People trust the pharmaceutical companies not just with their money, but their lives. In the case of counterfeit medicines, the stakes are high. Once cheated, in extreme cases, there may be no further recourse for the consumer. Hence the onus is on the pharmaceutical companies to protect their customers and their brand reputation. With emerging technology, we are a step closer to tackling the menace of counterfeit drugs. Yet, we have a long way to go before these practices percolate across all pharmaceuticals worldwide.
The year 1982 saw a shocking incident of tampering with Johnson and Johnson’s Tylenol pills. They were laced with potassium cyanide, resulting in the mass poisoning of people across the United States, leading to what would later be known as the Chicago Tylenol murders. Johnson and Johnson, contrary to expectations, received a pat on the back for their crisis management. The company actively issued public warnings about the incident and immediately recalled 31 million bottles of Tylenol. Following the incident, the company took it upon themselves to make the packaging of their medicines tamper-proof. Also, the incident acted as a catalyst for federal anti-tampering laws.
Through preliminary observations, the authorities hypothesized that someone took out the pill bottles from the local groceries, laced them with a lethal dose of cyanide, and put them back. It is not hard to imagine this happening in the 80s. The packaging back then was not adequately tamper-proof. Inefficient security features in stores perhaps emboldened the criminal(s) involved. However, we live in a society very different from the 80s.
Along with stringent regulations, we now have highly efficient anti-counterfeiting technology.
While stringent laws and regulations may act as a deterrent, we can make it next to impossible for the counterfeit drug market to survive with new-age technologies. Let’s explore a few forms of emerging technology that can identify, rectify, and prevent counterfeit drugs from entering the market.
The Pharmaceutical Market in India
India is a ripe market for global pharmaceuticals, given the country’s population, growing middle class, stable economy, and substantial improvement in the health care sector. Due to inexpensive manufacturing costs and high demand, India is a global leader in the production of low-cost generic medicines. In terms of volume of production, India’s pharmaceutical market is the third-largest in the world. In terms of value, India stands as the 13th largest globally. These numbers are reassuring for a developing country; however, here are some alarming facts that need our attention.
- The Special 301, 2019 report by the Office of the United States Trade Representative (USTR) stated that up to 20 percent of drugs sold in the Indian market are counterfeit. Drugs like these present a serious threat to patient health and safety.
- The Indian government officials have refuted the claims of USTR. According to the estimates of India’s own Union Health ministry, about 3% of the drugs in the Indian market fall under the ‘falsified or sub substandard’ category. Of this, 0.02 % could be ‘spurious or harmful.’
- The market for active ingredients used in medicines is volatile. The growing environmental regulations add to the already soaring cost of raw materials. The time gap between the placing of the order for an active ingredient and the selling of the finished product is substantial. These external factors make substituting a few active ingredients with substandard raw materials a profitable business proposition.
- The inadequate infrastructure in terms of the quality of roads in developing countries complicates distribution. It leaves the products open to theft and enables counterfeit products to enter the market.
Now that we have explored some common issues plaguing the pharmaceutical companies in developing countries like India, let us shift our focus to potential solutions.
Emerging Technology and Standard Techniques for Arresting the Counterfeit Menace in the Pharma Sector
The Tylenol tragedy was completely avoidable. All that was needed was technology to detect evidence of tampering. Medicines, in contrast to most products, need the utmost care in terms of packaging. Inadequate care in packaging can lead to not just counterfeits and duplicates, but the reduction in the potency of the drug as well. Tamper-evident technology, as the name suggests, makes any attempt at tampering evident to the consumer or other stakeholders.
It provides a visual indication of a breach. The US Food and Drug Administration guidelines clearly state that tamper evidence must be something that a consumer can identify. Tamper-proof and tamper-evident packaging is for the benefit of the less knowledgeable consumers. What may be evident to experts may be misinterpreted or over-read by a consumer. Hence a tamper-evident packaging comes with warning statements like ‘do not use if seal is damaged or broken.’
❖ It should be impossible to reach the container without visibly breaching the tamper-evident barrier
❖ The tamper-evident barrier must be hard to replicate
❖ The packaging must have instructions or warnings that help customers detect tampering.
Some standard tamper-evident techniques include:
❖ Film wrappers with distinctive design wrapped around the entire container. These must be preferably transparent.
❖ Blister or strip foils wherein the plastic or the cover needs to be wholly torn to take out the capsules/tablets
❖ Heat shrink bands which are wrappers with distinct designs applied and sealed on the entire product using heat. One cannot easily replace these without apparent damage to the seal.
❖ Manufacturers use tamper-proof holographic labels in addition to breakable caps. When stuck on the product, one cannot open the package without breaking the seal. These are high on adhesion and challenging to replicate
In addition to these, manufacturers commonly use arsenal containers, breakable caps, sealed tubes, as tamper-evident techniques. Also, some products have in-built tamper-evident controls. Most In Vitro Diagnostics (IVDs) have guidelines on test- method failures. These indicate if the product is damaged and helps reduce false positives or false negatives.
Along with these techniques, companies can use an automatic labeling system and ink coding while packaging. The technique protects the product throughout its journey.
Blockchain Technology in Supply Chain
In the year 2012, a fake drug Avastin made a twisted entry to the market. The original drug, Avastin, is the product of Roche AG Holding, Switzerland. The drug is used to supplement chemotherapy. Commonly used by patients undergoing treatment for certain types of lung, colon, and kidney cancers, the fake batch had no active ingredients.
Instead, it contained salt, starch, and some unrelated chemicals. What is alarming is the innocuous and almost clandestine entry of this product into the mainstream market. The authorities faced a challenge in tracing the origins of the fake drug since the Turkish company listed on the papers was a sham company. There was no pharmaceutical plant on the registered address. All the authorities found was a textile mill.
A drug distributor in Switzerland, unaware of the problem with that batch, bought Avastin from a middleman in Egypt. The batch then made its way to Danish and UK distributors. Distributors from the USA bought the fake Avastin from UK distributors and started selling it directly to the physicians. Avastin traveled through multiple overseas suppliers, and the counterfeit cancer drug was finally marketed through doctors, thereby creating one more weak link for counterfeit medicines.
The above example highlights, among others, the complex global supply chain issues in the pharmaceutical sector. In its book ‘Countering the Problem of Falsified and Substandard Drugs’, the National Academies Press highlights some critical areas in this regard:
- A ready to be sold drug package changes many hands. The supply chain is difficult to trace. Multiple points of entry and multiple trading companies that handle the product, do not get into quality checks and controls each time. From manufacturing, packaging, distributing to selling, spurious drugs have multiple points of entry.
- Manufacturers may not know the source of the ingredients used in the drug
- Inadequate and poor storage management, with little monitoring
- Manufacturers, globally, do not follow a uniform supply chain system. The difference in rules, regulations, and practices across manufacturers and countries complicates the tracking systems of the pharmacies. We thus have an array of fragmented data.
- Thefts and diversions, i.e., pilfering, can occur at any point in the supply chain. Without being able to document every move of the product, it is difficult to identify the point at which fake products enter the supply chain.
India’s Niti Aayog rightly believes that blockchain technology can fix the complex global supply chain issues of medicine. In the inaugural session of the International Blockchain Congress, Chief Executive Officer of NITI Aayog Amitabh Kant addressed said per Economic Times that “There is a need to use blockchain to track and trace medicines and spurious drugs. Therefore, Niti Aayog, in collaboration with Apollo Hospitals and Oracle, is putting the pharmaceutical supply chain in blockchain for complete traceability of drugs from manufacturer to consumer to protect our citizens from the menace of spurious medicines.”
Blockchain technology has all the entities of the drug supply chain like manufacturers, logistic experts, distributors, traders, pharmacies, and more on a trusted network powered by the blockchain. As the product makes its journey from manufacturing to sales, the technology captures every transaction or change of hands. There is a permanent record of the history of the product. Along with reducing human errors, cost, and time, it can help in plugging in the points that allow for counterfeiting.
Blockchain Extended to the End-User
Initially, the supply chain for medicines ended with it reaching the pharmacies. However, companies are now experimenting with extending the blockchain technology to the consumption stage. They are working on linking the digital identities of the patients with dispensers. These can then be used to report the consumption pattern to the prescribers or insurance companies. With this, it is possible to record and prevent over-consumption.
Serialization for Tracking and Tracing:
According to a recent proposal by the Drug Technology Advisory Board of India 14-digit unique identity number is to be printed on each strip and bottle of some 300 pharmaceutical brands. The products are also to contain a mobile number of the company marketing the brand. The proposal is voluntary as of now. However, pharmaceutical companies are already bracing themselves for this change.
The distinguishing nature of this proposal is that it empowers consumers to be active participants in tackling the menace of counterfeit products. One SMS or WhatsApp message to the printed mobile number can help the consumer know about the authenticity of the product. The stakeholders are still discussing the exact mechanisms of the portal. However, serialization for tracking and tracing medicines has been in use for some time. With serialization moving from sequential to random, it is proving to be quite useful in detecting fake medicines.
Radio Frequency Identification (RFID) can be used to automatically track the tags on the products. These tags contain electronically stored information on the product. However, RFIDs can, at times, become expensive and impractical.
Artificial Intelligence (AI) combined with tracing and tracking technology is another option.
For pharmaceutical companies, more important than ‘what is’ in the supply chain, is ‘what could be’. While blockchain, IoT, tracking and tracing technologies can provide a bulk of data, AI-powered analytics can offer additional capabilities that are beyond brand building and protection. It can use the track and trace data to make real-time supply decisions by analyzing the disease patterns, prevailing ecosystems, and more. It can improve contingency planning, inventory management, procurement planning, and optimization of production while making the supply chain more transparent. It can perhaps also understand the patterns of entry points for counterfeit products.
Drug manufacturers are now increasingly realizing that they need to take the onus of the complex issue of counterfeit medicines. Take the Tylenol murders lightly at your own peril. With increased public awareness and government scrutiny, using the best technology available for fighting counterfeit drugs has multiple benefits. It not just protects the customers but also safeguards the pharmaceuticals from possible prosecution and Insurance claims.
At Acviss, we believe in empowering consumers and enabling a business to protect themselves from the counterfeit market. We understand the business and social cost of counterfeits. Acviss has serviced more than seventy customers in the last two years, of which nine have been from the pharma sector. The number shows the high magnitude of the problem of counterfeiting in pharmaceuticals.
Ranging from offering solutions with blockchain, authenticity verification, track and trace, tamper-evident packaging, we are growing stronger by the day. We keep track of the government regulations and the global trends to offer cost-effective and efficient solutions to our clients. We are doing our bit to make this world a safer place. What about you?