Features
Poor-quality and counterfeit medicines and unnecessary drugs
by Saman Gunatilake
Emeritus Professor of Medicine and Neurologist
University of Sri Jayewardenepura
Key facts
* Substandard and counterfeit medical products affect people all around the world.
* At least 1 in 10 medicines in low- and middle-income countries are substandard or falsified.
* Countries spend an estimated US$ 30.5 billion per year on substandard and falsified medical products.
* Substandard and falsified medical products are often sold online or in informal markets.
The circulation of substandard medicines in the developing world is a serious clinical and public health concern. Studies have revealed that in low-and-middle income countries, more than 13 percent of the essential medicines that are considered as priority for basic healthcare are of poor quality and falsified. In Asia and Africa, the prevalence of poor-quality medicines was ranging from 11 to 48 percent. In low- and middle-income countries, 19 percent of antimalarial drugs and 12 percent of antibiotics are substandard or counterfeit. Sri Lanka is also not immune from these problems. A research paper published in the journal BMC Health Services Research in 2023 titled “Quality of medicines in Sri Lanka: a retrospective review of safety alerts” revealed that over a period of three years, in 2018 to 2021, contamination was the most frequent cause of defective medicines, while stability defects, packaging and labelling defects and active ingredient defects were other causes. In addition, the findings showed that some manufacturers were accountable for repetitive withholdings and recalls of medicines from use, which reflects the ignorance of quality control measures and weak regulatory inspections, violating Good Manufacturing Practice (GMP). These measures have been enhanced and enforced strictly following changes in regulatory bodies, such as the National Medicine Regulatory Authority (NMRA), and it is likely that the situation is much better today. Recently, a newspaper reported that 13 batches of different types of medicines have been withheld, or recalled, due to poor quality.
There are two main categories of poor-quality medicines: Substandard and counterfeit. WHO defines ‘substandard medicines’ as authorized medical products that fail to meet either their quality standards or their specifications, or both, and ‘falsified or counterfeit medicines’ as “medicines that are deliberately and fraudulently mislabelled with respect to identity composition or source”. Counterfeits may include products with correct or incorrect ingredients, without active ingredients, with insufficient active ingredients, or with fake packaging’’. For example, some time back one-third to one-half of the vital anti-malarial agent artesunate bought in mainland South-East Asia was counterfeit, containing no or sub-therapeutic active ingredient. We all are familiar with the fake immunoglobulin scam which happened in our country. These products are often created and distributed with the intent to deceive consumers for financial gain.
Substandard and counterfeit medical products pose significant threats to public health globally. They can be ineffective at treating the illness, as they may contain incorrect ingredients or incorrect dosages. They can even be directly harmful to patients if they contain contaminants or toxic substances. In Sri Lanka, a few years ago, the contamination of eye drops with fungi was reported causing blindness, and contaminated injections causing severe infections such as meningitis. Both substandard and counterfeit medical products put patients’ health at risk, undermine the effectiveness of health systems, and erode trust in health and care providers. Most of the patients we see are aware of the problems we have had with poor quality drugs and some insist that the doctors dispense good quality medicines and some go to the extent of even bringing the medicines that they have bought or got from hospitals to be double checked.
There is a substantial economic burden, too, with the country’s finances wasted due to ineffective treatments, increased healthcare costs and loss of productivity. For patients, the consequences are serious: ineffective or harmful products can exacerbate illnesses, lead to complications and prolonged suffering and even death. Patients may unknowingly consume medications that contain toxic substances or incorrect dosages, resulting in poisoning, treatment failure, and exacerbation of diseases. Trust in healthcare providers and systems erodes, leaving communities vulnerable and fearful. With the global spread of this issue, no region is spared, with both developed and developing countries having to grapple with this man-made danger to our health.
Sophisticated networks manufacture these products, exploiting the demand for affordable medical treatments. The increase in online sales, through unauthorized sites, has further worsened the issue, allowing counterfeit products to reach consumers more easily. To tackle this problem, robust legal frameworks, regional and international cooperation, heightened public awareness and stronger enforcement measures are required. These steps are crucial to safeguarding the integrity of health systems and ensuring the availability of safe and effective medical products.
In this background, everyone is at risk of encountering substandard and falsified medical products. The following are more at risk – vulnerable populations, countries lacking social protection and with weaker health systems, individuals buying medical products from unauthorized sources (including online), countries with a poor supply chain and countries with an increased demand of specific and urgent supply of medical products requiring bypass of standard regulatory measures.
Tackling substandard and counterfeit medical products is challenging due to limited resources and infrastructure in many regions, especially in low- and middle-income countries. Counterfeiters are using sophisticated methods that make detection difficult. The rise of online purchases and informal markets makes it hard to monitor and control the distribution of these products. Additionally, the vast number of medical products in circulation, worldwide, makes comprehensive regulation and monitoring a significant challenge.
Combating the problem
Strengthening medicine regulatory authorities and in our country the NMRA, improving quality of production, and facilitating the availability of relatively inexpensive, good quality medicines are key to combating the problem. Sustained political will and financial support for coordinated action from health officials, police, custom officials and MRAs is vital. Poorer countries will find it difficult to implement quality assurance measures. WHO has estimated that around 30% of countries have no good drug regulation capacity that functions effectively. The lack of financial and human resources, trained personnel in MRAs make investigation and control of poor-quality drugs impossible. Increased provision of essential drugs free or at subsidized costs for major diseases would undercut the counterfeiters.
Preventing, detecting and responding to substandard and falsified medical products require robust regulatory systems which enforce the highest possible quality standards for medical products. Measures are required to prevent the manufacture, sale and consumption of substandard and falsified medical products by implementing systems to detect any substandard and falsified medical products already in the supply chain. Responding quickly and proportionately to any incident detected, in ways that safeguard patients, and the supply chain, are important, taking appropriate action, whilst not causing unnecessary shortages. Governments must ensure that regulations and legal frameworks keep pace with technological developments and the regulatory standards are upheld and enforced in a consistent and transparent manner.
Public awareness campaigns are crucial to educate people about the risks of buying medical products from unauthorized sources. It is crucial to support local healthcare providers and ensure they have access to safe, affordable medical products. This involves strengthening healthcare infrastructure, providing training and resources and implementing policies that guarantee the availability of genuine, cost-effective medicines for all communities.
WHO response
WHO addresses the issue of substandard and falsified medical products through coordinated political and technical responses. The Member State mechanism was established to facilitate global collaboration among WHO Member States. It aims to promote and reinforce national and international efforts to prevent, detect and respond to substandard and falsified medical products. This mechanism allows member states to share information, experiences and best practices, ensuring a unified and effective global response. It also supports the development of regulatory frameworks, capacity building and the promotion of legal measures to combat these threats to public health.
The WHO Global Surveillance and Monitoring System (GSMS) is a comprehensive initiative launched in 2013 to enhance the detection, reporting and response to substandard and falsified medical products. By providing national regulatory authorities with a robust information portal, the GSMS facilitates the sharing of data on suspect products, enabling timely alerts and coordinated actions across borders. This system is vital to improve the accuracy and speed of identifying these products, supporting evidence-based policymaking, and strengthening regulatory capacities globally. Its collaborative approach ensures that health systems are better equipped to protect public health and maintain the integrity of medical supplies.
Together, the Member State mechanism and GSMS provide a comprehensive framework for addressing the complex challenge of substandard and falsified medical products, enhancing global public health safety.
Unnecessary drugs
Recently our Minister of Health has stated that there are many unnecessary drugs in the market and that steps will be taken to curb this menace. This is very true and as prescribing doctors we see many unnecessary drugs in the market. What are unnecessary drugs? There are two main categories 1) An approved drug being used as treatment when it is really not necessary for the patient 2) Products marketed as medicines where their clinical value is not proven.
The Centers for Medicare and Medicaid (CMS) in USA define an Unnecessary Drug as any drug used in excessive dosage (including duplicate drug therapy); for excessive duration; without adequate monitoring; without adequate indications for its use; in the presence of adverse consequences which indicate the dose should be reduced or discontinued. The term Unnecessary Drug is often misunderstood, incorrectly used and poorly applied. A recent survey published by the chief pharmaceutical officer for England, concludes that up to 110 million medicines handed to patients each year may be unnecessary and even potentially harmful. In England, 15 percent of people now take five or more medicines a day, while seven percent are on eight drugs or more. Sometimes two or three painkillers are given when one would suffice. This applies to antibiotics, too, and haphazard use can lead to unwanted drug interactions, side effects and drug resistance. Vitamin supplements also are widely used, a single patient being on many vitamins when there is no real indication. Some vitamins in excess can be harmful and as routine supplements vitamins really serve no purpose.
Factors contributing to the misuse of medication include health system and regulatory failures, poor prescribing practices on the part of physicians, ease of access to medications from pharmacists without requiring a prescription as well as a lack of education among patients about their medications. Increasingly, healthcare providers around the world are seeing “deprescribing” as a solution. This process, led by pharmacists and doctors, involves systematically discontinuing medicines that are inappropriate, duplicative or unnecessary.
Use of drugs without proven clinical benefit
These are drugs available in the market that have not been subjected to proper clinical evaluation. Accepted practice is for new drugs to undergo various stages of evaluation before use in humans. Once the laboratory, animal and human safety studies are done, a new drug is subjected to a clinical trial. If the product is proven to be of benefit in a clinical trial, then the regulatory body of the country (The United States Food and Drug Administration FDA in the USA, The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, NMRA in Sri Lanka). However, in our country what are assumed to be herbal products and Ayurveda products don’t need to go through these stringent checks. As a result, they are in the market and advertised in newspapers and electronic media, these products, misleading the public. It is also of concern that even universities of ours are marketing drugs of no proven clinical value using this loophole in the regulatory process.
Substandard medicines are a problem in Sri Lanka similar to that of other low- and middle-income countries. The challenges posed by poor quality medicines are increasingly becoming global, requiring international cooperation at all levels. To ensure quality medicines reach the market and the public, strong country plans, regulators with power to act, technical assistance to genuine manufacturers, awareness among healthcare workers and the public are important areas that must be strengthened. Governments in rich countries should not tolerate the export of substandard pharmaceutical products to poor countries, while developing country governments should improve their ability to detect substandard medicines.
Spread of counterfeit drugs is a modern-day menace which is seen internationally, especially so in developing countries. The problem assumes added significance in view of rapid globalization. The market of spurious and counterfeit drugs is a well-organized crime. Poverty, high cost of medicines, lack of an official supply chain, legislative weaknesses, easy accessibility to printing technology, ineffective law enforcement machinery, and light penalties provide the counterfeiters with an enormous economic incentive without much risk. The consequences of the use of such medicines may vary from treatment failure, serious adverse events and even death. Proper drug quality monitoring, enforcement of laws and legislation, an effective and efficient regulatory environment, and awareness and vigilance, on part of all stakeholders are required to tackle this problem.
Features
Silence of the majority keeps West Asian conflict raging
With no military quick-fix in sight to the ongoing, convoluted West Asian conflict it ought to be clear to the rationally inclined that there is no other way to a solution to the blood-letting other than through a negotiated one. Unfortunately, there are not many takers the world over for such an approach.
Consequently the war rages on incurring the gravest human costs to all relevant sides. Whereas it should be obvious to the Trump administration that Iran wouldn’t be backing down any time soon from its position of taking on the US frontally and with the required military competence in the Hormuz Strait and adjacent regions, the US demonstrates a stubbornness to persist with war strategies that are showing no quick, positive results on the ground.
Clearly, the virtual ‘lock down within a lock down’ situation in the Strait is not proving beneficial for either party. Instead, the spilling of civilian blood in particular continues with unsettling regularity along with an all-encompassing economic crisis that carries a staggering material toll for ordinary people all over the world.
From this viewpoint it is commendable for Pakistan to offer itself as a peace mediator and go ‘the extra mile’ to keep the principal parties engaged in some sort of negotiatory process. But its efforts need to win greater support from the world community. It is a time for peace-makers the world over to stand up and be counted.
It is also a time for straight-talking. To his glowing credit Pope Leo XIV is doing just that and he is the only religious head worldwide to do so. Very rightly he has called on President Trump to end the war through negotiations and described it as ‘unjust’ and ‘a scandal to humanity’.
May this crucial cause be taken up by more and more world leaders, is this columnist’s wish. Instead of speaking fatalistically about a ‘Third World War’, decision and policy makers and commentators, and these are found in plenty in Sri Lanka as well, would do better to help in drumming-up support for a peaceful solution and the latter is within the realms of the possible.
Incidentally, the commonplace definition of the phrase ‘World War’ is quite contentious and it would be premature to speak forebodingly about one right now. The fissures within the West on the Middle East conflict alone rule out the possibility of a ‘World War’ occurring any time soon.
Instead, it would be preferable for the international community, under the aegis of the UN, to take the ‘straight and narrow’ path to a peaceful solution. As implied, this path is no easy avenue; it is cluttered with obstacles that only doughty peace makers could take on and clear.
However, the path to a negotiated peace is worth taking and no less a power than the US should know this. After all, the US ‘bled white’ in Vietnam and had to bow out of the conflict, realizing the futility of pursuing a military solution. A similar lesson should have been learned by Russia which bled futilely in Afghanistan. It too is in an unwinnable situation in Ukraine.
The Pope’s observations to President Trump on negotiating peace have earned for him some snarls and growls of criticism but with time these critics would realize that peace could come only by peaceful means and not through ‘the barrel of a gun.’
For far too long the ‘silent majority’ of the world has allowed politicians to take the sole initiative on working towards peaceful solutions to conflicts and wars. As could be seen, the results have been disastrous. The majority of politicians speak the language of Realpolitik only and this tendency runs contrary to the ways of the selfless peace maker.
Power, which is the essence of Realpolitik, and peace are generally at loggerheads in the real world. Power and self-aggrandizement have to be shelved in the pursuit of durable peace anywhere and it is a pity that the likes of Donald Trump and his team are yet to realize this.
At this juncture the ‘peace constituency’ or the silent majority would need to take centre stage and play their rightful role as the ‘Conscience of the World’. If the latter begins to take on the cause of peace in earnest everywhere, the politicians would have no choice but to pay heed to their cause and take it up, since a contrary course would earn for them public displeasure and votes.
An immediate challenge would be for the ‘peace constituency’ to come together and act as one. Right now, such a coordinating role could be played effectively by only the UN and its agencies. Practical problems are likely to get in the way but these need to be managed insightfully and resourcefully by all stakeholders to peace.
In fact the time couldn’t be more appropriate for the backers of peace to come together and work as one. Right now, economic pressures are increasing worldwide and no less a public than that in the US is beginning to feel them in a major, crushing way.
Going ahead the US public, along with other polities, would find the economic consequences of war to be intolerable. There would be no choice but for governments and peoples to champion peace. Peace makers would need to ‘strike while the iron is hot.’
The success of the above endeavours hinges on the importance humans attach to their consciences. The danger about prolonged wars is that they deaden consciences; particularly those of politicians. The latter deaden their consciences to the extent that they prove impervious to the pain and suffering wars incur.
Thus, the ‘peace constituency’ has its work cut out; it cannot rest assured that politicians would prove sensitive to their demands. The latter would need to be constantly dinned into the hearts and minds of politicians and decision-makers if peaceful solutions to conflicts are to be arrived at.
Likewise, the publics of war-torn countries would need to demand the activation and sustaining of accountability processes with regard to those sections that are suspected of committing war crimes and like atrocities. Those publics that cease to demand accountability from powerful sections among them which are faced with war-time atrocity charges are as good as condemning themselves to lives of permanent dis-empowerment and enslavement.
Features
Don’t take the baby: In the quiet night, mother always returns

Chaminda Jayasekara
There is a particular stillness in Sri Lanka’s forests, after dusk — a kind of hushed expectancy where shadows lengthen, cicadas soften their chorus, and the night begins to breathe in its own rhythm. It is a world that does not reveal itself easily. You have to wait for it. You have to listen.
And then, suddenly, you see them — a pair of luminous, unblinking eyes suspended in the dark.
The Grey Slender Loris, or unahapuluwa, emerges, not with drama, but with quiet precision. Small, slow-moving, and almost impossibly delicate, it is one of Sri Lanka’s most enigmatic nocturnal primates — a creature that has survived millennia by mastering the art of stillness.
Yet, during these months — from late March through July — the forests hold a more tender story. It is the breeding season of the slender loris, and with it comes a scene that is often misunderstood by those who encounter it for the first time: a tiny infant, alone on a branch, barely three inches long, its fragile body silhouetted against the night.

Grey Slender Loris with twin babies
To many, it appears to be a moment of abandonment.
To nature, it is a moment of trust.
“People often act out of compassion, but without understanding what they are seeing,” explains Chaminda Jayasekara of the University of Hertfordshire. “A baby loris left alone is not necessarily in danger. In fact, it is part of a natural process that is critical for its survival.”
According to Jayasekara, when a baby loris is about a month old, the mother begins a remarkable routine. As darkness settles, she gently places her infant on a secure branch and moves off into the forest to forage. Her journey can take her hundreds of metres away — sometimes close to 800 metres — as she searches for insects and other small prey.
In those hours of solitude, the infant is not abandoned. It is learning.
Clinging to the branch, it begins to explore its immediate surroundings. Tentatively, almost hesitantly, it reaches out — testing balance, grip, and instinct. It may attempt to catch tiny insects, mimicking behaviours it will one day rely on entirely. This is its first classroom, and the forest its only teacher.
“Those early nights are crucial,” Jayasekara says. “The baby is developing motor skills, coordination, and the ability to interact with its environment. These are things that cannot be replicated in captivity.”
And yet, this is precisely where human intervention often disrupts the process.
Across rural and even semi-urban Sri Lanka, stories circulate of well-meaning individuals who come across a lone baby loris and assume the worst. Driven by concern, they pick it up, take it home, or attempt to hand-rear it — believing they are saving a life.

Grey Slender Loris
But the reality is far more complex — and far more tragic.
“When a baby is removed unnecessarily, it loses something fundamental,” Jayasekara emphasises. “It loses the chance to learn how to survive in the wild. Without that, even if it survives in the short term, its long-term prospects are extremely poor.”
The forest, after all, is not just a habitat. It is a living, evolving system of lessons — how to detect predators, how to navigate branches, how to hunt silently, how to recognise territory. These are not instincts alone; they are behaviours refined through experience.
And the mother, contrary to assumption, is rarely far away.
“If people simply waited — even for several hours — they would often see the mother return,” Jayasekara explains. “She knows exactly where she left her baby. Her absence is temporary, purposeful.”
The advice from conservationists is clear and consistent: observe, but do not interfere.
If you encounter a baby loris, watch quietly from a distance. Avoid using bright lights or making noise. Give it time — at least 10 to 12 hours — before drawing conclusions. In most cases, the situation will resolve itself, just as nature intended.

35 days old Grey Slender Loris
Only if the animal is clearly injured, or if there is strong evidence of abandonment after prolonged observation, should intervention be considered — and even then, it must be done through the proper channels, particularly the Department of Wildlife Conservation.
Attempting to care for such a delicate animal at home is not only ineffective but often fatal.
Sri Lanka is home to two species of slender loris — the Grey Slender Loris and the Red Slender Loris — each adapted to specific ecological zones across the island. Both are protected under national legislation and recognised internationally as species requiring urgent conservation attention.
Their threats are many: habitat loss, road mortality, illegal pet trade, and, increasingly, human misunderstanding.
Yet, in the midst of these challenges, there are also signs of hope.

In recent years, the slender loris has become the focus of a unique form of wildlife tourism — one that values patience over spectacle. Night walks, conducted with trained naturalists and strict ethical guidelines, offer visitors a chance to witness the loris in its natural environment without disturbing its behaviour.
At places like Jetwing Vil Uyana, this approach has been refined into a model of responsible eco-tourism. Over more than a decade, the property has developed a dedicated Loris Conservation Project, recording thousands of sightings while educating visitors and supporting local communities.
Here, the loris is not handled, chased, or exploited. It is simply observed — a quiet presence in a carefully protected landscape.
“The success of such initiatives shows that conservation and tourism do not have to be at odds,” Jayasekara reflects. “When done responsibly, tourism can actually support conservation by creating awareness and value for these species.”
There is something profoundly moving about encountering a loris in the wild. It does not roar or charge. It does not demand attention. Instead, it exists — quietly, deliberately — as it has for millions of years.
And perhaps that is why it is so easily misunderstood.

In a world that often equates visibility with importance, the loris reminds us that some of the most extraordinary lives unfold beyond the spotlight.
It also reminds us of something else — something simpler, yet harder to practice.
Restraint.
Because conservation is not always about stepping in. Sometimes, it is about stepping back. About recognising when nature does not need our help, but our patience.
So if, on some future night, you find yourself walking beneath the trees, and your light catches a tiny figure sitting alone on a branch — do not rush forward.
Pause.
Watch.
Let the moment unfold.
Because somewhere, moving silently through the darkness, guided by instinct and memory, a mother is already on her way back.
And by morning, the forest will be whole again.
By Ifham Nizam
Features
Kumar de Silva: 40 years of fame and flair
We first saw him on the small screen in January 1986 – a relatively raw, totally untrained and a very nervous 24-year-old presenting ‘Bonsoir’ on ITN.
And now, 40 years later, and as one looks back, one realises what a multi-dimensional journey Kumar de Silva has navigated across the small screen yes, from your television screens to your laptops, and iPads, tabs, and mobile phones.
Says Kumar: “It is the French language I speak that opened the world of television to me, 40 years ago. It was ‘Bonsoir’ alone, and so to my French teacher at Wesley College, Mrs. BA Fernando, to ‘Bonsoir’, and to the Embassy of France in Sri Lanka, I am eternally grateful”.

Promoting the French language, and culture, in Sri Lanka, in a big way
Kumar went on to say that on the heels of ‘Bonsoir” came ‘Fanclub’, on ITN, describing it as yet another resounding success story which saw him as a music DJ on TV.
His inherent talent saw him handle a range of contrasting programmes across ITN, TNL, Prime TV and SLRC with consummate ease – from News Reading, Business Talk Shows, Celebrity Chats, to Dhamma discussions, on Poya Days, to name a few.

Kumar – the 1986 look
Trained in Paris in television production and presentation, the Government of France, in 2012, conferred on him the title of ‘Chevalier dans l’Ordre des Arts et Lettres’ (Chevalier in the Order of Arts and Letters) in recognition of his contribution to promoting the French language, and culture, in Sri Lanka.
In celebration of his four decades on the small screen, Kumar recently launched ‘Bonsoir Katha’, the Sinhala translation (by Ciara Mendis) of his English book ‘Bonsoir Diaries’ (2013), at a gala soiree. at the Alliance Francaise de Colombo, under the distinguished patronage of the French Ambassador in Sri Lanka, Remi Lambert, and francophone President Chandrika Kumaratunga.
He’s now excited about launching the French version of this book, ‘Les Coulisses de Bonsoir’, in Paris, in autumn this year. It is currently being translated by Guilhem Beugnon, a former Deputy Director of the Alliance Francaise de Colombo. This will, co-incidentally, also be Kumar’s 30th visit to Paris.

Chief Guest French Ambassador in Sri
Lanka Remi Lambert
Says Kumar: “The word GRATITUDE means a lot to me and so I always make it a point to spend time with two very special French people every time I go to France. One is Madame Josiane Thureau, formerly of the French Foreign Ministry, who began ‘Bonsoir’ in Sri Lanka. way back in the mid-1980s. The other is Madame Aline Berengier, the lady who designed the ‘Bonsoir’ logo – the Sri Lankan elephant in the colours of the French national flag”.
Kumar is also a much-sought-after Personal Development and Corporate Etiquette Coach in Colombo’s corporate world. Over the past 15 years, tens of thousands of corporates, have been through the different modules of his interactive training sessions. There have also been thousands of school leavers and undergraduates from national and private universities, many of whom will constitute the corporates of tomorrow.

Guest of Honour francophone President Chandrika Kumaratunga at the gala soiree
at the Alliance Francaise de Colombo
The multi-talented Kumar turns 65 next year, and his journey on the small screen still continues – you see him on the (monthly) ‘Rendez-Vous with Yasmin and Kumar’ on the French Embassy’s YouTube Channel, and (every Friday) on ‘Fame Game with Rozanne and Kumar’ on Daily Mirror Online, Hi Online and The Sun Online.
There’s yet another podcast in the pipeline, he indicated, but diplomatically declined to give us details. All he said, with a glint in his eye, was, “It will hit your screens soon.”
Whatever he has in mind, one can be certain that the new programme will continue to showcase Kumar de Silva’s enduring presence in Sri Lanka’s entertainment scene.
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