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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109211
Status
Published
Date of creation
2015-11-10 14:41 UTC (andrew.bowers@cbd.int)
Date of publication
2015-11-10 14:41 UTC (andrew.bowers@cbd.int)

Origin of report
1. Country
  • India
Contact officer for report
Coordinates
Mr. Hem Pande
Special Secretary, Ministry of Environment, Forest & Climate Change
Ministry of Environment, Forest & Climate Change
Indira Paryavaran Bhavan, Jor bagh Road
New Delhi
India, 110003
Phone:011-24695130
Fax:011-24695137
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 Third National Report included collection of information from various relevant documents and inputs from subject specific expert and representatives from concerned ministries/ departments and institutions. The inputs were collected through an inter-ministerial cum expert meeting of representatives of concerned ministries and agencies as well as experts familiar with obligations under the Cartagena Protocol on Biosafety.
Copy of the draft report was circulated to various stakeholders including ministries/ departments, enforcement agencies, academic institutions involved in biotechnology research, industry, industry associations, farmers associations, NGOs etc. Concerned experts and agencies were consulted at various stages during the preparation and validation process and one to one discussions were held with relevant experts. Important line ministries and agencies whose inputs were critical to the preparation of the Third National Report were included viz. Department of Agriculture & Cooperation, Ministry of Agriculture, Indian Council of Agricultural Research, Department of Biotechnology, Customs Department, National Biodiversity Authority, Directorate of Plant Protection, Quarantine and Storage,  National Bureau of Plant Genetic Resources etc. participated actively during the process. The draft report was validated by organizing a national consultation with stakeholders.
Submission
10. Date of submission
2015-11-09
11. Time period covered by this report
Start date
2011-11-01
11. Time period covered by this report
End date
2015-10-31
Party to the Cartagena Protocol on Biosafety
Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
This question is relevant to indicators 1.1.1, 2.1.1, 2.1.2, and 3.1.2 of the Strategic Plan
  • A domestic regulatory framework is fully in place
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
This question is relevant to the indicator 1.1.1 of the Strategic Plan
  • 2001 or earlier
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.
The Ministry of Environment, Forest and Climiate Change (MoEFCC) 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 to 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:
REGULATIONS:
i. Protection of Plant Varieties and Farmers Rights Act,2001
ii. Biological Diversity Act, 2002
iii.Plant Quarantine (Regulation of Imports into India) - Order, 2003
iv.Food Safety & Standards Act, 2006
v.Notification relating to Inclusion of GM Policy in the  Foreign Trade Policy (2006-09) by Directorate General of Foreign Trade
vi.The Export (Quality Control & Inspection) Act 1963 and Scheme for Non GMO Certification  (Doc No. EIC/NON GMO Cert Scheme/ Aug 2006/Issue II) & it related Amendment No. 1, Amendment No.2
GUIDELINES:
viii. Recombinant DNA Safety Guidelines, 1990
ix. Revised guidelines for research in transgenic plants, 1998
x. Guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics and other biologicals, 1999
xi. Guidelines & SOPs for conduct of confined field trials of regulated, GE Plants, 2008
xii. Guidelines & Protocols for the safety assessment of foods derived from GE Plants, 2008      
xiii. Guidelines for Institutional Biosafety Committees (IBSCs), 2011
xiv. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2012
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.Drugs and Cosmetics Rules (8th Amendment), 1988
3. Recombinant DNA Safety Guidelines, 1990
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.
6. Guidelines for Institutional Biosafety Committees (IBSCs), 2011
7. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2012
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
This question is relevant to indicator 1.8.1 of the Strategic Plan
  • No
26. Does your country regulate the contained use of LMOs?
This question is relevant to indicators 1.1.2 and 1.8.2 of the Strategic Plan
  • 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 conditions are regulated under the provisions of Rules for Manufacture/ Use/ Import and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or cell (Rules, 1989) under the EPA, 1986 and the Plant Quarantine (Regulation of Import into India) Order, 2003.
For import of LMOs for 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 import of LMOs (transgenic plant material) for research purposes, ICAR-National Bureau of Plant Genetic Resources (NBPGR) is the Nodal Institute to issue import permit after the technical clearance by Review Committee on Genetic Manipulation (RCGM) under Rules, 1989. Technical clearance is based on the safety of the material and national need taking into consideration the contained facilities available with the importer for transgenic material. Phyto-sanitary certificate issued by the authority of exporting country accomapny the import.
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 OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
This question is relevant to indicators 1.1.2 and 3.1.4 of the Strategic Plan
  • Yes
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
32. 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
33. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.4 of the Strategic Plan
  • Yes
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.5 of the Strategic Plan
  • No
38. 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
39. 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
46. 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 and hence no applications are accepted for direct introduction into the environment. Though, applications were received for conduct of trials using imported LMOs from time to time such imports for direct introduction into the environment were not considered and instead permitted only for research under contained use. The trials were permitted only after review of data generated in contained conditions in India.
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
- 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.
6. A Biosafety Support Unit has been set up by the DBT in 2014, consisting of scientists from multiple disciplines to assist regulatory committees in evaluation of various proposals.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
47. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
49. 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?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • Yes
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • No
58. 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
59. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
60. Has your country ever received a request for a review of a decision?
  • No
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
66. 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 MoEFCC. Constitution of appropriate appelate authority is being considered.
Article 13 – Simplified procedure
67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
68. Has your country ever applied the simplified procedure?
  • No
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
71. 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
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
76. 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.
Articles 15 & 16 – Risk Assessment and Risk Management
77. Has your country established a national framework for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?
  • Yes
79. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
This question is relevant to indicator 2.2.3 of the Strategic Plan
a) Risk assessment:
  • 100 or more
b) Management / Control:
  • 100 or more
c) Monitoring:
  • 100 or more
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
This question is relevant to indicator 2.2.6 of the Strategic Plan
  • Yes
84. Does your country have the capacity to detect, identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • Yes
c) Assess:
  • Yes
d) Monitor:
  • Yes
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • No
88. 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?
This question is relevant to indicator 1.4.1 of the Strategic Plan
  • No
89. Has your country ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs, e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?
This question is relevant to indicator 1.3.3 of the Strategic Plan
  • Yes
90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):
  • Commercial production
  • Field trial
  • LMOs for Contained use
91. If you answered Yes to question 89, were the summary reports of the risk assessments submitted to the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only
92. If you answered Yes to question 89, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs for direct use as food, feed, or for processing?
  • Yes, always
93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?
  • None
94. 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, to some extent
95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
96. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
This question is relevant to indicator 2.2.4 of the Strategic Plan
  • Yes
97. Here you may provide further details on the implementation of Articles 15 and 16 in your country
Article 15: 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.  India is following a case by case approach to risk assessment and risk management which is in line with international best practices.  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. Regulatory agencies have conducted risk assessments of LMOs for contained use, field trials and commercial purposes. So far, risk assessments of LMOs for direct use as food, feed or processing has not been conducted as India has not been a Party of import for such LMOs.
In view of the diverse range of organisms being subjected to genetic engineering and advances in techniques being used, constant efforts are made by the regulatory agencies for development of specific criteria/guidance to deal with the same.
A Risk Analysis Framework and guidelines for environmental risk assessment of GE plants are being prepared under the ongoing Phase II Capacity Building Project on Biosafety. Elements of the guidance and the training material developed by the CBD Secretariat are used in capacity building activities involving risk assessment and management of LMOs.
Continuous efforts are underway for strengthening the institutional capabilities and core competence of the personnel for implementation of Article 15 of the Protocol. A Biosafety Support Unit has been set up by the DBT in 2014, consisting of scientists from multiple disciplines to assist regulatory committees in evaluation of various proposals.
Article 16: 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
98. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
99. 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
100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
This question is relevant to indicator 1.8.3 of the Strategic Plan
  • Yes
101. 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
105. 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
106. 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
107. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • No
108. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes, to some extent
109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?
  • Existing types of documentation
110. 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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?
  • Existing types of documentation
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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
113. If you answered Yes or Yes, to some extent to question 112, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?
  • Existing types of documentation
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
This question is relevant to indicator 1.6.4 of the Strategic Plan
  • Yes
115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes, to some extent
116. How many customs officers in your country have received training in the identification of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • 50 or more
117. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
118. How many laboratory personnel in your country have received training in detection of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • 10 or more
119. Does your country have reliable access to laboratory facilities for the detection of LMOs?
This question is relevant to indicator 2.3.2 of the Strategic Plan
  • Yes
120. How many laboratories in your country are certified for LMO detection?
This question is relevant to indicator 2.3.3 of the Strategic Plan
  • 5 or more
121. How many of the certified laboratories in the previous question are currently operating in the detection of LMOs?
This question is relevant to indicator 2.3.4 of the Strategic Plan
  • 5 or more
122. 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, ICAR-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 ICAR-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.
India has several laboratories in both public and private sector who have required infrastructure and manpower for detection of LMOs. Efforts are underway to further strengthen a network of labs by enhancing infrastructure and providing training under UNEP/GEF supported Phase II Capacity Building Project on Biosafety.
Officers from enforcement agencies such as customs, quarantine, agriculture extension etc.  are apprised about the provisions of the Cartagena Protocol on Biosafety from time to time. Presentations are regularly organized of all new probabtioners of Indian Revenue Service.
Article 19 – Competent National Authorities and National Focal Points
123. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?
  • Not applicable
124. 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
125. Here you may provide further details on the implementation of Article 19 in your country
The Government of India has designated MoEFCC 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)
126. Please provide an overview of the status of the mandatory 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.
This question is relevant to indicator 3.1.5 of the Strategic Plan
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
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
c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
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
e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
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
j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
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
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
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 and in the BCH
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
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
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
127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
128. 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
129. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, in some cases
130. Has your country experienced difficulties accessing or using the BCH?
This question is relevant to indicator 4.1.8 of the Strategic Plan
  • No
131. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
132. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years:
This question is relevant to indicator 4.3.1 of the Strategic Plan
  • 10 or more
133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • 10 or more
134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • National website
  • Printed copies
135. 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 MoEFCC 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.  Five  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/) and website established by the Department of Biotechnology (DBT) on biosafety regulations (http://dbtbiosafety.nic.in)
Article 21 – Confidential information
136. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
137. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
138. 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
139. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
This question is relevant to indicator 1.2.6 and 3.1.8 of the Strategic Plan
  • Yes
140. 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
141. If you answered Yes to question 140, how were these resources made available?
  • Bilateral channels
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
143. If you answered Yes to question 142, how were these resources made available?
  • Bilateral channels
144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
145. If you answered Yes to question 144, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 157.
  • Difficult
146. 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)
147. 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
148. If you answered Yes to question 147, 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
149. During the current reporting period, has your country carried out a capacity-building needs assessment?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • Yes
150. If you answered Yes to question 149, has this information been submitted to the BCH?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
151. Does your country still have capacity-building needs?
This question is relevant to indicator 1.2.7 of the Strategic Plan
  • Yes
152. If you answered Yes to question 151, 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
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
153. Has your country developed a capacity-building strategy or action plan?
This question is relevant to indicator 1.2.2 of the Strategic Plan
  • Yes
154. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
This question is relevant to indicator 1.2.4 of the Strategic Plan
  • Yes
155. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
This question is relevant to indicator 1.2.3 of the Strategic Plan
  • 1 per year or more
156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • No
157. 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 MoEFCC 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 MoEFCC for targeted stakeholders viz; key government officials, Custom officials, Institutions, Industries, Universities, NGOs etc. 
India is implementing the UNEP/GEF supported Phase II Capacity Building Project on Biosafety which has the focus on four thrust areas viz. Risk Assessment and Risk Management, Handling, Transport, Packaging and IDentification, Socio-economic consierations and enhancing public awareness. Wide range of stakeholders are involved in  various activities under the project.
India has contributed in training personnel from other developing countries. Furthermore, Indian biosafety experts regularly participated in the workshops organized by other countries 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
158. 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
159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
This question is relevant to indicator 5.3.2 of the Strategic Plan
  • Yes
160. Does your country have any awareness and outreach programmes on biosafety?
This question is relevant to indicator 5.3.1 of the Strategic Plan
  • Yes
161. If you answered Yes to question 160, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place (e.g. local, national, etc.):
This question is relevant to indicator 5.3.1 of the Strategic Plan
Agencies at both national and state level are engaged in undertaking awareness and outreach programme on biosafety. These include central government ministries and departments concerned with biotechnology, academic and research institutions and state level agricultural universities, etc.
162. Has your country established a biosafety website searchable archives, national resource centres or sections in existing national libraries dedicated to biosafety educational materials?
This question is relevant to indicators 2.5.3 and 5.3.3 of the Strategic Plan
  • Yes
163. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
This question is relevant to indicator 5.2.1 of the Strategic Plan
  • One or more
164. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
165. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
166. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
167. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Yes
168. If you answered Yes to question 167, please indicate the modalities used to inform the public:
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
  • Mailing lists
169. If you indicated more than one modality for public participation in question 168, which one was most used?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
170. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
171. How many academic institutions in your country are offering biosafety education and training courses and programmes?
This question is relevant to indicator 2.7.1 of the Strategic Plan
  • 5 or more
172. Please indicate the number of educational materials and/or online modules on biosafety that are available and accessible to the public in your country:
This question is relevant to indicators 2.7.2 and 5.3.4 of the Strategic Plan
  • 10 or more
173. 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, to some extent
174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?
  • Yes
175. 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?
  • Never
176. 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 ) for public access.
Rules, 1989 does not mandatorily provide for public review/consultation.  The national policy documents viz. National Biodiversity Action Plan, 2008; National Biotechnology Development Strategy, 2014 etc. have provisions regarding enhancing public awareness and participation.  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. Biosafety outreach material such as brochures, booklets etc. is regularly prepared and circulated to stakeholders
Article 24 – Non-Parties
177. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
178. Has your country ever imported LMOs from a non-Party?
  • Yes
179. Has your country ever exported LMOs to a non-Party?
  • No
180. If you answered Yes to questions 178 or 179, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes
181. If you answered Yes to questions 178 or 179, was information about these transboundary movements submitted to the BCH?
  • No
183. 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.
Article 25 – Illegal transboundary movements
184. 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
185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
186. 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?
If you replied Never to question 186 please go to question 191
  • Never
191. 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
192. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
This question is relevant to indicator 1.7.2 of the Strategic Plan
  • No
193. 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
194. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
This question is relevant to indicator 1.7.1 of the Strategic Plan
  • 5 or more
195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:
This question is relevant to indicator 1.7.3 of the Strategic Plan
Socio-economic considerations have been taken into account by the regulatory authorities during the decisions taken with respect to LMOs approval/considered for approval so far. Specific studies to study the socio-economic impact were undertaken to facilitate decisions in case of Bt cotton and Bt brinjal
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to some extent
197. 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 information exchange on socio-economic aspects of LMOs for specific cases arose during the reporting period; however, cooperation on general understanding of the issues has been continuing.
Article 27 – Liability and Redress
198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • Yes
200. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
This question is relevant to indicator 2.4.1 of the Strategic Plan
  • No
201. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
This question is relevant to indicators 1.5.2 and 2.4.2 of the Strategic Plan
  • Yes
202. 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 ratified the Nagoya-Kuala Lumpur Supplementary Protocol on Liability Redress to the Cartagena Protocol on Biosafety in December, 2014.
Article 28 – Financial Mechanism and Resources
203. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
This question is relevant to indicator 1.2.5 of the Strategic Plan
  • 1,000,000 USD or more
Article 33 – Monitoring and reporting
204. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol?
This question is relevant to indicator 3.1.6 of the Strategic Plan
a) Monitoring system:
  • Yes
b) Enforcement system:
  • Yes
205. Has your country submitted all the previous due National Reports?
  • Yes
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.
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
The option of "Yes, to some extent" should be provided as an option in questions such as Q. 82 and 114.