How to Register a Pharmaceutical Company in Pakistan

Starting a pharmaceutical company in Pakistan is a highly regulated process that demands full compliance with national health, licensing, and corporate laws. Whether your focus is manufacturing, importing, distributing, or wholesaling medicines, you must follow a clearly defined path involving SECP, FBR, DRAP, and provincial health authorities.

This comprehensive guide outlines all key steps, authorities involved, required documents, timelines, and compliance checks necessary to register and launch a legal pharmaceutical company in Pakistan.

✅ 1. Choose the Right Business Structure

Start by selecting the legal structure that suits your pharmaceutical operations:

Sole Proprietorship

• Registered via FBR (NTN only)

• Operates under the owner’s CNIC

• ⚠️ Not recommended for manufacturing due to limited credibility and liability protection.

Partnership (AOP)

• Register with the Registrar of Firms and FBR

• Suitable for distribution or retail; less preferred for manufacturing due to shared liability.

Private Limited Company (Pvt Ltd)

• Incorporated via SECP

• Offers separate legal identity and is the most credible form for pharmaceutical businesses.

• Strongly recommended for both manufacturing and large-scale distribution.

Single Member Company (SMC Pvt Ltd)

• Ideal for solo founders

• SECP-registered

• Suitable for trading and distribution, but not preferred for manufacturing.

✅ 2. Register Your Company with SECP

All pharmaceutical companies (except sole proprietorships) must register with the Securities and Exchange Commission of Pakistan (SECP).

Steps to Incorporate:

• Name Reservation: Apply through SECP’s eServices Portal. Include terms like “Pharmaceuticals”, “Pharma” or “Healthcare” in the proposed name.

• Submit Documents:

  • CNICs of all directors

  • Memorandum & Articles of Association (clearly stating pharmaceutical objectives)

  • Forms 1, 21, and 29

• Pay Registration Fee: Via bank or online

• Certificate of Incorporation: Issued by SECP within 1–2 business days

✅ 3. Register with FBR for NTN & STRN

National Tax Number (NTN)

Mandatory for all business structures. Apply via FBR IRIS Portal.

Required Documents:

• CNICs of directors

• SECP certificate

• Business address proof (rent agreement or ownership deed)

• Letterhead and utility bill

Sales Tax Registration (STRN)

Required for businesses dealing in APIs or pharmaceutical products. Register with FBR or provincial revenue authorities.

✅ 4. Obtain Drug Licenses from DRAP & Provincial Health Authorities

Pharmaceutical businesses must comply with Drug Act 1976 and DRAP Act 2012.

🔹 Types of Licenses:

📍 Drug Manufacturing License (DML) – DRAP

Step-by-step process:

1. Site Verification

   • Apply to DRAP with Form-1

   • Minimum land area: 2,000 sq. yards

2. Layout Approval

   • Submit site and machinery layout per GMP (Good Manufacturing Practices)

3. Facility Construction

   • Build the plant according to approved design

4. Final DML Application

   • Documents required:

     • SECP Certificate & NTN

     • Environmental NOC

     • Technical staff credentials (e.g., registered pharmacist, QC manager)

     • Fee challan

5. Inspection & Issuance

   • DRAP team inspects site

   • If compliant, Drug Manufacturing License (Form-2) is issued

   • Valid for 5 years, renewable

📍 Drug Sale / Distribution License – Provincial Health Dept.

Apply to the Health Department of your province (Punjab, Sindh, KPK, Balochistan).

Requirements:

• SECP incorporation & NTN

• Pharmacist appointment letter

• Drug sale premises proof (rental deed or ownership)

• Refrigeration equipment (if required)

• Pharmacist registration with Pharmacy Council of Pakistan

✅ 5. Product / Brand Name Registration with DRAP

If you’re launching your own branded medicine, you must register the product with DRAP before selling.

Submit the Following:

• Product formula and dosage

• Clinical and toxicity data

• Specifications & protocols

• Labeling and packaging samples

• CTD Form 5F (Common Technical Document)

DRAP’s Pharmaceutical Evaluations Division reviews the file. Upon approval, you’re allowed to produce, label, and market your product.

✅ 6. Obtain Additional Regulatory Registrations

🚫 Penalties for Non-Compliance

Operating a pharmaceutical business without proper licensing can lead to:

• Heavy fines by DRAP or Drug Courts

• Suspension or cancellation of licenses

• Imprisonment for counterfeit or unauthorized drug sales

• Permanent blacklisting and closure of operations

📋 Pharmaceutical Licensing Checklist

💼 Need Help Starting Your Pharma Company?

At CompanyRegistrationOnline.com, we offer complete registration support:

✅ SECP & FBR Registration
✅ DRAP Licensing Process
✅ Legal Documentation & Layout Planning
✅ Qualified Pharmacist Hiring
✅ POS Compliance & Trade License Setup

Contact our legal & compliance experts to start your pharmaceutical company—professionally, efficiently, and fully compliant.