Unlocking Pharma Traceability in Pakistan: Lessons from Turkey's Track & Trace Triumph

Pakistan struggles with pharmaceutical serialization and track & trace. Drawing lessons from Turkey’s success and supported by DRAP’s 2025 reforms—including S.R.O. 1587(I)/2025 (PIC/S-GMP adoption) and antimicrobial batch data reporting—discover the roadmap to building a resilient, fraud-proof, and patient-safe drug supply chain.

Introduction: Why Track & Trace Matters More Than Ever

Pharmaceutical traceability is no longer a futuristic concept—it is a public health necessity. For Pakistan, counterfeit drugs, reimbursement fraud, and gaps in drug quality assurance continue to pose risks to patients and the national healthcare economy. The solution lies in building a robust Track & Trace system that ensures every pill, vial, and blister pack can be authenticated across its journey from factory to patient.

While Pakistan has struggled with inconsistent rollouts and regulatory hurdles, Turkey successfully built the world’s first end-to-end pharmaceutical Track & Trace system (İlaç Takip Sistemi, ITS), virtually eliminating falsified drugs from its regulated supply chain.

Now, in 2025, Pakistan has a renewed opportunity. With new regulatory advances from DRAP—including S.R.O. 1587(I)/2025, which adopts PIC/S-GMP international manufacturing standards, and a directive requiring mandatory antimicrobial batch/import data submission via DRIS—Pakistan is signaling that it is serious about raising the bar on compliance and transparency.

The key question: Can Pakistan leverage Turkey’s lessons and its own new reforms to finally implement serialization and achieve true pharmaceutical traceability?

Part I: How Turkey Got It Right

A seminal study by Parmaksiz, Pisani, and Kok highlighted why Turkey’s ITS system succeeded where others failed. Four pillars were critical:

1. 1. Unwavering Political Determination Turkey’s government lost nearly $1 billion annually due to “barcode scamming,” where pharmacies claimed reimbursement for drugs never dispensed. This financial hemorrhage created political urgency. Even when the system crashed at launch, political leaders doubled down instead of retreating.

Lesson for Pakistan: Serialization must be treated as a national crisis response—not a side project. Political continuity across administrations is non-negotiable.

1. 2. Consolidated Market Leverage Turkey merged insurers into the Sosyal Güvenlik Kurumu (SGK), a single payer controlling 95% of the pharmaceutical market. Compliance was non-negotiable: no ITS, no market access.

Lesson for Pakistan: With its fragmented financing system (government tenders, private insurers, out-of-pocket payments), Pakistan lacks a dominant payer. Regulators must instead wield leverage by mandating serialization for all drugs supplied to government hospitals, tenders, and reimbursement-linked schemes.

1. 3. Reimbursement Linked to Verified Dispensing Pharmacists in Turkey only got reimbursed after scanning a DataMatrix code. No scan, no payment. This aligned financial incentives with compliance.

Lesson for Pakistan: Unless serialization is tied to financial incentives, compliance will always appear as a cost center. Linking verification with payments in public tenders and insurance reimbursements is critical.

1. 4. Flexible Implementation Turkey listened to stakeholders and adapted. When scanning individual packs slowed down production, case-level aggregation was introduced. Flexibility built trust and operational feasibility.

Lesson for Pakistan: Must avoid a rigid, one-size-fits-all rollout. Pilots, feedback loops, and phased expansions are essential.

Part II: Pakistan’s Serialization Journey So Far (to Early 2023)

Pakistan has made multiple attempts to implement serialization:

• Legal foundation: DRAP Act 2012 empowers regulators to mandate traceability.

• Early initiatives: Attempts in the 2010s failed due to industry resistance, unclear timelines, and cost concerns.

• Phased rollout (2022–23): DRAP engaged 18 leading pharma companies to serialize 10 drug brands. However, expansion was slow, and enforcement at the point of dispensing remained absent.

By early 2023, Pakistan’s serialization progress was nascent, fragmented, and fragile—a stark contrast to Turkey’s rapid success.

Part III: Fresh Winds — DRAP’s 2025 Notifications

2025 has brought two game-changing reforms from DRAP, signaling stronger regulatory will and a culture of compliance.

1. S.R.O. 1587(I)/2025: Adopting PIC/S-GMP Standards

• DRAP officially adopted Good Manufacturing Practices (GMP) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

• This aligns Pakistan with internationally recognized quality standards.

• Manufacturers must now comply with global norms in facility design, quality control, documentation, and staff training.

Why it matters for serialization: Strong GMP is the foundation of serialization. Without standardized manufacturing and packaging processes, serialization data becomes unreliable. By harmonizing with PIC/S, Pakistan is building the infrastructure for trustworthy serialization.

2. Antimicrobial Batch & Import Data Reporting via DRIS

• All manufacturers/importers must submit annual antimicrobial batch production and import data through DRIS.

• Data will support antimicrobial stewardship and AMR surveillance.

• Enforcement shows DRAP’s seriousness about digital data compliance.

Why it matters for serialization: Serialization is fundamentally about data capture and reporting. By enforcing antimicrobial data submission, DRAP is building technical and cultural readiness for end-to-end pharmaceutical data traceability.

Part IV: Bridging Turkey’s Lessons and DRAP’s 2025 Reforms

Pakistan now has an unprecedented opportunity:

• Political Commitment: The 2025 reforms show DRAP has regulatory teeth. What’s needed is visible top-level political championing.

• Market Leverage: Tie compliance to government supply contracts and insurance reimbursements—replicating Turkey’s “no compliance, no payment” model.

• Incentives for Stakeholders: Pharmacists and distributors must see financial benefit in compliance, not just cost. A reimbursement-linked gatekeeper model is the way forward.

• Adaptive Implementation: Build on antimicrobial reporting pilots to expand serialization, starting with essential, high-risk medicines (e.g., insulin, cardiac, antibiotics).

Part V: A Practical Roadmap for Pakistan (2025 Onwards)

1. Pilot Project (2025–26): Target 10–15 essential medicines. Apply serialization across manufacturers → distributors → government hospitals. Tie distributor/hospital payments to successful serialization scans.

2. Leverage Government Market Power: Make serialization mandatory for all drugs supplied in government tenders and public hospitals.

3. Scale Gradually: Expand to private hospitals and pharmacies, guided by feedback loops. Allow aggregation flexibility (case vs. pack scanning).

4. Institutionalize Compliance: Use PIC/S-GMP inspections to ensure serialization capability is embedded in every manufacturer. Extend DRIS-style reporting beyond antimicrobials to all serialized medicines.

5. Publicize Success: Measure KPIs (counterfeit reduction, recall speed, verification rates). Share wins publicly to build trust among patients and stakeholders.

Conclusion: More Than a Barcode, A National Reform

Turkey’s success proves serialization is not just an IT project—it is a political, economic, and operational reform. Pakistan, after years of false starts, now has a fresh chance.

With DRAP’s 2025 reforms as a springboard, Pakistan must align political will, create financial incentives, and adopt a phased but adaptive rollout. If done right, serialization can protect millions of patients, safeguard the national healthcare economy, and elevate Pakistan’s pharma industry to global standards. The time to act is now.