SOP for Pharmacy in Pakistan (Free PDF Download)

Pharmacy SOP for Pakistan (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy in Pakistan — covering DRAP requirements, provincial drug-sale licensing, the qualified-person rules, procurement, dispensing, recall handling and recordkeeping. 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 Pakistan in line with the DRAP Act 2012, the Pharmacy Act 1967 and provincial drug rules.

2. Scope

Applies to the qualified person, all pharmacists, dispensers and support staff at [Pharmacy Name], [Address].

3. Regulatory Background

• The Drug Regulatory Authority of Pakistan (DRAP), established under the DRAP Act 2012, regulates drug quality, safety and registration nationally.
• Retail drug sale licences are issued by the provincial health authorities (district health office) — applications are filed on Form 5 with the proprietor and qualified-person dossiers.
• Under the Pharmacy Act 1967, pharmacists are registered as Category A (degree holders) or Category B; a qualified person (pharmacist, Category B or dispenser with Pharmacy Council registration) must be posted at the premises.
• Prescription-only medicines may only be sold against a valid prescription from a licensed physician.
• Adverse drug reactions are reported to DRAP's National Pharmacovigilance Centre (NPC) under the Pharmacovigilance Rules 2022.
• Always confirm the current fee schedule, forms and inspection steps with the provincial health authority before applying, as they vary by province.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Confirm the current Form 5 dossier and fee schedule with the district health office — requirements vary by province.
2. Appoint the qualified person (pharmacist / Category B / dispenser) with Pharmacy Council registration, CNIC and qualification documents attached to the application.
3. Prepare the premises dossier: rental or ownership proof, premises location and internal maps, refrigerator availability.
4. Pass the premises inspection and display the current drug sale licence prominently in the pharmacy.

5.2 Procurement

1. Source medicines only from DRAP-registered products and licensed distributors.
2. Verify registration numbers on every incoming consignment; keep distributor authorization letters on file.
3. Check expiry dates, batch numbers and physical condition on receipt; quarantine anything suspect.

5.3 Storage

1. Store per label conditions; maintain the cold chain for thermolabile products with twice-daily temperature logs.
2. Separate quarantined, expired and recalled stock in a clearly marked area.

5.4 Dispensing

1. Dispense prescription-only medicines only against valid prescriptions, verified by the qualified person.
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 (DRAP, manufacturer or internal finding), the qualified person 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 DRAP's National Pharmacovigilance Centre.
2. File a copy of each report with the pharmacy's records.

5.7 Recordkeeping

1. Keep prescription registers, purchase invoices, temperature logs, recall files and ADR reports for the full retention period required by regulation.
2. Make all records available to drug inspectors on demand.

6. Pro Tips

• File provincially, think nationally. The drug sale licence comes from the province, but the products must be DRAP-registered — verify both chains, not just one.
• Never open without the qualified person posted. The licence names the qualified person and their registration must be attached — a pharmacy without one on the premises is the fastest route to a sealed shop.
• Keep distributor authorization letters. They are part of the expected dossier and the first thing inspectors ask for when tracing a suspect batch.
• Drill the recall. Run a mock recall once a year; the first time you trace a batch should not be during a real one.
• Temperature logs are legal evidence. Twice-daily fridge logs, signed — inspectors ask for them first after a cold-chain complaint.

7. Frequently Asked Questions

Q1: Who licenses a pharmacy in Pakistan? A: DRAP regulates drugs nationally under the DRAP Act 2012, but the retail drug sale licence itself is issued by the provincial health authorities (district health office) on Form 5.

Q2: Who must be posted at the pharmacy? A: A qualified person — a pharmacist (Category A), Category B registrant or dispenser — with Pharmacy Council registration, whose documents are attached to the licence application.

Q3: Can prescription medicines be sold without a prescription? A: No. Prescription-only medicines may only be sold against a valid prescription from a licensed physician, verified by the qualified person.

Q4: How are adverse drug reactions reported? A: To DRAP's National Pharmacovigilance Centre (NPC) under the Pharmacovigilance Rules 2022, with a copy kept in the pharmacy's records.

Q5: What documents does the licence application need? A: The proprietor dossier (CNIC, photos, domicile, affidavit, premises proofs and maps) plus the qualified-person dossier (qualification, Pharmacy Council registration, CNIC, photos) — confirm the current list with the district health office, as it varies by province.

Q6: Is a recall SOP mandatory? A: A written product tracking and recall procedure is expected as part of professional practice — maintain batch-level traceability from supplier to patient so any recall can be executed immediately.