SOP for Pharmacy in Bangladesh (Free PDF Download)

Pharmacy SOP for Bangladesh (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy (drug shop) in Bangladesh — covering DGDA licensing, pharmacist registration, prescription rules, procurement, dispensing, storage, 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 Bangladesh in line with the Drug and Cosmetics Act 2023 and DGDA regulations.

2. Scope

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

3. Regulatory Background

• The Directorate General of Drug Administration (DGDA) is the government regulatory body that licences retail drug shops and pharmacies.
• The Pharmacy Council of Bangladesh (PCB) registers pharmacists; individuals holding a valid Grade A, B or C pharmacist registration may apply to the DGDA for a retail pharmacy licence.
• Retail drug licences are granted for 2 years and are renewable — diary the renewal date and start the paperwork early.
• Under the Drug and Cosmetics Act 2023, antimicrobials and other prescription medicines must not be dispensed without a prescription from a registered physician — only listed OTC medicines may be sold over the counter.
• The DGDA's Model Pharmacy / Model Medicine Shop accreditation programme sets higher infrastructure and service standards — consider accreditation as a quality differentiator.
• Always confirm the current application forms, fee schedule and inspection checklist with the DGDA before applying.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Confirm the current retail drug licence application forms and fee schedule with the DGDA.
2. Appoint the pharmacist in charge: valid PCB registration (Grade A, B or C), with registration certificate and commitment letter in the dossier.
3. Prepare the premises dossier: trade licence, rental agreement, bank solvency certificate, premises photographs and layout plan.
4. Pass the DGDA inspection and display the current drug licence prominently in the pharmacy.

5.2 Procurement

1. Source medicines only from licensed manufacturers, importers and distributors.
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; 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 medicines — including all antimicrobials — only against a valid prescription from a registered physician.
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 (DGDA, 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 national pharmacovigilance system.
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 DGDA inspectors on demand.

6. Pro Tips

• Renewal is biennial — diary it. The 2-year licence cycle is easy to let lapse; start the renewal dossier well before expiry to avoid trading unlicensed.
• Prescription discipline is the law now. The 2023 Act is explicit on antimicrobials — train every dispenser that "no prescription, no sale" is non-negotiable.
• Consider Model Pharmacy accreditation. It is a visible quality mark in a crowded market and forces the infrastructure upgrades inspectors want to see anyway.
• 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 Bangladesh? A: The Directorate General of Drug Administration (DGDA) licences retail drug shops and pharmacies; the Pharmacy Council of Bangladesh (PCB) registers pharmacists.

Q2: Who can apply for a retail pharmacy licence? A: Any individual holding a valid pharmacist registration — Grade A, B or C — may apply to the DGDA for a retail pharmacy licence.

Q3: How long is a retail drug licence valid? A: Two years, renewable. Confirm the current renewal procedure and fee schedule with the DGDA.

Q4: Can antibiotics be sold without a prescription? A: No. Under the Drug and Cosmetics Act 2023, antimicrobials and other prescription medicines must not be dispensed without a prescription from a registered physician.

Q5: What is the Model Pharmacy programme? A: A DGDA accreditation initiative setting higher infrastructure, personnel and service standards for retail medicine shops — accredited outlets are certified as Model Pharmacies or Model Medicine Shops.

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.