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.