Counterfeit Drugs in the Market: What you Should Know

Medication is used by people around the world to treat life-threatening illnesses, prevent pregnancy, and manage chronic diseases. Unknowingly, however, individuals use counterfeit medications daily—even in industrialised nations with well-functioning healthcare systems. They risk their life for something they ought to be able to rely on.

The pharmaceutical business and international drug authorities are always trying to remove counterfeit and subpar medications from the market. Still unanswered is the following: What precisely are fake medications? How serious is the issue of counterfeit drugs? And who is in danger?

What are Fake Drugs?

Fake drugs are produced and packaged to resemble genuine brand-name prescriptions, but they sometimes include very little or none of the pharmaceutical ingredients stated on the label. Gullible patients might be seriously in danger from fake medications that are part of the illegal supply chain. Sometimes the active elements in these phoney medications are missing, so they just don’t offer the necessary therapeutic value.

In the worst situation, some may include hazardous materials. Interpol reports that it has been discovered that several counterfeit medications include cement, rat poison, arsenic, or mercury.

The use of fake medications can have detrimental effects on people’s health on a worldwide scale as well as on communities and individuals.

In low- and middle-income nations, one out of every ten medications fail due to inferior or fraudulent ingredients, according to the World Health Organisation (WHO). This not only results in avoidable fatalities but also erodes public confidence in healthcare. For instance, every year, between 72,430 to 169,271 youngsters pass away from pneumonia as a result of ingesting fake medications.

More about Counterfeit Drugs

Certain counterfeit drugs contain real antibiotics and antivirals, but generally in much lesser quantities than what is indicated on the label. It is insufficient to completely cure the illness, and it may allow germs to evolve and proliferate, so exacerbating the rising threat of antibiotic-resistant illnesses to public health.

Additionally, medications that appear wherever they shouldn’t be in fake pills may contain them, which increases the risk of overdose and death. The U.S. Drug Enforcement Administration (DEA) issued a safety advisory in September 2021 about the rising usage of the powerful synthetic opioid fentanyl in counterfeit medications.

The amount of dosages comprising at least 2 milligrams of fentanyl, what is regarded as a deadly dose, has increased “dramatically,” according to their findings. They also mentioned that to put things in perspective, a lethal dosage of fentanyl may fit on the end of a pencil.

More counterfeit prescription opioids were recovered by the DEA along with additional law enforcement agencies in the first nine months of 2021—9.5 million—than in the combined two years prior. The quantity of fentanyl-containing tablets that the DEA confiscated increased by 430% between 2019 and 2021. The CDC reports that from May 2020 to April 2021, 2020, there were over 100,000 drug overdose deaths in the United States, a record high for a single year. Sixty-four per cent of these deaths included synthetic opioids.

Generic Medication vs. Counterfeit Medication

It’s critical to prove that generic drugs are not phoney or counterfeit when they provide the same benefits as name-brand drugs but at a cheaper price. Generic pharmaceuticals, however, could occasionally be a part of enforcement actions meant to decrease drug counterfeiting.

Generic drugs are put through extensive testing to make sure their quality is almost identical to that of the drug’s original composition and that they affect patients in the same way. Like new pharmaceuticals on the market, these medications must pass quality control testing and have appropriate labelling before they can be prescribed for general use.

Since they might not have undergone sufficient testing for efficacy and safety and can potentially damage patients, counterfeit drugs pose a serious risk to public health and safety. Another possible risk to patients is mislabelling, which can lead to mistakes or misunderstandings.

Substandard, Falsified, and Unregistered Drugs

Illegal drugs fall into several categories. The WHO replaced the word “counterfeit drugs” with the phrases “substandard” as well as “falsified medical products” in 2017, broadening the scope of international efforts to stop these counterfeit goods from reaching users.

Authorised medical items that do not fulfil the manufacturer’s quality criteria or specifications are considered substandard pharmaceuticals. This category includes medications that have expired or were improperly maintained.

Contrarily, falsified drugs are pharmaceuticals that purposefully or dishonestly erroneously have their legitimacy, structure, or source. Examples of this include legitimate medications that have been taken and resold, illicit medications that have been reconfigured to resemble name-brand items, or counterfeit medications that omit the active ingredient specified on the label. Drug manufacturers in India need to acquire manufacturing drug license to streamline the operations of their medical business.

Unlicensed and unregistered medications make up a third category. These are pharmaceuticals sold in marketplaces without the approval or evaluation of the local health authorities. While some of these subpar, fake, or unregistered medications may be useful in treating illnesses, their unregulated status renders them dangerous, unpredictable, and a significant issue that has to be closely monitored.

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Who’s Affected by Drug Counterfeiting?

Anything profitable is going to be faked. Both generic and proprietary drugs are impacted by this. Costly prescription medications, such as those used in cancer or AIDS treatment, can be quite profitable for questionable companies. The most often counterfeited medications are antibiotics, especially in low-income countries where many individuals cannot afford the exorbitant cost of medications.

Fake “lifestyle” drugs are becoming more and more popular in high-income nations to cure erectile dysfunction. In theory, all patients are vulnerable, notwithstanding potential variations at the national level. When acquiring pharmaceuticals overseas or on the internet, patients should exercise caution.

What Are the Health Risks?

Drugs are used to both prevent and cure illness. To counterfeiters, that is of little consequence. Giving patients a medication that is identical to the original medicine is not something they are interested in doing. These medications have a reduced quality or amount of the component, even if a phoney medication has some active elements.

For example, this may result in an ineffective vaccine or test outcome, or it may even induce microorganisms to develop resistance to the initial active ingredient. There’s a reason why lawmakers devised a complex process for clinically evaluating, approving, and monitoring medications.

In the most severe situations, counterfeiters add hazardous or harmful ingredients to their goods in an attempt to mimic the genuine article’s “effect”—more accurately, a side effect rather than a genuine medical quality.

In the end, patients want trustworthy, clear information on the purpose, use, and dose of their medications. Prescriptions are necessary for this reason: to shield patients from the serious risks and possible harm that come with using a medication. The patient is informed about the medication’s administration, proper dose, and any adverse effects by the prescribing doctor or chemist. Bypassing this safe consultation for the patient, anyone who gives prescription medicine without a prescription does so.

Only pharmacies may sell some medicinal supplies. Even though they are not prescription drugs, only employees with training in pharmacy may provide them to patients. Patients shouldn’t take such product offerings on the internet at face value.

Counterfeit Drugs: The Problem on a Global Scale

For many years, the majority of the world’s population lacked access to prescription medications, immunisations, and medical equipment that are widely available in wealthy nations, making fake pharmaceuticals and their side effects a major issue in low-income and developing countries. The absence of rules in some areas combined with this void has given rise to markets for counterfeiters.

Today, nations all over the world are battling phoney medications and their side effects because of the rise of internet pharmacies. For instance, counterfeit medications can occasionally find their way into genuine supply chains in the United States, where it’s believed that 1% of prescriptions filled at typical pharmacies may be false. However, the majority of counterfeit and subpar medications in the United States and other industrialised nations are bought online.

Too many people think that only low- and middle-income nations are at risk from these harmful fakes, but Kubiak argues that is just untrue. In affluent nations, counterfeit medications have long existed and are now significantly more accessible due to a rise in internet sales brought on by the COVID-19 epidemic.

2011 Poll by the Global Alliance for Safe Online Pharmacies

According to a 2021 poll conducted by the Global Alliance for Safe Online Pharmacies, more than half of adult Americans have bought medications online for conditions ranging from diabetes and asthma to treatments for cancer and replacement therapy for hormones. Furthermore, almost half of them erroneously think that all online pharmacies that provide goods for sale in the United States have FDA approval and adhere to safety standards. However, the same analysis also indicates that almost 95% of internet pharmacies globally are operating illegally.

Additionally, fake medicine producers now have access to customers in Western Europe, Canada, and other wealthy countries with less closely regulated healthcare systems thanks to online pharmacies. Thousands of internet pharmacies providing illegal or counterfeit pharmaceuticals were shut down in May 2021 as a result of an INTERPOL operation combining law enforcement as well as medical officials from 92 countries.

More than 9 million illegal pharmaceuticals and medical equipment were also found, including 500,000 unauthorised surgical masks in Italy and 3 million counterfeit pills in the United Kingdom. The fake medications included everything from painkillers and sleeping drugs to antibiotics, antimalarials, and even cancer therapies.

Risks of Counterfeit Drugs in Online Pharmacies

With the emergence and expansion of Internet pharmacies, the issue of fake pharmaceuticals is becoming more and more prevalent. Compared to prescription drugs purchased at a real pharmacy, online pharmacy purchases are more likely to be fake, especially if the online pharmacy is located outside of established or Western countries.

Because of this, regulations governing internet pharmacies have been established in nations like the US and the UK, requiring that the online pharmacy’s actual location be located in the same nation. Though there is still more work to be done, this is contributing to a decrease in the prevalence of fake pharmaceuticals.

Patients in remote places can more easily use online pharmacies, which provide a helpful service of providing prescriptions to consumers at a reduced cost. Before making an online purchase, patients should make sure the pharmacy is legitimately registered and authorised to offer drugs.

Pharma Industry’s Reaction to Counterfeit Drug Threats

For the pharmaceutical industry, which makes money from the sale of real pharmaceuticals, counterfeit drugs pose a serious threat. Reducing the prevalence of fake drugs and ensuring that the general population gets access to those that have undergone safety and effectiveness testing are in their best interests as well as the interests of public health.

Pharmaceutical producers and distributors have thus begun making investments in specific initiatives to lessen the effects of fake drugs. Developing technology for medicine tracing and authentication is one strategy to lessen the influence and viability of fake pharmaceuticals.

Strategies for Reducing Counterfeit Drug Incidence

Let’s take a look at the strategies that can help to reduce Counterfeit Drug Incidence:

• Package: To increase the difficulty of counterfeiting, incorporate certain design aspects into your package.

In addition to becoming mandated by the FDA, serialisation on packaging keeps counterfeit medications out of the supply chain. For instance, a product’s packaging may be uniquely identifiable throughout the production and distribution processes thanks to the GS1 Data Matrix.

 To confirm that the goods and packaging are distinct, there are additional features like barcodes and RFID tags. Because of these distinctive product identifiers, counterfeiters find it more difficult to imitate the goods, and a well-designed traceability system can follow it along the supply chain to stop theft. Additional detection layers, such as holographs, can enhance a product’s security.

Consumer safety increases with the amount of information that can be transmitted and maintained via unique product IDs; in the hospital setting, GS1 DataMatrix can reduce hazardous drug use by up to 75% and prescription mistakes by 50%.

• Increase Knowledge and Collaborate with regulatory organisations.

Various regulatory agencies have put in place measures to prevent counterfeiting. To support preventive measures, pharmaceutical companies and participating countries are expected to collaborate, raise issues, and improve programs such as stricter policies for offenders to be enforced and the latest developments and guidelines that companies must follow from organisations like the Food and Drug Administration (FDA) in the US and the World Health Organisation (WHO).

The FDA has an alert network for counterfeit medications, which notifies members of any complaints about fake drugs that are received. This benefits local professionals and customers as well as the healthcare community by educating and enlightening them.

To assist pharmaceutical businesses in navigating the impending DSCSA regulations and maintaining the safety and security of their supply chains, regulatory bodies can also provide helpful information. One example of this is the FDA’s medical supply chain toolbox.

Additionally, the only pharmacies that sell authorised medications are those accredited by the National Association Boards of Pharmacy (NABP). The FDA and the NABP are partners in a compounding pharmacy’s exchange of information effort. Consequently, it is critical to engage in the system and collaborate with regulatory bodies to enhance its overall functionality and notify the global and national networks about high-risk counterfeit goods.

• Assign a specific person or team to keep an eye on supply chain security.

The importance of security cannot be overstated. If your regular staff lacks the necessary skills, it may be worthwhile to hire a specialised security agency. You may hire this out from outside, specialised businesses. Theft prevention needs to be a top priority in addition to supply chain security monitoring and enhancement.  To avoid counterfeiting, several areas of product safety require information exchange and communication among members of the organisation. This is because there are several methods to tamper with a product.

• Maintain supply chain integrity by placing verification points at various chain links.

A pharmaceutical medicine supply chain consists of several connections, thus it’s critical to have a clear and distinct product identification, purity, and quality as it moves through the chain. The point at which raw materials are received at a plant, processed (e.g., dosed into vials), packaged into cartons and pallets, and received at distribution centres are some of the critical links in the supply chain.

Particularly susceptible to forgery and manipulation are these connections. For this reason, it is essential to verify the unique product IDs through processes like customs inspections and physical copies of any supporting documents. Maintaining the chain’s integrity is crucial, and pharmaceutical companies should be aware of their supply source and engage in ongoing communication with supply chain experts—including quality control, if necessary—at every stage of the procedure. Improved medication and medicine control and safety will result from this.

Challenges Due to Counterfeit Drugs in India

Counterfeit drugs in India cause a significant number of challenges for the healthcare system. Given below are the key challenges for the healthcare system due to counterfeit drugs in India-

• It increases the economic burden on the healthcare infrastructure of the country.
• It can lead to a loss of business opportunities and market share.
• Corruption is prevalent in the healthcare system of the country.
• India’s drug regulatory system has inadequate testing facilities, weak infrastructure, and a lack of drug inspectors.

In order to overcome these challenges, businesses must develop a strong healthcare mechanism that must align with the healthcare goals of India. It’s essential for ventures to secure Drug License and manufacture drugs that don’t violate the guidelines of CDSCO.

Conclusion

Fighting fake medications is a serious public health issue that calls for coordinated actions by government agencies, the pharmaceutical sector, medical experts, and patients. Strengthening legislation, raising awareness, and using technology are some of the ways we may drastically lower the occurrence of fake drugs.

Customers need to be on the lookout, for making purchases from reliable vendors and understanding the dangers associated with using internet pharmacies. By working together, we can make the pharmaceutical industry safer and guarantee that patients get the high-quality drugs they require. To get expert assistance in securing a drug license and CDSCO registration, visit https://corpbiz.io/.

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