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Drugs Act, 1976

Act· 1976· 29 pages
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Summary

The Drugs Act, 1976 regulates the import, export, manufacture, storage, distribution and sale of drugs in Pakistan, aiming to ensure that medicines and related products sold to the public are safe, effective, and properly labelled. Section 3 defines 'drug' very broadly -- covering not just medicines but also contraceptive devices, surgical dressings, disinfectants, and even pesticides that pose a health hazard -- and separately defines an 'adulterated drug' (contaminated, mixed with foreign substances, or diluted), a 'misbranded drug' (mislabelled, missing required warnings, or making false claims), and a 'counterfeit drug' (one whose packaging imitates another manufacturer's product).

Chapter II sets out the administrative machinery: Sections 4 to 6 give the government power to regulate the import, manufacture and sale of drugs, while Section 7 requires drugs to be registered with a Registration Board before they can be sold. Section 8 establishes the Pakistan National Formulary, and Section 9 creates an Appellate Board to hear appeals against regulatory decisions. Sections 14 to 16 set up Federal and Provincial Drug Testing Laboratories and Government Analysts to test drug samples, and Sections 17 to 19 empower Inspectors to examine premises and enforce compliance.

Chapter III (Sections 23-26) prohibits importing, manufacturing or selling unregistered, adulterated, misbranded, or counterfeit drugs, and controls how drugs are advertised, sampled, and labelled.

Chapter IV covers offences: Section 27 sets penalties for violations and Section 28 provides for enhanced penalties on a subsequent offence, though the extract available here does not show the specific fine or imprisonment figures, so these should be verified against the current text rather than assumed. Section 29 allows forfeiture of offending drugs, and Section 31 establishes special Drug Courts to hear cases under the Act. Section 35 allows publication of an offender's name.

Section 45 repeals the earlier Drugs Act, 1940, the Drugs (Generic Names) Act, 1972, and the Drugs Ordinance, 1976, while preserving existing manufacturing and sale licences during a transition period. A footnote shows the definitions in Section 3 have themselves been amended since 1976 (for example by an Ordinance in 2002), so this should be treated as a law that has evolved since its original enactment.

Key topics

drug registration and licensingadulterated, misbranded and counterfeit drugsdrug import, manufacture and saleDrug Courts and inspectorspharmaceutical regulation

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