Drug law questions test which law, which body and which schedule. These notes summarise the structure; read the official sections for exact wording, penalties and amounts, which change through amendments.
How this book helps in the exam
- Which law created which body (DRAP, Pharmacy Council, Drug Courts).
- Who can sell, store or inspect drugs, and under which licence.
- What counts as misbranded, adulterated, spurious or substandard.
- Pharmacist registration and ethics.
What the book covers
10 high-yield topics. Each has the points most often examined and links to practise them.
1Drugs Act 1976
- Regulates import, export, manufacture, storage, distribution and sale of drugs.
- Defines misbranded, adulterated, spurious and substandard drugs.
- Provides for Federal and Provincial Inspectors and Drug Courts.
- Provincial Quality Control Boards decide on prosecutions in the provinces.
2DRAP Act 2012
- Created the Drug Regulatory Authority of Pakistan as the federal regulator after the 18th Amendment.
- DRAP handles registration, licensing of manufacture, pricing, and pharmacovigilance.
- It also covers medical devices, biologicals and alternative medicines.
- The Policy Board is DRAP's main decision-making body.
3Pharmacy Act 1967
- Established the Pharmacy Council of Pakistan and the Provincial Pharmacy Councils.
- Registers pharmacists and keeps the register (Category A for degree holders).
- Approves pharmacy education standards and institutions.
- Regulates the practice of pharmacy and removal from the register for misconduct.
4Drug rules and schedules
- Provincial drug rules set the sale licences for pharmacies and medical stores.
- Schedules list controlled and prescription-only drugs.
- Licences specify the qualified person who must supervise sale.
- Records of controlled drug sales must be kept for inspection.
5Registration and licensing
- No drug can be sold in Pakistan without DRAP registration.
- The Registration Board decides on applications for new and generic products.
- Manufacturing needs a DRAP licence and GMP compliance.
- Imports need registration and import permissions.
6Drug pricing
- DRAP fixes maximum retail prices under its drug pricing policy.
- Selling above the approved price is an offence.
- Hardship cases allow review of prices of essential medicines.
- Prices must be printed on the pack.
7Controlled substances
- Narcotics are also governed by the Control of Narcotic Substances Act 1997.
- Controlled drugs need special records, storage and prescriptions.
- Pakistan follows the UN conventions on narcotic and psychotropic substances.
- Precursor chemicals are also controlled.
8Pharmacovigilance
- DRAP runs the national pharmacovigilance centre that collects adverse event reports.
- Healthcare professionals and companies should report suspected adverse reactions.
- Serious and unexpected reactions are priorities for reporting.
- Signals can lead to label changes, restrictions or withdrawal.
9Medical devices and health products
- DRAP regulates medical devices under its own device rules, graded by risk class.
- Alternative medicines and health products (nutraceuticals, herbal, homeopathic) are enlisted separately from drugs.
- Higher-risk device classes face stricter registration and evidence requirements.
- Health claims on these products must not present them as cures for disease.
10Pharmacist ethics and conduct
- The pharmacist's first duty is patient welfare and safety.
- Patient information is confidential.
- A pharmacist must not dispense a drug they believe is substandard or spurious.
- Lending your registration to a store you do not supervise is misconduct.
These are PharmaPrep's own notes on the knowledge this book teaches. No text, tables or figures are reproduced from it. Read the book for full explanations, and check doses and laws against current official sources.
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