INTRODUCTION
In India, the manufacture, import, research, and release of Genetically Engineered Organisms (GEOs), as well as products made by the use of such organisms are governed by The Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells, (commonly referred to as “Rules 1989) notified by the Ministry of Environment, Forest and Climate Change (MoEF&CC), on December 5, 1989, under the Environment (Protection) Act 1986.
The Rules 1989 are broad in scope and cover the 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 roles have been notified under the Rules 1989.
Institutions handling microorganisms or GE organisms with inherent risks are required, with the assistance of the Institutional Biosafety Committee (IBSC), to develop an on-site emergency plan. This plan should be regularly updated in accordance with the manuals/guidelines provided by the RCGM and copies should be made available to the District Level Committee/State Biotechnology Coordination Committee and the Genetic Engineering Appraisal Committee.
IBSC COMMITTEE
The Institutional Biosafety Committee (IBSC) of RIIDL Foundation is a registered and accredited committee under the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India. In accordance with DBT guidelines, the IBSC is primarily responsible for reviewing and granting clearance for project proposals falling under restricted categories of research involving genetically modified organisms (GMOs), living modified organisms (LMOs), and recombinant DNA (rDNA) materials while adhering to DBT guidelines. RCGM makes decisions based on applications approved by the IBSC.
IBSC, apart from formulating biosafety programs for institutional research activities, conducts onsite evaluations, and assessments, and monitors research facilities, ensuring adherence to biosafety guidelines and procedures. It oversees the regulatory process at the institutional level, updating principal investigators on project approvals, and rejections, and providing assistance on biosafety issues related to genetic material research, ensuring the safety of all involved. IBSC assesses field experiments and reviews emergency plans to ensure adequate risk assessment and management.
The Chairperson, Member Secretary, Biosafety Officer, and DBT nominee of IBSC have specific roles. Additionally, Principal Investigators of projects are pivotal in complying with the regulatory framework. The constitution, composition, role and functions, information for compliance requirements, and processes to be followed while dealing with hazardous microorganisms, GE organisms or cells, and products thereof in line with Rules 1989 is described in “Guidelines and Handbook for Institutional Biosafety Committee”.
COMMITTEE MEMBERS
Ms Bhavna Pandya
Chairperson
Microbiology and Synthetic Biology
Bioriidl Head, RIIDL Foundation
Dr Vainav Patel
DBT Nominee
Biochemistry and Virology
Scientist E and Head, ICMR-NIRRH, Department of Biochemistry and Virology
Ms. Apekshakumari Patel
Member Secretary
Microbiology and Synthetic Biology
Research Assistant, RIIDL Foundation
Dr Jyotirlatha Bangera
Biosafety Officer
Medicine
Professor & Head of Department, K.J. Somaiya Medical College
Dr Deepak Modi
External Expert
Genetics
Scientist F, ICMR-NIRRH
Dr Maithili Athavale
External Expert
Cancer Biology
Assistant General Manager R&D (Cancer Biology), Godavari Biorefineries Pvt Ltd
Dr Seema Sambrani
Internal Expert
Biotechnology
Assistant Director, SK Somaiya College
Dr Lolly Jain
Internal Expert
Microbiology
Vice Principal, K. J. Somaiya College of Science and Commerce
Dr Kafil Ahmed
Internal Expert
Biotechnology
Chief Scientific Officer, Techinvention Lifecare Pvt Ltd
GUIDELINES
How to apply for ethical clearance from the Institutional Biosafety Committee (IBSC).
Note:
All applicants are advised to review the Indian Biosafety Rules & Regulations.