safety of the material and the national need and taking into consideration the facilities available with the importer for in-soil tests on the transgenic material. The importer of a transgenic plant material is required to furnish, an appropriate phyto-sanitary certificate issued by the authority of the country of export.Technical clearance for such imports is given by RCGM and the import permit is issued by NBPGR.
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • Yes
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
34. Does your country have the capacity to detect and identify LMOs?
  • Yes
35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
37. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Not applicable
39. If you answered Yes to question 38, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • Not applicable
40. If you answered Yes to question 38, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • Not applicable
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
42. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
50. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment:
1.India has not imported any LMOs for the purpose of intentional release into the environment during the reporting period. Therefore, experience in implementing Article 7-10  is limited. 
2.Direct import of seeds for the purpose of field trials or intentional introduction into the environment is not permitted as per the policy decisions taken by the regulatory authorities.
3.Decisions on the intentional introduction of LMOs (irrespective of whether it is  imported  or domestically developed) are  taken as per the provisions under Rules, 1989 and the following Biosafety Guidelines: 
- Recombinant DNA Safety Guidelines, 1990 & 1994
- Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation, 1998
- Guidelines and SOPs for the conduct of Confined Field Trials of Transgenic Plant, 2008
- Guidelines for the Safety Assessment of GM Foods, 2008
-Protocols for Safety Assessment of Genetically Engineered Plants / crops, 2008.
4. There is a three tier system of approval for LMOs and products thereof under Rules, 1989. The initial assessment of the applications begins at the institutional level itself by the Institutional Biosafety Committees (IBSCs). The IBSC evaluates the proposal and recommends it to the next higher authority i.e. Review Committee on Genetic Manipulation (RCGM).  The RCGM sends its recommendations to GEAC after an indepth evaluation, which is the apex committee for approval. 
5. RCGM consists of experts from multiple disciplines, whereas GEAC has representatives from line ministries as the members, in addition to subject specific experts. Both these committees analyze each proposal based on the notified guidelines and protocols.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
  • Yes
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
  • Yes
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • Yes
55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?
  • No
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • Yes
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • No
63. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP:
India has not been a Party of import of LMOs for the purpose of food , feed or processing  during the reporting period.Therefore, experience in implementing Article 11  is limited.
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
65. Has your country ever received a request for a review of a decision?
  • No
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
71. Here you may provide further details on the implementation of Article 12 in your country:
There is a mechanism for review of decisions under domestic regulatory framework, wherein the applicants can approach regulatory authorities for reconsideration of their cases .  In addition to the above, Rules, 1989 provide for review of decisions by an appeal mechanism . It has been indicated in clause 19 that any person aggrieved by a decision made by GEAC in pursuance with these rules, may within 30 days from the date on which the decision is communicated to him prefer an appeal to such authority as may be appointed by the MoEF. 
The National Green Tribunal has been established on 18.10.2010 under the National Green Tribunal Act 2010 for effective and expeditious disposal of cases relating to environmental protection and conservation of forests and other natural resources including enforcement of any legal right relating to environment and giving relief and compensation for damages to persons and property and for matters connected therewith or incidental thereto. It is a specialized body equipped with the necessary expertise to handle environmental disputes involving multi-disciplinary issues. The Tribunal's dedicated jurisdiction in environmental matters shall provide speedy environmental justice and help reduce the burden of litigation in the higher courts. The Tribunal is mandated to make and endeavour for disposal of applications or appeals  within 6 months of filing of the same.
Article 13 – Simplified procedure
72. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
73. Has your country ever applied the simplified procedure?
  • No
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
76. Here you may provide further details on the implementation of Article 13 in your country:
No simplified procedure has been adopted by India in implementing Article 13 during the reporting period.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
80. Here you may provide further details on the implementation of Article 14 in your country:
Since India has neither been a Party of import nor a Party of export of LMOs, we have not entered into any bilateral, regional or multi-lateral agreements or arrangements as per the provisions of Article 14 during the reporting period.
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • Yes
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • Yes
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • No
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Yes, always
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • In some cases only
90. In the current reporting period, if your country has taken decisions regarding LMOs, how many risk assessments were conducted in the context of these decisions?
  • Less than 10
91. Has your country ever required the exporter to conduct the risk assessment(s)?
  • Not applicable
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • Yes, always
93. Here you may provide further details on the implementation of Article 15 in your country:
All decisions on the import and domestic use of living modified organisms are made by the GEAC on the basis of thorough assessment of the potential risks posed by the organism, as per stringent requirements under the Rules, 1989 and biosafety guidelines issued from time to time.  Risk assessment requirements under the Rules, 1989 are consistent with the requirements under the Protocol and as are provided for in Annex III.
There are well defined review and approval processes for various activities involving LMOs i.e. import and shipment, research in contained facilities viz. laboratory, greenhouse or nethouse, confined field trials and conduct of biosafety studies.  The guidelines provide for categorization of LMOs into various biosafety levels based on  their characteristics, which are taken into consideration while undertaking risk assessment.
In view of the diverse range of organisms being subjected to genetic engineering, constant efforts are made by the regulatory agencies for development of specific criteria/guidance to deal with the same. Continuous efforts are underway for strengthening the institutional capabilities and core competence of the personnel for implementation of Article 15 of the Protocol.
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • Yes
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes
97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • No
98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • No
99. Here you may provide further details on the implementation of Article 16 in your country, including any details regarding risk management strategies, also in case of lack of scientific certainty on potential adverse effects of LMOs:
The GOI is following case by case approach in evaluating potential risks posed by activities involving LMOs. Based on the risk assessments suitable risk management strategies are prescribed by the regulatory agencies to prevent and control risks within acceptable limits.
In India, Bt cotton was approved in 2002 after extensive biosafety and agronomic evaluation.  There were several conditions laid by GEAC while according approval for Bt cotton for risk management. These included continuous monitoring of development of insect resistance under the aegis of Central Institute of Cotton Research, the premier institution involved in cotton research.
Article 17 – Unintentional transboundary movements and emergency measures
100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?
  • Yes
101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • No
103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
107. Here you may provide further details on the implementation of Article 17 in your country:
During the reporting period, there were no known occurrences under Indian jurisdiction that led, or could have led, to an unintentional transboundary movement of a living modified organism that had, or could have had, significant adverse effects on the conservation and sustainable use of biological diversity and/ or human health.
Article 18 – Handling, transport, packaging and identification
108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes, to some extent
109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • No
110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • No
111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
  • Yes
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
  • Yes
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes, to some extent
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes, to some extent
115. Here you may provide further details on the implementation of Article 18 in your country:
During the reporting period, India has neither been an importer nor exporter of LMOs except for the purpose of research and therefore experience in implementing Article 18 is limited to that extent.  However, domestic regulations are in place, which require prior approval of competent authorities, before import /export of LMOs irrespective of the purpose it is being imported for.

In respect of imports of LMOs for the purpose of contained use, rDNA Biosafety Guidelines, 1990 stipulate detailed procedure for import including the type of containment, packaging, labelling, contact point and documents to accompany shipment. For the import of transgenic plant material for reserach purpose, NBPGR is the nodal institute.   Clearance for import of transgenic plant material, for research purposes is issued by the RCGM under Rules, 1989 based on the safety of the material and the national need and taking into consideration the facilities available with the importer for in-soil tests on the transgenic material. The importer of a transgenic plant material is required to furnish, an appropriate phyto-sanitary certificate issued by the authority of the country of export. The technical clearance of imports is given by RCGM and import permit is issued by the NBPGR.  

As per the DGFT notification, at the time of import, all consignments containing products which have been subjected to genetic modification will carry a declaration stating that the product is 'Genetically Modified'.In case a consignment does not carry such a declaration and is later found to contain genetically modified material, the importer is liable to penal action under the Foreign Trade (Development and Regulation) Act, 1992.
Article 19 – Competent National Authorities and National Focal Points
116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?
  • Yes
117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?
  • Yes
118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?
  • Yes, one
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes
123. Here you may provide further details on the implementation of Article 19 in your country:
The Government of India has designated MoEF as its Competent National Authority (CNA). The CNA has notified national focal points for CPB, BCH and Emergency measures on the BCH.
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
124. Please provide an overview of the status of the information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
124.a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
124.b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
124.c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
124.g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
124.h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information not available
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information not available
124.l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information not available
124.m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information available but not in the BCH
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
124.o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available but only partially available in the BCH
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, in some cases
128. Has your country experienced difficulties accessing or using the BCH?
  • No
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Not applicable
130. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
131. Here you may provide further details on the implementation of Article 20 in your country:
In accordance with the requirement under Article 20 of CPB, a National BCH Portal was set up as part of the Phase-I Capacity Building Project on Biosafety.  India had established its BCH as per one of the options provided by SCBD wherein the relevant information could be posted on the National BCH and periodically the Central Portal would retrieve the meta data.  However, due to security reasons an open-ended access from the NIC website was not available and therefore inter-operability between the National BCH and CBD Central portal was not functional.
In view of similar difficulties expressed by other parties, the SCBD has modified the BCH and also options for participation by Parties. In line with the above it has been decided by the Ministry of Environment & Forests to dispense with the National BCH and opt for direct online submission of information through the central portal using Hermes. 
Subsequently  the following information has been provided on the BCH.
a. National laws, regulations and guidelines for manufacture, import, export, storage and use of Living Modified Organisms (LMOs).
b. Contact details of competent authorities, national focal points and emergency contacts.
c. Capacity building project database and country needs.
d.       Decisions and summaries of risk assessments
Regarding  information to be provided to the BCH in respect of decisions and declarations for import/export of LMOs, India so far has neither been a Party of import or export of LMOs except imports for the purpose of research and development. India has not notified  any simplified procedure and also not entered into any bilateral, regional or multilateral agreements or arrangements for import of LMOs. During the period of reporting there has been no occurrence of unintentional/illegal transboundary movement of LMOs, which has been brought to the notice of the Government. In respect of domestic use of LMOs, Bt cotton is the only transgenic crop approved for commercial cultivation in India.  Six  different events have been approved and information on decisions taken has been posted on BCH.
In addition to BCH, other websites have been created to disseminate information about activities involving LMOs in the country.  These include GEAC website ( http://moef.nic.in/modules/project-clearances/geac-clearances/) wherein the relevant information about applications and decisions is posted and two websites established by the Department of Biotechnology (DBT) on biosafety regulations (http://dbtbiosafety.nic.in) and database on research involving GMOs namely Indian GMO Research Information System (http://www.igmoris.nic.in).
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
134. Here you may provide further details on the implementation of Article 21 in your country:
The Government of India has notified Right to Information Act, 2005 (RTI) vide Gazette notification no 25 dated June 21, 2005. RTI lays down procedure for treatment and disclosure of information treated as confidential by third party. It provides for exemption from disclosure of information including commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party, unless the competent authority is satisfied that larger public interest warrants the disclosure of such information.
The guidelines for conduct of Confined Field Trials of Regulated GE plants, 2008 and the Guidelines for Safety Assessment of Foods derived from GE plants,2008 also have provision for treatment of confidential business information.
Article 22 – Capacity-building
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
136. If you answered Yes to question 135, how were these resources made available?
  • Bilateral channels
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
138. If you answered Yes to question 137, how were these resources made available?
  • Bilateral channels
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • Yes
140. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
141. If you answered Yes to question 140, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 150.
  • Difficult
142. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Implementation of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase II)
143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • Yes
146. Does your country still have capacity-building needs?
  • Yes
147. If you answered Yes to question 146, indicate which of the following areas still need capacity-building.
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Handling of confidential information
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
148. Has your country developed a capacity-building strategy or action plan?
  • No
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • No
150. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
India is committed to effective implementation of the obligations under Cartagena Protocol on Biosafety and therefore capacity building activities are an ongoing process through national and international resources.
Pursuant to successful completion of  GEF/ World Bank supported capacity building project for implementing national biosafety framework (NBF) related to the transboundry movement of LMOs in June 2007, a full scale project on capacity building for biosafety for GEF funding has been developed by MoEF with the support of UNEP. The phase-II project through GEF resources is conceptualized to supplement the ongoing biosafety capacity building initiatives in India, integrate international experience and promote regional cooperation. The proposal has recently been approved by the GEF council.
However, there were certain difficulties in accessing funds from GEF primarily due to operational reasons, extensive documentation requirements and review process, leading to delays in timely project sancions. In such instances, by the time funds become available, changes in national policies could affect the project implementation schedule and outcome. 
India participated in the BCH capacity building project supported by Global Environment Facility (GEF) and United Nations Environment Programme (UNEP). Under the UNEP-GEF BCH phase II project, a series of training workshops were organized by MoEF for targeted stakeholders viz; key government officials, Custom officials, Institutions, Industries, Universities, NGOs etc. 
India is hosting the eleventh Conference of the Parties (COP11) to the Convention on Biological Diversity (CBD) and the sixth Conference of the Parties serving as Meeting of Parties (COP-MOP-6) to be held in Hyderabad in October 2012. As part of its commitments, India is hosting the following three preparatory meetings at New Delhi:
1.Workshop on Capacity-Building for Research and Information Exchange on Socio-economic Impacts of Living Modified Organisms under the Cartagena Protocol on Biosafety on November 14-16,2011
2.Asia-Pacific Regional Workshop on the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety" on November 17-18, 2011
3.Asia Sub-regional Training of Trainers' Workshop on the Identification and Documentation of LMOs on November 21-25,2011 .
India has contributed in training personnel from other developing countries. Furthermore, Indian biosafety experts participated in the workshops organized by the Govt. of Vietnam, Thailand, Sri Lanka, Bhutan, Malaysia and others for exchange of information, sharing of experiences on implementation of the national biosafety regulations, risk assessment and management and other related issues. Similarly experts from various countries have been interacting with Indian counterparts and participating in events organized in India.
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
152. Has your country established a biosafety website?
  • Yes
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • Yes
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • More than 5
160. Here you may provide further details on the implementation of Article 23 in your country:
Information on activities  involving LMOs including the research and development, confined field trials and environmental release are made available on the websites of concerned ministries. ( http://www.envfor.nic.in/divisions/csurv/geac/geac_home.html,http;//http://www.dbtbiosafety.nic.in  and http://www.igmoris.nic.in ) for public access.
Though the domestic regulatory framework does not explicitly provide for public review/consultation, the regulatory agencies have been adopting consultative process while reviewing the applications as well as formulating the guidance documents. The information about the regulatory framework and the guidance has been widely distributed to create awareness among stakeholders. Outcome of the public consultation is also made available in the public domain.
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
162. Has your country ever imported LMOs from a non-Party?
  • Yes
163. Has your country ever exported LMOs to a non-Party?
  • No
164. If you answered Yes to questions 162 or 163, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes, always
165. If you answered Yes to questions 162 or 163, was information about these transboundary movements submitted to the BCH?
  • No
166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?
  • Not applicable
167. Here you may provide further details on the implementation of Article 24 in your country:
Public and private sector organizations actively involved in research in biotechnology have been regularly importing various strains of living modified microorganisms, cell lines and other LMOs from non Parties for the purpose of contained use only. However, information about such imports is not posted on websites because it involves confidential business information and relates to research at preliminary stages of product development.
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Never
175. Here you may provide further details on the implementation of Article 25 in your country:
Rules 1989 and Foreign Trade Policy (FTP) provide for penal provisions, in case of illegal transboundary movement of LMOs.
It has been stated in the FTP that all imported goods shall be subject to domestic Laws, Rules, Orders, Regulations,technical specifications, environmental and safety norms as applicable to domestically produced goods. Also there is a provision for penalty in case of violation of any condition of such authorisation or fails to fulfill export obligation, he shall be liable for action in accordance with Foreign Trade  (Delopment and Regulation) Act, 1992, the Rules and Orders made there under and any other law for time being in force.

The Customs Act, 1962, provides for "Detection of illegally  imported goods and prevention of the disposal thereof" and "Prevention or detection of illegal export of goods".


Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • Not applicable
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to a limited extent
178. Here you may provide further details on the implementation of Article 26 in your country:
Since India has been neither a Party of import nor export of LMOs, no occasion for cooperation with other parties on research and information exchange on socio economic aspects of Living Modified Organisms arose during the reporting period.

India is hosting Workshop on Capacity-Building for Research and Information Exchange on Socio-economic Impacts of LMOs under the Cartagena Protocol on Biosafety on November 14-16, 2011 at New Delhi.
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • Yes
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • Yes
181. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress:
India has signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability Redress to the Cartagena Protocol on Biosafety on October 11, 2011 and the process of ratification has been initiated.  Prior to ratification, a study has been commissioned to a legal expert to examine the implications of the Supplementary Protocol and to suggest whether the existing domestic laws are sufficient to comply with India's obligations to the above protocol, indicate relevant provisions and changes, if any, required for ensuring compliance.
India is also hosting the "Asia and Pacific Regional Workshop on the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety"  on 17 - 18 November 2011 at New Delhi.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
183. If your country did not submit previous reports, indicate the main challenges that hindered the submission
  • Not applicable
Other information
184. Please use this field to provide any other information on issues related to national implementation of the Protocol, including any obstacles or impediments encountered.
India has been neither an importer nor exporter of LMOs except for the purpose of research and contained use and therefore experience is limited.The implementation of CPB is through the existing rules and guidelines. Constant efforts are underway to strenghthen the implementation of various provisions. 

During the reporting period the Govt. has taken a decision to release two more events of Bt cotton developed in the country. In addition, several transgenic crops such as Brinjal, Rice, Okra, Pigeon pea, Chick pea, Mustard, Potato, Castor, Maize, sorghum, cabbage, cauliflower,cotton,tomato, groundnut, wheat,watermelon, papaya, banana, sugarcane, rubber etc are in different stages of development and field testing.
Comments on reporting format
185. Please use this field to provide any other information on difficulties that you have encountered in filling in this report.
In some of the questions such as 124(c) and 130, an additional option of 'Not Applicable' could be included. Similarly addition of option of 'to a limited extent' to question 60,148,168 and 169, would be useful. Also the protected version of reporting format could be  made more user friendly.