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/BS/17/685/2016-PID on 30.08.2016

 

The composition of IBSC of Cotton University:

Chairperson

Prof. B C Goswami, Vice Chancellor, Cotton University

DBT nominee

Prof.  Lingaraj Sahoo, Indian Institute of Technology, Guwahati

 

Outside Experts

Prof.  Probodh Borah, AAU, Veterinary College, Khanapara

Dr Mojibur R Khan, IASST, Paschim Boragaon, Guwahati

Biosafety Officer

Dr Chandana Ray Das, Assistant Professor, Obstetrics and Gynaecology Department, Gauhati Medical College  and Hospital

Member Secretary

Dr Raju Bharalee,  Assistant Professor,  MBBT, Cotton University

 

 

 

Internal Experts

Dr Purabi Deka Bose, Assistant Professor,  MBBT, Cotton University

Dr Nameirakpam Nirjanta Devi, Assistant Professor,  MBBT, Cotton University

Dr Namram Sushindrajit Singh, Assistant Professor,  Department of Zoology, Cotton University

Dr Hrishikesh Upadhyaya, Assistant Professor,  Department of Botany, Cotton University

Dr A K Verma,

Assistant Professor,  Department of Zoology, Cotton University

 

 

 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

 

 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



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