Page 32 - CMA Journal (Jan-Feb 2026)

Focus Section

Biannual warnings issued promptly by the Drug regulatory control and lack of post-marketing
Regulatory Authority of Pakistan also confirm that monitoring lower the overall accountability of the system
falsified and spurious products continue to be detected and undermine enforcement ability (Rasheed et al., 2019).
(Drug Regulatory Authority of Pakistan alerts [DRAP], 2025). The supply chain comprises several middlemen, such as
In addition to clinical hazards, counterfeit medicines manufacturers, distributors, wholesalers, and retailers,
disrupt markets, decrease state revenue, and raise which introduce a complexity of documentation and
medical expenses, indicating the structural flaws in more diversion opportunities or the chance of
traceability and regulatory alignment. substitutes, especially where no batch-level tracing and
real-time validation systems are in place (Organization,
The pharmaceutical regulatory system in Pakistan has
been structurally reformed over the past ten years. 2017). In addition to this, the lack of digital integration
Institutional strengthening notwithstanding, between national authorities limits information
institutional vulnerabilities are indicated in enforcement dissemination and swift response. The lack of
data and surveillance reports. Table 1 summarizes the key transparency and auditability is further exacerbated by
regulatory milestones and enforcement developments relying on paper-based or siloed systems that prevail in
between the years 2010–2025. LMICs (Ozawa et al., 2018). These knowledge lapses
require governance reforms that are based on improved
An example of the persistent vulnerability and the traceability and regulatory coordination.
requirement to enhance traceability and vigilance can be
seen in Figure 1, which illustrates 877 cases of Blockchain for Governance
substandard and falsified medical products reported in
113 different countries (2017–2021) with a 36.3% yearly The significance of the concept of blockchain to the
growth (World Health Organization, 2024). pharmaceutical supply chain is based on enhancing
governance rather than the technological novelty itself.
WHO GSMS Cumulative Reporting (2017–2021) Being a decentralized, cryptographically secured ledger,
it provides time-stamped records that cannot be
WHO GSMS Reported Incidents (Cumulative Trend 2017–2021) modified without consensus, increasing documentation
integrity and the reliability of audits (Anam et al., 2025).
800 This immutability enables end-to-end traceability
Cumulative Reported Incidents 400 minimize information asymmetry and preclude any
between distribution, manufacturing, and dispensing to
600
possibility of diversion or counterfeit infiltration in
fragmented supply chains (Adekola & Dada, 2024).
Regulatory control can be strengthened further by
automating compliance checks and creating real-time
200
al., 2026). Nevertheless, the mentioned advantages of
0 anomaly alerts with the help of smart contracts (Vijaya et
governance can be achieved only when blockchain is
2019
2017 (Aug) 2018 Year 2020 2021 integrated into the institutional framework and
and
coordination
institutional
reinforced
by
interoperability standards (Bali et al., 2022).
Prevalence Comparison Bar Chart
Blockchain to Strengthen Pharmaceutical Control
According to Figure 2, 10–13.6 percent of medical
products in LMICs are of poor quality or falsified The pharmaceutical supply chain in Pakistan has
(Organization, 2017; Ozawa et al., 2018), which highlights traceability and documentation flaws that can be
the existing gaps in supply chains, including in Pakistan. addressed by blockchain, a solution with a governance
focus. With its irrevocable and time-stamped registry, it
14 can improve data integrity and post-market surveillance,
12 and unit-level serialization can provide end-to-end
traceability and minimize the risks of diversion and
10
counterfeit infiltrations (Adekola & Dada, 2024; Casino et
8
al., 2019).
6
Blockchain reduces information asymmetry and
4 enhances accountability among supply chain
2 participants by increasing transparency (Kshetri, 2018).
Coupling blockchain with regulators, such as DRAP, may
0
WHO (2017) Ozawa et al. (2018) enable real-time monitoring, faster recalls, and
trustworthy audit trails, while smart contracts can
Pharmaceutical Supply Chain Weaknesses automate compliance checks (Bali et al., 2022).
Nevertheless, the benefits rely less on the technology
The continued existence of poor-quality and counterfeit itself and more on regulatory integration and
drugs in Pakistan lies in the structural vulnerabilities of coordinated implementation (Mackey & Nayyar, 2017).
the pharmaceutical supply chain in the nation. Disjointed
30 ICMA’s Chartered Management Accountant, Jan-Feb 2026