Institutional barriers and enablers to implementing and complying with internationally accepted quality standards in the local pharmaceutical industry of Pakistan: a qualitative study

Abstract

Complying with good manufacturing practices (GMP) and ensuring a quality system is integral to production and supply of quality medicines and achieving universal health coverage. This study focus on the local production of medicines in Pakistan, a lower middle-income country that has observed considerable growth in the number of pharmaceutical companies over the past two decades. Against this background, we investigated: (1) How is quality assurance (QA) and GMP compliance understood and acted upon by local pharmaceutical manufacturers?; (2) What are the institutional barriers and enablers for QA and GMP compliance in the local pharmaceutical sector from the perspective of key stakeholders?; and (3) What are the institutional barriers and enablers for strengthening local regulatory capacity to improve QA in the industry in the long term? We used a qualitative study design involving 22 interviews of the drug regulatory bodies (n = 9), academia (n = 3) and local manufacturers (n = 10), identifying key themes in data by thematic analysis. Document analysis was used to collect additional information and supplement the interview data. We identified that manufacturing facilities operated under different GMP standards and interpretations, pointing towards an absence of harmonization in quality standards across the industry. Views diverged about the status of GMP compliance, with interviewees from academia presenting a more critical view compared with regulators who promoted a more positive story. Among the barriers explaining why companies struggled with quality standards, the lack of a mindset promoting quality and safety among profit-oriented manufacturers was prominent. At the federal level, DRAP’s establishment represented an institutional improvement aiming to promote QA through inspections and guidance. While some positive measures to promote quality have been observed, the need for DRAP to strengthen its technical and regulatory capacity, enhance its engagement in international collaboration and learning, and improve transparency and accountability were highlighted. Overall, since the challenges in Pakistan are shared with other low- and middle-income countries with local production, there is a need to commit to international collaborative mechanisms, such as those lead by WHO, on this issue.

Pharmacovigilance in emerging economies: modeling interaction among barriers

“…Patient PV knowledge (barrier 11), or lack thereof, seemed to influence what PV-specific transgressions that pharmaceutical supply chain and its stakeholders could get away with in emerging economies (Ampadu et al. , 2018; Tauqeer et al. , 2019).…”

“…(5) In addition, PV-related KAP factors for patients in emerging economies (barriers 11, 12, and 13) were not comingled into one set as these barriers had varying levels of influences in our ISM-based hierarchical model due to driving and dependence powers that were comparatively dissimilar. Patient PV knowledge (barrier 11), or lack thereof, seemed to influence what PV-specific transgressions that pharmaceutical supply chain and its stakeholders could get away with in emerging economies (Ampadu et al, 2018;Tauqeer et al, 2019). Patient PV knowledge, along with pharmaceutical industry attributes, which in turn affected patient's attitude towards PV (barrier 12), ranged from socio-cultural beliefs (Eliasson, 2006) to cynicism towards PV reporting (Waring, 2005).…”

“…The predicament of outdated PV systems is further accentuated in emerging economies due to suboptimal national health policies, antiquated infrastructure, bare-bone resources among other factors (Agoro et al, 2018;Alshammari et al, 2019;Ampadu et al, 2018;Isah et al, 2012;Kumar et al, 2016;Maigetter et al, 2015;Mehta et al, 2010;Olsson et al, 2010;Pirmohamed et al, 2007), and sums up the herculean task to establish and maintain effective PV systems. Furthermore, overall capacity and effectiveness of PV systems in emerging economies needs to be raised considerably to align well with regulatory harmonization and convergence standards (Isah et al, 2012;Mehta et al, 2010;Suwankesawong et al, 2016;Tauqeer et al, 2019).…”

Tackling the global impact of substandard and falsified and unregistered/unlicensed anti-tuberculosis medicines

“…This is confirmed by the difficulty faced by LMICs when it comes to implementing certain guidelines such as the WHO’s good manufacturing practices. 98 Hence, other interventions must be appropriately adjusted and applied for implementation in LMICs. These include improvement of legal sanctions, increased stewardship, advocacy and regional cooperation in the implementation of international guidelines.…”

Tackling the blind spot of poor-quality medicines in Universal Health Coverage

“…A low manufacturing capacity for finished pharmaceutical products also means that most medicines would need to be imported, which can lead to the import of poor-quality medcines. In LMICs that do have a high local manufacturing capacity, quality may not always be assured, or the focus of the NRA may not be on quality assurance because of capacity challenges [ 46 , 47 ]. For example, in Pakistan, a study of twenty-seven ibuprofen API samples used by manufacturers in the country found that 81.5% (22/27) failed to comply with pharmacoepial specifications [ 48 ].…”