Modern biotechnology, based on recombinant DNA (rDNA) technology and genetic engineering, has transformed research and innovation across healthcare, biotechnology, and life sciences. As the development and use of Hazardous Microorganisms (HMOs), Genetically Modified Organisms (GMOs), and Living Modified Organisms (LMOs) continue to grow, ensuring their safety through proper regulatory evaluation is essential. Form E3 is used for the submission of safety study reports for HMOs, GMOs, and LMOs, excluding genetically engineered (GE) crops and plants intended for agricultural and environmental use. Principal Investigators (PIs), research institutions, biotechnology companies, and other eligible organizations conducting such studies must submit these reports to the Review Committee on Genetic Manipulation (RCGM) to demonstrate compliance with India’s biosafety regulations and support the safe development and application of modern biotechnology.
Form E3: Submission Of Report Of Safety Studies Of Hazardous Microorganisms (HMOs), Genetically Modified Organisms (GMOs)/ Living Modified Organisms (LMOs) Other Than Ge Crops/ Plants For Agricultural And Environmental Usegenetically Engineered (GE) Crops/Plants For Agricultural And Environmental Use
What is Application for Submission Of Form E3: Submission Of Report Of Safety Studies Of Hazardous Microorganisms (Hmos), Genetically Modified Organisms (Gmos)/Living Modified Organisms (Lmos) Other Than Ge Crops/Plants For Agricultural And Environmental Usegenetically Engineered (Ge) Crops/Plants For Agricultural And Environmental Use
Who Can Apply for Submission Of Form E3: Submission Of Report Of Safety Studies Of Hazardous Microorganisms (Hmos), Genetically Modified Organisms (Gmos)/Living Modified Organisms (Lmos) Other Than Ge Crops/Plants For Agricultural And Environmental Usegenetically Engineered (Ge) Crops/Plants For Agricultural And Environmental Use
Documents Required for this Submission Of Form E3: Submission Of Report Of Safety Studies Of Hazardous Microorganisms (Hmos), Genetically Modified Organisms (Gmos)/Living Modified Organisms (Lmos) Other Than Ge Crops/Plants For Agricultural And Environmental Usegenetically Engineered (Ge) Crops/Plants For Agricultural And Environmental Use
- Colour photocopy of all the minutes and / or permit(s) issued earlier by IBSC / IAEC / RCGM / GEAC
- Biology of HMOS and / or GEOS
- Environmental safety studies
- Appropriate references and any other relevant information
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 Form E3: Submission Of Report Of Safety Studies Of Hazardous Microorganisms (Hmos), Genetically Modified Organisms (Gmos)/Living Modified Organisms (Lmos) Other Than Ge Crops/Plants For Agricultural And Environmental Usegenetically Engineered (Ge) Crops/Plants For Agricultural And Environmental Use
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 Form E3: Submission Of Report Of Safety Studies Of Hazardous Microorganisms (Hmos), Genetically Modified Organisms (Gmos)/Living Modified Organisms (Lmos) Other Than Ge Crops/Plants For Agricultural And Environmental Usegenetically Engineered (Ge) Crops/Plants For Agricultural And Environmental Use
FAQ
Form E3 is used to submit safety study reports for HMOs, GMOs, and LMOs to the RCGM.
Principal Investigators (PIs) and organizations conducting safety studies on eligible organisms.
HMOs are Hazardous Microorganisms that require biosafety assessment before approval.
GMOs are Genetically Modified Organisms, while LMOs are Living Modified Organisms developed using modern biotechnology.
Yes, if the study falls under the applicable biosafety regulations.
Applicants must submit the prescribed safety study report along with the required supporting documents.
Yes. Biotechnology companies conducting eligible safety studies can submit Form E3.