As mandated in the Rules, 1989 of Environment (Protection) Act, 1986, Review Committee on Genetic Manipulation (RCGM) administered by the Department of Biotechnology, Ministry of Science and Technology has formulated "Regulations and Guidelines on Biosafety of Recombinant DNA Research and Biocontainment, 2017" for regulating recombinant DNA research through Institutional Biosafety Committees and mechanism that regulate them. The guidelines include a whole range from the research, contained/laboratory use; import/export; storage and handling; manufacturing; disposal and emergency procedure and facility certification. These guidelines are based on current scientific information, best practices and from the experience gained while implementing the biosafety frameworks within the country. This document specifies the practices for handling (Manufacture, Use, Import, Export, Exchange and Storage) of hazardous biological material, recombinant nucleic acid molecules and cells, organisms and viruses containing such molecules to ensure an optimal protection of public health and of the environment. The document provides clarity on biosafety requirements and recommendations for laboratory facilities such as facility design, biosafety equipment, personal protective equipment, good laboratory practices and techniques, waste management, etc.
The Rules 1989 are broad in scope and covers area of research as well as large scale handling of hazardous microorganisms, GE organisms or cells and products thereof. In order to implement the Rules in the entire country, six competent authorities and their roles have been notified. Institutional Biosafety Committee (IBSC) is one of such competent authorities which operates at Institutional level.
Institutional Biosafety Committee (IBSC)
Any organisation, which undertakes research involving handling of hazardous microorganisms and/or GE organisms, shall establish an IBSC at institutional level to ensure that all activities conducted comply with the guidelines notified under "Regulations and Guidelines on Biosafety of Recombinant DNA Research and Biocontainment, 2017". It is a statutory committee that operates from the premises of an organisation. It is in a unique position to conduct onsite evaluation, assessment and monitoring of adherence to the biosafety guidelines and provide overall oversight of the regulatory process at the institutional level. The decisions taken by the next higher committee i.e., Review Committee on Genetic Manipulation (RCGM), which operates from the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India are based on the applications submitted by the investigators with the approval of IBSC.
For details composition, role and functions of IBSC please refer to the "Guidelines and Handbook for Institutional Biosafety Committees" 2nd Edition, May 2011.
As per mandatory requirement IBSC of Cotton University has been constituted and registered with Department of Biotechnology, Ministry of Science and Technology, Govt. of India, vide office memorandum no BT/IBKP/127/2020 on 09.03.2020
The composition of IBSC of Cotton University:
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Chairman |
Dr Bhabesh Chandra Goswami Vice Chancellor, Cotton University |
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DBT Nominee |
Dr Probodh Borah Professor, College of Veterinary Science, Assam Agricultural University, |
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Member Secretary |
Dr Raju Bharalee Asst Prof., Cotton University, Department of Molecular Biology and Biotechno |
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Biosafety Officer |
Dr Sumi Deka Demonstrator, Dept of Biochemistry Gauhati Medical College and Hospital, Department of Biochemistry |
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Outside Expert |
Dr Pranjan Barman Asst Prof., Gauhati University, Department of Biotechnology. |
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Dr Debabrat Baishya Asst Prof., Gauhati University, Dept. of Bioengineering and Technology |
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Internal Members |
Dr Nameirakpam Nirjanta Devi Asst Prof., Cotton University, Dept. of MBBT |
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Dr Namram Sushindrajit Singh Asst Prof., Cotton University, Dept. of Zoology |
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Dr Akalesh Kumar Verma Asst Prof. Cotton University, Dept. of Zoology |
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Dr Hrishikesh Upadhyaya Asst Prof., Cotton University, Dept. of Botany |
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Dr Leena Borah Asst Prof., Cotton University, Dept. of EBWS |
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Dr Mausumi Ganguly Professor, Cotton University, Dept. of Chemistry |
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Dr Purabi Deka Bose Asst Prof., Cotton University, Department of Molecular Biology and Biotechno |
Brief guidelines for submitting application for clearance by the IBSC
It is mandatory to inform the IBSC and get its prior approval for undertaking any work/project (including PhD/Dissertation/in-house work) in the University involving rDNA technology, or any kind of genetic manipulation or any potentially hazardous biological materials. IBSC reviews such projects on a regular basis and ensure the safety part of it. On the basis of information provided by the concerned PI, the IBSC would review the project and may give permission to start the experiment or forward it to the Review Committee on Genetic Manipulation (RCGM); Department of Biotechnology, (DBT), Government of India, New Delhi for approval in appropriate format.
Submission of details of project requiring IBSC approval
1.The PI have to submit a duly signed hard copy and a soft copy (through mail) of the application and supporting documents (a soft copy and a signed hard copy of the approved/sanctioned project/proposal) to the member secretary much before the commencement of the IBSC meeting for approval in a specific format Click here for application format. An e-mail would be sent to all HODs asking for submission of application by concerned PIs for approval so that same can be circulated to the IBSC members before the commencement of the meeting.
2. Application may be submitted any time. The project would be evaluated and considered for approval in the next IBSC meeting.
3. It is the duty of the primary investigator (PI) to inform IBSC about experiments involving recombinant DNA (rDNA) technology, genetically modified organisms (GMOs) or living modified organisms (LMOs) through the application as stated above. PI have to clearly specify the work component/s of the project for which the IBSC approval is sought.
4. While preparing the application, the PI have to note the following points
- For experiments involving rDNA or use of any hazardous biological materials or microorganisms, the PI must mention the required biosafety level as well as the risk category of organisms to be used in the experiment as per guidelines mentioned in Chapter II of "Regulations and Guidelines on Biosafety of Recombinant DNA Research and Biocontainment, 2017"
- The assignment of the risk category of any microorganism(s) being handled as part of the experimental protocol must be determined based on the information provided in Table 1 of chapter II of the above said guidelines.
- PI must indicate the methodology to be used for decontamination and disposal of hazardous organisms or biological waste, if any.
- PI may please go through the "Regulations and Guidelines on Biosafety of Recombinant DNA Research and Biocontainment, 2017" for detail guidelines provided by DBT.
- The PI of the project is supposed to go through his responsibilities as specified in page 10 of the "Guidelines and Handbook for Institutional Biosafety Committees (IBSCs), 2011"
5. The submitted applications will be evaluated by the committee (and subject expert if required) and the applicant may be asked to provide other documents and necessary information if required for approval. IBSC may conduct onsite evaluation, assessment and monitoring of adherence to the biosafety guidelines with overall oversight of the regulatory process, at the institutional level.
6. A meeting of IBSC will be scheduled and the date will be communicated to the applicant at least 20 days in advance. The applicant may be asked to present his/her project proposal to the committee and a decision will be communicated to applicant. IBSC may approve the project or may ask the PI to forward the same through IBSC to the next higher competent authority for approval in formats as specified in pages from 63 to 118 of "Guidelines and Handbook for Institutional Biosafety Committees (IBSCs), 2011". These forms may be downloaded from http://www.dbtindia.nic.in/regulations/applications-formats/. The PI may go to eLearning website (http://ibsc.biotech.co.in/) on "Regulatory Compliance by the Institutional Biosafety Committees (IBSC).
Contact Address:
Dr Raju Bharalee
Member Secretary, Institutional Biosafety Committee (IBSC)
Cotton University, Department of Molecular Biology and Biotechnology
Mob: 9435547840
E-mail: rajubh2@gmail.com