Customs Law

In Pakistan, the regulation of the manufacture, import, export, storage, distribution, and sale of therapeutic products is governed by the Drug Regulatory Authority of Pakistan Act, 2012 (DRAP Act 2012) and the Drugs Act, 1976. These laws establish a comprehensive legal framework aimed at ensuring the safety, efficacy, and quality of therapeutic products available in the market.

Key Objectives of the DRAP Act 2012:

• Interprovincial Trade and Commerce: Facilitates and enhances trade and commerce of therapeutic products across provinces.

• Coordination and Enforcement: Coordinates with and enforces the provisions of the Drugs Act, 1976 to streamline regulatory processes and ensure compliance.

Scope of Regulation: The DRAP Act 2012 and the Drugs Act, 1976 encompass a wide range of therapeutic products, including:

• Drugs: Medications prescribed for treatment or prevention of diseases.

• Biological Products: Products derived from biological sources used for therapeutic purposes.

• Medical Devices: Instruments and devices used for diagnosis, treatment, or monitoring of health conditions.

• Medicated Cosmetics: Cosmetic products with therapeutic properties.

• Alternative Medicines: Non-conventional treatment methods, including herbal and traditional medicines.

• Health and OTC Products: Over-the-counter products intended for general health maintenance and minor ailments.

Regulatory Mechanisms: The regulatory framework established under these Acts includes several critical components to ensure the integrity of therapeutic products:

• Registration: The process for formally recognizing and listing therapeutic products for legal sale.

• Marketing Authorization: Permission granted to manufacturers for the commercial distribution of their products.

• Vigilance and Market Surveillance: Monitoring and controlling the quality and safety of products in the market.

• Licensing of Establishments: Certification required for manufacturing, storage, and distribution facilities.

• Regulatory Inspection: Routine and ad-hoc inspections to ensure compliance with regulatory standards.

• Laboratory Testing: Testing of products to verify quality, safety, and efficacy.

• Clinical Trials Oversight: Supervision of clinical research to ensure ethical and scientific standards are met.

• Pharmacovigilance: Monitoring and assessing adverse effects of drugs post-marketing.

• Lot Release of Biologicals: Approval process for the release of biological products for public use.

These comprehensive regulations are supported by various rules and guidelines that provide detailed instructions on compliance and enforcement, ensuring that therapeutic products meet the highest standards of safety and efficacy.

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