India has become a significant destination for world-class biopharmaceutical research and development, particularly in the field of biosimilars. With the introduction of the Similar Biologics Guidelines in 2012, the country has emerged as a leading player in the development of similar biologic products. Approval from the Review Committee on Genetic Manipulation (RCGM) is required before initiating preclinical and/or safety studies of similar biologics developed using Genetically Modified Organisms (GMOs) or Living Modified Organisms (LMOs) for healthcare, industrial, or other applications. Principal Investigators (PIs) must apply to the RCGM prior to commencing such research. This approval is applicable to organizations and entities conducting preclinical or safety studies of recombinant DNA (rDNA) products developed using GMOs/LMOs.
APPLICATION TO RCGM TO CONDUCT PRECLINICAL AND/OR SAFETY STUDIES OF FORM C3a: SIMILAR BIOLOGIC DEVELOPED USING GMOs/ LMOs FOR HEALTHCARE AND INDUSTRIAL USE FORM C3b: NEW rDNA PRODUCT DEVELOPED USING GMOs/ LMOS
What is Application for Application to RCGM to Conduct Preclinical and/or Safety Studies of Form C3a: Similar Biologic Developed Using GMOs/LMOs for Healthcare and Industrial Use Form C3b: New rDNA Product Developed Using GMOs/LMOs
Who Can Apply for Application to RCGM to Conduct Preclinical and/or Safety Studies of Form C3a: Similar Biologic Developed Using GMOs/LMOs for Healthcare and Industrial Use Form C3b: New rDNA Product Developed Using GMOs/LMOs?
Documents Required for this Application to RCGM to Conduct Preclinical and/or Safety Studies of Form C3a: Similar Biologic Developed Using GMOs/LMOs for Healthcare and Industrial Use Form C3b: New rDNA Product Developed Using GMOs/LMOs
- Colour photocopies of the minutes of the relevant IBSC meeting(s)
- Colour photocopies of RCGM permit(s) issued earlier
- Acceptability criteria / certificate of analysis (as specified in pharmacopeia or equivalent regulation)
- Protocol for immunogenicity studies
- Protocols for preclinical or other safety studies
Act and Rules
Role of Shamkris and Process of Application to RCGM to Conduct Preclinical and/or Safety Studies of Form C3a: Similar Biologic Developed Using GMOs/LMOs for Healthcare and Industrial Use Form C3b: New rDNA Product Developed Using GMOs/LMOs
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 Conduct Preclinical and/or Safety Studies of Form C3a: Similar Biologic Developed Using GMOs/LMOs for Healthcare and Industrial Use Form C3b: New rDNA Product Developed Using GMOs/LMOs
FAQ
It authorizes the initiation of preclinical and/or safety studies for similar biologics developed using GMOs/LMOs.
The approval is issued by the Review Committee on Genetic Manipulation (RCGM).
Yes, approval must be obtained before commencing preclinical or safety studies.
Principal Investigators (PIs), research institutions, biotechnology companies, and other eligible organizations.
No, it applies to similar biologics intended for healthcare as well as industrial use.
Preclinical studies and safety studies involving similar biologics developed using GMOs/LMOs.
Yes, eligible academic and research institutions may apply through the designated Principal Investigator.
GMOs (Genetically Modified Organisms) and LMOs (Living Modified Organisms) are organisms altered through modern biotechnology techniques.
Yes, if the rDNA products are developed using GMOs/LMOs and require preclinical or safety studies.