Often referred to as a drug manufacturer, a licensed organisation is set up to study, manufacture, market, and supply medications for the healthcare industry. Because of its direct effects on human health, this industry is closely regulated. Discovery, distribution, and use of medications are controlled by the pharmaceutical company’s rules. Public safety standards to prevent unfavourable side effects, advertising limitations, and intellectual property protections for pharmaceutical research are covered by these rules, as are those on prescribing and dispensing medicines.

While imports satisfy the other 20%, local producers in Pakistan cover roughly 80% of the medical requirements. A copy of their National Identity Card, land deed or lease, company information, director or partner information, and a layout of the planned site should all be submitted by anyone seeking to establish a pharmaceutical plant.

Site Verification

To make sure no nearby activity releases noxious odours, vapours, or too much dust, soot, or smoke, the proposed location is verified. For licensing, a least plot size of 2,000 square yards is needed. Usually taking 3–4 weeks, site verification costs PKR 5,000.

Layout Plan

Applicants must provide a layout plan detailing the operational workflow. The Board reviews it for compliance with current manufacturing practices per Schedule B-1 of the Drug Rules 1976. Once approved, this process generally takes 3–4 weeks. The fee for layout plan approval is PKR 1,000 per section, while revisions or expansions cost PKR 500 per section.

Application for Drug Manufacturing License

Once the facilities are ready, a formal application is submitted using Form-I of the Drug Rules, including the necessary fees, to assess production and quality control arrangements.

There are four primary types of licenses for drug manufacturing:

• Basic manufacturing license
  
  
• Semi-basic manufacturing license
  
  
• Formulation license
  
  
• Repacking license
  
  

A pharmaceutical unit may apply for multiple licenses. As per Rule 3 of the Drug Rules 1976, applications are submitted to the Secretary of the Central Licensing Board. Five-year licenses can be renewed. Until a decision is made, the current license is good pending renewal. Non-compliance could lead to suspension, revocation, or rejection of renewal.

Conditions for licenses are specified as follows:

• Basic or semi-basic manufacturing: Rule 15
  
  
• Formulation: Rule 16
  
  
• Repacking: Rule 18
  
  

License Fees (Schedule F)

• Basic: PKR 10,000
  
  
• Semi-basic: PKR 10,000
  
  
• Formulation: PKR 35,000
  
  
• Repacking: PKR 20,000
  

Drug Registration

Drug registration is overseen by the Federal Government’s Registration Board under the Drugs Act, 1976, ensuring the safety of medicines.

Form-5 is used for locally made medications; imported medicines use Form-5(A) under the Drugs Rules 1976. New compounds can take 6–12 months for approval; branded generics usually take three to six months. Each drug strength requires a separate registration, valid for five years, and is renewable.

Experimental Manufacturing License

Under Rule 21 of the Drug Rules 1976, individuals or entities wishing to manufacture drugs for experimental purposes must apply using Form-3 to the Secretary of the Central Licensing Board. Approval is granted in Form-4.

Drug Registration Fees (Rule 26(3)

• New drug molecule: PKR 15,000
  
  
• Imported drugs: PKR 15,000
  
  
• Locally manufactured drugs, including Galenicals: PKR 8,000
  

Applicable Legislation

• Drugs Act, 1976
  
  
• Drug Regulatory Authority of Pakistan Act, 2012
  
  
• Drugs (Licensing, Registering & Advertising) Rules, 1976

Start your pharmaceutical business the right way. Contact us now for expert guidance on licensing, registration, and compliance in Pakistan.