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India - Agricultural Biotechnology, annual report

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Table of contents

Report highlights:

Bt cotton is currently the only commercially approved biotech crop in India. Over the last ten years, six events and more than 1100 Bt hybrids have been approved for commercial cultivation. As a result, India has emerged as the second largest producer and exporter of cotton in the world. In 2010, the Government of India (GOI) announced a moratorium on the approval process for Bt brinjal (eggplant). Since then there has been no movement in resuming the approval process. Research has also been hampered by a new Genetic Engineering Appraisal Committee directive which requires applicants to obtain a “No Objection Certificate (NOC)” from the relevant state authority before commencing biotech field crop trials. On May 10, 2012, the Supreme Court of India instituted a six-member Technical Expert Committee to review and recommend biosafety risk assessment studies for genetically modified (GM) crops.

Executive summary:

Agricultural trade between the United States and India reached $3.4 billion in calendar year (CY) 2011. U.S. exports to India amounted to $723 million, while U.S. imports from India reached $2.68 billion, skewing the agricultural trade balance nearly 4 to 1 in India’s favor. India’s agricultural exports to the U.S. include guar gum, shrimp, cashew nuts, spices, tea, essential oils, rice, vegetable oil and processed fruits & vegetables. U.S. agricultural exports to India include tree nuts, soybean oil, fresh fruits, cotton, pulses and forest products. 

The 1986 Environmental Protection Act (EPA) lays the foundation for India’s biotechnology regulatory framework (see Annex 1). The Indian biotech regulatory system adopts a precautionary approach for the biosafety assessment of food and agricultural products. Annex 2 of the EPA outlines the procedures for importing biotech products, including products used for research. 

Under current Indian regulations, all biotech food/agricultural products or products derived from biotech plants/organisms must receive formal approval from the Genetic Engineering Appraisal Committee prior to commercialization or imports (the GEAC is India’s apex biotech regulatory body). Soybean oil derived from Round-up Ready soybeans is the only biotech food/agricultural product currently approved for import. In CY 2010, U.S. soybean oil exports to India were estimated at a record $132 million, but declined sharply in CY 2011 to $94,000 due to market conditions. 

In November 2007, the Government of India (GOI) introduced a National Biotech Development Strategy, outlining a plan to set up an independent and autonomous national biotech regulatory authority that would provide a single window mechanism for biosafety clearance of genetically engineered products and processes. The Department of Biotechnology (DBT) under the Ministry of Science and Technology (MST) has the responsibility to establish and operationalize the new Biotechnology Regulatory Authority of India (BRAI). After a consultative process involving interdisciplinary and inter-ministerial experts, state governments and other stakeholders, the DBT submitted a draft BRAI bill 2012 for parliamentary approval. Pending action by the Indian Parliament, the existing regulatory framework will continue to oversee biotechnology regulation. 

Bt cotton is the only biotech crop currently approved for commercial cultivation in India. Since 2002, the GOI has approved six Bt cotton events and more than 1100 Bt cotton hybrids for commercial cultivation. In October 2009, the GEAC recommended the approval of commercial cultivation of Bt brinjal (eggplant). However, on February 9, 2010, following a series of public consultations, the Ministry of Environment and Forest (MoEF) announced a moratorium on the approval of Bt eggplant until the regulatory system could ensure food and environmental safety. More than two years have passed since the moratorium announcement, but there has been little progress on either biosafety assessment or approval of Bt eggplant. 

On July 6, 2011, the GEAC introduced new procedures for authorizing biotech crop field trials, requiring applicants (technology developers) to obtain a “no objection certificate (NOC)” from the relevant state government. The GEAC decision has hampered ongoing field trials as only a few states have issued NOCs. 

On May 10, 2012, the Supreme Court of India instituted a six-member Technical Expert Committee to review and recommend biosafety risk assessment studies for genetically modified (GM) crops. The Technical Expert Committee was given two months to develop recommendations that may affect the current/existing biotech regulatory system/processes.