India

The Republic of India occupies the greatest part of South Asia. It is bordered by six countries – Pakistan, China, Nepal, Bhutan, Bangladesh, and Myanmar. New Delhi is the capital city. It has a total population of 1,080 million (July 2005 est.).

India’s total land area is 1,269,000 sq. miles (3,287,000 sq. km), 57% of which is arable land. Of the total cropped area, 211,100 sq. miles (546,700 sq. km) is irrigated.

The Indian agriculture sector employs 256 million of the total 378 million labor force of India. It is the largest producer of milk, fruits, cashew nuts, coconuts and tea in the world, the second largest producer of wheat, vegetables, sugar and fish and the third largest producer of tobacco and rice. In 2004, the top 3 crops planted were rice (23.85%), coarse cereals (16.49%) and wheat (13.79%); rice also being the top exported agricultural product. The agricultural exports for the fiscal year, 2003-04, amounted to $6506 million.

General Biotech Scenario
Government Support

The Indian Government has laid out an infrastructure suited for the growth of biotechnology research over the past two decades. It 1986, the government created the Department of Biotechnology (DBT) to oversee the development of biotechnology application projects, demonstration of proven technologies and training of human resource in States and Union Territories.

Crops Being Field Tested or Commercialized

Both laboratory research and field trials are already being conducted on various genetically modified crops that include rice, tobacco, potato, tomato, Brassica, mustard/rapeseed, and cotton.

Agricultural Scenario
Role of Agriculture in the Country

The agriculture sector has a vital place in the economic development of India as it provides 23.6% of the gross domestic product (GDP) and accounts for one sixth of the total value of the country’s exports. About 290 million of the workforce depends on agriculture alone.

However, a looming problem is the continuing shrinkage of cropland per person which threatens India's food security. In 1960, each Indian had an average of 0.21 hectares of grainland. By 1999, the average had dropped to 0.10 hectares per person, or less than half as much. And by 2050, it is projected to shrink to a meager 0.07 hectares per person.

India’s farm sector had a record food grain production of over 220 million tonnes. It has also been estimated that the growth rate in the agriculture and allied sector was 9.6 per cent in 2003-04 and is said to grow 1.1 per cent in the current year.

Description of Agricultural Sector (Major Crops Grown; Crop Exports)

About two-thirds of the Indian population derives their livelihood directly from agriculture either as landowners or as landless labor. As such, the country has achieved self-sufficiency in food grain production and has tripled its grain harvest over the last half century. It is fast becoming globally competitive in the agricultural sector.

India, through its GEAC (spell out GEAC), approved its first GM crop, Bt cotton, to be grown on a commercial scale in March 2002. As of 2005, a total of 20 Bt cotton hybrids are approved for planting in different zones all over the country.

Government Plan for Agriculture

India’s government is supportive of initiatives in agriculture. The National Policy on Agriculture seeks to actualize the vast untapped growth potential of Indian agriculture, strengthen rural infrastructure to support faster agricultural development, promote value addition, accelerate the growth of agro business, create employment in rural areas, secure a fair standard of living for the farmers and agricultural workers and their families, discourage migration to urban areas and face the challenges arising out of economic liberalization and globalization. (link: http://www.indiancommodity.com.agpolicy.htm)

Public Sector/Private Sector Initiatives

India has a large research and educational infrastructure to carry out biotechnology research, comprising 31 agriculture universities, 204 central and state universities, and more than 500 national laboratories and research institutions. Presently, there are three types of ongoing research activities: R&D projects in priority crops, multi-institutional projects on development of transgenics and quality trait studies in wheat.

The establishment of a Biotechnology Golden Jubilee Park for Women encourages women entrepreneurs to take up biotechnology enterprises that benefit women in particular.

The Biotech Sector
Government Support (Biotechnology Acts; Biotech Plan)

The Government of India realized the need for creating a separate institutional framework to strengthen biology and biotechnology research in the 1980s. Modern biological research is supported by the following scientific agencies: Council of Scientific and Industrial Research, Indian Council of Agricultural Research, Indian Council of Medical Research, and the funding agencies like the Department of Biotechnology, Department of Science and Technology and the University Grants Commission. Biotechnology was given a boost in 1982 with the establishment of the National Biotechnology Board.

The success and impact of the National Biotechnology Board prompted the Government to establish a separate Department of Biotechnology (DBT) in 1986. The DBT has close interaction with the State Governments particularly through S and T Councils for developing biotechnology application projects, demonstration of proven technologies, and training of human resource in States and Union Territories.

The DBT came out with a document (http://dbtindia.nic.in/vision.html) representing a ten-year vision of India’s biotechnologists and some eminent non-resident Indian scientists associated with the programs and advisory committees of the DBT. Its vision statement is: “Attaining new heights in biotechnology research, shaping biotechnology into a premier precision tool of the future for creation of wealth and ensuring social justice specially for the welfare of the poor.”

The vision documents states that transgenics of rice, brassica, mungbean, pigeonpea, cotton, potato, tomato, and some vegetables like cabbage, and cauliflower would complete field assessment and some of them would be ready for large-scale seed production by 2005. Nutritionally enhanced potato and BT cotton are among the important ones. Transgenic wheat with more protein content and better quality and also higher lysine content and market assisted breeding program is expected to be introduced in farmers field by 2003-2005.

Regulatory Environment

Biosafety

India first issued rules and procedures for handling GM organisms in December 1989. The Department of Biotechnology published these rules in 1990 and subsequent revisions were made in 1994 and 1998.

These ensure an effective evaluation of transgenic plants before they are given clearance for release in the field. The 1998 version elaborates the procedures for screening transgenic plants and seeds for toxicity and allergenicity.

Organizational Structure of Relevant Institution

Safety guidelines for recombinant DNA research and development in India were made by the Recombinant DNA Advisory Committee set up by the Department of Biotechnology in consultation with experts working in this area and representatives from different ministries. Regulatory mechanism for the development and evaluation of transgenics as per the recombinant DNA safety guidelines is based on a three-tier system with the Institutional Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM), and Genetic Engineering Approval Committee (GEAC).

Institutional Biosafety Committee (IBSC)

Chaired by the Head of the Institution or his nominee, the committee has members from different disciplines, a Biosafety Officer and one member nominated by the Department of Biotechnology. The committee’s functions are to:

* Provide half yearly report on the ongoing projects to the Review Committee on Genetic Manipulation (RCGM) regarding the observance of the safety guidelines on accidents, risks and on deviations, if any;

* Review and clear project proposals falling under restricted category that meets the requirements under the guidelines; and

* Synchronize the biosafety programme to the level of risk assessment.

Review Committee on Genetic Manipulation (RCGM)

The RCGM functions under the Department of Biotechnology and has representatives of various ministries and scientists from different disciplines. The committee is headed by an eminent biotechnologist and has the following functions:

* Establish procedures for regulatory process with respect to an activity involving genetically engineered organisms in research, production and applications related to environmental safety;

* Review the reports in all approved ongoing research projects involving high-risk category and controlled field experiments, to ensure that safeguards are maintained as per guidelines; and

* Recommend the type of containment facility and the special containment conditions to be followed for experiments.

The RCGM has a “Monitoring-cum-Evaluation Committee” to design field experiments. It likewise formats the collection of scientific data on plants grown under contained conditions as well as in limited field trials.

Genetic Engineering Approval Committee (GEAC)

As an inter-ministerial committee under the Ministry of Environment and Forests, it is the competent authority for release of GMOs into the environment. It is chaired by the Additional Secretary, Department of Environment and Forests and has members from different ministries and scientists drawn from different disciplines. The Ministry of Environment and Forests issues authorizations to applicants on the basis of approvals accorded by the GEAC. The important functions of the committee are:

* Import, export, transport, manufacture, process and selling of any microorganism or genetically engineered substances or cells including foodstuffs and additives;

* Discharge of genetically engineered/classified organisms/cells from laboratories, hospitals and related areas into environment;

* Large-scale use of genetically engineered organisms/classified microorganisms in industrial production and applications (Production shall not be commenced without approval); and

* Deliberate release of genetically engineered organisms. The approval will be for a period of 4 years.India does not have an official food safety policy on genetically modified foods. Its Prevention of Food Adulteration Act, which took effect in 1954, is still the basic document. In 1998, its biosafety guidelines required that GM seeds, plants, and plant parts be separately screened for toxicity and allergenicity. This guideline gives India a rather permissive and a full promotional safety policy toward GM foods.

For more information on biosafety regulations in India, visit http://envfor.nic.in/divisions/csurv/biosafety/biosafety_regulations.htm

IPR

India did not have a strong intellectual property rights policy for decades because it relied exclusively on its own public sector scientists and extension agents, rather than private investors or international private companies to stimulate innovation in agriculture. In 1988, a New Seed Policy liberalized industrial licensing policies which allowed multinational seed companies to make significant investments. These developments pressured India to enact a basic Plant Variety Protection Act (PVPA), a draft which was submitted to Parliament in 1993. Events like the TRIPS agreement in World Trade Organization required a redrafting of the act and another version of the PVPA was submitted to Parliament in 2000.

India’s own draft PVPA law incorporates a farmers’ rights provision. It proposes an institutional mechanism designed to ensure the rights of farming communities to financial compensation for any earlier contributions they might have made to the plant varieties that will finally be protected under the act. The 1999 draft of India’s PVPA certifies the rights of villages and local communities to claim contribution to the evolution of plant varieties, and to then receive appropriate financial compensations paid from a centrally managed National Gene Fund.

Labeling

Foods grown in India for export must be labeled according to the policies of the importing countries. Labeling requirements are likely to be imposed as soon as GM food crops are released by the GEAC for commercial planting. Transgenic pharmaceutical products in India that have been deregulated for sale by GEAC must be labeled as GM.

Other Countries:

• Asia
• Europe
• North America
• Oceania
• South America

Summary Report on the Global Status of Commercialized Biotech/GM Crops - [View the 2004 report]

Transgenic Crops - [Click Here]

Extensive Study on Bt Cotton - [Click Here]

Download the complete copy of the ISAAA Briefs on Global Status/Review of GM Crops - [Click Here]

SciDev.Net's dossier on GM crops - [Click here]

Global Status of Approved Genetically Modified Plants -  [Click here]

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