Just after midnight, a family from southern Sri Lanka found themselves racing against time on the country’s dimly lit highways, clutching a small vial that meant the difference between life and death.
Earlier that evening, a critically ill patient at the Galle National Hospital had been diagnosed with severe internal bleeding. Doctors urgently prescribed either octreotide or intravenous terlipressin – both essential medicinal drugs commonly used to control life-threatening haemorrhages. But the hospital had neither in stock.
With no time to spare, hospital staff told the patient’s relatives to source the medicine themselves.
What followed was a frantic overnight search across the Southern Province. Pharmacies in Galle, Matara, and nearby towns were contacted one after another, but none had the medicine. As the patient’s condition worsened, the family was advised by a contact in the pharmaceutical industry to travel to Colombo, where supplies were more likely to be available.
They left Galle late at night, driving nearly 130 km north. Their hopes briefly rose when they were told the medicine might be available at a pharmacy attached to a private hospital in Thalawathugoda. However, on arrival, they were told it was out of stock.
It was only after several more phone calls that the family learnt that the State Pharmaceuticals Corporation (SPC) outlet near the Colombo Town Hall still had limited supplies. They purchased the medicine and began the long drive back south, reaching the Galle National Hospital at around 2.30 a.m.
With the medicine used for treatment, the patient survived. “We breathed a collective sigh of relief. May this not happen to anyone else,” one of the patient’s family members, speaking on condition of anonymity, told The Sunday Morning.
While the incident had a positive outcome, it has once again exposed the fragility of Sri Lanka’s medicine supply chain and raised uncomfortable questions about access, regulation, and preparedness within the country’s healthcare system.
A system under pressure
At present, industry representatives insist there is no nationwide shortage of essential medicines in the private market. However, they warn that this stability may be short-lived.
The Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) has cautioned that shortages could emerge as early as March if the National Medicines Regulatory Authority (NMRA) does not expedite the renewal of hundreds of pending import licences.
According to the SLCPI, nearly 800 medicine importer licences are currently awaiting renewal.
“As of now, the situation is manageable,” said SLCPI President Shantha Bandara. “But if the NMRA continues to delay these renewals of import licences, the country will face shortages within months. This is not speculation; it is a matter of supply timelines.”
Sri Lanka remains heavily dependent on imported pharmaceuticals, particularly for specialised and life-saving medicines. Even short administrative delays can disrupt procurement cycles, leading to sudden stockouts at hospitals and pharmacies.
Short-expiry medicines
Alongside fears of shortages, pharmacy owners have raised concerns about the increasing circulation of short-expiry medicines in the local market.
All-Island Private Pharmacy Owners’ Association (AIPPOA) Media Secretary Sidath Suranga claimed that pharmacies were being forced to sell medicines close to their expiry dates because pharmaceutical companies were unwilling to accept returns.
“Pharmacies are stuck,” he said, adding: “If medicines are not sold in time, there is no structured mechanism for returning them. Companies are not legally bound to take them back.”
The association has urged the NMRA to introduce a clear national policy governing the return, disposal, and compensation of expired or near-expiry medicines.
The pharmaceutical industry, however, disputed the claim that companies are refusing returns.
“This is not as simple as it sounds,” said Bandara. “There is a deep and complex mechanism behind returns. It is incorrect to say companies are not accepting them. Multiple factors influence these processes,” he said, adding that Sri Lanka did, in fact, lack a formal legal framework regulating medicine returns.
The debate over short-expiry medicines has significant implications for patient safety.
According to the US Food and Drug Administration (FDA), drug expiration dates are determined through rigorous scientific stability testing conducted by manufacturers. These dates indicate the period during which a medicine is expected to retain its full strength, quality, and purity when stored as directed.
The FDA warns that expired or improperly stored medicines may lose effectiveness or degrade into potentially harmful compounds – risks that are particularly serious for patients with life-threatening conditions.
In Sri Lanka, where regulatory oversight and post-market surveillance remain limited, the presence of short-expiry medicines raises concerns regarding both safety and ethical practice. The Asian Development Bank too had highlighted structural weaknesses in the public health supply chain in its Pharmaceutical Supply Chain Assessment for Sri Lanka, released in March 2025.
Despite operating nearly 20 bulk warehouses, five cold rooms at central medical stores, and 26 regional warehouses – with a total storage capacity of over 35,900 cubic metres – the system suffers from critical operational gaps.
While most facilities adhere to basic security standards and the First Expired, First Out (FEFO) method, experts warn that the absence of robust inventory controls increases the risk of wastage, stockouts, and compromised medicine quality.
These systemic weaknesses often translate into sudden shortages at the hospital level – forcing families, like the one in Galle, to take desperate measures. While the family in question was able to travel between cities quickly and source the medicines needed, many families in Sri Lanka are unable to do so.
Pricing controls
Beyond availability, industry stakeholders warn that Sri Lanka’s medicine pricing policies could soon undermine their quality.
Both pharmacists and manufacturers claim that the current pricing controls – introduced to improve affordability – are, in fact, discouraging high-quality international suppliers from entering or remaining in the market.
According to the SLCPI, multiple court cases are currently challenging the NMRA’s pricing formula, while parallel discussions are ongoing with the Government.
Suranga echoed these concerns, saying that the NMRA’s approach of setting a mid-price between the highest and lowest priced versions of a medicine had resulted in unintended consequences.
“European manufacturers operate with higher costs and thinner margins,” he said. “Under the current pricing model, they simply cannot compete. As a result, internationally recognised European medicines are disappearing from shelves.”
Ironically, he added, consumers had not benefited either. “Prices of cheaper medicines have not dropped as expected, and higher-quality options are vanishing. So nobody wins.”
Who tests the quality?
Another long-standing concern in the pharmaceutical sector is quality assurance. Significant issues related to the quality of certain pharmaceuticals have been reported over the past decade, and cases currently before the Judiciary have further heightened concerns about medicine quality.
At present, the NMRA largely relies on documentary evidence provided by manufacturers to approve medicines. Industry representatives argue that this is insufficient.
“We need a proper national laboratory capable of testing molecular composition,” Suranga said. “Paper guarantees are not enough. We must verify whether the medicine arriving in Sri Lanka truly matches the quality described.”
Approximately 95% of medicines in Sri Lanka’s private sector are imported from India and Bangladesh. While Indian pharmaceuticals dominate global generic markets – supplying around 20% of global volumes and 40% of US generics – questions remain about batch-to-batch consistency without local testing infrastructure.
India’s pharmaceutical industry benefits from production costs estimated to be 30–50% lower than Europe’s, driven by cheaper labour and utilities. However, it remains heavily dependent on imported raw materials, sourcing up to 70% of active pharmaceutical ingredients from China.
Europe, by contrast, leads in high-value patented medicines, biologics, and complex therapies, but faces rising energy and labour costs – making it less competitive under strict price caps.
The Government maintains that Asia now supplies much of the world’s pharmaceuticals – not only to Sri Lanka but globally as well. While industry representatives agree with this, they remain insistent that global reliance be matched by domestic safeguards.
“Electronics, food, medicine – everything comes from the same regions,” Suranga said. “But other countries test rigorously. Without laboratories, how do we know whether Sri Lanka is getting the same quality?” he questioned.
NMRA response
Responding to the allegations, NMRA Chairman Dr. Ananda Wijewickrama said that suppliers were required to take back expired medicines or drugs that raised quality concerns.
However, he stressed that the NMRA would take legal action against pharmacies that sold expired or contaminated medicines. “Legal remedies are in place to protect consumers,” he said.
Addressing concerns over medicine quality, Dr. Wijewickrama questioned whether pharmaceutical companies were implying that they imported low-quality medicines into Sri Lanka by raising issues about medicines manufactured in India and Bangladesh.
He also noted that the NMRA had received complaints from consumers about certain medicines being sold above the Maximum Retail Price (MRP), adding that the authority would take necessary legal action against the pharmacies involved.