What is the impact of the counterfeit drug industry in South East Asia? What is being done to address the dangers of drug counterfeiting? The prevalence of counterfeit drugs is severely affecting the health of the world. People depend on medicines to help them with their ailments and to save lives. Fake medicines not only endanger individuals, but also the pharmaceutical industry as a whole. Fake medicines can create a bad image for a legitimate company. Counterfeit medicines damage company profits and branding. Both the governments of the world and the pharmaceutical sector must work together to eradicate this menace.
In Southeast Asia, fake medicines are prolific, especially where access to real medicine is challenging. Low-income people and poor health centers have to find affordable medicines. Most often, when they do find cheap medicines, they are substandard or fake. It not only prolongs patients’ immediate suffering, but could also lead to long term microbiological resistance, thus making the problem more difficult to eradicate.
Pfizer has recently discovered that their successful drug Viagra is being copied by counterfeiters. In Hong Kong, approximately 40 percent of Viagra tablets sold are fakes. This seriously cuts into their sales and puts patients at risk. To counter this, Pfizer has adapted serialization technologies, enabling their products to be tracked. This is one way of combating counterfeit drugs.
What are fake medicines?
While there is no single agreement as to what constitutes fake medicines, the World Health Organization (WHO) uses the definition of fake medicine as “drugs that are deliberately and fraudulently mislabeled with respect to identity and/or source.”
In 2017, WHO did an analysis of the drugs purchased and found that 10.5 percent of the drugs in low and middle-income countries are sub-standard. Not surprisingly, south and east Asian countries such as China and India are some of the countries notorious for counterfeit drugs.
According to the Pharmaceutical Security Institute, Asia has the world’s largest share of counterfeit drugs. China and India are two of the largest counterfeit drug manufacturers, so the manufacture and distribution of counterfeit drugs remains unhampered in these populous regions.
The extent of the problem
It is not just Asia where counterfeit drugs are found. They appear all over the whole world. Once a medical product is unavailable, or too expensive in a particular region, fake medicines fill in that demand.
India and China are considered the major sources of these counterfeit drugs. They produce the majority of the world’s medicines. This means that the probability of fake medicines being produced there are also high. For example, half of the deaths from the opioid problem in the US resulted from synthetic heroin called fentanyl, which was manufactured in China. The drug contained counterfeit medications.
The internet has facilitated the sale of both legitimate and counterfeit drugs. The proliferation of online selling has permitted the relative anonymity of the seller, while also allowing users to self-diagnose what’s ailing them. Online users would rather self-diagnose than visit a legitimate doctor. This contributed to the boom in fake drugs.
Not only China and India have a counterfeit drug problem. Included also are Myanmar, Vietnam, and Thailand, which are major transit points for drug trafficking. The World Customs Organization (WCO) said in a report that 50-60% of illicit traffic is shipped via Southeast Asian (SEA) seaports. This makes SEA an ideal place to transport fake medicines in the region and on a global scale.
Fake medicines cover all types of medications. They can be facial care, antibiotics, or even vaccines. Right now, around 10% of the medicines available in the Asian market are fakes. Sometimes, they can be mistaken for generic drugs, which are legitimate copies of branded medical products. These are produced after patent protection has lapsed, or under certain exceptions provided by Intellectual Property laws. In turn, Good Manufacturing Practices (GMP) and quality standards apply to generics just as they do to the branded medicines.
• A procedure was introduced so that countries can submit samples for testing through the INTERPOL Liaison Office in Bangkok (LOBANG).
• The Health Science Authority (HSA) Criminalistics Laboratory in Singapore offered its forensics analysis services (including forensic botany) to participating countries.
Minute quantities of unknown substance matter can be found in the packaging as well as within the product itself. Forensic testing can identify the probable location of the illegal factories by testing pollen grains and plant materials found in the confiscated products, leading to their subsequent seizure and arrest of the owners.
One preventive measure is the Falsified Medicines Directive in Europe which requires manufacturers to install safety features on all medicines. They must also contribute funds to a verification system to ensure the genuineness of pharmaceutical products. The Directive makes it compulsory for the pharma companies to place on packaging unique identifiers such as barcodes and anti-tamper devices. These requirements can be used for similar measures in Asia.
The WHO introduced the Global Surveillance and Monitoring System for countries to report any acts of substandard and falsified medical products in a structured format. Member countries will relay the information about substandard and falsified drugs to WHO, which will input it to a database.
Another use of the system is to identify the extent to which the counterfeit drugs proliferate in a particular area. This method of recording can track the movement and patterns of the fake drugs and warn the public of the presence of these drugs
Countering falsified drugs is through legislation. Governments can pass laws to penalize the manufacturers of fake medicines and seize their equipment.
For example, India has recently passed legislation on mandatory barcoding of all pharmaceutical products. Once the drugs are scanned, they are identified immediately. This improves the traceability of medicines, allowing fakes to be easily identifiable.
Blockchain-based systems can also be used to combat counterfeit drugs. The systems are based on peer-to-peer (P2P) topology, it is a distributed ledger technology (DLT) that can store data globally on thousands of servers – while allowing anyone on the network to see everyone else’s entries in near real-time. In this way, the pharma industry and governments can consolidate their data on the activities and movement of fake drugs.
Case in point, in 2018, the National Institution for Transforming India (NITI) reported that they were partnering with US-based computer technology company Oracle13 to deploy blockchain technology to track the movement of pharmaceutical products. Having an extensive database for products enables countries to keep track of pharmaceutical products, preventing entry of counterfeits while in transit or during inventory listing.
Alerting the authorities through the Rapid Alert System for Combating Counterfeit Medicines. Introduced by Prof. Mohamed Ibrahim Izham in 2005, it is a rapid alert mechanism for WHO member countries, and partner organizations. When counterfeit medicines are present in a covered region, authorities are alerted immediately and rapid response actions are taken.
This system relays reports of cases of counterfeit medicines and shares information on cases of counterfeit medicine. All cases are sent to the Public Health Unit for confirmation with the involved country; alerts are sent to all participants in the communication network. This initiative upgraded surveillance from a passive to an active system. It can detect cases of counterfeit drugs and reveal the magnitude and nature of the problem.
With the cooperation of the countries’ Health Ministries, Customs, Drug Regulatory authorities, and the Police force in the participating country, the WHO is working with Interpol and the world customs organization to thwart attempts for any fake medicines to enter the delivery system.
The problem of this system that it is difficult to implement because of the slow reactions of the member countries to relay the alerts. Once the fake drugs are identified, they often disappear from the market prior to seizure.
What will be done in the future to eradicate fake or substandard medicines?
Substandard medicines are a major problem in India. The Drug Controller General of India reiterated that, as the quality regulator, they were developing proper mechanisms to stop the manufacture and sale of counterfeit drugs to prevent them from reaching the patients, by improving the quality of the country’s medicines.
In October 2018, China’s Drug Administration Law underwent revision to make harsher penalties for counterfeit drug makers and to improve the mandates of the industry. The revision will include a “full traceability” and a drug recall system. The prevalence of substandard products meant that the government was forced to take action as a preventative measure.
WHO and government countermeasures against counterfeiters
Operation Jupiter –South America
Operation Jupiter was launched in cooperation with Interpol in South America between November 2004 and April 2005. The operation led to the arrests of thousands; and seizures of millions of counterfeit goods, including cigarettes, CDs, computers, electrical components and thousands of fake pharmaceutical products.
Operation Storm in Southeast Asia
Operation Storm was formed to build on the intelligence result’ that came from Operation Jupiter to investigate concerns in counterfeit pharmaceuticals in Southeast Asia.
Counterfeit medicines are a much more serious threat than fake CDs or T-Shirts. In the operation, inter-country and country level trainings were taken part in GMP, quality assurance, and surveillance techniques. Officials from Customs, Drug Regulatory Agencies, and the Police, who did not have basic experience in identifying counterfeit pharmaceuticals, were trained, and key people from the transit points were trained to take samples for testing the drugs.
The conference was held to plan and obtain cooperation from the necessary government players and the private sector. Officials from national agencies, together with the Operation Storm Coordination Team, established lines of communication. There was also an agreement that countries should begin identifying medium-level targets, since these were realistic and could be implemented within the first year of implementation.
The overt phase of Operation Storm lasted for six months, beginning on 15 April and finishing on 15 September 2008.
Priority focus drugs
•Antibiotics, specifically those for pneumonia and child-related illnesses
As a result of Operation Storm, more than 100 pharmacies and illicit drug outlets shut down and 33 suspects were arrested.
Successful raids on legal and illegal markets show improved results in terms of seizures, arrests, convictions, and the shutdown of illegal websites.
• Network for regulators & law enforcement agencies
• Technical support for medicines registration China, Cambodia, Mongolia etc.
• Pharmacovigilance center were established in Cambodia and Viet Nam
Customs authorities are now trained and equipped with rapid detection devices. Customs operations are essential and need to be a component of multiagency teams handling the counterfeit medicine trade. Customs agents must know how to distinguish between generic and counterfeit drugs.
Regional transit points have been improved with mobile laboratory units for the identification of counterfeit drugs. They are also supplied to train and support health workers. Questionable samples are sent for forensic testing.
A total of 270 laboratory units for protection from counterfeit drugs are now in operation in 65 countries worldwide, mostly in Africa and Southeast Asia.
The proliferation of counterfeit drugs in south-east Asia will continue to cause issues for patients and the pharmaceutical industry. Steps are now taken to mitigate the problem, including marking the medicines with serial numbers and improving the traceability of drugs.
Concerned government agencies, working together with Interpol, can also help to combat the situation. These measures will further reduce counterfeit trafficking, improving human health, and bringing back the brand image of the pharmaceutical companies.
Several countries are undertaking legislation to curb counterfeits, but have discovered that the laws have also impaired the import of legitimate generic medicines. Customs confusion has led to halting the transit of good generics.
Intelligence from Operation Storm has confirmed the data gained from previous operations. That data can be used to convince countries in the Greater Mekong region of the significance of cooperation to control the proliferation of counterfeit pharmaceuticals that pose a danger to public health and safety.
In countries that have no medicine registration system, quality assurance measures must be embedded in the procurement process to ensure the safety, efficacy, and quality of pharmaceutical products.
Additionally, a system for monitoring and maintaining product quality throughout the product’s storage life must be in place. If these are followed, counterfeit products can be eliminated.