This approval is required for research involving genetically modified organisms (GMOs) or living modified organisms (LMOs) for agricultural and environmental applications or for biopharmaceutical, healthcare, and industrial use that does not fall under Category I or Category II genetically engineered (GE) experiments as defined in the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017. Principal Investigators (PIs) must obtain prior approval from the Review Committee on Genetic Manipulation (RCGM) before commencing such research. It is applicable to institutions with a registered Institutional Biosafety Committee (IBSC) that intend to undertake research involving GMOs/LMOs for agricultural, environmental, biopharmaceutical, healthcare, or industrial purposes.
Application To Rcgm To Carry Out Research And Development Involving Hazardous Microorganisms (HMOs), Genetically Modified Organisms (GMOs)/ Living Modified Organisms (LMOs) 1. Form D1: Agricultural And Environmental Application 2. Form C1: Biopharmaceutical Healthcare And Industrial Use
What is Application for Application to RCGM to Carry Out Research and Development Involving Hazardous Microorganisms (HMOs), Genetically Modified Organisms (GMOs)/Living Modified Organisms (LMOs) Form D1: Agricultural and Environmental Application Form C1: Biopharmaceutical, Healthcare and Industrial Use
Who Can Apply for Application to RCGM to Carry Out Research and Development Involving Hazardous Microorganisms (HMOs), Genetically Modified Organisms (GMOs)/Living Modified Organisms (LMOs) Form D1: Agricultural and Environmental Application Form C1: Biopharmaceutical, Healthcare and Industrial Use
- Research institutions conducting research involving Genetically Modified Organisms (GMOs) or Living Modified Organisms (LMOs).
- Universities and academic institutions carrying out recombinant DNA (rDNA) research.
- Government research organizations involved in biotechnology research.
- Biotechnology companies undertaking research and development activities.
- Pharmaceutical and biopharmaceutical organizations working with GMOs/LMOs.
- Industrial organizations conducting GMO/LMO-based research for industrial applications.
- Agricultural research organizations developing genetically modified crops or related technologies.
- Environmental research organizations working on GMO/LMO applications.
- Registered Institutional Biosafety Committees (IBSCs) planning research that does not fall under Category I or Category II GE experiments, as per the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017.
Documents Required for this Application to RCGM to Carry Out Research and Development Involving Hazardous Microorganisms (HMOs), Genetically Modified Organisms (GMOs)/Living Modified Organisms (LMOs) Form D1: Agricultural and Environmental Application Form C1: Biopharmaceutical, Healthcare and Industrial Use
- Description of the HMOs, GMOs/LMOs and product(s) thereof proposed to be employed in the research proposal (in scientific terms)
- 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 Application to RCGM to Carry Out Research and Development Involving Hazardous Microorganisms (HMOs), Genetically Modified Organisms (GMOs)/Living Modified Organisms (LMOs) Form D1: Agricultural and Environmental Application Form C1: Biopharmaceutical, Healthcare and Industrial 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 Application to RCGM to Carry Out Research and Development Involving Hazardous Microorganisms (HMOs), Genetically Modified Organisms (GMOs)/Living Modified Organisms (LMOs) Form D1: Agricultural and Environmental Application Form C1: Biopharmaceutical, Healthcare and Industrial Use
FAQ
RCGM approval is required for eligible research involving Hazardous Microorganisms (HMOs), Genetically Modified Organisms (GMOs), and Living Modified Organisms (LMOs).
Registered research institutions, universities, biotechnology companies, and organizations with an Institutional Biosafety Committee (IBSC).
Form D1 is for agricultural and environmental applications, and Form C1 is for biopharmaceutical, healthcare, and industrial use.
Yes. The research proposal must generally be reviewed and recommended by the Institutional Biosafety Committee (IBSC) before submission to RCGM.
The timeline depends on the completeness of the application and the RCGM review process.
Yes. Eligible biotechnology, pharmaceutical, and industrial organizations can apply through their registered IBSC.
Yes. Approval must be obtained before initiating applicable research involving HMOs, GMOs, or LMOs.
Yes. Shamkris Global provides end-to-end assistance with documentation, application preparation, submission, and regulatory compliance.