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

1. Obtain necessary licenses and permits from the State FDCA and NDPS authorities before procurement.
2. Ensure Ethics Committee approval of protocol involving controlled drugs.

5.2 Procurement and Receipt

1. Procure controlled substances only from authorized vendors with valid licenses.
2. 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

1. Store in a restricted-access, double-lock system vault with temperature monitoring.
2. Record access and movement in Annexure-2: Controlled Drug Access Log.

5.4 Dispensing and Administration

1. Only the designated study pharmacist may dispense the substance based on protocol requirements.
2. Administer under direct supervision of the investigator or designee.
3. Record in Annexure-3: Controlled Drug Dispensing and Administration Log.

5.5 Accountability and Reconciliation

1. Maintain ongoing reconciliation of:
   • Received quantity
   • Used quantity
   • Remaining quantity
2. Update Annexure-4: Inventory Reconciliation Sheet after each study phase.

5.6 Disposal or Return

1. Unused, expired, or returned drug to be destroyed as per Schedule M or returned to vendor.
2. Destruction must be approved by regulatory authority and documented in Annexure-5: Controlled Substance Disposal Log.

5.7 Inspections and Audits

1. All logs and records to be kept audit-ready and presented during regulatory inspections.
2. 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

1. Controlled Substance Receipt Log – Annexure-1
2. Controlled Drug Access Log – Annexure-2
3. Controlled Drug Dispensing and Administration Log – Annexure-3
4. Inventory Reconciliation Sheet – Annexure-4
5. 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