| dc.description.abstract | Objective: Production and consumption of substandard medicines remain a significant public health issue globally and in Pakistan, a low-income country with an ever-increasing number of local pharmaceutical producers, it is no different. An essential basic prerequisite for the development of quality medicines is that requirements of good manufacturing practices (GMP) are fulfilled and that a system of quality assurance appropriate to the manufacture of pharmaceutical products is taken into account. There is a limited amount of literature on major barriers and opportunities to implementing internationally approved quality standards GMP and quality assurance mechanisms in manufacturing facilities in the developing countries. Taking this into account, a study on the status of GMP compliance and quality assurance of medicines is needed to generate knowledge to fill this gap in Pakistan. This study aimed to describe the situation of GMP compliance and quality assurance focusing on local production of medicines (generics, branded generics) by national pharmaceutical companies of Pakistan highlighting the barriers to their non-conformance and improvements made to implement and enforce them. Methodology: This study used a qualitative exploratory approach to interview 22 key informants from the drug regulatory authority, academia, and local producers. Moreover, document analysis was used to collect additional information and supplement the data obtained through interviews. Findings: This study showed that local GMP standards have been adopted from WHO GMP guidelines and have not been updated. The GMP compliance and quality assurance varied from company to company across the country, and a majority of the local companies were facing many barriers to adhere to these basic rules. Informants presented divergent views on the status and understanding around GMP and quality assurance (QA): from the regulators point of view it has improved; based on manufacturers’ perceptions, it is steady, and academics see a dearth of knowledge and understanding around it. Improvements made to assure quality from the regulatory viewpoint include the establishment of an independent head, counselling and fair time given to companies to shift to GMP and encouragement to be above-board. However, many barriers have been identified that hamper companies to fully comply with and authorities to adequately assure the required quality standards. These included financial restrains, a dearth of quality-oriented institutional mind-set and technical and regulatory incapacity of the drug regulatory authority. Financial restraints are an underlying barrier to procure raw materials, recruit trained human resources, upgrade the expertise of hired staff, purchase better equipment and embrace technology. Recommendations put forward by the informants include initiation of training workshops, timeliness and increased predictability, capacity building and resource upgrading; and a trade-off between legislation and pharmaceutical business sustainability and establishment of a drug information portal. Conclusion: The local producers and regulators of drugs face many challenges regarding implementation of GMP and a fully functional quality assurance system. An important and robust collaboration is needed between the two bodies with a common aim to provide quality medicines to patients at affordable prices. | eng |