Pharmaceutical Industries in Developing Nations:

A Review of Challenges and Benefits of GMP Implementation

Abstract
Close to 2 billion people worldwide lack access to essential medicines, a greater percentage being
the people from low- and middle-income countries (LMICs). The main barriers blocking them from
receiving essential medication include low manufacturing capacity, lack of advanced technologies in the
manufacturing of pharmaceutical products, inadequate infrastructure, human resources, and weak
regulatory provisions on the quality of medicines.
Good manufacturing practices (GMP) are elements in quality management that guarantee that
pharmaceutical products are manufactured and monitored, adhering to quality standards suitable
to their intended use and meeting all the regulations. Lack of GMP compliance has allowed
substandard and falsified medicines to find their way into health facilities; this in return brings
negative implication like antimicrobial resistance to the people domiciled in developing
countries.
The main barriers towards implementation of GMP in developing countries include
limited resources, weak regulations, human resources, financial constraints, and lack of training
to the personnel in the manufacturing sectors of the pharmaceutical industries.

Introduction
Close to 2 billion people worldwide lack access to essential medicines, a greater percentage being
the people from low- and middle-income countries (LMICs). The main barriers blocking them from
receiving essential medication include low manufacturing capacity, lack of advanced technologies in the
manufacturing of pharmaceutical products, inadequate infrastructure, human resources, and weak
regulatory provisions on the quality of medicines[1]. Ozawa et al work reveals that about 13.6% of all the
medicines received by LMICs are either substandard or falsified, with antibiotics and antimalarials taking
the lead with 12.4% and 19.1% respectively; thus explaining the antimicrobial resistance and prevalence
of malaria in developing countries[2]. It is evident in Ayukekbong et al studies that one of the several
factors that cause antimicrobial resistance in developing countries is the lack of appropriate functioning
drug regulatory mechanisms which is associated with the implementation of GMP in pharmaceutical
industries[3]. Despite the challenges faced by developing countries, there is a need to protect the
population. All regulations and measures that have been highlighted under GMP guidelines needs to be
fully adhered by the manufacturers of pharmaceutical products in LMICs.
Good manufacturing practices (GMP) [4] are elements in quality management that
guarantee that pharmaceutical products are manufactured and monitored, adhering to quality
standards suitable to their intended use and in compliance with regulatory requirements. It forms
the basis of quality products. When GMP regulations are adhered to, it contributes to achieving
key quality attributes of pharmaceutical products. Parameters that define the quality of medicines
include strength, identity, purity, and quality. Therefore, the main aim of GMP is to regulate and
minimize the intrinsic risks associated with the process of pharmaceutical manufacturing[5].
Benefits of GMP implementation
Many countries globally have legislated that pharmaceutical industries (PI) and medical
companies shall follow GMP guidelines, and according to Wasiullah et al., some companies have
created their own GMP guidelines that conform to the legislation. Their ultimate goal is to
safeguard the health of the public[4]. The pharmaceutical industry is expanding, thus
representing a capital-intensive venture. Consequently, establishing a manufacturing facility that
fully meets GMP requirements requires substantial financial investment.[6]. Despite these
figures being justifiable, it is important to note when unregulated production is allowed to
operate and, in the long run, leads to tragic accidents. It can lead to much more loss, like loss of
human life, sanctions, fines, or even legal measures, which will be more expensive than
following the due diligence of putting GMP into place.

Challenges to implementation of GMP

The Kenya Pharmaceutical Diagnostic Report 2020 indicates that some of the challenges
faced by several pharmaceutical industries included financial constraints, technical capacity,
human resources, and regulatory oversight, among others[7, 8]. Voykelatos agrees that one of the
biggest challenges faced by the pharmaceutical industry when applying for GMP is the operation
cost. He argued that the total compliance cost could rise to a quarter of the total budget, which
means it siphons up to 25 percent of the total expenditure[9]. Evidence reports from 26 sub-
saharan countries show that inadequate resources, weak regulations, and lack of investments and
incentives to promote local manufacturing remain hindrances to GMP compliance[10]. Limited
training of personnel, financial constraints, and lack of stringent enforcement of the regulations
are evident from a case report of Nepal's status of GMP compliance[11].
It clearly explains that a lot of investment needs to be considered when implementing
and complying with GMP standards. GMP compliance in Kenya can be understood from the
result of structural compliance and compliance with organizational measures. Pharmaceutical
industries can be grouped as low risk, medium risk, and high risk based on their level of
adherence to GMP standards targeting the five key principles of GMP in PI, which include
people, processes, procedures, premises, and products [7, 12].

Conclusion
The ultimate role of adhering to GMP is to ensure that the PI produces products of high
quality and meets all the regulations as enshrined in the GMP guidelines[13]. Olanrewaju's
findings agree that quality assurance is an element that ensures that the products are consistently
being produced while maintaining the required quality and improving public health[14].
Sanitation and hygiene of the entire manufacturing process ensure it is clean and free from cross
and mix contamination. Additionally, all the manufacturing processes are required to undergo
qualification and validation[15], which guarantees that every step is in check, and quality is
maintained for all the products being produced. Quality control, on the other hand, is achieved by
having a robust system that ensures there is monitoring that verifies the quality of the
products[8].
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