Registration of an organisation with an Institutional Biosafety Committee (IBSC) is mandatory before conducting any research involving recombinant DNA (rDNA) technology or hazardous microorganisms under the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms/Genetically Engineered Organisms or Cells, 1989. As per the Handbook for Institutional Biosafety Committee, 2020, organisations must first register their IBSC to become eligible for research activities involving genetic manipulation of microorganisms, plants, or animals. The scope includes work with bacterial, fungal, parasitic, viral, rickettsial, chlamydial, and other special category microorganisms, ensuring that all biosafety research is carried out in compliance with national regulatory requirements.
Registration of Organisation
What is Application for Registration of Organisation
Who Can Apply for Registration of Organisation
Documents Required for this Registration of Organisation
- Registration / Notification / Order Document
Act and Rules
Rules for the Manufacture, Use, Import, Export and Storage of Hazardous micro-organisms/Genetically engineered organisms or cells, 1989 (known as Rules 1989)
Guidelines on Similar Biologics, 2016
Guidelines for the conduct of Confined Field Trials of Regulated, Genetically Engineered (GE) Plants, 2008
Rules for the Manufacture, Use, Import, Export and Storage of Hazardous micro-organisms/Genetically engineered organisms or cells, 1989 (known as Rules 1989)
Environmental Risk Assessment of Genetically Engineered Plants: A Guide for Stakeholders, 2016
Guidelines for the Environmental Risk Assessment of Genetically Engineered Plants, 2016
Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, 2008
Environmental Risk Assessment of Genetically Engineered Plants: A Guide for Stakeholders, 2016
Guidelines for the Environmental Risk Assessment of Genetically Engineered Plants, 2016
Role of Shamkris and Process of Registration of Organisation
Shamkris adopts a results-oriented approach to ensuring compliance with the mandatory requirements for obtaining the Application. With a simple and guided methodology, Shamkris helps organizations achieve the necessary application in a timely and cost-effective manner. Shamkris offers 100% support in advisory, guidance, and compliance, ensuring smooth processing for obtaining the application.
The Application acquisition process described below:
Advisory for the document required
Preparation of documents as per application & list of documents.
Certificate File
Inspection by the department if required
Certificate department
Certificate issued
Yearly Compliance if Applicable
Renewal when due
Who can issue Approval for Registration of Organisation
FAQ
IBSC registration is the approval required for organizations conducting research involving hazardous microorganisms or genetically engineered (GE) organisms.
Any organization handling hazardous microorganisms or GE organisms for research or related activities.
Yes. Registration is mandatory before undertaking eligible rDNA research and related activities.
Research institutions, universities, biotechnology companies, pharmaceutical organizations, and government laboratories.
Research involving hazardous microorganisms, recombinant DNA (rDNA), and genetically engineered (GE) organisms.
Yes. Registration must be completed before undertaking applicable research activities.
Organization details, proposed IBSC composition, and supporting regulatory documents, as applicable.
The timeline depends on the completeness of the application and regulatory review.