Standard Operating Procedure for Use of Controlled Substances in Bioequivalence (BE) Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/108/2025 |
| Supersedes | SOP/BA-BE/108/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for the lawful and safe use of controlled substances in Bioequivalence (BE) studies including their procurement, receipt, storage, dispensing, administration, accountability, and destruction, in accordance with NDPS Act and regulatory requirements.
2. Scope
This SOP applies to all clinical and pharmacy personnel involved in the handling and administration of controlled substances during BE study conduct at the clinical research facility.
3. Responsibilities
- Pharmacist: Ensures receipt, secure storage, dispensing, documentation, and return/destruction of controlled substances.
- Principal Investigator (PI): Supervises administration and ensures compliance with ethical and legal standards.
- QA Officer: Reviews logs and checks physical inventory periodically.
- Clinical Research Coordinator (CRC): Assists in reconciliation and documentation during dosing activities.
4. Accountability
The Head of Clinical Operations and Authorized Pharmacist are accountable for regulatory compliance in the use and tracking of controlled substances used in BE trials.
5. Procedure
5.1 Regulatory Approvals
- Obtain necessary licenses and permits from the State FDCA and NDPS authorities before procurement.
- Ensure Ethics Committee approval of protocol involving controlled drugs.
5.2 Procurement and Receipt
- Procure controlled substances only from authorized vendors with valid licenses.
- Upon receipt:
- Verify batch number, expiry date, quantity
- Enter details in Annexure-1: Controlled Substance Receipt Log
- Label “Controlled Drug – Store Securely”
5.3 Storage and Security
- Store in a restricted-access, double-lock system vault with temperature monitoring.
- Record access and movement in Annexure-2: Controlled Drug Access Log.
5.4 Dispensing and Administration
- Only the designated study pharmacist may dispense the substance based on protocol requirements.
- Administer under direct supervision of the investigator or designee.
- Record in Annexure-3: Controlled Drug Dispensing and Administration Log.
5.5 Accountability and Reconciliation
- Maintain ongoing reconciliation of:
- Received quantity
- Used quantity
- Remaining quantity
- Update Annexure-4: Inventory Reconciliation Sheet after each study phase.
5.6 Disposal or Return
- Unused, expired, or returned drug to be destroyed as per Schedule M or returned to vendor.
- Destruction must be approved by regulatory authority and documented in Annexure-5: Controlled Substance Disposal Log.
5.7 Inspections and Audits
- All logs and records to be kept audit-ready and presented during regulatory inspections.
- Ensure periodic internal QA audits and reconciliation reports.
6. Abbreviations
- BE: Bioequivalence
- CRC: Clinical Research Coordinator
- PI: Principal Investigator
- QA: Quality Assurance
- NDPS: Narcotic Drugs and Psychotropic Substances
- FDCA: Food and Drug Control Administration
7. Documents
- Controlled Substance Receipt Log – Annexure-1
- Controlled Drug Access Log – Annexure-2
- Controlled Drug Dispensing and Administration Log – Annexure-3
- Inventory Reconciliation Sheet – Annexure-4
- Controlled Substance Disposal Log – Annexure-5
8. References
- NDPS Act, 1985
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules
- FDA and CDSCO Guidelines for Controlled Drug Use in Research
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Controlled Substance Receipt Log
| Date | Drug Name | Batch No. | Qty Received | Received By | Checked By |
|---|---|---|---|---|---|
| 15/04/2025 | Methylphenidate | MPH202504 | 100 tablets | Pharmacist | QA |
Annexure-2: Controlled Drug Access Log
| Date | Name | Role | Purpose | Signature |
|---|---|---|---|---|
| 16/04/2025 | Rajesh Kumar | Pharmacist | Pre-dose dispensing | Signed |
Annexure-3: Controlled Drug Dispensing and Administration Log
| Date | Volunteer ID | Drug Name | Qty Dispensed | Administered By | Witness |
|---|---|---|---|---|---|
| 17/04/2025 | VOL-108-006 | Methylphenidate | 1 tablet | PI | CRC |
Annexure-4: Inventory Reconciliation Sheet
| Date | Drug | Qty Received | Qty Used | Balance | Verified By |
|---|---|---|---|---|---|
| 17/04/2025 | Methylphenidate | 100 | 6 | 94 | QA Officer |
Annexure-5: Controlled Substance Disposal Log
| Date | Drug | Qty Destroyed | Method | Authorized By | Witnessed By |
|---|---|---|---|---|---|
| 17/04/2025 | Methylphenidate | 10 | Incineration | Regulatory Inspector | QA Officer |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 12/01/2022 | 1.0 | Initial SOP | Regulatory Compliance | QA Head |
| 17/04/2025 | 2.0 | Added detailed annexures and NDPS workflow | Audit Readiness | QA Head |