India has become a leading destination for world-class research and development (R&D) in the biopharmaceutical sector, particularly in the field of biosimilars. Following the publication of the Similar Biologics Guidelines in 2012, the country has established a strong regulatory framework for the development and evaluation of biologic products. This approval is required for the submission of reports related to preclinical or other safety studies of similar biologics and new recombinant DNA (rDNA) products developed using Genetically Modified Organisms (GMOs) or Living Modified Organisms (LMOs). It is applicable to organizations, institutions, and Principal Investigators (PIs) involved in such research activities, who must submit the necessary reports to the Review Committee on Genetic Manipulation (RCGM) before initiating the studies, ensuring compliance with biosafety and regulatory requirements.
SUBMISSION OF REPORT Form C5a: PRECLINICAL OR OTHER SAFETY STUDIES OF SIMILAR BIOLOGIC DEVELOPED USING GMOs/ LMOs Form C5b: NEW rDNA PRODUCT DEVELOPED USING GENETICALLY MODIFIED ORGANISMS (GMOs)/ LIVING MODIFIED
What is Application for Submission Of Report Form C5a: Preclinical Or Other Safety Studies Of Similar Biologic Developed Using Gmos/Lmos Form C5b: New rdna Product Developed Using Genetically Modified Organisms (Gmos)/Living Modified
Who Can Apply for Submission Of Report Form C5a: Preclinical Or Other Safety Studies Of Similar Biologic Developed Using Gmos/Lmos Form C5b: New rdna Product Developed Using Genetically Modified Organisms (Gmos)/Living Modified
Documents Required for this Submission Of Report Form C5a: Preclinical Or Other Safety Studies Of Similar Biologic Developed Using Gmos/Lmos Form C5b: New rdna Product Developed Using Genetically Modified Organisms (Gmos)/Living Modified
- Colour photocopies of the minutes of the relevant IAEC meeting(s)
- Colour photocopies of the minutes of the relevant IBSC meeting(s)
- Colour photocopies of RCGM permit(s) issued earlier
- Flow chart depicting fermentation / production and purification process highlighting key features
- Acceptability criteria / certificate of analysis (as specified in pharmacopeia or equivalent regulation)
- Tabulated individual animal data over time indicating mean test results substantiated with line / bar charts
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 Submission Of Report Form C5a: Preclinical Or Other Safety Studies Of Similar Biologic Developed Using Gmos/Lmos Form C5b: New rdna Product Developed Using Genetically Modified Organisms (Gmos)/Living Modified
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 Submission Of Report Form C5a: Preclinical Or Other Safety Studies Of Similar Biologic Developed Using Gmos/Lmos Form C5b: New rdna Product Developed Using Genetically Modified Organisms (Gmos)/Living Modified
FAQ
Form C5a is used to submit reports of preclinical or other safety studies for similar biologics developed using GMOs/LMOs.
Form C5b is used to submit reports for new recombinant DNA (rDNA) products developed using Genetically Modified Organisms (GMOs) or Living Modified Organisms (LMOs).
Principal Investigators (PIs), biotechnology companies, research institutions, universities, CROs, and organizations conducting eligible studies using GMOs/LMOs.
Yes. Principal Investigators must submit the required reports to the Review Committee on Genetic Manipulation (RCGM) before initiating the research, as applicable.
It ensures regulatory compliance, biosafety oversight, and proper evaluation of preclinical and safety studies before research progresses.