NATIONAL BIOSAFETY REGULATORY FRAMEWORK IN INDIA Government of India has developed gradually a necessary regulation for the development
t 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
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. Monitoring safety regulation at district level.
REGULATORY MECHANISM Department OF Biotechnology
Ministry of Environment and Forests.
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)
Recombination DNA Advisory Committee (RDAC) A committee constituted by DBT referred as Recombination DNA Advisory Committee. Main function
To take note of development in biotechnology at national and international levels on current topics. Recommend safety regulation for research and application. To develop long term policy for research and development in rDNA research.
To formulate the safety guideline for rDNA research to be followed in India.
To recommended type of training programme for technician and research fellow for making them adequately qware of hazards and risk involved in
rDNA research.
Institutional Biosafety Committee (IBSC)
Institutional Biosafety Committee (IBSC) are to be constituted in all centres engaged in genetic engineering research and production activities. 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. A member with medical qualifications - Biosafety Officer (in case of work with pathogenic agents/large scale use). 4 . One member nominated by DBT. 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. To recommend to RCGM about category III risk or above experiment and to seek RCGM approval. To act as nodal point for interaction with statutory bodies. To ensure experimentation at designated location taking into account approved protocol. Training of personnel on biosafety. Instituting health monitoring programme for laboratory personnel. IBSC will provide half yearly report on the ongoing project to RCGM regarding the observance
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 - procedure for regulatory process with respect to activity involving genetically engineered organisms in research, production and applications related to environmental safety. To 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. To recommended the type of containment facility and the special containment conditions to be followed for experimental trials and for certain experiments. To advise customs authorities on import of biologically active material, genetically engineered substances or products and on excisable items to Central Revenue and Excise. To assist Department of Industrial Development, Banks towards clearance of applications in setting up industries based on genetically engineered organisms. To assist the Bureau of Indian Standards to evolve standards for biologics produced by rDNA technology. To advise on intellectual property rights with respect to rDNA technology on patents. To act as nodal point for interaction with statutory bodies.
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, industrial production, environmental release and field applications. The composition of the Committee would be as follows:
Chairman - Additional Secretary, Department of Environment Co-Chairman - Expert Nominee of Secretary, DBT. Representatives of concerned Agencies and Departments: Ministry of Industrial Development Department of Science & Technology Department of Ocean Development Department of Biotechnology 3. Expert Members: Director-General, Indian Council of Agricultural Research Director General, Indian Council of Medical Research Director-General, Council of Scientific & Industrial Research Director-General, Health Services (Ministry of Health & Family Welfare) Plant Protection Adviser (Ministry of Agriculture) Chairman, Central Pollution Control Board 3 Outside experts in individual capacity. 4. Member Secretary - Official of, DOEn
The functions include giving approval from environmental angle on: Import, export, transport, manufacture, process, selling of any microorganisms or genetically engineered substances or cells including food stuffs and additives that contains products derived by Gene Therapy. Discharge of Genetically engineered/classified organisms/cells from Laboratory, 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). Deliberate release of genetically engineered organisms. The approval will be for a period of 4 years.
State Biotechnology Co-ordination Committee.
In each state there is a SBCC headed by chief Secretary where research and application of GMOs are contemplated. Main function: Power to inspect, investigate and to take punishable action in case of violation of statutory provision through the State Pollution Control Board or Directorate of Health etc. To review periodically the safety and control measure in various institutions handling GMOs. To act as nodal agency at State level to assess the damage, if any, due to release of GMOs and to take on site control measure.
DISTRICT LEVEL COMMITTEE
Is headed by district Collector as an authoritative unit to monitor safety regulation. Main function: To monitor the safety regulation in installations. Has power to inspect, investigate and report to the SBCC or the GEAC about compliance or non-compliance or r-DNA guideline or violations under EPA. To act as nodal agency at District level to assess the damage if any, due to release of GMOs and to take on site control measure.
