Company Registration In Pakistan is a comprehensive process regulated by the Securities and Exchange Commission of Pakistan (SECP) and the Drug Regulatory Authority of Pakistan (DRAP). This process involves strict adherence to corporate, licensing, and regulatory requirements to ensure compliance with national laws governing the pharmaceutical industry. Below is a step-by-step guide for registering a pharmaceutical company in Pakistan:
Step 1: Decide on the Type of Company
The first step is to determine the legal structure of the company. For pharmaceutical businesses, the most common structure is a private limited company, as it offers limited liability and facilitates growth. Other structures, like partnerships or sole proprietorships, may also be considered for smaller ventures, but these lack the scalability and legal protections of private limited companies.
Step 2: Choose a Unique Name for the Company
Select a unique name for your pharmaceutical company. The name must comply with SECP’s naming guidelines, avoiding prohibited terms or those resembling existing companies. Use SECP’s Company Name Search Tool to confirm availability before proceeding. Once the name is finalized, apply for a reservation through SECP’s eServices portal. Upon approval, you will receive a Name Reservation Certificate valid for 90 days.
Step 3: Prepare Incorporation Documents
The following documents are required to register the company with SECP:
- Memorandum of Association (MoA): This document outlines the objectives of your company, such as manufacturing, importing, or distributing pharmaceutical products. Be specific about the scope of activities.
- Articles of Association (AoA): This details the internal governance and operational structure of the company.
- Director and Shareholder Details: Include CNICs or passports of all directors and shareholders.
- Forms 1, 21, and 29: These forms are mandatory for compliance with the Companies Act, 2017. They include the declaration of compliance, notice of the registered office, and particulars of directors and officers.
These documents should be carefully drafted, preferably with the assistance of a legal expert specializing in corporate law.
Step 4: Submit the Incorporation Application
File the incorporation application online through SECP’s eServices portal. Pay the applicable registration fees based on your company’s authorized capital. After successful submission and review, SECP will issue a Certificate of Incorporation, officially recognizing your company as a legal entity.
Step 5: Obtain a Drug Manufacturing License
To operate as a pharmaceutical company, you must secure a Drug Manufacturing License from the Drug Regulatory Authority of Pakistan (DRAP). The application process involves:
- Application Submission: Apply DRAP, specifying the manufacturing activities, production capacity, and types of pharmaceutical products (e.g., tablets, capsules, syrups, or injectables).
- Site Inspection: DRAP will inspect the proposed manufacturing facility to ensure it meets the requirements of Good Manufacturing Practices (GMP).
- Approval of Premises: Secure approval for the premises and layout of the manufacturing plant.
- Licensing Fees: Pay the required licensing fees.
- Issuance of License: Once the application is approved, DRAP issues a Drug Manufacturing License, allowing you to manufacture pharmaceuticals.
Step 6: Register Pharmaceutical Products
Each pharmaceutical product must be registered with DRAP before production or marketing. Submit a product dossier containing detailed information about the composition, formulation, testing methods, and safety of the drug. DRAP reviews the dossier, and if it meets regulatory standards, the product is granted registration.
Step 7: Register with the Federal Board of Revenue (FBR)
Company Registration In Lahore with the Federal Board of Revenue (FBR) to obtain:
- National Tax Number (NTN): Required for filing taxes.
- Sales Tax Registration Number (STRN): Mandatory if your company deals with taxable goods or services.
You can register for both NTN and STRN online through the FBR’s portal.
Step 8: Open a Corporate Bank Account
Once your company is registered with SECP and FBR, open a corporate bank account in the company’s name. Provide your Certificate of Incorporation, NTN, and other necessary documents to the bank.
Step 9: Environmental Compliance
Pharmaceutical companies must comply with environmental laws. Obtain an Environmental Impact Assessment (EIA) approval from the provincial Environmental Protection Agency (EPA) to ensure your manufacturing facility adheres to environmental standards.
Step 10: Hire Skilled Professionals
Pharmaceutical companies are required to employ qualified professionals, such as:
- Pharmacists: To oversee production and ensure compliance with GMP.
- Quality Control Officers: To maintain product standards.
- Regulatory Affairs Specialists: To handle licensing and compliance matters.
DRAP mandates the presence of qualified personnel to ensure operational compliance.
Step 11: Comply with Labor Laws
Register your company with labor and social security institutions such as:
- Employees Old-Age Benefits Institution (EOBI): For pensions and old-age benefits.
- Provincial Social Security Institutions: For healthcare and other employee benefits.
These registrations ensure compliance with labor laws and provide social protection for employees.
Step 12: Fulfill Ongoing Compliance
After registration, maintain compliance with SECP, DRAP, and FBR by:
- Submitting annual financial statements to SECP.
- Filing tax returns with FBR.
- Renewing licenses and product registrations with DRAP.
Conclusion
Registering a pharmaceutical company in Pakistan requires careful planning and adherence to corporate and regulatory requirements. From incorporation with SECP to obtaining a Drug Manufacturing License from DRAP, each step is critical for legal and operational compliance. Engaging professionals like Hamza & Hamza Law Associates, such as corporate lawyers and regulatory consultants, can simplify the process, ensuring a successful launch of your pharmaceutical business.