India is one of the few countries in Asia that has instituted biosafety regulations. How effective are these regulations? Are they well enforced? Doubts were raised when an institute under the Ministry of Agriculture was found to be violating biosafety guidelines.

The symposium on 'Biotechnology and Biodiversity: Scientific and Ethical Issues', was held in New Delhi in November 1996. The participants exchanged views on policy formulation; monitoring systems; and public participation in biosafety regulations in India. They were representatives from governments, academia, international agricultural research centres such as the International Rice Research Institute (IRRI), private companies and non­governmental organizations (NGOs). The symposium was jointly organized by the United States Department of Agriculture (USDA) and the Indian Institute of Management (IIM).

Transgenic research trials
In India, a number of research projects involving Genetically Modified Organisms (GMOs), with both contained and field trials, are already in progress. This points to the urgency of assessing the effectiveness and enforcement of biosafety regulations in the country. For example, during the symposium, the conducting of an unauthorized transgenic field trial was revealed. The trial was conducted by the Indian Agricultural Research Institute (IARI), an autonomous institute under the Indian Ministry for Agriculture. The IARI scientists have introduced a synthetic toxin gene, CryIA(b), obtained from Japan into the native variety of an eggplant, Solanum melongena. Since August 1996, Bacillus thuringiensis (Bt) plant expressing gene Solanum melongena was being grown in an experimental plot of 60 square meters at the IARI compound in New Delhi. Nets were the only protective cover of the experimental plot. This clearly violated biosafety guidelines. Since the symposium, the Indian media has been covering this unauthorized trial. As a result in December 1996, IARI was ordered by the government to burn down the experimental plot.
Currently, the total area under transgenic field trials in India is nearly two acres. The annual report from the Department of Biotechnology (DBT) has listed two field trials. The first is by Proagro­PGS India Ltd. which imported transgenic mustard from Plant Genetic Systems (PGS) in Belgium. They started the field trial in 1994 at Gurgaon (Haryana) and Bangalore (Karnataka).
Aside from field trials, the company also conducts contained glasshouse experiments in Gurgoan. Proagro­PGS India Ltd. had imported from PGS Belgium tomato seeds containing a Bt CryIA(b) gene. Experiments have been designed to analyze its resistance to tomato fruit worms native to India. When the results are positive, the company intends to conduct field trials within a year. The company also plans to conduct contained glasshouse trials for Bt eggplants.
The second field trial is by Mahyco of Bombay, in collaboration with the US­based company Monsanto, which has imported seeds of cotton variety containing Bt genes. The field test is being conducted at Jalna, Maharashtra. This involves the backcrossing of the transgenic cotton with domestic cotton lines. The experiments will evaluate resistance of the transgenic cotton plants to bollworm. In India, the estimated annual loss due to bollworms damage to cotton is US$ 40 million.
Many of the glasshouse trials imply a subsequent increase in field trials in the near future. A further increase in the amount of research projects involving transgenics is also very likely.

Institutional framework
India's Biosafety and Recombinant DNA Guidelines (1990) falls under the Environment (Protection) Act of 1986. In 1994, after India signed the Biodiversity Convention, the DBT revised its earlier guidelines to accommodate the safe handling of GMOs in research, application and technology transfer. This includes the large scale production and deliberate release of GMOS plants, animals and products into the environment. Guidelines are also provided for the shipment and importation of GMOs for laboratory research.
There is no permanent secretariat to monitor the trials of the  GMOs. Instead the regulations are implemented by various ad hoc committees. The most important committees are: the Institutional Biosafety Committees (IBSC), responsible for the local implementation of guidelines; the Review Committee on Genetic Manipulations (RCGM) responsible for issuing permits; and the Genetic Engineering Approval Committee (GEAC) responsible for monitoring the large­scale and commercial use of transgenic materials. These committees have statutory authority. Most of the committee members are from the scientific community and staff of DBT and the Ministry of Environment and Forestry. DBT appoints the members to the committees.
The GEAC is supposed to be assisted by the State Biotechnology Coordination Committees (SBCC) and District Level Committees (DLC). However, none of the 26 states have established SBCC and DLC committees, not even in areas where field trials are already taking place.
Moreover, while committee members are drawn from the scientific community, many are not well versed in biosafety issues and risk assessment. The committees function under different departments and lack coordination. Consequently, decision making is inefficient.

Criticism of the policy
Biosafety regulations come under severe criticism from environmentalists and industries alike. Industries claim that the absence of a transparent system has led to unnecessary doubts in the minds of the public about the implications of GMOs. Moreover, the DBT deals with companies on a case­by­case basis. This prevents the industries from pleading their cases collectively. However, this also presents some advantage to the industries. For example, they do not have to take a public stand on any controversies regarding transgenics. Additionally, the lack of clear guidelines enables industries to have more influence on the guideline formulation and implementation.
Some industries claim that the regulatory authorities often come out with whimsical guidelines. When the guidelines need amendments, arbitrary arguments arise. One point of argument was the isolation distance of the trial field from related conventional crops. DBT earlier came out with a regulation distance of 100 metres. After disagreements with an industry, after eight, long months the DBT amended its stand to 70 meters. The usual debate between industrial firms and DBT stems from the lack of data to serve as models for local experiments. DBT's knowledge base and scientific base for determining protocol for field testing remains weak. Industrial firms prefer to use data from other countries and suggest that there is no need to "reinvent the wheel" in experiments involving GMOs.
Environmental organizations such as the Gene Campaign  and the Research Foundation for Science Technology and Ecology (RESTE) criticize biosafety policy for ignoring specific Indian needs and environmental conditions. For instance, copying the USA legislation, as some critics accuse India of, neglects the dangers of cross­fertilization. The danger is much higher in a biodiversity­rich country like India compared to a biodiversity­poor country like USA. Environmentalists criticise the RCGM for not involving any participation from either research level (universities, research institutes) or user level (industry, consumers, farmers). As a consequence, both the governing bodies and the system of policy making lack transparency. The absence of NGO representation in any of the regulatory committees has been particularly noted. According to Vandana Shiva of RESTE, they have the technical experts in biosafety assessment to merit participation in these committees.
In the symposium in New Delhi, representatives from the Ministry of Environment and Fishery openly admitted that they do not have the structure or resources in terms of finance, expertise and facilities to effectively assess, enforce and monitor biosafety regulations in India. At this stage, India's experience has been limited to small field trials. Doubts are being raised about the country's preparedness to meet the potential risks arising from GMOs. For instance, when transgenic crops are commercialized on a large scale, can biosafety regulations be monitored? As of now, the absence of an effective system to monitor imports of agricultural commodities and plant materials appears to be highly problematic.
In India the dangers of GMOs receive a lot of public and media attention. The apprehensions about GMOs are linked, amongst others, with concerns for biodiversity preservation. Cross­fertilization may result in the loss of indigenous species because of competition in the ecological system. The potential dangers include the displacement or destruction of indigenous or endemic species; and exposure of species to new pathogens.
In response to such criticisms, DBT plans to conduct activities to enhance awareness and technical expertise about biosafety. This includes training of scientists, and visits to countries with biosafety policies such as the USA. DBT hopes to improve their data base on biosafety regulations. On the other hand, NGOs such as RESTE are contributing to the information campaign. However, the overall institutional capacity building to effectively enforce and monitor biosafety policies remain inadequate.

India at international biosafety fora
Despite backlogs in domestic biosafety policy and enforcement, India also has to deal with these issues in the international arena. The United Nations Environment Programme (UNEP) and World Health Organisation (WHO) have issued international guidelines for the safe use of GMOs. At UNEP, the 'Protocol on Biosafety' is being formulated under the Convention on Biological Diversity. This protocol includes public participation by making available the results of any testing and monitoring involving GMOs. However, this has not been adopted in the Indian policy. Parts of OECD guidelines on risk evaluation have also been included in the Indian guidelines. Some companies in India think that what has been adopted is very precautious and does not follow the familiarity principle in biosafety assessment. The familiarity principle involves the notion that the country has knowledge and experience in testing the crops involved; and thereby has the basis to predict how the crop will behave once it is released into the environment. In the precautionary principle approach each case is isolated from other experiences, and is separately reviewed.
Given the commitments that India has made in international fora, the country will have to take a long and hard look at the existing mechanisms aimed at ensuring that biotechnology does not have an adverse impact on the environment. Aside from lack of participation and slow clearances, Indian regulatory bodies need political support and technical expertise to effectively enforce and monitor trials involving GMOs.
Sachin Chaturvedi

Research and Information System for the  Non­Aligned and Other Developing Countries (RIS), India Habitat Centre Zone IV, Fourth Floor Lodhi Road, New Delhi 110 003. E­mail: panchmuk@giasdl01.vsnl.net.in

Sources
Alam Ghayur (1996), Genetically Modified Organisms: biosafety implications for India. Paper submitted at the satellite symposium to the Third International Crop Science Congress, New Delhi.

India, Government of (1996), Annual Report 1995­96. Department of Biotechnology.
"IARI Scientists are in Trouble Over New Variety", Times of India, 10 December 1996.

Personal Communications with Suman Sahai (Gene Campaign), P.K.Ghosh (Department of Biotechnology), P.K. Agarwal (Proagro­ PGS), Dr.V.R. Gadwal (MAHYCO), K.P.S. Chauhan (Ministry of Environment and Forests), Afsar Jafri (Research Foundation for Science, Technology and Ecology), and Sivramiah Shantharam (United States Department of Agriculture).