SOP for Pharmacy in Nepal (Free PDF Download)

Pharmacy SOP for Nepal (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy in Nepal — covering Department of Drug Administration (DDA) licensing, Nepal Pharmacy Council registration, recall handling, recordkeeping and pharmacovigilance. Adapt the bracketed fields to your premises and adopt it as your operations manual.

1. Purpose

To define the licensing, staffing, procurement, dispensing, storage, recall and recordkeeping procedures required to operate a retail pharmacy in Nepal in line with DDA regulations and the Codes on Sale and Distribution of Drugs, 2024.

2. Scope

Applies to the pharmacist in charge, all pharmacists and assistant pharmacists, and support staff at [Pharmacy Name], [Address].

3. Regulatory Background

• The Department of Drug Administration (DDA) registers pharmacies under the Drug Act 1978 (2035 BS); no person may sell or distribute drugs without registering with the DDA and obtaining the certificate under the Drug Registration Regulation 2038.
• The Nepal Pharmacy Council registers pharmacists and assistant pharmacists who practise in the country.
• The Codes on Sale and Distribution of Drugs, 2024 set the Good Pharmacy Practice standards enforced by the DDA.
• The pharmacy must be managed by pharmacy personnel recognised under the Drug Act and registered with the DDA.
• A written product tracking and recall SOP is required, and records must be kept for the period DDA regulations require — confirm the current retention period with the DDA.
• Suspected adverse drug reactions are reported to the DDA's pharmacovigilance system.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Prepare the application in the Schedule-8 format with the pharmacy degree or diploma certificate, Nepal Pharmacy Council registration, citizenship documents, premises map and rent agreement.
2. Appoint the pharmacist or assistant pharmacist whose licence will be used for the premises; the house owner and the pharmacist must be present at the DDA when filing.
3. Register the pharmacy with the DDA and obtain the registration certificate before selling or distributing any drug.
4. Display the current DDA registration certificate prominently in the pharmacy.

5.2 Procurement

1. Source medicines only from DDA-registered products and licensed suppliers.
2. Verify product registration on every incoming consignment.
3. Check expiry dates, batch numbers and physical condition on receipt; quarantine anything suspect.

5.3 Storage

1. Store per label conditions; protect stock from direct sunlight, dust and moisture, and maintain refrigeration where required.
2. Separate quarantined, expired and recalled stock in a clearly marked area.

5.4 Dispensing

1. Dispense only against valid prescriptions for prescription-only medicines, verified by a pharmacist or assistant pharmacist.
2. Counsel every patient on dosage, duration and storage.
3. Record each dispensing in the prescription register.

5.5 Product tracking and recall

1. Maintain batch-level traceability from supplier to patient for every product.
2. On a recall notice (DDA, manufacturer or internal finding), the pharmacist in charge initiates the recall immediately.
3. Identify and quarantine all affected batches, notify patients where required, and return stock per the recall notice.
4. Document the entire recall: batches, quantities, notifications, returns.

5.6 Pharmacovigilance

1. Report every suspected adverse drug reaction to the DDA's pharmacovigilance system.
2. File a copy of each report with the pharmacy's records.

5.7 Recordkeeping

1. Keep prescription registers, purchase invoices, recall files and ADR reports for the period the DDA requires.
2. Make all records available to DDA inspectors on demand.

6. Pro Tips

• One licence, one pharmacy. The Council has suspended licences used across two pharmacies on a single certificate — never lend a pharmacist's registration to another premises.
• Drill the recall. Run a mock recall once a year; the first time you trace a batch should not be during a real one.
• Verify supplier registrations. Re-check your top suppliers' product registrations periodically, not just at onboarding — registrations lapse.
• Counsel at the counter. Most Nepali patients visit the pharmacy before a doctor — dosage counselling is both a legal expectation and your best defence against dispensing errors.
• Keep the certificate current. DDA registration must be renewed on schedule; an expired certificate on the wall is an offence.

7. Frequently Asked Questions

Q1: Who licenses a pharmacy in Nepal? A: The Department of Drug Administration (DDA) registers pharmacies under the Drug Act 1978; the Nepal Pharmacy Council registers the pharmacists and assistant pharmacists who practise in them.

Q2: What documents are needed to register a pharmacy? A: The Schedule-8 application with the pharmacy degree or diploma certificate, Nepal Pharmacy Council registration, citizenship documents, a premises map and the rent agreement, filed at the DDA with the house owner and pharmacist present.

Q3: Can a pharmacy open without a pharmacist? A: No. The pharmacy must be managed by pharmacy personnel recognised under the Drug Act and registered with the DDA — a pharmacist or assistant pharmacist.

Q4: How long must pharmacy records be kept? A: For the period DDA regulations require — confirm the current retention period with the DDA, and keep prescription registers, purchase records, recall files and ADR reports for at least that long.

Q5: How are adverse drug reactions reported? A: Suspected adverse drug reactions are reported to the DDA's pharmacovigilance system, with a copy kept in the pharmacy's records.

Q6: Is a recall SOP mandatory? A: Yes — a written product tracking and recall procedure is required, with batch-level traceability from supplier to patient.