Drug Laws · Short notes

Drug Rules and Schedules: Short Notes & Cheat Sheet

The main federal rules under the Drugs Act, provincial sale rules, labelling requirements, and controlled and prescription-only drugs.

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Short notes

Read these before you attempt the topic's MCQs.

The rulebook around the Drugs Act

The Act sets principles; rules supply the detail. Federal rules cover making and trading; provincial rules cover selling.

Federal rules under the Drugs Act 1976

1976 rules: Drugs (Licensing, Registering and Advertising) Rules; Drugs (Import and Export) Rules; Drugs (Appellate Board) Rules; and Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules.
1978 rules: Drugs (Specifications) Rules (official standards drugs must meet) and Drugs Research Rules.
Drugs (Labelling and Packing) Rules 1986: what must appear on labels and packs.
Newer DRAP rules: Alternative Medicines and Health Products (Enlistment) Rules 2014, Medical Device Rules 2017, Bio Study Rules 2017 (clinical and bioequivalence studies), Ethical Marketing to Healthcare Professionals Rules 2021, Pharmacovigilance Rules 2022 and Therapeutic Goods Advertisement Rules 2025.

Provincial sale rules

Each province has drug rules for licensing and running retail and wholesale outlets: Punjab Drugs Rules 2007, Sindh Drugs Rules 2010, Khyber Pakhtunkhwa Drugs Rules 1982, Balochistan Drugs and Therapeutic Goods Rules 2021, Islamabad Capital Territory Drugs Rules 2013 and AJK Drugs (Sale) Rules 2021.
They set storage conditions, record keeping, the qualified person's presence, and the sale of prescription-only medicines.
Prescription-only medicines must not be sold without a valid prescription from a registered medical or dental practitioner.

Labels and controlled drugs

Labels must include the name (with the generic name shown prominently), strength, registration number, batch number, manufacturing and expiry dates, manufacturer's name and address, retail price and storage conditions.
Warnings and directions are also given in Urdu, and 'Keep out of reach of children' is required.
Physician samples are marked as not for sale.
Narcotic and psychotropic drugs are also controlled by the Control of Narcotic Substances Act 1997. They need separate storage, registers and special prescriptions.
Rules are amended often; always check the latest official text.

Cheat sheet

High-yield facts in one place. Cover the right-hand column and test yourself.

Main rules

Rules	Cover
Licensing, Registering and Advertising Rules 1976	Manufacturing licences, registration, advertising
Import and Export Rules 1976	Cross-border trade in drugs
Specifications Rules 1978	Recognised pharmacopoeial standards
Drugs Research Rules 1978	Research on drugs
Labelling and Packing Rules 1986	Label and pack requirements
AMHP (Enlistment) Rules 2014	Alternative medicines, health products
Medical Device Rules 2017	Medical devices
Bio Study Rules 2017	Clinical trials, bioequivalence studies
Pharmacovigilance Rules 2022	ADR reporting and safety
Punjab Drugs Rules 2007	Sale licensing in Punjab
Sindh Drugs Rules 2010	Sale licensing in Sindh
Control of Narcotic Substances Act 1997	Narcotics and psychotropics

Label must show

Item	Why
Generic name (prominent)	Identification
Registration number	Proves it is registered
Batch number	Traceability and recalls
Manufacturing and expiry dates	Shelf life
Retail price	Price control
Storage conditions and warnings	Safe use

Memory aids

L-I-S-L: 1976, 1976, 1978, 1986: Licensing (1976), Import/Export (1976), Specifications (1978), Labelling (1986) rules.

Exam traps

Sale of drugs is governed by provincial rules, not by the federal licensing rules.
The generic name must be shown prominently on the label, not only the brand name.
Narcotics are regulated by both drug law and the Control of Narcotic Substances Act.
The Labelling and Packing Rules date from 1986, a decade after the Act.

Revised? Now test yourself.

Attempt the Drug Rules and Schedules MCQs while the notes are fresh. Anything you get wrong is saved to your incorrect list for the next revision round.