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NATIONAL BIOSAFETY REGULATORY FRAMEWORK IN INDIA • Government of India has developed gradually a necessary regulation for the development

and evaluation of GMOs and rDNA research work. In India, the Ministry of Environment and Forests (MoEF) promulgated in Dec 1989, the rules and procedure for manufacture, import, research, use and release of GMO as well as products made from such organism. This was done under the provision of the Environment Protection Act 1986 rule 1989 to provide for protection and improvement of environment and the related matter. Any violation and non-compliance, including non-reporting of activities, in this area would attract the punishable action provided under the EPA. The rules and regulation cover the areas of research as well as large scale application of GMOs and product made their form. The rules also cover the application of hazardous microorganism which may not be genetically modified.

Indian Environment Protection Act 1986 Protection legislation Hazardous substances Central Govt. power Legal Provisions Penalties .

Ministry of Environment and Forests (MoEF) 1989 Objective Protect environment. nature and health Deal with application of gene technology and hazardous microorganism. Include Classification of Microorganism Scheme of approval Administrative mechanism .

Monitoring safety regulation at district level.Regulatory Frame work Government of India Department of Biotechnology Ministry of Environment and Forest RDAC Policy recommendation RCGM Manual of guideline Monitoring safety Procedure for restricting GEAC approval of GMO activities Permission of large scale Experiments Institutional Biosafety committee Implementation of guideline State Biosafety co-ordination Committee Regulation of Violation relating to GMOs District level co-ordination Committee. .

Recombination DNA Advisory Committee (RDAC) Review Committee in Genetic Manipulation(RCGM) Genetic Engineering Approval Committee(GEAC) State Biosafety co-ordination Committee(IBSC) District level co-ordination Committee. (DLCC) .REGULATORY MECHANISM Department OF Biotechnology Ministry of Environment and Forests.

•To develop long term policy for research and development in rDNA research.Recombination DNA Advisory Committee (RDAC) A committee constituted by DBT referred as Recombination DNA Advisory Committee. . •To recommended type of training programme for technician and research fellow for making them adequately qware of hazards and risk involved in rDNA research. Main function •To take note of development in biotechnology at national and international levels on current topics. •To formulate the safety guideline for rDNA research to be followed in India. •Recommend safety regulation for research and application.

•To recommend to RCGM about category III risk or above experiment and to seek RCGM approval.Biosafety Officer (in case of work with pathogenic agents/large scale use). The Committee will constitute the following: •Head of the Institution or nominee •3 or more scientists engaged in DNA work or molecular biology with an outside expert in the relevant discipline. •Instituting health monitoring programme for laboratory personnel. One member nominated by DBT. •A member with medical qualifications . Main activities are •To note and approve rDNA work •To ensure adherence of rDNA safety guideline of government. •To prepare emergency plan according to guideline.Institutional Biosafety Committee (IBSC) Institutional Biosafety Committee (IBSC) are to be constituted in all centre’s engaged in genetic engineering research and production activities. 4 . •Training of personnel on biosafety. •To ensure experimentation at designated location taking into account approved protocol. •To act as nodal point for interaction with statutory bodies. IBSC will provide half yearly report on the ongoing project to RCGM regarding the observance .

Banks towards clearance of applications in setting up industries based on genetically engineered organisms.Review Committee on Genetic Manipulation (RCGM): The RCGM will have the following composition: •Department of Biotechnology •Indian Council of Medical Research •Indian Council of Agricultural Research •Council of Scientific & Industrial Research •Three Experts in Individual capacity •Department of Science & Technology The RCGM will have the functions: •To establish procedural guidance manual . . production and applications related to environmental safety. •To advise on intellectual property rights with respect to rDNA technology on patents.procedure for regulatory process with respect to activity involving genetically engineered organisms in research. genetically engineered substances or products and on excisable items to Central Revenue and Excise. •To review the reports in all approved ongoing research projects involving high risk category and controlled field experiments. •To assist Department of Industrial Development. •To advise customs authorities on import of biologically active material. •To act as nodal point for interaction with statutory bodies. to ensure that safeguards are maintained as per guidelines. •To assist the Bureau of Indian Standards to evolve standards for biologics produced by rDNA technology. •To recommended the type of containment facility and the special containment conditions to be followed for experimental trials and for certain experiments.

Expert Nominee of Secretary. Central Pollution Control Board •3 Outside experts in individual capacity. Council of Scientific & Industrial Research •Director-General. Indian Council of Medical Research •Director-General. 4. Health Services (Ministry of Health & Family Welfare) •Plant Protection Adviser (Ministry of Agriculture) •Chairman.Additional Secretary. Expert Members: •Director-General. Indian Council of Agricultural Research •Director General. environmental release and field applications. Member Secretary . Department of Environment •Co-Chairman .Official of. DOEn . The composition of the Committee would be as follows: •Chairman . industrial production.Genetic Engineering Approval Committee (GEAC): Genetic Engineering Approval Committee (GEAC) will function under the Department of Environment (DOEn) as statutory body for review and approval of activities involving large scale use of genetically engineered organisms and their products in research and development. •Representatives of concerned Agencies and Departments: •Ministry of Industrial Development •Department of Science & Technology •Department of Ocean Development •Department of Biotechnology •3. DBT.

•Discharge of Genetically engineered/classified organisms/cells from Laboratory. selling of any microorganisms or genetically engineered substances or cells including food stuffs and additives that contains products derived by Gene Therapy. •Large scale use of genetically engineered organisms/classified microorganisms in industrial production and applications.The functions include giving approval from environmental angle on: •Import. manufacture. export. process. The approval will be for a period of 4 years. hospitals and related areas into environment. •Deliberate release of genetically engineered organisms. transport. . (Production shall not be commenced without approval).

•To review periodically the safety and control measure in various institutions handling GMOs. due to release of GMOs and to take on site control measure. •To act as nodal agency at State level to assess the damage. if any. Main function: •Power to inspect.State Biotechnology Co-ordination Committee. investigate and to take punishable action in case of violation of statutory provision through the State Pollution Control Board or Directorate of Health etc. . In each state there is a SBCC headed by chief Secretary where research and application of GMOs are contemplated.

•To act as nodal agency at District level to assess the damage if any. . investigate and report to the SBCC or the GEAC about compliance or non-compliance or r-DNA guideline or violations under EPA.DISTRICT LEVEL COMMITTEE Is headed by district Collector as an authoritative unit to monitor safety regulation. due to release of GMOs and to take on site control measure. Has power to inspect. Main function: To monitor the safety regulation in installations.