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Pakistan Product Registration & Certification

Primary Regulatory Agency: DRAP (Drug Regulatory Authority of Pakistan)
Official Website: www.dra.gov.pk

Important Notes

  • DRAP Registration: All pharmaceuticals, biologicals, and certain medical devices require mandatory registration with the Drug Regulatory Authority of Pakistan to obtain a registration certificate for import, manufacture, or sale.
  • Local Authorized Agent Requirement: Foreign manufacturers must appoint a locally registered Pakistani company (importer/agent) as the registration holder to submit applications and assume all regulatory and legal responsibilities.
  • Technical Documentation & WHO Prequalification: Complete English technical documentation is required. DRAP places high value on WHO Prequalification (PQ) and approvals from Stringent Regulatory Authorities (e.g., FDA, EMA), which can simplify or expedite review.
  • Labeling & Language Requirements: Product labels and instructions must be in both English and Urdu. Core information (name, ingredients, dosage, expiry, storage) must be clearly displayed in both languages.
  • Price Control & Maximum Retail Price (MRP): All registered products must undergo price registration with DRAP, and the government-approved MRP must be printed on packaging; selling price cannot exceed MRP.
  • Bioequivalence Study Requirement (Generics): Registration of generic drugs, especially oral solid dosage forms, typically requires a Bioequivalence (BE) study conducted in Pakistan or at designated facilities.

Pakistan Specific Requirements

  • Large Population-Driven Generic-Dominant Market: As the world's fifth-most populous country, the market is vast but with limited purchasing power, dominated by generics where price competition is extremely intense.
  • Parallel Public-Private Healthcare System: The public system provides basic care but is resource-constrained; the growing private sector (hospitals, clinics, pharmacies) is the main channel for innovative and higher-value products.
  • Reliance on International Reference Approvals: With limited resources, DRAP's review often references existing approvals from WHO, FDA, EMA, etc. International certification serves as a crucial "fast-track" passport.
  • Rise of the Local Pharmaceutical Industry: Domestic pharmaceutical companies are growing in strength, becoming not only market competitors but also potential manufacturing partners or licensees for international firms.
  • Stringent Price Control & Supply Chain Challenges: Strict price controls squeeze profit margins, while currency volatility, complex customs clearance, and distribution logistics pose ongoing operational hurdles.
Medical Devices
Cosmetics
Health Supplements

Medical Devices Registration

Regulatory Requirements

  • Medical Device Registration Certificate
  • Classification Management by Risk Level (Class A, B, C, D)
  • Complete Technical Documentation and Test Reports
  • Quality Management System Certificate (ISO 13485)
  • English/Urdu Bilingual Labeling
  • Free Sale Certificate
  • Certificate of Origin
  • GMP Certificate
  • Stability Study Data
  • Pakistan Local Agent Agreement
  • Local Test Reports

Main Process

  • Product Classification Determination
  • Technical Documentation Preparation
  • Local Agent Appointment
  • DRAP Application Submission
  • Sample Testing Completion
  • Registration Certificate Acquisition

Registration Timeline

12-24 months

Official Fees

PKR 150,000 - 3,000,000

Service Fees

$15,000 - $48,000

Regulatory System Overview

DRAP

Drug Regulatory Authority of Pakistan

Responsible for registration approval, import licensing, quality supervision, and market regulation of medical devices, pharmaceuticals, and health products. Operates as the primary health product regulatory authority under the Ministry of National Health Services, Regulations and Coordination, Pakistan.

PSQCA

Pakistan Standards and Quality Control Authority

Responsible for developing mandatory product standards, conducting product certification and testing, ensuring specific product categories comply with Pakistan national standards

M/o NHSR&C

Ministry of National Health Services, Regulations and Coordination Pakistan

Responsible for developing national health policies, pharmaceutical regulatory frameworks, and public health standards, overseeing DRAP operations and enforcement

Medical Devices Registration Process

1

Product Classification Determination

Determine product risk classification according to Pakistan medical device regulations (Class A-D)

2

Technical Documentation Preparation

Prepare complete technical documentation including product specifications, test reports, quality system certificates

3

Local Agent Appointment

Appoint authorized agent in Pakistan responsible for registration and regulatory affairs

4

DRAP Application Submission

Submit medical device registration application and all technical documents to DRAP

5

Sample Testing

Complete mandatory product testing in Pakistan accredited laboratories

Cosmetics Registration

Regulatory Requirements

  • Cosmetic Registration Certificate
  • Ingredient Safety Assessment Report
  • English/Urdu Bilingual Labeling
  • Good Manufacturing Practice Certification
  • Product Information File
  • Microbiological Test Reports
  • Stability Study Data
  • PSQCA Mandatory Certification (for specific products)
  • Heavy Metals and Contaminants Testing
  • Prohibited Ingredients Compliance Proof

Main Process

  • Ingredient Compliance Assessment
  • Safety Assessment Completion
  • Local Agent Appointment
  • Registration Application Submission
  • PSQCA Certification Acquisition

Registration Timeline

6-15 months

Official Fees

PKR 80,000 - 600,000

Service Fees

$8,000 - $22,000

Regulatory System Overview

DRAP

Drug Regulatory Authority of Pakistan

Responsible for registration approval, import licensing, quality supervision, and market regulation of medical devices, pharmaceuticals, and health products. Operates as the primary health product regulatory authority under the Ministry of National Health Services, Regulations and Coordination, Pakistan.

PSQCA

Pakistan Standards and Quality Control Authority

Responsible for developing mandatory product standards, conducting product certification and testing, ensuring specific product categories comply with Pakistan national standards

M/o NHSR&C

Ministry of National Health Services, Regulations and Coordination Pakistan

Responsible for developing national health policies, pharmaceutical regulatory frameworks, and public health standards, overseeing DRAP operations and enforcement

Cosmetics Registration Process

1

Ingredient Compliance Assessment

Verify all ingredients comply with Pakistan cosmetic regulations

2

Safety Assessment Report

Prepare product safety assessment report and technical documentation

3

Local Agent Appointment

Appoint authorized agent in Pakistan responsible for registration affairs

4

Registration Application Submission

Submit cosmetic registration application to relevant regulatory authorities

5

PSQCA Certification

Obtain mandatory certification from Pakistan Standards and Quality Control Authority for specific product categories

Health Supplements Registration

Regulatory Requirements

  • Health Supplement Registration Certificate
  • Ingredient Safety and Quality Proof
  • English/Urdu Bilingual Labeling
  • Good Manufacturing Practice Certification
  • Scientific Basis for Efficacy Claims
  • Stability Study Data
  • Heavy Metals and Contaminants Testing
  • Microbiological Test Reports
  • Nutritional Composition Analysis
  • Traditional Use Evidence (if applicable)

Main Process

  • Product Classification Confirmation
  • Technical Documentation Preparation
  • Local Agent Appointment
  • Registration Application Submission
  • Sample Testing Completion

Registration Timeline

9-18 months

Official Fees

PKR 100,000 - 1,000,000

Service Fees

$10,000 - $28,000

Regulatory System Overview

DRAP

Drug Regulatory Authority of Pakistan

Responsible for registration approval, import licensing, quality supervision, and market regulation of medical devices, pharmaceuticals, and health products. Operates as the primary health product regulatory authority under the Ministry of National Health Services, Regulations and Coordination, Pakistan.

PSQCA

Pakistan Standards and Quality Control Authority

Responsible for developing mandatory product standards, conducting product certification and testing, ensuring specific product categories comply with Pakistan national standards

M/o NHSR&C

Ministry of National Health Services, Regulations and Coordination Pakistan

Responsible for developing national health policies, pharmaceutical regulatory frameworks, and public health standards, overseeing DRAP operations and enforcement

Health Supplements Registration Process

1

Product Classification Confirmation

Confirm product falls under health supplements category, determine applicable registration classification

2

Technical Documentation Preparation

Prepare complete technical documentation including ingredient analysis, safety evidence, efficacy proof

3

Local Agent Appointment

Appoint authorized agent in Pakistan with appropriate qualifications

4

Registration Application Submission

Submit health supplement registration application to DRAP

5

Local Testing

Complete mandatory product quality testing in Pakistan accredited laboratories