under Schedule Y in India.

3. Responsibilities

• Regulatory Affairs Manager: Ensures that all study submissions are in accordance with Schedule Y requirements.
• Principal Investigator: Complies with responsibilities outlined under Investigator obligations of Schedule Y.
• QA Officer: Audits processes and documents for compliance with Schedule Y.
• Clinical Research Coordinator: Maintains regulatory essential documents and supports audit readiness.

4. Accountability

The Head of Regulatory Affairs is accountable for ensuring that all BA/BE studies conducted are in full compliance with Schedule Y requirements from study initiation to archival.

5. Procedure

5.1 Review of Schedule Y Provisions

1. All study staff must be trained on the current version of Schedule Y.
2. Maintain a controlled copy of Schedule Y in the Quality and Regulatory Documentation Library.

5.2 Clinical Trial Authorization (CTA)

1. Ensure BE protocol is filed to CDSCO along with Form 44 and requisite fees.
2. Attach Investigator Undertaking (Form 2), Institutional Ethics Committee (IEC) approval, and reference product labeling.

5.3 Ethics Committee Compliance

1. Ensure study protocol, informed consent forms, and any advertisement material are approved by IEC before subject enrollment.
2. All SAE reporting must follow 24-hour and 14-day reporting timelines as per Schedule Y.

5.4 Volunteer Protection and Consent

1. Ensure audio-visual informed consent recording where applicable.
2. Provide complete explanation of risks, study objectives, and rights of subjects as per ethical guidelines.

5.5 Documentation Compliance

1. Maintain Investigator Site File (ISF) as per Schedule Y structure.
2. Verify availability of:
   • Form 44 approval
   • IEC approval letters
   • CRFs and subject logs

5.6 Study Monitoring and Audits

1. Schedule periodic monitoring visits by QA and sponsor monitors.
2. Ensure documentation of protocol deviations, SAEs, consent deviations, and other observations.

5.7 Reporting and Archival

1. Compile Clinical Study Report (CSR) in Schedule Y format for submission to CDSCO.
2. Archive all records for at least 5 years post study completion or as directed by sponsor.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CDSCO: Central Drugs Standard Control Organization
• CSR: Clinical Study Report
• QA: Quality Assurance
• IEC: Institutional Ethics Committee

7. Documents

1. Schedule Y Reference Copy – Annexure-1
2. Form 44 Submission Checklist – Annexure-2
3. IEC Approval Tracking Sheet – Annexure-3
4. SAE Reporting Log – Annexure-4
5. Archival Checklist – Annexure-5

8. References

• Schedule Y – Drugs and Cosmetics Rules, 1945 (Amended 2005)
• ICH E6(R2) – Good Clinical Practice
• Indian GCP Guidelines 2001

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Schedule Y Reference Copy

Controlled version of Schedule Y guidelines – latest amendment dated 2023.

Annexure-2: Form 44 Submission Checklist

Document	Available	Remarks
Study Protocol	Yes
Form 2 – Investigator Undertaking	Yes

Annexure-3: IEC Approval Tracking Sheet

Protocol ID	IEC Approval Date	Version	Renewal Due
BE-111-2025	01/03/2025	1.0	01/03/2026

Annexure-4: SAE Reporting Log

Volunteer ID	Event Date	Reported to IEC	Reported to CDSCO
VOL-111-003	05/04/2025	06/04/2025	08/04/2025

Annexure-5: Archival Checklist

Document Type	Archived	Location
ISF	Yes	Archive Room Shelf A2

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial SOP release	Regulatory Compliance	QA Head
17/04/2025	2.0	Expanded annexures and tracking logs added	Schedule Y Update	QA Head