Biosafety and Biocontainment Requirements for Biopharma Research and Manufacturing

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Research and manufacture of biopharmaceutical products involves the use of genetically engineered (GE) organisms and/​or pathogenic organisms. All such organisms are governed under Rules for the Manufacture, Use/​Import/​Export and Storage of Hazardous Micro Organisms/​Genetically Engineered Organisms or Cells (Rules,1989)” under the Environment (Protection) Act, 1986. Guidelines have been issued by the Department of Biotechnology (DBT), Government of India for biocontainment requirements for research as well large-scale use.

As per the Indian biosafety regulations, organizations handling genetically modified organisms (GMOs), recombinant DNA materials, and non-GE hazardous microorganisms for research or production purposes are required to constitute an Institutional Biosafety Committee (lBSC). IBSC is the nodal point for implementation of the biosafety guidelines in an institution. The IBSC is one of the key statutory bodies operating directly from the premises of the institution and is responsible for proper implementation of biosafety, rules, regulations, and guidelines. It is mandatory to constitute an IBSC by all institutional handling hazardous microorganisms and/​or GE organisms. The IBSCs are set up with approval from the DBT. Compliance and reporting requirement for IBSCs are detailed in Indian Biosafety Knowledge Portal (IBKP), a portal managed by DBT.

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