Why Are Imported Medicines Released Without Even Basic Testing?

“An investigative note on systemic quality gaps in Sri Lanka’s pharmaceutical imports.”

Sri Lanka enforces mandatory quality verification for food items, consumer goods, and agricultural imports before Customs release. Analytical reports, compliance certificates, and inspections are treated as non-negotiable safeguards.

Yet medicines—products that directly determine life or death—are routinely released into the country without even basic preliminary quality checks.

This contradiction is no longer defensible. What is emerging is not a single failure, but a structural weakness in the way Sri Lanka regulates pharmaceutical imports.

The Minimum That Is Missing: Basic Import-Level Safeguards

No one is demanding full pharmacopoeial testing at ports of entry. That would be impractical.

However, at minimum, the following should be mandatory before Customs release:

• Certificate of Analysis (CoA) verification against approved specifications

• Visual inspection and particulate/foreign matter screening, especially for injectables

• Labeling, batch, and manufacturer consistency checks

• Cold chain and storage condition verification for temperature-sensitive products

These are internationally accepted baseline controls.

Yet for medicines in Sri Lanka, they are either inconsistently applied or entirely absent.

A System Built to React, Not Prevent

Recent quality-related incidents in the pharmaceutical sector have exposed a dangerous reality:

post-market testing is being used as the primary safety mechanism.

When problems are identified only after distribution, the system has already failed.

Medicines—particularly injectables and critical hospital drugs—should never reach patients without at least:

• Authentic CoA validation

• Preliminary contamination or particulate screening

• Initial risk assessment for sterility-related failures

This is not a matter of technical complexity.

It is a matter of regulatory design.

What Sri Lanka is facing is not an isolated lapse, but a pattern of preventable exposure caused by weak import-stage controls.

Customs Has the Power—But Not the Technical Mandate

Sri Lanka Customs has clear legal authority to hold, quarantine, and restrict consignments where risk is identified.

However, Customs cannot conduct pharmaceutical quality assessments on its own.

That technical responsibility lies with the National Medicines Regulatory Authority (NMRA).

Customs officials have repeatedly indicated the need for NMRA to:

• Allocate qualified pharmaceutical assessors to entry ports

• Deploy analysts for preliminary screening of high-risk medicines

• Establish a structured quarantine mechanism for suspect consignments

Yet no permanent system has been operationalised.

No interim safeguards.

No emergency protocols.

No transparent explanation to the public.

The Missing Link: Medicine Quarantine Laboratories

Sri Lanka already maintains quarantine laboratories for food, agriculture, and animal health imports.

Medicines—arguably the highest-risk category—have none.

Dedicated pharmaceutical quarantine laboratories at major entry ports could:

• Verify CoA authenticity

• Perform rapid particulate and contamination screening

• Identify high-risk injectables for further testing

• Hold consignments until minimum safety clearance is granted

Without such facilities, patients effectively become the testing environment.

That is ethically indefensible.

Food Is Tested. Fertilizer Is Tested. Why Not Medicines?

This remains the most disturbing inconsistency in Sri Lanka’s regulatory framework:

• Food items → Quality certification required before release

• Consumer goods → Standards verification mandatory

• Medicines → Released first, evaluated later (if at all)

There is no scientific justification for this imbalance.

Only administrative inertia and regulatory complacency.

How Many Warnings Are Required?

This editorial must ask the questions regulators continue to avoid:

• How many quality alerts are needed before import-level checks become mandatory?

• How many hospital-level withdrawals must occur before preventive controls are prioritised?

• Must patient harm be documented before CoA verification is enforced?

Public health regulation must be preventive, not reactive.

In this context, silence is not neutrality.

It is regulatory neglect.

What Must Be Implemented Immediately

Harideshaya calls for minimum, realistic, and achievable reforms:

1. Mandatory CoA verification at all medicine entry ports

2. Preliminary particulate and foreign-matter screening for injectables

3. Immediate establishment of medicine quarantine laboratories

4. Deployment of NMRA pharmaceutical assessors alongside Sri Lanka Customs

5. Public accountability for regulatory delays and inaction

These are not radical demands.

They are the bare minimum required to protect patients.

Sri Lanka does not lack laws.

It lacks urgency, execution, and institutional accountability.

Medicines must never be treated as ordinary cargo.

They are substances with the power to heal—or to harm.

Harideshaya will continue to ask the uncomfortable questions,

because patient safety cannot wait for bureaucratic convenience.