Drug Quality Control and Regulatory Challenges in Pakistan’s Pharmaceutical Industry

Abstract

Quality control of drugs and efficacy of regulation are significant to safe and effective therapeutic products in any healthcare system. Pharmaceutical industry in Pakistan is an important sector in the provision of drugs within the country but there is a big institutional and operational issues associated with drug quality control and regulation. This paper reviews the history of pharmaceutical regulation in Pakistan, regulatory framework, quality assurance and key bottlenecks in the pharmaceutical regulation of the country, with special reference to the regulatory performance of the Drug Regulatory Authority of Pakistan (DRAP), implementation of Good Manufacturing Practices (GMP), and the existence of substandard and counterfeit drugs. Based on a mixed method of policy study, institutional evaluation, and drug quality monitoring information, the study points to the gaps in legal regulations, enforcement limitations, human resources supply challenges, and institutional obstacles in alignment with international standards. The results underline the necessity of the strengthened regulatory framework, the increased availability of the quality control infrastructure, and policy amendments to bring the drug regulation in Pakistan in line with the international standards. The paper summarizes with specific suggestions on how to promote drug quality control and regulatory control in Pakistan.