A call for coexistence

by Ifham Nizam

Sri Lanka’s human-elephant conflict (HEC) has become an increasingly tragic symbol of the struggle between conservation and development. As one of Asia’s most biologically diverse nations, the island is home to the majestic Asian elephant, a species listed as endangered by the International Union for Conservation of Nature (IUCN).

However, rapid habitat loss, expanding human settlements, and poorly planned infrastructure projects have created a volatile situation for both humans and elephants, says Centre for Environmental Justice (CEJ) Chairperson Hemantha Withanage.

“The toll is staggering. In 2023, Sri Lanka witnessed the deaths of 470 elephants and 160 humans due to conflict. Such statistics, while alarming, only scratch the surface of a deeper, systemic issue threatening the coexistence of these two species.”

Amidst this crisis, the Centre for Environmental Justice (CEJ), supported by public consultations and expert guidance, has proposed a robust plan to address the issue.

Historical Perspective

The roots of the human-elephant conflict in Sri Lanka trace back to centuries. Elephants have been deeply revered in Sri Lankan culture, symbolising wisdom, power, and spirituality. Historically, traditional agricultural practices allowed space for both human communities and wildlife to coexist harmoniously.

However, this balance shifted dramatically during the colonial period. The British introduced extensive plantation systems, railways, and roads, disrupting elephant migration routes. Post-independence, Sri Lanka’s rapid population growth and urbanisation exacerbated the problem. Forests were cleared for agricultural projects, such as the Mahaweli irrigation scheme and industrial ventures, further fragmenting elephant habitats.

Today, elephants and humans share about 40% of Sri Lanka’s total land area, with 70% of the elephant range overlapping human settlements. This close proximity has turned peaceful coexistence into a deadly conflict.

Causes and Impacts

House damaged by a wild elephant

Elephant deaths are predominantly caused by human activities, including gunshots, electrocution, poisoning, and accidents. Unauthorised electric fences and trap devices, like hakkapatas (explosives hidden in food) claim hundreds of lives annually. Conversely, elephants raid crops, such as rice, maize, and coconuts, causing significant economic losses to farmers.

For many rural communities, the financial burden is immense. Farmers lose an estimated $200 annually to crop damage, with average property damages costing individuals 145,000 Sri Lankan rupees over five years. These losses, coupled with the fear of human casualties, fuel resentment toward elephants, prompting retaliatory killings.

Proposed Solutions

The CEJ’s comprehensive proposal integrates insights from affected communities, government officials, and Wildlife experts. The aim is not only to mitigate the conflict but also to create sustainable coexistence.

Strengthening Electric Fences

Electric fences are a widely used mitigation measure, but their effectiveness has been limited by poor maintenance and improper design. CEJ emphasises the need for standardised fences regulated by authorities, powered by solar energy where electricity access is limited. Community involvement in construction and maintenance is essential to ensure long-term success.

Preserving Habitats and Corridors

The loss of elephant corridors and habitat fragmentation are primary drivers of HEC. CEJ advocates for a national land-use policy to protect these critical areas. Identifying and gazetting undeclared forests as protected areas can help preserve migration routes and reduce conflict.

Community Engagement and Awareness

Education plays a pivotal role in addressing HEC. CEJ recommends awareness programmes in schools, religious institutions, and villages to promote understanding of elephant behaviour and effective conflict prevention methods. Communities can also be trained to use deterrents like chili-based barriers and maintain natural corridors.

Compensation and Insurance

Currently, only a fraction of the damages caused by elephants are compensated. A robust and transparent compensation scheme is vital to rebuilding trust between communities and conservation authorities. Insurance programmes for crops and property damage should be expanded to reduce economic losses.

Innovative Conflict Mitigation Techniques

New approaches, such as GPS collaring, can monitor elephant movements and predict potential conflict zones. Biological fences using plants like Palmyra trees or citrus crops, which elephants avoid, are also gaining traction. However, further research and trials are needed to assess their feasibility.

Addressing Elephant Mortality

To curb elephant deaths, CEJ proposes stricter regulations against unauthorised electric fences, poisoning, and hakkapatas. Establishing a hotline and offering rewards for reporting illegal activities could deter offenders. Agro-wells, often death traps for elephants, should be covered or fenced.

Integrated Development Planning

Large-scale infrastructure projects have often disregarded environmental management plans, exacerbating HEC. CEJ recommends integrating elephant conservation into development policies, ensuring that projects allocate funds for mitigating their ecological impact.

The Role of Policy and Governance

Effective governance is crucial to implementing these solutions. CEJ’s proposal includes the creation of divisional-level HEC mitigation committees comprising government officials, local communities, and conservationists. These committees can oversee the maintenance of electric fences, monitor illegal activities, and ensure proper land-use planning.

Furthermore, a presidential task force dedicated to HEC mitigation could provide the leadership and resources needed to implement the proposed national action plan. Regular evaluations and adaptive management strategies will help refine interventions based on real-time data and outcomes.

Challenges and the Road Ahead

Despite the ambitious plans, challenges remain. Political interference in land allocation, unplanned development projects, and insufficient funding for conservation efforts hinder progress. The 2023 Budget allocated only 100 million rupees for maintaining 4,000 km of electric fences and constructing 200 km of new fences, far below what is required.

Additionally, community resistance to certain measures, such as relocating problematic elephants, highlights the need for transparent communication and trust-building initiatives.

Yet, the solutions proposed by CEJ offer a glimmer of hope. With a multi-stakeholder approach, incorporating science, community wisdom, and policy frameworks, Sri Lanka has the opportunity to turn the tide on HEC.

Vision for Coexistence

The human-elephant conflict in Sri Lanka is more than an environmental issue; it is a test of the country’s ability to balance development with conservation. By prioritising coexistence, Sri Lanka can protect its natural heritage while ensuring the safety and livelihoods of its people.

As CEJ’s report highlights, coexistence is not just a necessity but a possibility. With concerted effort, the majestic Asian elephant can continue to roam the island, not as a threat, but as a cherished symbol of Sri Lanka’s rich biodiversity.

by Geewananda Gunawardana Ph.D.

It is a relief to see that some actions are being taken to safeguard the nation’s medicinal drugs supply. Marking the World Antimicrobial Resistance Week, Health Minister Dr. Nalinda Jayatissa stated that laws and regulations governing medicinal drugs must be strengthened. Seeing what has happened to the country’s drug supply in the recent past, that may come as an understatement. The half a billion-dollar question is whether the new administration will be effective in changing the system even if it has good intentions and political muscle. There are a few reg flags raised already. The reason for that doubt is that this problem is shrouded in mystery, presumed to be a subject that we mortals could not understand, a subject only accessible to a certain class of elite. This information gap makes finding a solution to this problem several orders of magnitudes harder than that for many other problems facing the country.

Our problems are not new. In the late nineteenth century, when a shrewd businessman started selling bottled stream water as a panacea, the American authorities saw the need for verifying and regulating medicinal products. That was the beginning of the US Food and Drug Administration. For better or for worse, the infamous human immunoglobulin fiasco when senior officials were caught passing bottled water has triggered Sri Lanka’s FDA moment. We had a system in place, but as the no confidence vote in the parliament highlighted, it had been callously disregarded with impunity for decades. This is not limited to the health sector but deep rooted in all institutions. The continued adoration of the main culprit after the fact shows our ingrained tendency to venerate the elite blindly no matter what harm they inflict. Change has arrived, but success is not guaranteed; we the public must continue to be vigilant.

Vulnerability of systems

The recent incident in which a crook swindled passports right in front of the junior minister highlights the vulnerability of our systems, the gaping information gap, and the extent of disregard for law and order. If a lawmaker can be blinded to a simple protocol, hoodwinking even a well-meaning expert in the field can be child’s play when it comes to drug safety. The process is so convoluted that the proverbial entering through one ear and coming out the other can be extended to any other pore. The decades of neglect and corruption in drug regulation necessitate an all-out war against the system; applying band-aids here and there will not work. Eliminating the information gap is a major step in that process.

There are three main functional areas of specialization involved in getting safe medications to the patients: discovery and development of a drug, diagnosis of the ailment and prescription of the drug, and dispensing the drug to the patient in the prescribed manner. The professionals involved are pharmaceutics experts, medical doctors, and pharmacists. Except in research settings that exist in drug discovery and development organizations, the interactions between the three disciplines stated above are limited. The most common exchange of information takes place through the salespeople of the drug manufacturers; there is no need to explain whose interest they have in mind. As a result, there exists an information gap. Many tend to take it for granted that the world’s drug supply is safe and efficacious; in fact, to the dismay of this writer, a person in a responsible position made a statement to that effect, recently. That would have been true in an ideal world.

The World Health Organization report (2017) estimates that 1 in 10 medicines in low- and middle-income countries are substandard or falsified, and the losses incurred as a result is about $ 30.5 billion annually. According to another report (jamanetworkopen.2018.1685), the figures are higher: 13% substandard drugs and $200 billion in economic losses. No numbers are available for Sri Lanka, but the name of a former health minister should be sufficient to highlight the enormity of the problem, which is reprehensible by any human standards, to say the least.

It is obvious why the substandard drug manufactures target low-income countries and countries with corrupt systems: they are easy targets. We Sri Lankans have more reasons to be vigilant as there are vultures within the system hellbent on looting public funds with impunity and are ready and willing to collude with them. However, there are two powerful tested and proven approaches to curb all these evils. They are Quality Assurance (QA) and Quality Control (QC). If properly administered, they do not leave any room for corruption within this process. However, the irregularities associated with purchasing practices must be dealt with separately.

The scientists that discover, develop, and bring drugs to market identify a set of qualities or attributes of drugs that must be maintained for them to be safe and efficacious. These requirements are known as specifications, and they include a list of tests to be performed on each drug, the analytical test procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. All such information for all approved drugs is available through the drug manufacturers, approving agencies of the region, and international organizations such as WHO and the International Council for Harmonization (ICH). Following such guidance, these qualities of the drugs and any external factors that may affect them must be monitored and controlled throughout the life of the drug.

Two vital stages

This is done in two stages: quality assurance involves having all necessary precautions in place during manufacture, packaging, storage, distribution, and throughout the shelf life at the pharmacy and the patient’s home. Fortunately, the WHO has a programme for certifying manufacturers and suppliers that meet these stringent requirements. Any drug purchased must be accompanied by a certificate of analysis (CoA), which lists the required qualities, and the test results relevant to that specific lot of drugs. If the drug originates from a WHO certified manufacturer, the CoA is a document that can be trusted. Naturally, having such quality assurance measures is costly, and their products could be more expensive than those coming from uncertified manufacturers. The certificates of analyses originating from non-certified manufacturers require verification by the purchasing country. The verification process becomes much more difficult with injectables and vaccines. The quality control of ‘biologics’ requires special techniques. This is how the low-income countries get in trouble, by going for the least expensive suppliers of drugs.

Even under the best of conditions, things can go wrong, and subpar drugs can enter the system unintentionally. The objective of quality control, the second measure, is to assure that the manufactured product meets all the specifications throughout its life. Therefore, incorporation of a full-fledged quality control function to the system is necessary for ensuring the safety and efficacy of the drugs provided to the patient, not just when it leaves the manufacturing facility. Testing drug samples during the supplier selection process is a necessary step. However, an often-overlooked aspect of this practice is that the samples provided by non-certified manufacturers may not represent the bulk product supplied to the end users. Therefore, periodic testing of drugs circulating through the system is necessary to assure their quality.

Quality control involves performing a set of tests according to the specification set forth by the drug manufacturer in agreement with the approving regulatory agency of the region or country. These tests are various spectroscopic methods to test drug purity, potency, identity, and other critical characteristics. Once the drug is released by the manufacturer, the quality control function goes to the pharmacist, not the doctor nor the pharmaceutics scientist.

The quality control activity must be conducted in accordance with the current Good Manufacturing Practices (cGMP) as described by international agencies like the ICH. An important feature of cGMP is that when implemented properly, it ensures data integrity, traceability, verifiability, and accountability. Almost all the test methods prescribed in specifications are now instrument based. There are hardly any wet chemistries involved as used in pharmacy practice at the turn of the century. As a result, the entire process can be digitalised. That is the system change we need to eliminate corruption. That is the way to bring in desperately needed transparency and accountability.

If the reader gets the impression that what was discussed above are new concepts to the Sri Lankan scene, they are mistaken. Hundreds, if not thousands, of laboratories in many countries are performing these tasks routinely safeguarding their drug supply. They manage to catch inadvertent manufacturing errors and prevent costly and damaging outcomes in a timely fashion. What went wrong in our country?

Bibile and Kottegoda

We have had concerned and forward-looking people like Professors Bibile and Kottegoda and many others who foresaw what was to come. It may come as a surprise, but all the laws and regulations that are necessary to assure the safety and efficacy of drugs exist in the books – the country’s rules and regulations. The facilities, people, and procedures are in place. However, things didn’t go as they expected. According to news reports, there is a shortage of pharmacists in the country. The agency’s labs are not only poorly equipped, but the existing equipment is inadequate and outdated. The agency has become a non-entity; if the fake immunoglobulin samples were tested for identity at a minimum, for example, the debacle that ensued could have been averted.

We must hold all three branches of the government responsible for the erosion of this institution; they have not done their job. They are expected to be independent bodies providing checks and balances. Somewhere along the way, they all got together and colluded to hoodwink us, the people. The situation we are in is no accident: besides the rampant corruption, Sri Lanka did not have a formal academic programme to train pharmacists until recently. Initial efforts to start pharmacy programmes were opposed by the medical profession. Why? Because they viewed it as a threat to their hierarchy in the system. The agency’s laboratories were not maintained at adequate levels because the politicians saw it as an impediment to their nefarious activities. Let us have no illusions that our government, all three branches, were responsible for creating the national ecosystem that made cGMP in state-owned organisations a complete mockery. We the people are responsible as well; after elections, we pay no attention to governance till the next election. If they throw some bones at us, we let them do what they wish. Ignorance reigns throughout.

Fortunately, things have changed favourably. The judiciary liberated itself from the political grip, people cleaned up the rotten politics as best they could. The new President has sent a stern signal that things will be different. He did not send his beloved mother to Singapore for treatment at taxpayer’s expense as previous rulers did. What else is missing? The role of one and a half million civil servants of the country. They have an enormous responsibility at this critical juncture not to let the word bureaucracy become another dirty word like the elite. They are the men and women, our relatives, friends, and colleagues who carry out the day-to-day business of the government. They are expected to be experts in their respective fields and perform their duties according to standard operating procedures without any political bias. The president or the 225 members of the parliament alone cannot run the country no matter how well-meaning their intentions are.

Power of people to make change

We the people have the power to replace the president and the members of the parliament, but we cannot hire or fire bureaucrats. Our system is such that they enjoy lifelong employment regardless of their performance. They get promoted and their pay increases automatically irrespective of their performance. This lack of responsibility is not sustainable. In addition, we must recognize the fact that due to our entrenched practice of political favoritism, some positions were filled with people who are not qualified to carry out their duties. That is not acceptable in any place, but in the drug safety business, which is a recipe for disaster. Therefore, we must recognize the administration’s right to retrain or replace those who do not meet their job descriptions, irrespective of their political affiliations, for the good of the country. That may be unpleasant, but that is the reality.

We must plan for building this expertise in the country. Pharmacy education in our universities must be expanded to include the pharmaceutics functions, especially the analytical aspects. The opportunity exists for the local manufacture of most widely used drugs. That will need expertise on many subjects at various levels. We must develop a culture that encourages innovation; there are many unmet needs as well as opportunities in this field. For example, there is the opportunity to bring Ayurvedic practices to the twenty-first century and add value. Health care is one of the largest industries consuming about 10% of the GDP of most developed countries.

There is no argument that we must procure our drugs from the most affordable sources. However, it must be kept in mind that they are less expensive due to cost-cutting measures taken by the manufacturers, and that could have implications for quality. Therefore, it is paramount that we maintain the integrity of the quality control functions at our end to assure the safety and efficacy of the drugs made available to the patients. This is especially important with the intravenous drugs as there is no room for error; once the drug is injected, there is no way to take it back. Investing in qualified personnel, training, and upgrading the agency’s testing capabilities could be negligible compared to the waste of funds spent on subpar drugs and the suffering they cause.

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.