THEORETICAL ASPECTS IN THE FORMATION OF
PEDAGOGICAL SCIENCES
International scientific-online conference
112
DRUG PRODUCTION AND ITS REGULATORY REQUIREMENTS:
EXPANDING THE SCOPE OF PHARMACEUTICAL SAFETY AND
INNOVATION
Dilnoza Tursunova Alisher qizi
Lecturer, Department of Language Teaching, Andijan
Branch of Kokand University
Ilhomjon Komiljonov
Student, Faculty of Medicine, Pharmacy Department,
Andijan Branch of Kokand University
https://doi.org/10.5281/zenodo.15656823
Abstract
This expanded article delves deeply into the pharmaceutical manufacturing
process, examining the global and national regulations, quality assurance
mechanisms, clinical and post-marketing evaluations, and the environmental
and ethical implications of drug production. It explores the growing role of
digital innovations such as AI and bioinformatics in the sector and emphasizes
Uzbekistan’s achievements and challenges. A comparative analysis of
international best practices is also provided, aimed at informing policy reforms
and fostering sustainable pharmaceutical development.
Keywords:
Pharmaceutical industry, GMP, GxP, AI in pharma, drug safety,
pharmacovigilance, clinical trials, eco-pharma, regulatory harmonization,
Uzbekistan healthcare.
Introduction
Pharmaceutical manufacturing is not merely an industrial activity; it is a
“critical element of global public health”. Drug safety, efficacy, and accessibility
depend on a robust framework of scientific innovation, regulatory compliance,
ethical considerations, and technological advancement. With rising chronic
diseases, pandemics, and antibiotic resistance, the “demand for reliable and
innovative drug production” has never been higher. In this context, countries
like Uzbekistan are navigating the balance between domestic capacity building
and alignment with international quality benchmarks.[2]
Global Frameworks and Standards
The pharmaceutical industry is governed by strict regulatory guidelines,
including:
-Good Manufacturing Practices (GMP)
-Good Laboratory Practices (GLP)
-Good Clinical Practices (GCP)
-Good Distribution Practices (GDP)
THEORETICAL ASPECTS IN THE FORMATION OF
PEDAGOGICAL SCIENCES
International scientific-online conference
113
These collectively form the GMP framework, ensuring that drugs are
consistently produced and controlled to meet quality standards. Regulatory
agencies such as the FDA (USA), EMA (EU), PMDA (Japan), and WHO PQ
(Prequalification) oversee compliance globally.[3]
In comparison, Uzbekistan’s regulatory ecosystem is evolving, with
increasing adoption of GMP guidelines, ISO certification, and improved
pharmacovigilance mechanisms. However, “regulatory harmonization” with
global partners such as the “International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use (ICH)” remains a
critical step forward.
Extended Production Pipeline
Beyond the conventional six stages, modern drug development also
includes:
-Target identification and validation (genomic screening)
-Lead optimization through computational chemistry
-Toxicogenomics and in silico testing to predict adverse effects
-Real-World Evidence (RWE) gathered from electronic health records post-
launch
-Lifecycle management, including patent expiry strategies and biosimilar
development
These stages are now enhanced through “bioinformatics, machine learning”,
and “cloud-based data sharing platforms”, accelerating discovery while
maintaining regulatory integrity.
Quality Control and Global Risks
Drug falsification is a “global epidemic”. According to the OECD (2020),
counterfeit medicines account for up to USD 200 billion annually. The WHO
(2022) estimates that 1 in 10 medical products in low- and middle-income
countries is substandard. This not only erodes public trust but also increases
antimicrobial resistance and health expenditures.
Case Study: In 2022, Gambia reported the death of 66 children due to
contaminated cough syrups, traced to toxic diethylene glycol and ethylene glycol
content. This tragic incident underscores the vital importance of batch-level
traceability, analytical testing, and ethical manufacturing.
The Uzbek Context: Strengths and Gaps
Progress:
-Over 200 pharmaceutical companies operating as of 2023
-50+ GMP-certified enterprises
THEORETICAL ASPECTS IN THE FORMATION OF
PEDAGOGICAL SCIENCES
International scientific-online conference
114
-Local production covers 80% of domestic drug demand
-Implementation of electronic drug traceability via barcodes
Challenges:
-Insufficient R\&D investment (less than 0.5% of pharma revenue)
-Limited access to “clinical trial infrastructure”
-Skills gap in “bioengineering and regulatory science”
-Inadequate enforcement of “eco-compliance protocols”
Artificial Intelligence and Precision Manufacturing
AI applications in drug development are transforming traditional timelines:
-Molecular discovery using deep learning (e.g., Atom Net, DeepMind Alpha
Fold)
-Trial matching and patient recruitment optimization
-Predictive toxicology using neural networks
-Digital twins of drugs for simulation of efficacy scenarios
According to McKinsey (2021), AI integration can reduce development time
by up to 30% and costs by 15–20%. Countries investing in pharma-tech clusters
(e.g., Singapore, Switzerland, India) are outpacing peers in both innovation and
regulatory efficiency.
Environmental Sustainability in Pharma
The eco-impact of pharmaceutical production is increasingly scrutinized.
Residual active pharmaceutical ingredients (APIs) are found in:
-Surface water and rivers (e.g., acetaminophen, diclofenac)
-Agricultural soil via sludge reuse
-Animal tissue through bioaccumulation
EMA (2021) urges manufacturers to adopt
green chemistry principles
,
improve
wastewater treatment
, and monitor
API emissions
. Uzbekistan’s 2023
regulation on environmental safety in pharma is a key milestone, though
implementation and auditing mechanisms must be strengthened.
Ethical and Social Responsibility
Drug production involves moral responsibility at every level — from
clinical transparency
to
fair pricing policies
and access to essential medicines.
Scandals like the 2012 Pakistan tragedy or the 2023 India eye drop
contamination highlight the devastating consequences of negligence.
Ethical production includes:
-Transparent clinical data sharing
- Informed consent procedures
- Avoiding exploitative pricing
THEORETICAL ASPECTS IN THE FORMATION OF
PEDAGOGICAL SCIENCES
International scientific-online conference
115
- Ensuring drug availability in rural and vulnerable populations
Emerging technologies such as AI-driven drug interaction alerts, blockchain
for drug authenticity, and telepharmacy services offer promising solutions to
many of these problems. Yet, without clear policy frameworks and cross-sector
collaboration, these tools remain underutilized. To maximize the pharmacy
sector’s contribution to public health, policymakers must establish support
systems that enable pharmacists to practice at the top of their licenses and
integrate pharmacy data with national health information systems.[1, 558]
Recommendations for Uzbekistan
To bolster pharmaceutical safety and innovation, the following measures
are proposed:
1. Join international harmonization platforms (e.g., ICH, PIC/S)
2. Invest in pharma-specific R\&D centers with AI and biotech focus
3. Strengthen pharmacovigilance through mobile health (mHealth)
reporting tools
4. Introduce green production incentives
5. Launch postgraduate programs in regulatory affairs and clinical trials
6. Establish regional reference laboratories for independent quality testing
Conclusion
Drug manufacturing is at the intersection of health, science, economy, and
ethics. As Uzbekistan moves toward self-sufficiency and international
recognition in pharmaceutical production, it must embrace quality control,
regulatory transparency, innovation, and environmental responsibility as
guiding principles. A future-oriented pharmaceutical industry will not only
protect public health but also stimulate scientific and economic growth.
References:
1.
D.A. Tursunova, X.T. Axmedova. Current issues and future directions in
pharmacy: a scientific perspective. vol. 11 No. 2 (2025): International journal of
scientific researchers
https://worldlyjournals.com/index.php/IJSR/article/view/12093/16404
2.
World Health Organization. (2022). Substandard and falsified medical
products.
3.
Ministry of Health of Uzbekistan. (2023). Pharmaceutical industry
statistics.
4.
Kumar, R., Singh, J., & Verma, A. (2019). Journal of Pharmaceutical
Research.
5.
McKinsey & Company. (2021). AI in pharma R\&D.
6.
OECD/EUIPO. (2020). Trade in Counterfeit Pharmaceutical Products.
THEORETICAL ASPECTS IN THE FORMATION OF
PEDAGOGICAL SCIENCES
International scientific-online conference
116
7.
European Medicines Agency. (2021). Environmental Risk Assessment.
8.
Legal Portal of Uzbekistan (Lex.uz). (2022). Regulation of drug circulation.
9.
BBC News. (2012). Pakistan Punjab drug scandal.
10.
WHO. (2023). Gambia cough syrup investigation.
11.
DeepMind AlphaFold. (2022). Protein structure database.
