Standard Operating Procedure for Regulatory Compliance for GMOs in Biosimilar Development

Department	Biosimilars
SOP No.	SOP/BS/040/2025
Supersedes	SOP/BS/040/2022
Page No.	Page 1 of 13
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To define the procedure for complying with national and international regulations governing the use of Genetically Modified Organisms (GMOs) in biosimilar research and development, ensuring legal authorization, risk control, and biosafety documentation.

2. Scope

This SOP applies to all projects involving GMOs in the biosimilar lifecycle, from vector construction to cell banking, including submissions to regulatory authorities such as IBSC, RCGM, and DCGI.

3. Responsibilities

• Regulatory Affairs Officer: Coordinates all submissions, approvals, and renewals with IBSC, RCGM, and GEAC.
• Principal Investigator: Provides technical details and risk assessment documentation.
• Biosafety Officer: Maintains records of compliance certificates, approvals, and biosafety audits.

4. Accountability

The Quality Assurance Head is accountable for ensuring that all GMO work is authorized and documented in accordance with the Biosafety Rules, 1989 under the EPA Act and that no unauthorized genetic engineering activities are carried out.

5. Procedure

5.1 Institutional Biosafety Committee (IBSC) Approval

1. Submit the following documents:
   • Form I (as per DBT format)
   • Risk Assessment Report
   • GMO Details: Vector, Host, Insert
2. Obtain signed minutes of IBSC approval and retain a copy in the GMO Compliance Folder (Annexure-1).

5.2 RCGM Submission

1. Applicable for:
   • Scale-up of recombinant DNA work
   • Animal studies
   • Field trials
2. Submit Form III to RCGM with:
   • Detailed project report
   • IBSC approval copy
   • Environmental risk management plan
3. Track submission and follow up for approval. Document communication in RCGM Submission Log (Annexure-2).

5.3 Compliance Documentation

1. Maintain hard and soft copies of:
   • IBSC Minutes
   • RCGM Clearance Letters
   • Import/Export NOC (if applicable)
   • Biosafety Level (BSL) Certifications
2. Log each activity involving GMOs in the GMO Activity Register (Annexure-3).

5.4 Audit Readiness

1. Update regulatory matrix every quarter.
2. Conduct mock audits using the GMO Compliance Checklist (Annexure-4).

6. Abbreviations

• IBSC: Institutional Biosafety Committee
• RCGM: Review Committee on Genetic Manipulation
• GEAC: Genetic Engineering Appraisal Committee
• DCGI: Drug Controller General of India

7. Documents

1. GMO Compliance Folder (Annexure-1)
2. RCGM Submission Log (Annexure-2)
3. GMO Activity Register (Annexure-3)
4. GMO Compliance Checklist (Annexure-4)

8. References

• Biosafety Rules, 1989 under EPA Act, Govt. of India
• WHO Biosafety Manual, 4th Edition
• CDSCO Guidance on rDNA Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: GMO Compliance Folder Index

Document Type	Date	Submitted To	Filed By	Location
IBSC Minutes	01/04/2025	IBSC Secretariat	Rajesh Kumar	Folder-A

Annexure-2: RCGM Submission Log

Submission ID	Date	Project Title	Status	Remarks
RCGM-040-2025	02/04/2025	CHO Cell Line Evaluation	Under Review	Follow-up on 10/05

Annexure-3: GMO Activity Register

Date	Activity	GMO ID	Location	Person Responsible
01/05/2025	MCB Expansion	GMO-CHO-K1	BSL-2 Lab	Sunita Reddy

Annexure-4: GMO Compliance Checklist

Checklist Item	Status	Comments
IBSC Approval on File	Yes	Valid till 31/03/2026
RCGM Approval (if needed)	Pending	Expected in May 2025
Biosafety Certificates	Yes	Lab audited March 2025

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Updated RCGM submission formats and annexures	Regulatory revision