Standard Operating Procedure for Ensuring Compliance with Schedule Y Clinical Requirements in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/111/2025 |
| Supersedes | SOP/BA-BE/111/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define a standardized procedure for ensuring full compliance with the provisions of Schedule Y of the Drugs and Cosmetics Rules, 1945, during the planning and conduct of Bioavailability/Bioequivalence (BA/BE) studies in India.
2. Scope
This SOP applies to all staff involved in clinical trial operations, regulatory affairs, documentation, monitoring, and quality assurance of BA/BE studies regulated 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
- All study staff must be trained on the current version of Schedule Y.
- Maintain a controlled copy of Schedule Y in the Quality and Regulatory Documentation Library.
5.2 Clinical Trial Authorization (CTA)
- Ensure BE protocol is filed to CDSCO along with Form 44 and requisite fees.
- Attach Investigator Undertaking (Form 2), Institutional Ethics Committee (IEC) approval, and reference product labeling.
5.3 Ethics Committee Compliance
- Ensure study protocol, informed consent forms, and any advertisement material are approved by IEC before subject enrollment.
- All SAE reporting must follow 24-hour and 14-day reporting timelines as per Schedule Y.
5.4 Volunteer Protection and Consent
- Ensure audio-visual informed consent recording where applicable.
- Provide complete explanation of risks, study objectives, and rights of subjects as per ethical guidelines.
5.5 Documentation Compliance
- Maintain Investigator Site File (ISF) as per Schedule Y structure.
- Verify availability of:
- Form 44 approval
- IEC approval letters
- CRFs and subject logs
5.6 Study Monitoring and Audits
- Schedule periodic monitoring visits by QA and sponsor monitors.
- Ensure documentation of protocol deviations, SAEs, consent deviations, and other observations.
5.7 Reporting and Archival
- Compile Clinical Study Report (CSR) in Schedule Y format for submission to CDSCO.
- 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
- Schedule Y Reference Copy – Annexure-1
- Form 44 Submission Checklist – Annexure-2
- IEC Approval Tracking Sheet – Annexure-3
- SAE Reporting Log – Annexure-4
- 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 |