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Beyond blame: The systemic crisis in Sri Lanka’s medicine regulation

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AHP President Ravi Kumudesh

The recent suspension of ten Indian-manufactured injections by Sri Lanka’s medicines regulator has done more than ignite a fresh “substandard medicines” scare. It has laid bare a chronic, systemic failure in the nation’s pharmaceutical governance – a failure that transcends political parties and individual ministers.

According to Ravi Kumudesh, President of the Academy of Health Professionals (AHP), this episode is not an isolated scandal but the latest symptom of a regulatory regime that operates on personality and discretion rather than transparent, evidence-based science.

The public’s current anxiety, Kumudesh argues, stems from a dangerous confluence: an allegation of microbial contamination in an injectable, the blanket suspension of ten products from one manufacturer, and the opaque controversy surrounding an “Indian Pharmacopoeia” agreement. “When these three collide,” he states, “the outcome is predictable: not clarity, not confidence – but a national regulatory regime that the public is asked to ‘trust’ without being given the evidence required to trust.”

A problem rooted in system, not scapegoats

Kumudesh insists that framing this crisis around former Health Minister Keheliya Rambukwella or the current minister, Dr. Nalinda Jayatissa, misses the fundamental point. The core issue is a system that has remained stubbornly unchanged across administrations. “The public has watched governments change while the internal decision-making circle inside the regulatory system appears to remain remarkably stable,” he observes. This creates a perilous pattern where the same insiders sometimes act as public critics and at other times as ‘story managers’ within the system, leading to public perception of a credibility gap that no mere statement can bridge.

From hospital test to national edict: A question of protocol

The central controversy, Kumudesh explains, is not the precautionary suspension itself but the evidence pathway that led to it. “A hospital laboratory can detect signals. But national regulatory action requires national-level validation,” he emphasises. The critical, uncomfortable questions he raises are: If Sri Lanka’s own national medicine quality laboratory still lacks full public confidence, how can a hospital test justify a nationally consequential suspension? And if subsequent international or confirmatory tests contradict the initial finding, who repairs the shattered trust and clinical disruption?

He warns that Sri Lanka has seen this movie before – products removed amid public alarm only to be reintroduced later, creating clinical chaos and eroding faith. “Regulatory panic creates clinical chaos,” Kumudesh notes. The proper response to a contamination allegation, he outlines, is systematic: isolate temporarily, collect samples under strict chain-of-custody, and verify through recognised reference testing – not “suspend and shout.”

The unanswered questions: Procurement and agreements

Kumudesh points to glaring gaps in public accountability. One key question remains unanswered: were pre-shipment test reports for these injections reviewed? “If yes: where are the reports? If no: how did the system allow high-risk products in?” he asks, stressing that procurement is a patient-safety responsibility, not mere paperwork.

Furthermore, the shadow over the reported “Indian Pharmacopoeia” agreement exemplifies the systemic opacity. “If an agreement exists, the first duty is public disclosure,” he asserts. Without it, the public cannot assess whether Sri Lanka is strengthening its standards or inadvertently weakening its own scrutiny and liability pathways.

The path forward: Evidence over emotion

For Kumudesh, the solution lies in a radical shift from personality-based to evidence-based regulation. “Committees do not fix systems – systems fix systems,” he says, critiquing the cyclical political response of appointing committees after each crisis. His prescription is structural:

= Establish a stable, transparent regulatory protocol immune to political or personal influence.

= Build a credible, independent national medicine quality laboratory with recognised competency.

= Enforce a clear, legally sound evidence pathway for all regulatory decisions.

= Ensure routine publication of key regulatory outcomes and decisions.

“Without a credible national laboratory,” he warns, “Sri Lanka remains permanently dependent on foreign timelines and credibility, while its own decisions are perpetually questioned.”

The ultimate question Kumudesh leaves for policymakers and the public is stark: “Is the fear of substandard medicines being used to protect patients – or to hide the system’s inability to prove the truth quickly, transparently, and credibly?” Until the architecture of regulation is rebuilt on the bedrock of science and transparency, he concludes, this crisis will not be the last. It will simply be the latest in a long line of failures that place patients and professionals in the crossfire of a system they cannot trust.

By Sanath Nanayakkare ✍️



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CBSL keeps overnight policy rates unchanged; latest review of IMF program awaited

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Dr. Nandalal Weerasinghe

The Central Bank kept its overnight policy rate unchanged yesterday as it awaited the latest ​review of a US $2.9-billion International Monetary Fund programme.

‘The Central Bank will maintain the overnight policy rate at 7.75 percent and stable inflation, healthy credit growth and steady economic expansion are the reasons for the decision, Central Bank Governor Dr Nandalal Weerasinghe said. The Central Bank Governor stated this yesterday at the monthly policy review meeting held at Central Bank head office in Colombo.

‘The Board arrived at this decision after carefully considering evolving developments and the outlook on the domestic front and global uncertainties, the Governor said.

Dr Weerasinghe said that the Board is of the view that the current monetary policy stance will support steering inflation towards the target of 5 percent

The CBSL Governor added: ‘Inflation measured by the Colombo Consumer Price Index (CCPI) remained unchanged at 2.1 percent in December 2025. However, food prices edged higher in December compared to November.

‘ This was due to supply chain disruptions caused by Cyclone Ditwah and higher demand for food during the festive season.

‘Inflation is projected to accelerate gradually and move towards the target of 5 percent by the second half of 2026. Core inflation, which excludes price changes in volatile food, energy and transport from the CCPI basket, has also shown some acceleration in recent months.

‘Core inflation is expected to accelerate further as demand in the economy strengthens. Meanwhile, inflation expectations appear to be well anchored around the inflation target.

‘The economy grew by 5.0 percent during the first nine months of 2025. Despite the slowdown in economic activity following Cyclone Ditwah in late 2025, early indicators reflect greater resilience.

‘Credit disbursed to the private sector by commercial banks and other financial institutions continued its notable expansion in late 2025.

‘This reflects increased demand for credit amid improving economic

activity and increased vehicle imports. Post-cyclone rebuilding is expected to sustain this momentum.

‘The external current account is estimated to have recorded a sizeable surplus in 2025, despite the widening of the trade deficit. Foreign remittances remained healthy during 2025.

‘Despite large debt service payments during the year, Gross Official Reserves were built up to USD 6.8 bn by the end of 2025.

‘This was mainly supported by the net foreign exchange purchases by the Central Bank and inflows from multilateral agencies. The Sri Lanka rupee depreciated by 5.6 percent against the US dollar in 2025 and has remained broadly stable thus far during this year. This includes the swap facility from the People’s Bank of China.

‘The Board remains prepared to implement appropriate policy measures to ensure that inflation stabilises around the target, while supporting the economy to reach its potential.’

By Hiran H Senewiratne

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Janashakthi Finance records 35% growth in Net Operating Income and LKR 389 Mn. PBT in Q3 FY26

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Rajendra Theagarajah, Chairman / Sithambaram Sri Ganendran, Chief Executive Officer

Janashakthi Finance PLC, formerly known as Orient Finance PLC and a subsidiary of JXG (Janashakthi Group) announced a strong financial performance for the nine-month period ended 31 December 2025, driven by sustained growth in its core businesses, disciplined execution and continued focus on scale and efficiency.

Commenting on the results, Rajendra Theagarajah, Chairman of Janashakthi Finance PLC, said, “The performance for the period reflects the clarity of our strategic priorities and the strength of our governance framework. With strong leadership in place that is confidently driving the business, we continue to grow steadily while maintaining balance sheet strength and stakeholder confidence.”

For the period under review, Profit Before Tax (PBT) rose by 39% year-on-year to LKR 389 million, supported by higher operating income and portfolio expansion. Net Operating Income increased by 35% year-on-year to LKR 2.2 billion, reflecting sustained lending activity and improved business scale.Net Profit After Tax (NPAT) amounted to LKR 240 million.

The Company’s Loans and Receivables portfolio grew by 49% year-on-year to LKR 29 billion, driven by demand across key lending segments and focused growth initiatives. Deposits increased to LKR 17 billion, recording a 14% year-on-year growth, reinforcing funding diversity and customer confidence.

Reflecting on the year’s progress, Sithambaram Sri Ganendran, Chief Executive Officer of Janashakthi Finance PLC, stated, “During the period, we focused on expanding our loan book responsibly, strengthening our funding base and enhancing operational capability. The growth achieved across our key indicators positions the Company strongly as we continue to execute our medium-term strategy and respond to market opportunities.”

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JKH posts strong Q3 EBITDA growth of 68% to Rs.23.76 billion driven by momentum across the portfolio

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Chairperson and CEO Krishan Balendra

Summarised below are the key operational and financial highlights of our performance during the quarter under review:

The Group continued to deliver a strong performance, with all businesses reporting improved profitability.

The operationalisation of two of the Group’s largest projects, the City of Dreams Sri Lanka integrated resort and the West Container Terminal (WCT-1) at the Port of Colombo, continued to progress well. The encouraging quarter-on-quarter momentum demonstrates the strong ramp up potential of both projects.

The country faced an unexpected challenge in November with Cyclone Ditwah, which impacted parts of Southeast and South Asia. The cyclone caused loss of lives, affected a significant portion of the population, and resulted in considerable infrastructure damage in certain areas of Sri Lanka. While the operations of the Group were disrupted during the few days of the cyclone, there were no significant operational or financial impact as a direct result of the cyclone and related flooding.

The Group and its staff supported relief efforts through various initiatives, including a substantial contribution of Rs.500 million from John Keells Holdings PLC and its affiliate companies towards the Government’s ‘Rebuilding Sri Lanka’ initiative.

Group earnings before interest, tax, depreciation and amortisation (EBITDA) at Rs.23.76 billion in the third quarter of the financial year 2025/26 is an increase of 68% against Group EBITDA of Rs.14.15 billion recorded in the third quarter of the previous financial year.

Cumulative Group EBITDA for the first nine months of the financial year 2025/26 at Rs.55.10 billion is an increase of 84% against the EBITDA of Rs.29.94 billion recorded in the same period of the financial year 2024/25.

During the quarter under review, the Group recorded fair value gains on investment property amounting to Rs.2.30 billion [2024/25 Q3: Rs.955 million], and net exchange losses of Rs.759 million [2024/25 Q3: gain of Rs.782 million], mainly due to the impact of the deprecation of the Rupee on the foreign currency denominated loan at City of Dreams Sri Lanka.

Profit attributable to equity holders of the parent is Rs.6.48 billion in the quarter under review, which includes fair value gains on investment property and net exchange losses amounting to Rs.1.45 billion. Profit attributable to equity holders of the parent for the corresponding period of the previous financial year was Rs.2.85 billion, which included fair value gains on investment property and net exchange gains amounting to Rs.1.70 billion.

The second interim dividend for FY2026 of Rs. 0.10 per share is aligned with the first interim dividend paid in November 2025. This reflects the expectation that the current momentum of performance will sustain or further improve going forward. The outlay for the second interim dividend is Rs.1.77 billion, which is an increase compared to Rs.881 million in the previous year.

(JKH)

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