Features

Poor-quality and counterfeit medicines and unnecessary drugs

Published

1 year ago

2025/01/6

Sahan Weerasooriya

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.

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Features

The Easter investigation must not become ethno-religious politics

Published

15 hours ago

2026/04/7

Sahan Weerasooriya

Zahran and other bombers

Representatives of almost all the main opposition parties were in attendance at the recent book launch by Pivithuru Hela Urumaya leader Udaya Gammanpila. The book written by the PHU leader was his analysis of the Easter bombing of April 2019 that led to the mass killing of 279 persons, caused injuries to more than 500 others and caused panic and shock in the entire country. The Easter bombing was inexplicable for a number of reasons. First, it was perpetrated by suicide bombers who were Sri Lankan Muslims, a community not known for this practice. They targeted Christian churches in particular, which led to the largest number of casualties. The bombing of Sri Lankan Christian churches by Sri Lankan Muslims was also inexplicable in a country that had no history of any serious violence between the two religions.

There were two further inexplicable features of the bombing. The six suicide bombings took place almost simultaneously in different parts of the country. The logistical complexity of this operation exceeded any previously seen in Sri Lanka. Even during the three decade long civil war that pitted the Sri Lankan military against the LTTE, which had earned international notoriety for suicide attacks, Sri Lanka had rarely witnessed such a synchronised operation. The country’s former Attorney General, Dappula de Livera, who investigated the bombing at the time it took place, later stated, upon retirement, that there was a “grand conspiracy” behind the bombings. That phrase has remained central to public debate because it suggested that the visible perpetrators may not have been the only planners behind the attack.

The other inexplicable factor was that intelligence services based in India repeatedly warned their Sri Lankan counterparts that the bombings would take place and even gave specific targets. Later investigations confirmed that warnings were transmitted days before the attacks and repeated again shortly before the explosions, yet they were not acted upon. It was these several inexplicable factors that gave rise to the surmise of a mastermind behind the students and religious fanatics led by the extremist preacher Zahran Hashim from the east of the country, who also blew himself up in the attacks. Even at the time of the bombing there was doubt that such a complex and synchronised operation could have been planned and executed by the motley band who comprised the suicide bombers.

Determined Attempt

The book by PHU leader Gammanpila is a determined attempt to make explicable the inexplicable by marshalling logic and evidence that this complex and synchronised operation was planned and executed by Zahran himself. This is a possible line of argumentation in a democratic society. Competing interpretations of public tragedies are part of political discourse. However, the timing of the intervention makes it politically more significant. The launch of the PHU leader’s book comes at a critical time when the protracted investigation into the Easter bombing appears to be moving forward under the present government.

The performance of the three previous governments at investigating the bombing was desultory at best. The Supreme Court held former President Maithripala Sirisena and several senior officials responsible for failing to act on prior intelligence and ordered compensation to victims. This judicial finding gave legal recognition to what victims had long maintained, that there was a grave dereliction of duty at the highest levels of the state. In recent weeks the investigation has taken a dramatic turn with the arrest and court production of former State Intelligence Service chief Suresh Sallay on allegations linked directly to the attacks. Whether these allegations are ultimately proven or disproven, they indicate that the present phase of the investigation is moving beyond negligence into possible complicity.

This is why the present moment requires political sobriety. There is a danger that the line of political division regarding the investigation into the Easter bombing can take on an ethnic complexion. The insistence that the suicide bombers alone were the planners and executors of the dastardly crime makes the focus invariably one of Muslim extremism, as the suicide bombers were all Muslims. This may unintentionally narrow public attention away from the unanswered questions regarding intelligence failures, possible political manipulation, and the allegations of a broader conspiracy that remain under active investigation. The minority political parties representing ethnic and religious minorities appear to have realised this danger. Their absence from the book launch was politically significant. It suggests an unwillingness to be drawn into a narrative that could once again stigmatise an entire community for the crimes of a handful of extremists and their possible handlers.

Another Tragedy

It would be another tragedy comparable in political consequence to the havoc wreaked by the Easter bombing if moderate mainstream political parties, such as the SJB to which the Leader of the Opposition belongs, were to subscribe to positions merely to score political points against the present government. They need to guard against the promotion of anti-minority sentiment and the fuelling of majority prejudice against ethnic and religious minorities. Indeed, opposition leader Sajith Premadasa in his Easter message said that justice for the victims of the 2019 Sri Lanka Easter Sunday attacks remains a fundamental responsibility of the state and noted that seven years on, both past and present governments have failed to deliver accountability. He added that building a society grounded in trust and peace, uniting all ethnicities, religions and communities, is vital to ensure such tragedies do not occur again.

Sri Lanka’s post war history offers too many examples of how unresolved security crises become vehicles for majoritarian mobilisation. The Easter tragedy itself was followed by waves of anti-Muslim suspicion and violence in some parts of the country. Responsible political leadership should seek to prevent any return to that atmosphere. There are many other legitimate issues on which the moderate and mainstream opposition parties can take the government to task. These include the lack of decisive action against government members accused of corruption, the passing of the entire burden of rising fuel prices on consumers instead of the government sharing the burden, and the failure to hold provincial council elections within the promised timeframe. These are issues that touch the daily lives of citizens and the health of democratic governance. They offer the opposition ample ground on which to build credibility as a government in waiting.

The search for truth and justice over the Easter bombing needs to continue until all those responsible are identified, whether they were direct perpetrators, negligent officials, or political actors who may have exploited the tragedy. This is what the victim families want and the country needs. But this search must not be turned into a partisan and religiously divisive matter such as by claiming that there are more potential suicide bombers lurking in the country who had been followers of Zaharan. If it is, Sri Lanka risks replacing one national tragedy with another. coming together to discredit the ongoing investigations into the Easter bombing of 2019 is an unacceptable use of ethno-religious nationalism to politically challenge the government. The opposition needs to find legitimate issues on which to challenge the government if they are to gain the respect and support of the general public and not their opprobrium.

by Jehan Perera

Features

China’s new duty-free regime for Africa: Implications for Global Trade and Sri Lanka

Published

15 hours ago

2026/04/7

Sahan Weerasooriya

Image courtesy The Global Times

* The new duty-free regime for Africa, announced by Chinese President Xi Jinping in February, is the most generous unilateral nonreciprocal trade concession offered by any country to developing countries since the beginning of the modern rule based international trading system.

* Yet, it is a clear violation of the cornerstone of the multilateral trade law, the Most-Favoured-Nation (MFN) principle.

* Hence, its implications on developing countries, without duty-free access to China, will be extremely negative. Sri Lanka is one of the few developing countries without duty-free access to China.

On 14 February, 2026, Chinese President Xi Jinping announced that China will grant zero-tariff treatment to 53 African nations, effective 01 May, 2026. Under this new unilateral policy initiative, China would eliminate all import tariffs on all goods imported from all the countries in Africa, except Eswatini. China already enforces a zero-tariff policy for 33 Least Developed Countries (LDCs) in Africa. Now this policy would be extended to non LDCs as well. This policy initiative clearly aims at reducing the continuously expanding trade deficit between China and Africa. In 2024, China’s trade surplus against Africa was recorded at US $ 61 billion.

This trade initiative, a precious gift amidst ongoing global trade tensions, is the most generous unilateral nonreciprocal trade concession given by any country to developing countries, since the beginning of the modern rule based international trading system.

Though this landmark announcement has far-reaching implications on global trade, as much as President Trump’s “Liberation Day” tariffs, it was almost overlooked by the global media.

Implications for Global Trade

This Chinese policy initiative, though very generous, is a clear violation of the Most-Favoured-Nation (MFN) principle and the “Enabling Clause” of the International Trade Law. The MFN principle is the cornerstone of the multilateral trading system under the World Trade Organisation (WTO) and is enshrined in Article I of the General Agreement on Tariffs and Trade (GATT). It mandates that any trade advantage, privilege, or immunity granted by a WTO member to any country must be extended immediately and unconditionally to all other WTO members. Though, the GATT “Enabling Clause” allows developed nations to offer non-reciprocal preferential treatment (lower tariffs) to developing countries without extending them to all WTO members, this has to be done in a non-discriminatory manner. By extending tariff concessions only to developing countries in Africa, China has also breached this requirement.

This deliberate violation of the MFN principle by China occurs less than 12 months after the announcement of “Liberation Day” tariffs by President Trump, which breached Article I (MFN) and Article II (bound rates) of the GATT. However, it is important to underline that the objectives of the actions by the two Presidents are poles apart; the US objective was to limit imports from all its trading partners, and China’s objective is to increase imports from African countries.

Though the importance of the MFN principle of the WTO law had eroded over the years due to the proliferation of preferential trade agreements and unilateral preferential arrangements, the WTO members almost always obtained WTO waivers, whenever they breached the MFN principle. Now the leaders of the main trading powers have decided to violate the core principles of the multilateral trading system so brazenly, the impact of their decisions on the international trading system will be irrevocable.

Implications for Sri Lanka

China’s unilateral decision to provide zero-tariff treatment to African countries will have a strong adverse impact on Sri Lanka. Currently, all Asian countries, other than India and Sri Lanka, have duty-free access, for most of their exports, into the Chinese market through bilateral or regional trade agreements, or the LDC preferences. Though Sri Lanka, India and China are members of the Asia Pacific Trade Agreement (APTA), preferential margins extended by China under APTA to India and Sri Lanka are limited.

The value of China’s imports from Sri Lanka had declined from US$ 650 million in 2021 to US$ 433 million by 2025. However, China’s exports to Sri Lanka increased significantly during the period, from US$ 5,252 million to US$ 5,753 by 2025. This has resulted in a trade deficit of US$ 5,320 million. Sri Lanka’s exports to China may decline further from next month when African nations with duty-free access start to expand their market share.

Let me illustrate the challenges Sri Lanka will face in the Chinese market with one example. Tea (HS0902) is Sri Lanka’s third largest export to China, after garments and gems. Sri Lanka is the largest exporter of tea to China, followed by India, Kenya and Viet Nam. During the last five years the value of China’s imports of tea from Sri Lanka had declined significantly, from US$76 million in 2021 to US$ 57 million by 2025. Meanwhile, imports from our main competitors had increased substantially. Most importantly, imports from Kenya increased from US$ 7.9 million in 2021 to US$ 15 million in 2025. For tea, the existing tariff in China for Sri Lanka is 7.5% and for Kenya is 15%. From next month the tariff for Kenya will be reduced to 0%. What will be its impact on Sri Lanka exports? That was perhaps explained by a former Ambassador to Africa, when he urged Sri Lankan exporters to “leverage duty free access from Kenya” to expand their exports to China!

(The writer is a retired public servant and a former Chairman of WTO Committee on Trade and Development. He can be reached at senadhiragomi@gmail.com)

by Gomi Senadhira

Features

Daughter in the spotlight …

Published

15 hours ago

2026/04/7

Sahan Weerasooriya

Jeevarani Kurukulasuriya was a famous actress and her name still rings a bell with many. And now in the spotlight is her daughter Senani Wijesena – not as an actress but as a singer – and she has been singing, since the age of five!

The plus factor is that Senani, now based in Australia, is also a songwriter, plays keyboards and piano, dancer, and has filmed and edited some of her own music videos.

Says Senani: “I write the lyrics, melody and music and work with professional musicians who do the needful on my creations.”

Her latest album, ‘Music of the Mirror’, is made up of 16 songs, and her first Sinhala song, called ‘Nidahase’, is scheduled for release this month (April) in Colombo, along with a music video.

‘Nidahase’,

says Senani, is a song about Freedom … of life, movement, love and spirit. Freedom to be your authentic self, express yourself freely and Freedom from any restrictions.

In fact, ‘Nidahase’ is the Sinhala translated version of her English song ‘Free’ which made Senani a celebrity as the song was nominated for a Hollywood Music in Media Award in the RnB /Soul category and reached the Top 20 on the UK Music weekly dance charts, as well as No. 1 on the Yes Home grown Top 15, on Yes FM, for six weeks straight.

Senani went on to say that ‘Nidahase’ has been remixed to include a Sri Lankan touch, using Kandyan drums and the Thammattama drum, with extra music production by local music producer Dilshan L. Silva, and Australia-based Emmy Award winning Producer and Engineer Sean Carey … with Senani also in the scene.

The song was written (lyrics and melody) and produced by Senani and it features Australian musicians, while the music video was produced by Sri Lanka’s Sandesh Bandara and filmed in Sri Lanka.

First Sinhala song scheduled for release this month … in Colombo

Senani’s music is mostly Soul, Funk and RNB – also Fusion, using ethnic sounds such as the tabla, sitar, and sarod – as well as Jazz influenced.

“I also have Alternative Music songs with a rock edge, such as ‘New Day’, and upcoming releases ‘Fly High’ and ‘Whisper’“, says Senani, adding that she has also recorded in other languages, such as Hindi and Spanish.

“As much of my fan base are Sri Lankans, who have asked me to release a song in the Sinhala language, I decided to create and release ‘Nidahase’ and I plan to release other original Sinhala songs in the future.

Senani has a band in Australia and has appeared at festivals in Australia, on radio and TV in Australia, and Sri Lanka.

She trained as a vocalist, through Sydney-based Singing Schools, as well as private tuition, and she has 5th Grade piano music qualifications.

And this makes interesting reading:

“I graduated from the University of Newcastle in Australia with a Bachelor of Medicine and I work part time as a doctor (GP) and an Integrative Medicine practitioner, with a focus on nutrition, and spend the rest of the time dedicated to my music career.”

Senani hails from an illustrious family. In addition to her mum, Jeevarani Kurukulasuriya, who made over 40 films, including starring in the first colour movie ‘Ranmuthu Duwa’, her dad is Dr Lanka Wijesena (retired GP) and she has two sisters – all musical; one is a doctor, while the other is a dietitian/ psychotherapist.