The Government of India has created a comprehensive framework for ensuring safety while dealing with transboundary movements of GMOs/LMOs. <br />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&nbsp; 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)&nbsp; 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.<br />The other relevant regulations and guidelines involving the manufacture, use, export, import and storage of LMOs include the following:<br />REGULATIONS:<br />i. Protection of Plant Varieties and Farmers Rights Act,2001<br />ii. Biological Diversity Act, 2002 <br />iii.Plant Quarantine (Regulation of Imports into India) - Order, 2003 <br />iv.Food Safety &amp; Standards Act, 2006 <br />v.Notification relating to Inclusion of GM Policy in the&nbsp; Foreign Trade Policy (2006-09) by Directorate General of Foreign Trade<br />vi.The Export (Quality Control &amp; Inspection) Act 1963 and Scheme for Non GMO Certification&nbsp; (Doc No. EIC/NON GMO Cert Scheme/ Aug 2006/Issue II) &amp; it related Amendment No. 1, Amendment No.2<br />GUIDELINES:<br />viii. Recombinant DNA Safety Guidelines, 1990<br />ix. Revised guidelines for research in transgenic plants, 1998<br />x. Guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics and other biologicals, 1999 <br />xi. Guidelines &amp; SOPs for conduct of confined field trials of regulated, GE Plants, 2008<br />xii. Guidelines &amp; Protocols for the safety assessment of foods derived from GE Plants, 2008&nbsp; &nbsp; &nbsp;&nbsp; <br />xiii. Guidelines for Institutional Biosafety Committees (IBSCs), 2011<br />xiv. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2012

Regulation of recombinant drugs and pharmaceuticals in India are guided by the following laws, guidelines and policy documents:<br />1. Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms/ Genetically Engineered Organisms or Cells, 1989 issued under EPA, 1986.<br />2.Drugs and Cosmetics Rules (8th Amendment), 1988<br />3. Recombinant DNA Safety Guidelines, 1990<br />4. Guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics and other biologicals, 1999.<br />5. Gazette Notification No. GSR 616(E) dated 4th October, 2006 exempting certain categories of recombinant pharma from the purview of Rules, 1989.<br />6. Guidelines for Institutional Biosafety Committees (IBSCs), 2011<br />7. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2012

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.<br />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.

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&nbsp; is limited.&nbsp; <br />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.<br />3.Decisions on the intentional introduction of LMOs (irrespective of whether it is&nbsp; imported&nbsp; or domestically developed) are&nbsp; taken as per the provisions under Rules, 1989 and the following Biosafety Guidelines:&nbsp; <br />- Recombinant DNA Safety Guidelines, 1990 <br />- Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation, 1998 <br />- Guidelines and SOPs for the conduct of Confined Field Trials of Transgenic Plant, 2008 <br />- Guidelines for the Safety Assessment of GM Foods, 2008 <br />-Protocols for Safety Assessment of Genetically Engineered Plants / crops, 2008. <br />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).&nbsp; The RCGM sends its recommendations to GEAC after an indepth evaluation, which is the apex committee for approval.&nbsp; <br />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.<br />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.

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

There is a mechanism for review of decisions under domestic regulatory framework, wherein the applicants can approach regulatory authorities for reconsideration of their cases .&nbsp; 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.

No simplified procedure has been adopted by India in implementing Article 13 during the reporting period

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: 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.&nbsp; India is following a case by case approach to risk assessment and risk management which is in line with international best practices.&nbsp; Risk assessment requirements under the Rules, 1989 are consistent with the requirements under the Protocol and as are provided for in Annex III. <br />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.&nbsp; The guidelines provide for categorization of LMOs into various biosafety levels based on&nbsp; 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.<br />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. <br />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.<br />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. <br />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. <br />In India, Bt cotton was approved in 2002 after extensive biosafety and agronomic evaluation.&nbsp; 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.

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.

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.&nbsp; 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.<br />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.&nbsp;&nbsp; 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.&nbsp;&nbsp; <br />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.<br />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.<br />Officers from enforcement agencies such as customs, quarantine, agriculture extension etc.&nbsp; 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.

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.

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.&nbsp; 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.&nbsp; 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.<br />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.&nbsp; <br />Subsequently&nbsp; the following information has been provided on the BCH.<br />a. National laws, regulations and guidelines for manufacture, import, export, storage and use of Living Modified Organisms (LMOs). <br />b. Contact details of competent authorities, national focal points and emergency contacts.<br />c. Capacity building project database and country needs.<br />d. Decisions and summaries of risk assessments <br />Regarding&nbsp; 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&nbsp; 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.&nbsp; Five&nbsp; different events have been approved and information on decisions taken has been posted on BCH. <br />In addition to BCH, other websites have been created to disseminate information about activities involving LMOs in the country.&nbsp; These include GEAC website ( <a href="http://moef.nic.in/modules/project-clearances/geac-clearances/">http://moef.nic.in/modules/project-clearances/geac-clearances/</a>) and website established by the Department of Biotechnology (DBT) on biosafety regulations (<a href="http://dbtbiosafety.nic.in">http://dbtbiosafety.nic.in</a>)

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. <br />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.

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.<br />Pursuant to successful completion of&nbsp; 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.<br />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.&nbsp; <br />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.&nbsp; <br />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&nbsp; various activities under the project.<br />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.

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.

Information on activities&nbsp; involving LMOs including the research and development, confined field trials and environmental release are made available on the websites of concerned ministries. ( <a href="http://www.envfor.nic.in/divisions/csurv/geac/geac_home.html">http://www.envfor.nic.in/divisions/csurv/geac/geac_home.html</a>, http;//<a href="http://www.dbtbiosafety.nic.in">http://www.dbtbiosafety.nic.in</a> ) for public access.<br />Rules, 1989 does not mandatorily provide for public review/consultation.&nbsp; The national policy documents viz. National Biodiversity Action Plan, 2008; National Biotechnology Development Strategy, 2014 etc. have provisions regarding enhancing public awareness and participation.&nbsp; 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

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.

Rules 1989 and Foreign Trade Policy (FTP) provide for penal provisions, in case of illegal transboundary movement of LMOs.<br />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&nbsp; (Delopment and Regulation) Act, 1992, the Rules and Orders made there under and any other law for time being in force. <br />The Customs Act, 1962, provides for "Detection of illegally&nbsp; imported goods and prevention of the disposal thereof" and "Prevention or detection of illegal export of goods".

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

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.

India has ratified the Nagoya-Kuala Lumpur Supplementary Protocol on Liability Redress to the Cartagena Protocol on Biosafety in December, 2014.

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.

The option of "Yes, to some extent" should be provided as an option in questions such as Q. 82 and 114.