Environment (Protection) Act, 1986

This act highlights various procedures and safeguards for handling of 'Hazardous Substances'. The act defines the term 'Hazardous Substances' as any substance by reason of its chemical properties or handling is liable to cause harm to humans and living organisms.

Section 6 of the act allows the government to make rules to regulate environmental pollution. Section 8 deals with persons handling hazardous substances to comply with procedural safeguards. And Section 25 gives overall powers to the government to make rules. Based on these three sections, in 1989 the government notified the Rules for Manufacture, Use, Import, Export and Storage of hazardous microorganisms and genetically engineered organisms (GMO) or cells. These rules are also applicable to new genetic technologies.

India has placed GMOs under the same category as hazardous microorganisms and their regulation is justified by their alleged potential to be hazardous substances or environmental pollutants. Development of further regulations has been in response to the need for regulatory oversight of the growing domestic community engaged in biotechnology research in both agricultural and pharmaceutical sectors. This also happened in response to debates within the European Union about the safe use of genetically modified organisms, during negotiations on regional directives on contained use and deliberate release of GMOs. The possibility that India might be a future importer of GMOs from OECD (Organization of economic cooperation and development) countries also spurred development of the domestic regulatory framework.

1990 Recombinant DNA Safety Guidelines (RADC)

According to these guidelines, any institution including research institution handling micro-organisms/genetically engineered organisms is required by law to have an Institute Bio-safety committee (IBSC). Currently, more than 300 such committees exist across the country. These committees have a government representative as a member. They undertake the responsibility of training personal on bio-safety and teaching them safe disposal of hazardous wastes. They also help move the organization towards adoption of an emergency plan.

Also, guidelines of recent origin deal with research in transgenic plants and guidelines for toxicity and allergenicity evaluation of transgenic seeds, plants and plant parts, and helps towards research in this arena and generation of safety information.

Biosafety Regulatory Framework

The Department of Biotechnology has been issuing new guidelines to match with the progress of technology. As per the guidelines issued by the Department of Biotechnology in the years 1990, 1994 and 1998; the initial rules that were enforced in 1989 have been elaborated and revised. In the year 1994 revised guidelines dealt with issues related with GMOs (Genetically Modified Organisms), genetic transformation of green plants, recombinant DNA technology in vaccine development and various other occupational safety and other related issues. Guidelines that were issued in 1998 were in respect to research in transgenic plants, toxicity, evaluation of transgenic seeds and plants. These rules add to the regulatory architecture by calling for toxicity and allergenicity data on transgenic plants and plant parts. They also clarify how the procedures governing import of genetically modified organisms for research are distinct from exports for release and commercialization. The only subtle difference between these two is that the 1994 guidelines essentially deal with agriculture as well as pharmaceutical issues, while the 1998 guidelines essentially deal only with issues related to transgenic use of agriculture.

The information to be taken into account in assessing GMO safety is contained in the 1990, 1994 and 1998 Biosafety guidelines. Information requirements are very similar to those in risk assessment models elsewhere. Indian risk assessment guidelines have drawn upon models used by the United States Department of Agriculture Plant and Animal Health Inspection Service (APHIS) as well as from biosafety guidelines elaborated by other OECD countries. Guidelines developed by international agencies, such as OECD and the World Health Organisation (WHO) have also served as models.

Institutional Advisory and Regulatory Bodies

The Government of India has constituted various advisory and regulatory bodies to help the scientific community and industry. The Review Committee on Genetic Manipulation (RCGM) monitors the safety related aspects in respect of on-going research projects involving genetically engineered organisms/hazardous microorganisms. This committee also brings out manuals of guidelines for various safety related procedures and operates under the Ministry of Biotechnology.

The other important committee is the Genetic Engineering Approval Committee (GEAC). It operates under the Ministry of Environment. It approves activities involving large-scale use of hazardous microorganisms and recombinants from the point of view of environment.

Codes of Conduct

The Indian Council of Medical Research (ICMR) developed codes of conduct for scientists engaged in biomedical research in 2000. These guidelines are consistent with the 1964 Helsinki declaration, which was later amended in 2000 based on principles of autonomy, privacy, justice and equity.

Export Control

India has a well-established export control mechanism in place.Export of Special Chemicals, Organisms, Materials, Equipment and Technologies (SCOMET) is permitted only against an export licence issued. In this respect, the Government of India have issued guidelines relating to the export of SCOMET items. Handbooks containing such guidelines are issued from time to time.

All dual use items and technologies are covered under the SCOMET list in eight different categories. Under this list, category 2 covers Microorganisms and Toxins. The list also covers plant pathogens and genetically modified organisms. Along with this list there are various guidelines particularly 94-98 guidelines which list micro organisms on the basis of differential risk assessment. The 2000 r-DNA guidelines are also a part of it.

The SCOMET List is currently notified in the Export Policy in Schedule 2.

After 2001, new mechanisms were evolved in India regarding Classifications of Export and Import Items, 2004-2009. The list contains all dual use items and technologies within 8 categories, in keeping with the Government of India requirements. These include nuclear and chemical sections and a section on Micro-organisms and Toxins.