Pharmacy Business in Bangladesh
The pharmacy business in Bangladesh is a highly regulated sector involving strict licensing, registration, and operational compliance. It plays a critical role in public health and is governed by a combination of drug control laws, business regulations, and health safety standards. This article outlines the legal framework, licensing process, compliance requirements, and practical considerations for operating a pharmacy business in Bangladesh.
Legal Framework
The pharmacy business is primarily governed by the following laws and regulations:
- Drugs Act, 1940
- Drugs (Control) Ordinance, 1982
- Drugs Rules, 1945
- Pharmacy Council Act, 2015
- Bangladesh Pharmacy Council Guidelines
- Drugs Policy, 2016
- Narcotics Control Act, 2018 (for controlled substances)
The regulatory authority is the Directorate General of Drug Administration (DGDA), under the Ministry of Health and Family Welfare.
Types of Pharmacies
In Bangladesh, retail pharmacy businesses fall under three general categories:
- A-Type Pharmacy (Retail Pharmacy):
Sells all prescription and over-the-counter (OTC) medicines. - B-Type Pharmacy (Semi-Qualified Shop):
Sells only OTC medicines and some prescription drugs as per allowed list. - C-Type (General Medicine Shop):
Permitted to sell only non-prescription and everyday medicine items.
A-Type and B-Type pharmacies must be managed or supervised by registered pharmacists with at least a diploma-level qualification.
Licensing and Registration Requirements
To operate a pharmacy, the following licenses and registrations are required:
1. Drug License (Retail Drug Sales License)
Issued by the Directorate General of Drug Administration (DGDA).
Requirements:
- Application in prescribed form
- Trade license
- National ID and photograph of the owner
- Copy of rental agreement or proof of ownership of premises
- Passport-size photographs of owner and pharmacist
- Certificate of registration of the employed pharmacist (from Pharmacy Council)
- Layout/design of the pharmacy premises
- Refrigerator (for temperature-sensitive medicines)
- Fire safety and waste disposal measures
Note: Premises must comply with minimum standards in size (at least 120 sq. ft.), hygiene, and storage facilities.
2. Trade License
Issued by the local City Corporation or Municipality. Must be renewed annually.
3. TIN Certificate
Tax Identification Number must be obtained from the National Board of Revenue (NBR).
4. VAT/BIN Registration
If the pharmacy’s turnover crosses the threshold (BDT 3 crore annually), a VAT registration (BIN) is required.
5. Pharmacist Registration
Pharmacists employed must be registered with the Bangladesh Pharmacy Council and possess at least a Diploma in Pharmacy from a recognized institution.
Application Process for Drug License
Step 1: Prepare Required Documents
- Complete application form (can be downloaded or collected from DGDA office)
- Trade license
- Layout plan of the pharmacy
- Photographs and identity documents
- Educational and professional certificates of the pharmacist
Step 2: Submit Application
Submit the application to the DGDA’s regional office with required fees.
Step 3: Site Inspection
A DGDA inspector will visit the premises to verify compliance with regulations.
Step 4: Issuance of Drug License
If all conditions are met, a retail drug license will be issued. Validity is typically one year and renewable.
Cost of Starting a Pharmacy Business
Expense Category | Estimated Cost (BDT) |
---|---|
Trade License | 2,000 – 5,000 |
Drug License Application | 3,000 – 5,000 (approx.) |
Pharmacist Registration | 2,000 – 5,000 |
Interior Setup/Fixtures | 1,50,000 – 3,00,000+ |
Refrigerator | 20,000 – 50,000 |
Inventory (Initial Stock) | 5,00,000 – 10,00,000+ |
Legal/Consultancy Fees | Varies |
Costs vary based on location, shop size, and inventory scale.
Renewal and Compliance
- Trade License: Renewed annually at the local government office.
- Drug License: Subject to periodic inspections and renewal every year.
- VAT/BIN: Must file monthly returns if registered.
- Employment of Pharmacist: A registered pharmacist must be physically present during operating hours, especially for A-Type and B-Type pharmacies.
- Display Requirements: Drug license, trade license, and pharmacist’s registration must be displayed prominently in the pharmacy.
- Record Keeping: Sales and purchase registers, prescription records, and invoices must be properly maintained and available for inspection.
Restrictions and Prohibitions
- No sale of expired, unregistered, or counterfeit drugs.
- Prescription-only drugs must not be sold without a valid doctor’s prescription.
- Sale of controlled substances (e.g., narcotics, psychotropics) is strictly regulated and requires additional authorization.
- Promotion of unauthorized medicines or unethical marketing practices is prohibited.
Penalties for Non-Compliance
Violations of the Drugs Act and DGDA regulations may result in:
- Fines and seizure of medicines
- Suspension or cancellation of drug license
- Criminal prosecution
- Business closure by order of court or regulatory authority
Franchising and Chain Pharmacies
In recent years, branded pharmacy chains have entered the market (e.g., Lazz Pharma, Health Aid, Arogga). Entrepreneurs may also consider franchising or partnerships, but all individual outlets must obtain separate trade and drug licenses and comply with DGDA rules.
Foreign Investment in Pharmacy
While retail drug sales are reserved for domestic entrepreneurs, foreign investment is permitted in the pharmaceutical manufacturing sector with clearance from Bangladesh Investment Development Authority (BIDA) and DGDA.
However, foreign nationals cannot directly own retail pharmacies, due to licensing and regulatory barriers. Joint ventures may be explored subject to sectoral restrictions.
Digital Pharmacies and E-Commerce
Online medicine delivery is an emerging trend, but it requires prior permission from DGDA and the Ministry of Health. These businesses must have:
- Valid retail drug license
- Physical pharmacy outlet
- Dedicated delivery system and prescription verification mechanism
- Compliance with the Digital Commerce Policy and DGDA’s online sales guidelines
Unlicensed online medicine sales are illegal and subject to strict action.
Summary Checklist
- ✅ Choose premises and sign rental agreement
- ✅ Obtain name clearance and trade license
- ✅ Hire a qualified pharmacist (for A/B-Type)
- ✅ Apply for drug license with DGDA
- ✅ Buy inventory, setup refrigerator, fire safety measures
- ✅ Display licenses and maintain records
- ✅ Renew licenses annually and comply with inspections
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