When a doctor in a rural health post in Karnali prescribes an antibiotic, they are acting on faith. Faith that the label matches the contents. Faith that the chemical structure hasn’t degraded in the heat. Faith that the regulatory system in Kathmandu has done its due diligence.

But as recent reports from The Kathmandu Post confirm, that faith is currently built on a foundation of sand. With over 24,000 varieties of medicine in the market and a testing capacity of just 648 samples a year, Nepal is not regulating its pharmaceutical market; it is merely witnessing it.

For the Ministry of Health and Population, this is not a logistical administrative hurdle—it is a slow-motion public health crisis. The current model of “test everything with limited resources” has failed. It is time for a radical policy pivot, moving from a model of comprehensive inspection (which is impossible) to strategic surveillance (which is imperative).

Drawing from successful regulatory reforms in Nigeria, Brazil, Mexico, and the Caribbean, here are the deep policy implications and necessary shifts for Nepal’s Ministry of Health.

Policy Pillar 1: From “Re-Testing” to “Regulatory Reliance”

The Status Quo: Currently, Nepal operates as if it is an island, attempting to independently verify the quality of every drug, regardless of where it comes from. This clogs the National Medicine Laboratory (NML) with redundant work.

The Policy Shift: The Ministry must formally adopt a policy of “Unilateral Reliance.”

Mexico’s regulatory body (COFEPRIS) solved its backlog by recognizing that it didn’t need to re-prove what the US FDA or the European Medicines Agency (EMA) had already proven. If a drug enters Nepal from a manufacturer already certified by a Stringent Regulatory Authority (SRA) or the WHO Prequalification program, it should enter a “Fast Track” channel.

• Implication for Nepal: The Department of Drug Administration (DDA) should amend the Drug Act to legally recognize certifications from trusted global bodies. This frees up the NML’s limited manpower to focus 100% of its testing capacity on high-risk categories: non-SRA imports, domestic production with a history of non-compliance, and generic drugs from unverified supply chains.

Policy Pillar 2: Democratizing the Inspection Process

The Status Quo: We have 20 drug inspectors for 25,000 pharmacies. This ratio guarantees failure. We are fighting a digital-age war with analog tools.

The Policy Shift: Mandate Track-and-Trace Technology at the point of import/manufacture.

Nigeria did not hire 10,000 new inspectors to clean up its market; it deputized 200 million citizens. By mandating Scratch-and-Text (MAS) technology, they allowed the end-user to verify the drug. Brazil took it further with the National Drug Control System (SNCM), tracking every unit from factory to pharmacy.

• Implication for Nepal: The Ministry needs to implement a mandatory serialization policy. Every medicine pack sold in Nepal must carry a unique identifier (like a GS1 DataMatrix code).
• Phase 1: Mandate this for all imported drugs (importers must bear the cost of labeling).
• Phase 2: Subsidize local manufacturers to adopt the technology. This shifts the burden of verification from the overworked inspector to the patient and the pharmacist.

Policy Pillar 3: Fiscal Sovereignty and the “Reference Standard” Crisis

The Status Quo: The NML relies on donor funding (previously USAID) to buy “reference standards”—the pure chemical benchmarks needed to test drugs. When the grant ended, the testing stopped. This is a violation of national health sovereignty.

The Policy Shift: Establish a “Quality Assurance Levy.”

We cannot rely on foreign aid to tell us if our medicine is poison. The cost of a reference standard (Rs 200,000) is high for a lab budget but negligible when amortized across the millions of tablets sold.

• Implication for Nepal: The Ministry should introduce a microscopic “Quality Cess” or fee on every batch of medicine registered for sale in Nepal. A fee of just 10 paisa per strip could generate a ring-fenced fund dedicated exclusively to purchasing reference standards and maintaining lab equipment. This ensures the NML is self-sustaining and immune to the whims of international donors.

Policy Pillar 4: Regionalizing the Burden

The Status Quo: Nepal tries to maintain a full-spectrum lab capable of testing everything from simple analgesics to complex biologics. This is resource-intensive and inefficient for a small economy.

The Policy Shift: Join or Form a South Asian Regulatory Network.

The Caribbean nations realized they were too small to fight Big Pharma individually. They formed the Caribbean Regulatory System (CRS) to pool resources.

• Implication for Nepal: The Ministry should aggressively pursue a Mutual Recognition Agreement (MRA) with neighboring regulatory bodies (specifically those with higher capacity). Furthermore, the government should accredit private labs and university research centers within Nepal to handle routine testing (like dissolution tests), reserving the NML’s high-end equipment for complex forensic analysis and legal verification.

The Human Cost of Inaction

We often talk about “policy” as dry text on paper. But let us be clear about what these policies mean in the real world.

When we fail to implement Risk-Based Sampling, a mother buys a fever syrup that is nothing but sugar water. When we fail to fund Reference Standards, a hospital treats a pneumonia patient with an antibiotic that has no potency, breeding drug-resistant superbugs that threaten the entire community.

The Ministry of Health stands at a crossroads. We can continue to mourn the lack of inspectors and budget, or we can change the rules of the game. By leveraging international standards, adopting digital tracking, and securing sovereign funding, Nepal can build a safety net that actually catches the fall.

The “recall” of a drug one year later is not a system working; it is a system confessing its failure. We can, and we must, do better.

Here are the verified sources used to construct the article and policy recommendations above:

1. Nepal’s Current Status & Data

• Primary Source: The Kathmandu Post, “Over 24,000 medicines are in Nepal’s market, only 648 tested last year,” published January 9, 2026.
• Key Data Points: Testing statistics (648 out of 24,000), shortage of reference standards (Rs 800k budget vs. Rs 50M need), and the specific recall of Levoflox-500 (Magnus Pharma).

2. Nigeria’s Mobile Authentication Service (MAS)

• Primary Source: National Agency for Food and Drug Administration and Control (NAFDAC) Official Guidelines on MAS.
• Supporting Research: National Institutes of Health (NIH), “Mobile authentication service in Nigeria: An assessment of community pharmacists’ acceptance,” which documents the deployment of scratch-off technology to verify drug authenticity via SMS.

3. Brazil’s Track-and-Trace System

• Primary Source: Brazilian Health Regulatory Agency (ANVISA), Law No. 13.410 (2016) establishing the Sistema Nacional de Controle de Medicamentos (SNCM).
• Technical Details: The mandate for GS1 DataMatrix codes (2D barcodes) for end-to-end serialization and tracing of pharmaceutical products to prevent cargo theft and counterfeiting.

4. Mexico’s Regulatory Reliance Model

• Primary Source: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), “Abbreviated Regulatory Pathways” and Equivalence Agreements.
• Policy Detail: Official agreements where Mexico recognizes marketing authorizations from “Reference Regulatory Authorities” (RRAs) like the US FDA, Health Canada, and EMA to expedite approvals and reduce local testing burdens.

5. The Caribbean’s Regional Pooling

• Primary Source: Caribbean Public Health Agency (CARPHA), “The Caribbean Regulatory System (CRS).”
• Policy Detail: The framework allowing CARICOM member states to pool resources into a single regional entity for the review and assessment of medicines, rather than each small island maintaining a full-scale independent laboratory.

6. General Global Standards

• Source: World Health Organization (WHO), “Global Surveillance and Monitoring System for Substandard and Falsified Medical Products.”