Abstract
General Background: Pharmaceutical companies have legal obligations to ensure the quality, safety, and proper distribution of medicines delivered to consumers. Specific Background: Drug quality assurance involves production and distribution standards, including Good Manufacturing Practices and Good Distribution Practices, while consumers require legal protection when medicines are defective or do not meet applicable standards. Knowledge Gap: Previous studies discussed pharmaceutical production, regulatory supervision, and drug distribution, but this study specifically examines the legal liability of pharmaceutical companies for drug quality defects throughout the distribution process. Aims: This study analyzes the legal obligations of pharmaceutical companies in maintaining drug quality and examines the relationship between Good Distribution Practices, product liability, consumer protection law, civil law, and health law. Results: Using normative legal research with a statutory approach, the study finds that pharmaceutical companies remain the primary legally liable parties for defective medicines, while liability may also arise for Pharmaceutical Wholesalers when defects result from improper distribution, storage, or transportation. Legal mechanisms include compensation, strict liability, product recall, and administrative sanctions where regulatory violations are established. Novelty: The study integrates pharmaceutical company liability with distribution-stage obligations and distinguishes the respective legal positions of pharmaceutical manufacturers and Pharmaceutical Wholesalers. Implications: The findings provide a legal framework for consumer protection and support the development of drug quality supervision and enforcement within the pharmaceutical distribution chain.
Key Findings Highlights
Pharmaceutical manufacturers remain the primary legally liable parties for defective medicines throughout the distribution chain.
Pharmaceutical Wholesalers carry legal obligations concerning storage, transportation, and Good Distribution Practices.
Product liability and strict liability operate within a layered legal responsibility system for consumer protection.
Keywords : Pharmaceutical Liability, Drug Quality, Consumer Protection, Product Liability, Strict Liability