Study guide

How to Prepare for the DRAP Assistant Director Test

DRAP officer tests reward candidates who understand how regulation actually works: who decides registration, how a factory is licensed, what an inspector checks and how a safety signal becomes a label change. This guide turns that into a study plan.

Updated 8 min read

Know what DRAP does

The Drug Regulatory Authority of Pakistan was established by the DRAP Act 2012, after health was devolved to the provinces. It is the federal regulator of therapeutic goods: drugs, biologicals, medical devices, and alternative medicines and health products.

Provinces kept retail and wholesale licensing, provincial inspections and provincial quality control boards. DRAP handles registration, manufacturing licensing, pricing recommendations, pharmacovigilance, clinical trial approval and federal inspections. Questions often test exactly where this line falls.

The boards and what each decides

  • Policy Board: oversees the Authority and approves its policies.
  • Registration Board: decides registration of drugs for marketing.
  • Central Licensing Board: grants and renews drug manufacturing licences.
  • Appellate Board: hears appeals against decisions of the boards.
  • Provincial Quality Control Boards (provincial): decide prosecution of provincial cases.

The laws and rules to read

  • DRAP Act 2012 and the Drugs Act 1976 (definitions of spurious, misbranded, adulterated, substandard and counterfeit drugs; inspectors' powers; Drug Courts).
  • Drugs (Licensing, Registering and Advertising) Rules 1976 and the labelling and packing rules.
  • Medical Devices Rules 2017 and the Alternative Medicines and Health Products (Enlistment) Rules 2014.
  • Bio-Study Rules 2017 for clinical trials and Pharmacovigilance Rules 2022.
  • Pharmacy Act 1967 and the Control of Narcotic Substances Act 1997.

International guidance you must recognise

Expect questions that name a guideline and ask what it covers. Learn the ICH families (Quality, Safety, Efficacy, Multidisciplinary), the five modules of the Common Technical Document, and the key WHO mechanisms: prequalification, the Global Benchmarking Tool, the Certification Scheme (CPP) and the INN programme. Know what PIC/S is and why membership matters for exports.

Pharmacovigilance and GMP as scenarios

Pharmacovigilance questions test definitions (serious versus severe, signal, PBRER), reporting timelines and causality categories. GMP questions describe a finding (an unvalidated cleaning process, missing line clearance, an out-of-specification result) and ask what it means or what must happen next. Practise both as MCQs until the vocabulary is automatic.

A four-week plan

  • Week 1: DRAP Act, Drugs Act and boards; one-page structure sheet.
  • Week 2: registration, CTD, bioequivalence, pricing and import control.
  • Week 3: GMP, validation, QA/QC, medical devices and health products.
  • Week 4: pharmacovigilance, ICH/WHO revision and two full timed papers.

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