💊 MEDICAL STORE BUSINESS IN PAKISTAN: A COMPLETE GUIDE

Starting a medical store in Pakistan is a promising business, but it operates under strict legal and regulatory frameworks to ensure public health and safety. This guide provides a comprehensive overview of the licenses, procedures, and compliance required to legally run a medical store or pharmacy in Pakistan.

⚠️ Important Disclaimer

This guide is for general informational and educational purposes only and is not legal advice. Business and licensing requirements may vary by location (province/district) and are subject to legislative or regulatory changes. Always consult a qualified professional or the relevant government authority for your specific case.

1. Introduction

A medical store in Pakistan is a regulated retail business that sells pharmaceutical drugs and medicines. The sale of medicines without the necessary licenses is a criminal offense. The licensing process and the regulatory bodies involved vary depending on whether you are setting up in Punjab, Sindh, Khyber Pakhtunkhwa (KPK), Balochistan, or the Islamabad Capital Territory (ICT). The most crucial step is obtaining a Drug Sales License, which governs retail pharmaceutical sales. The business can be registered under various legal structures, such as a Sole Proprietorship, Partnership, Single Member Company (SMC), or Private Limited (Pvt Ltd) company.

2. Regulatory Framework & Key Laws

Understanding the legal framework is the first step to compliance. Here's a breakdown of the key regulatory bodies and laws governing medical stores in Pakistan.

Regulatory Body	Responsibilities	Primary Governing Law
District Health Authority (DHA)	Issues Drug Sales Licenses (e.g., Form-6, Form-8) and conducts inspections at the district level.	Drugs Act, 1976
Provincial Health Departments	Enforce drug laws and oversee pharmaceutical activities within their respective provinces.	Drugs Act, 1976
Provincial Healthcare Commissions	Register healthcare establishments, enforce Minimum Service Delivery Standards (MSDS), and ensure patient safety.	Respective Provincial Acts (e.g., PHC Act 2010)
Drug Regulatory Authority of Pakistan (DRAP)	Ensures quality, safety, and efficacy of medicines at the federal level (primarily for manufacturers & importers).	DRAP Act, 2012
Federal Board of Revenue (FBR)	Issues National Tax Number (NTN) for tax registration.	Income Tax Ordinance, 2001
Provincial Pharmacy Councils	Register individual qualified pharmacists (Category-A) and pharmacy premises.	Pharmacy Act, 1967
Local Municipal Corporation	Issues a Trade License, allowing commercial operation on a physical premises.	Local Government/Municipal Laws
Securities and Exchange Commission of Pakistan (SECP)	Registers the company if operating as a Pvt Ltd or SMC (creates legal entity).	Companies Act, 2017

The fundamental laws include:

• Drugs Act, 1976: The primary legislation that governs the sale of medicines in Pakistan and creates the legal requirement for a Drug Sales License.
• Pharmacy Act, 1967: Regulates the pharmacy profession and requires a qualified, registered pharmacist to be on duty at all times.
• Provincial Healthcare Commission Acts: Specific acts for each province that mandate the registration of healthcare establishments, including medical stores if they provide any healthcare services.

3. Types of Pharmaceutical Businesses

Under the Drugs Act, 1976, different licenses are issued for different types of businesses:

• Medical Store (Form-6 License): A basic retail setup for selling over-the-counter and prescription medicines, without the mandatory presence of a qualified pharmacist. The space requirement is 96 sq. ft. with a minimum breadth of 8 feet and a minimum height of 8 feet.
• Retail Pharmacy (Form-8 License): A more comprehensive setup that must have a full-time, qualified pharmacist on duty to dispense medicines. A pharmacy typically requires a larger space, with one source citing 140 sq. ft.. This is the model Pakistan is moving towards to ensure safer dispensing.
• Wholesale Pharmacy (Form-7A/7B License): A license for distributing medicines in bulk to retailers, hospitals, and clinics.
• Pharmaceutical Manufacturing: Requires a more stringent license from DRAP and follows Good Manufacturing Practices (GMP).

To legally prescribe and dispense medicines, the presence of a qualified professional is essential:

• A Doctor (registered with PMDC) has the legal authority to prescribe medicines.
• A Qualified Pharmacist (registered with the Pharmacy Council of Pakistan) is required to be on duty to dispense medicines at a retail pharmacy (Form-8 license).

4. Step-by-Step Registration Process

Follow this detailed checklist to ensure you have all legal approvals before opening your medical store:

📝 Step 1: Business Name Selection & Pre-Registration

• Choose a Unique Business Name: Decide on a name for your business entity.
• SECP Name Reservation (for Companies): If you plan to register your pharmacy as a Private Limited Company or Single Member Company (SMC), you must first get your chosen name approved by the SECP via their eServices portal. For a sole proprietorship, you can skip this step.

🏢 Step 2: Business Legal Entity Registration

• SECP Company Registration (for Companies): File for incorporation of your company with the SECP, which will issue a Certificate of Incorporation and a Company Unique Identification Number (CUIN). This legally creates your business entity.
• Sole Proprietorship / Partnership: A sole proprietor can simply operate using their own CNIC, while a partnership needs to register a Partnership Deed with the Registrar of Firms. FBR registration (Step 5) is mandatory for all.

📍 Step 3: Secure Premises & Obtain Trade License

• Finalize a Premises: Find a location that meets the space requirements for a medical store (minimum 96 sq. ft.).
• Obtain Trade License: Apply for and obtain a Trade License from your local municipal corporation or district council. This is a fundamental legal document to operate any commercial business on a physical premises. Submit your CNIC, proof of ownership or rental agreement for the shop, and any other required fee.

💊 Step 4: Apply for Drug Sales License (Form-6/Form-8)

This is the most critical license for your medical store. The licensing authority is the District Health Officer (DHO) in your district, under the provincial Health Department.

• Collect Application Form: Visit the DHO office or their website to obtain the application form (often called Form-5 for a Drug Sales License).
• Complete Application: Fill out the application form carefully, providing details of the business and the proposed premises. You may need to apply for Form-6 (Medical Store) or Form-8 (Pharmacy) .
• Attach Required Documents:
  • Copies of your CNIC (and of all partners/directors).
  • Proof of business registration: Certificate of Incorporation (for companies) or Partnership Deed.
  • Proof of Trade License from municipal authorities.
  • Premises documents: Ownership papers or a valid rent agreement.
  • CNIC and registration proof of the proposed staff (e.g., pharmacist for Form-8).
  • An affidavit on stamp paper.
• Submit Application & Pay Fee: Submit the completed application with all supporting documents and pay the prescribed fee. The fee for a Form-6 retail license is approximately PKR 6,000.
• Premises Inspection: After submission, a Drug Inspector will visit the premises to verify compliance with storage standards (e.g., proper racks, cooling facilities, protection from sunlight).
• License Issuance: Once the application is approved and the inspection is passed, the DHO will issue the Drug Sales License, authorizing you to start selling medicines. The license issuance and renewal in the federal capital has been automated.

👨‍⚕️ Step 5: Ensure a Qualified Pharmacist (For Form-8 License)

If you are applying for a Retail Pharmacy (Form-8) license, you must have a qualified pharmacist registered with the Pharmacy Council of Pakistan. Their registration number will be part of your license application.

• Pharmacist's Qualifications: The pharmacist must hold a recognized pharmacy degree (Pharm-D) from a university recognized by the Pharmacy Council of Pakistan. They are enrolled in Register A by the Council.
• On-Premises Presence: The law requires that a registered pharmacist must be on duty during the store's operating hours to supervise the sale and dispensing of medicines. You cannot legally run a pharmacy without one.

💰 Step 6: Register with FBR for Tax Compliance

• Obtain National Tax Number (NTN): For any business, you must obtain an NTN from the FBR. You can register online via the FBR's IRIS portal. For a sole proprietorship, your personal CNIC serves as your NTN.
• Apply for Sales Tax Registration (If Applicable): If your annual turnover for your medical store is expected to exceed PKR 10 million, you must also register for Sales Tax and obtain an STRN through the IRIS portal. This is mandatory for collecting GST on sales.

🏥 Step 7: Register with Provincial Healthcare Commission (If Applicable)

• Punjab Healthcare Commission (PHC): While primarily for clinics/hospitals, if your pharmacy offers any diagnostic or minor treatment services, you will need to register with the PHC under the PHC Act 2010. The process involves submitting facility details, staff credentials, and an on-site inspection against Minimum Service Delivery Standards (MSDS).
• Sindh Healthcare Commission (SHCC): As of June 2025, SHCC has an online platform for registration. A pharmacy/medical store is categorized as a Category II healthcare establishment. The registration fee for a pharmacy/medical store is PKR 4,000. Annual renewal is PKR 20,000. Registration can be done via the SHCC online portal. If an establishment fails to get licensed, the SHCC can impose fines.

5. Key Regulations & Compliance

Once your medical store is operational, you must adhere to ongoing compliance to avoid penalties.

Regulatory Aspect	Key Requirement
Record Keeping	Maintain a complete record of all purchases and sales of drugs as per the Drugs Act, 1976. You must produce these records when requested by a Drug Inspector.
Drug Storage	Follow manufacturer guidelines for storage. Keep medicines in proper racks, maintain adequate cooling for temperature-sensitive products, and protect stock from direct sunlight. Controlled substances must be stored separately in a locked cabinet.
Licensed Staff	For a Form-8 pharmacy, ensure a qualified, registered pharmacist is present during all operating hours.
Qualified Staff for Vaccination	If you offer vaccination services, ensure the person administering the vaccine is a qualified doctor or a trained nurse/technician under proper supervision.
Authorized Sourcing	Procure medicines only from licensed pharmaceutical manufacturers, authorized distributors, or companies with valid Drug Sales Licenses. Avoid unverified sources.
Valid Licenses	All licenses (Drug Sales, Trade, SHCC) must be prominently displayed at the premises. Renew them promptly before their expiry.
No Expired/Unregistered Drugs	It is a serious offense to keep or sell expired or unregistered medicines. Always check expiry dates and source only DRAP-registered drugs.

6. Penalties for Non-Compliance

Non-compliance with drug laws can lead to severe legal consequences.

• License Suspension/Cancellation: The Quality Control Board can order the immediate suspension or cancellation of your drug sale license for violations.
• Heavy Fines: Courts can impose massive fines for serious offenses, such as selling unregistered drugs. In one instance, a pharmacy owner was fined Rs100 million.
• Imprisonment: Penalties can also include jail time. Selling spurious drugs carries a prison sentence of 5 to 10 years. The same pharmacy owner was also sentenced to one-year imprisonment.
• Sealing of Premises: Authorities have the power to seal medical stores for operating without a valid license or other severe violations. Not maintaining proper purchase/sale records is also a violation.

7. Recent Developments & Updates (2024-2026)

The regulatory landscape for medical stores and pharmacies in Pakistan is evolving. Here are some key recent updates:

• SHCC Online Registration (June 2025): The Sindh Healthcare Commission launched a new online platform for registration and licensing of healthcare establishments, including pharmacies, replacing manual procedures.
• DRAP Digitalization (Ongoing): The Drug Regulatory Authority of Pakistan is integrating its systems with the Pakistan Single Window (PSW) to facilitate online drug registrations and import/export licenses.
• Online Drug Sales License (Islamabad): The process for issuing and renewing drug sale licenses for medical stores in the federal capital has been fully automated, making it a paper-free process.
• Automated Drug Registration (DRAP): The federal health minister launched a mobile app in December 2023, enabling pharmaceutical companies to submit online applications for drug registration and licensing, speeding up the process.
• Strict Enforcement (Ongoing): There is a continued crackdown on violations of the Drugs Act, 1976 and DRAP Act, 2012, with authorities regularly taking action against stores selling unregistered or expired medicines.
• Drug Sale License to be Mandatory (Sindh): The Health Department of Sindh is working to enforce the law making a Drug Sale License (Form-6 or Form-8) a mandatory requirement for all medical stores in the province.

8. Contact Details for Regulatory Bodies

Here are some direct contacts for key regulatory bodies, which can be useful for inquiries:

• Ministry of National Health Services (Islamabad): 051- 9255407-9
• Drug Regulatory Authority of Pakistan (DRAP - Federal Level): 051- 9191100 (Website: www.dra.gov.pk)
• Punjab Healthcare Commission (PHC): 042- 99333161-68. Address: 185, Ahmed Block, New Garden Town, Lahore. Website: phc.org.pk
• Sindh Healthcare Commission (SHCC): Website: shcc.org.pk (Online registration portal: business.sindh.gov.pk)
• Pharmacy Council of Pakistan (Federal Level): Website: pcpisb.gov.pk
• Securities & Exchange Commission of Pakistan (SECP - Federal Level): Register via eServices portal at eservices.secp.gov.pk.