• SL’s regulatory and compliance checking systems not up to standard
• NMQAL found not to have met WHO standards benchmarking in many areas
• Cough syrups in concern in India are not registered in SL: NMRA
• Indian authorities shut down production of cough syrup linked to deaths

The recent deaths of at least 24 children in India after allegedly consuming a domestically manufactured cough syrup have reignited concern in Sri Lanka over the safety of imported medicines.

The tragedy, which has shaken India’s pharmaceutical industry, serves as a stark reminder of Sri Lanka’s heavy dependence on foreign manufactured medicines and its own fragile quality assurance systems.

Sri Lanka imports around 80% of its medicines, with India being the country’s largest supplier. For years, some health professionals have raised concerns about Sri Lanka’s inadequate capacity to test the quality of these imports.

Despite repeated warnings, the island’s medicine testing infrastructure remains outdated, understaffed, and largely unaccredited, raising questions about its ability to detect unsafe products before they reach patients.

The latest Indian incident involved several cough syrups which were found to contain diethylene glycol – a toxic chemical used in antifreeze – at levels nearly hundreds of times above permissible limits. The contamination led to the alleged deaths of 24 children and sparked an international outcry.

Following the revelation, Sri Lanka’s National Medicines Regulatory Authority (NMRA) confirmed that neither the cough syrup brands in question nor their manufacturers are registered in Sri Lanka. However, the incident has nonetheless renewed concerns over the country’s dependence on Indian pharmaceuticals and the robustness of its regulatory oversight.

India’s regulatory crackdown

Reports from international media last week revealed that India plans to scrap mandatory export testing requirements once its pharmaceutical firms upgrade facilities to international standards by the end of the year. However, both India’s Health Ministry and the Central Drugs Standard Control Organisation (CDSCO), the country’s top medicine regulator, had declined to comment on these plans.

A CDSCO spokesperson, responding to separate queries, told international media that medicines must be tested throughout the production process, not merely at the final stage. Yet, the same regulator admitted in October that several pharmaceutical companies had failed to comply with existing batch-testing regulations for both raw materials and finished products.

Against this backdrop, an internal audit of Sri Lanka’s National Medicines Quality Assurance Laboratory (NMQAL), which operates under the regulator, the NMRA, has uncovered grave operational failures, revealing why local testing may not be capable of identifying unsafe medicines in time.

The NMQAL is responsible for testing medicines submitted for registration, import, and post-market surveillance. However, the audit found that nearly four years after applying for international accreditation from the Sri Lanka Accreditation Board (SLAB) in 2020, the laboratory has yet to meet required standards under ISO 17025:2017.

Despite multiple extensions, the SLAB rejected further delays in September 2023, citing the lab’s continued failure to meet basic compliance criteria. A scheduled pre-compliance assessment in June 2023 was postponed due to staff shortages, leaving the facility unaccredited and casting doubt on the reliability and international recognition of its test results.

Dilapidated and outdated infrastructure

The audit found damaged ceilings and walls from water leaks, non-functional air-conditioning, frequent power interruptions, and inadequate ventilation – all of which compromise the stability of laboratory testing.

Equipment was another major concern. The report identified 18 missing instruments and 29 awaiting repairs, while several others remained uncalibrated or outdated. In such conditions, maintaining testing accuracy is nearly impossible, experts warn.

“The environment is completely unsuitable for a national-level testing facility,” the audit stated, citing poor lighting, unstable temperatures, and compromised safety conditions.

Perhaps most alarming is the human resource crisis at the NMQAL. The laboratory’s technical staff has fallen from 42 officers in 2015 to just 11 by November 2023 – barely 20% of its approved cadre of 54. Recruitment delays and limited professional development opportunities have left the remaining staff overburdened and undertrained.

The audit further noted that recommendations made by the World Health Organization’s (WHO) 2019 benchmarking programme which identified 15 key areas for improvement remain largely unimplemented. Unaddressed issues include weak environmental controls, poor sample management, outdated reporting systems, and inadequate chemical safety protocols.

Delays and backlogs

Performance data from 2022–2023 revealed a sharp decline in laboratory output. Testing completion rates dropped from 69% in 2022 to 32% by late 2023. Of 586 reports issued during that period, 38% were delayed beyond the 90-day limit, and 47 reports took over a year to complete.

Court-related testing fared even worse, with 100% of 102 judicial samples issued between 2022 and October 2023 exceeding the 28-day legal deadline. These delays, auditors warned, could jeopardise judicial proceedings and undermine confidence in the justice system’s ability to handle medical negligence or counterfeit drug cases.

Due to lack of equipment and skilled staff, biological and microbiological testing – crucial for identifying bacterial contamination or toxicity – has been “severely restricted”. Although the NMRA has legal authority under Section 39(1)(c) of its governing act to collaborate with local or international accredited labs, the audit found that partnerships with institutions such as the Industrial Technology Institute (ITI) had not been effectively utilised.

Despite these  shortcomings, auditors found that funding was not a major constraint. The NMRA had sufficient financial resources but failed to take timely or effective action to upgrade its facilities. Plans for a 23-storey NMRA and NMQAL complex were scrapped due to policy disputes and land issues, forcing operations to continue in cramped, unsuitable conditions.

Reform efforts underway

Amid growing scrutiny, the NMRA has launched a major renovation and capacity-building programme for the NMQAL, supported by the Asian Development Bank (ADB). The goal, officials say, is to achieve SLAB accreditation first, and eventually WHO recognition.

Speaking to The Sunday Morning, NMRA Chairman Dr. Ananda Wijewickrama confirmed that several improvement projects were underway.

“We have already started renovation and improvement work with ADB assistance,” Dr. Wijewickrama said. “Our first goal is to meet SLAB standards and then move towards WHO accreditation. There’s a clear roadmap in place.”

The NMQAL currently operates across two adjacent buildings – one historically used for laboratory work and another for regulatory functions. The newer building, requiring minimal refurbishment, is being repurposed for lab operations to allow testing to continue during phased renovations of the older structure.

“Roof repairs have already been completed, and other renovations are in progress,” Dr. Wijewickrama explained.

In parallel, the NMRA has recruited new technical staff this year, expanding testing capacity. The new recruits have completed initial training and are now fully engaged in analytical work. According to the Chairman, this has already led to a fivefold increase in productivity.

“The average number of tests per month has risen from around 60 to 280,” he noted. “We expect this to improve further.”

Dr. Wijewickrama emphasised that rebuilding the laboratory’s full capacity would take time. “Full operation is not something that happens overnight. A laboratory continuously evolves with new tests, technologies, and standards.”

Addressing public calls for stricter pre-distribution testing of all imported medicines, Dr. Wijewickrama clarified that testing every batch of imported medicines before release was not practical or standard practice worldwide.

“Medicines are produced and imported in batches. What we do is random testing using a risk-based stratification method, as recommended by the WHO,” he explained.

Under this system, the NMRA conducts random sampling from both public hospitals and the private sector to detect substandard or counterfeit products. Dr. Wijewickrama noted that expanding random testing remained central to Sri Lanka’s medicine safety strategy.

“By increasing random testing, we can identify poor-quality products early and discourage suppliers from bringing such products into the market,” he added.

GMOA calls for strengthened oversight

The Government Medical Officers’ Association (GMOA) has raised concerns over the quality of medicines supplied to the public health system, emphasising the urgent need for improved regulatory mechanisms and laboratory infrastructure.

Speaking to The Sunday Morning, GMOA Media Spokesman Dr. Chamil Wijesinghe highlighted recent incidents involving substandard medications, including human immunoglobulin and eye drops that resulted in patient complications. 

While Sri Lanka has not experienced the large-scale medicine-related disasters reported in some countries, Dr. Wijesinghe stressed that maintaining medicine quality remained a fundamental responsibility of the health system.

“Ensuring that patients receive high-quality, lifesaving medicine is a basic requirement,” he said. “Especially in a free public health system like ours, where medicines are funded through taxpayers’ money, quality cannot be compromised.”

Dr. Wijesinghe noted that the current NMRA laboratory was outdated, not having been upgraded in nearly three decades. While efforts have been made to establish a WHO-standard quality assurance lab in the country, previous attempts have been unsuccessful due to various challenges. “In the short term, the NMRA can utilise facilities in private and university laboratories to test medicine quality,” he suggested. 

He also emphasised the importance of stricter regulation in the medicine import and registration process, particularly during periods of emergency procurement, which were a contributing factor in recent complaints.

When asked about testing every medicine before distribution, Dr. Wijesinghe acknowledged that current capacities were insufficient. “Ideally, we should test before registration, before release to the market, and conduct random checks thereafter. Currently, testing is mostly complaint-based, and capacity must be enhanced,” he said.

The GMOA acknowledged recent efforts by the NMRA to increase testing capacity from 60 to 280 tests per month but noted that this still fell short of meeting national demand. Despite limitations, he commended the authority’s decisive actions in regulating suppliers and improving oversight.

“Strengthening the NMRA, establishing a WHO-standard quality assurance lab, and ensuring a consistent medicine supply are crucial steps to prevent complications and protect public health,” he stressed.

Incidents like the Indian cough syrup tragedy expose global vulnerabilities and highlight why Sri Lanka’s medicine regulatory framework faces mounting pressure to modernise.

While the NMRA’s ongoing reforms move slowly, the challenges are steep. Without accredited laboratories, adequate staff, and modern infrastructure, ensuring the safety and efficacy of every medicine on Sri Lankan shelves remains an uphill battle.