Can Technology Lead the Charge Against Counterfeit Medicines?

Did you hear about India's recent counterfeit medicine scandal? In August 2023, Sun Pharma uncovered fake drugs being sold from unauthorized vendors. The Indian government quickly seized counterfeit products worth Rs. 2 Crores. This incident sparked global concern over India’s pharmaceutical integrity.

However, there is promising news! Technologies like blockchain and AI are emerging as powerful tools to tackle these issues, potentially transforming the industry and restoring trust in India's pharmaceutical market.
 

How do counterfeit medicines appear, and where do they originate?
 

Counterfeit medicines are falsified drugs that closely resemble generic medicines, to the extent that even healthcare professionals struggle to distinguish them. They are manufactured by unlicensed groups other than the original manufacturers. This is a serious concern that should not be overlooked.
 

Research to identify counterfeits in India found that drugs coming directly from the manufacturer's facility are trustworthy. However, the risk of fake or spurious drugs arises when products are transferred between the various layers of the complex supply chain, like wholesalers, distributors, or sub-distributors. At each transfer point from the manufacturing factory to the patient, drugs can be stolen, adulterated, or replaced. The consequence of such malpractice leads to financial loss for drug makers and, more importantly, poses a significant risk to patient safety.
 

How serious are counterfeits?
 

Did you know that India is the leading source of counterfeit medicines? In recent years, India has become a key player in manufacturing brand-name prescription drugs and conducting clinical trials at a much lower cost than the US. While this showcases the growing capabilities of India's pharmaceutical industry, counterfeit medicines are also a significant challenge. It is estimated that India contributes to about 75% of all falsified medicines worldwide. 
 

These counterfeit drugs are widespread in sectors where there is potential for huge profits. In fact, three-quarters of counterfeit medicines globally originate from India, making it the number one source. This has resulted in thousands of deaths each year, either due to harmful ingredients in counterfeit drugs or because these fake medicines don't effectively treat patients.
 

Isn't it worse for people to die from counterfeit drugs rather than the diseases themselves? This issue certainly requires urgent attention in India.
 

What are anti-counterfeiting technologies used in the industry today?

WHO suggests the following:

• Overt technology
• Covert technology
• Forensic techniques
• Serialization/track and trace technologies
• Emerging technologies like Blockchain with AI/IoT

Let us decode them in detail one by one.

How can technologies help to fight counterfeit medicines?
 

Below mentioned are a few product identification technologies used to identify counterfeit medicines.
 

1. Labeling

The traditional approach to ensuring the integrity of medicinal products involves labeling with a batch number and expiry date. However, this labeling can be easily duplicated. To overcome this, several overt or covert technologies are used to eliminate counterfeits.
 

2. Overt technologies (visible features)

These features are visible and can be seen transparent in the product itself. A few examples include:

• Holograms.
• Optically Variable Devices (OVD).
• Color-shifting security inks and films.
• Security graphics.
• Sequential product numbering.
• On-product marking.

Let us examine one example, holograms, which are more commonly seen.
 

Holograms

This technology provides visual authentication that can be difficult to replicate for counterfeit medicines. Also, this technology is not easily automated; it requires an authenticated label or an accurate image for visual comparison. Unfortunately, there are instances of fake holograms which have been found in many spurious antimalarial drugs in India. 

3. Covert technologies (hidden markers) 

These require specific detection devices. Examples are invisible printing, embedded images, digital watermarks, hidden marks and printing, anti-scan design, laser coding, substrates, and odor.
 

4. Forensic techniques 

These involve specific markers such as chemical taggants, biological taggants, DNA taggants, isotope ratios, and micro-tagants. These forensic markers serve as identifiers that aid in detecting counterfeit pharmaceuticals. They cannot be seen without special equipment and are incorporated into the packaging of pharmaceutical products during manufacturing. Each batch of products possesses its unique set of markers, enabling verification of product authenticity by comparing the marker on the packaging with the corresponding entry in the manufacturer's database.

5. Serialization/track and trace technologies

Serialization involves assigning each unit of a product a unique code. This code helps track and confirm its authenticity as it moves through the supply chain. Examples of serialization include barcoding and RFID technologies.
 

i. Barcoding: The simplest and least expensive technology for tracking counterfeits in a supply chain. It is widely adopted in many pharmaceutical industries, not just limited to them. The retail sector of India has made barcoding a standard technology to track all inventory and sales. While this technology already exists and is used to identify batches or large quantities of products, it can and should be deployed at the pharmacy level. 

For instance, pharmacies could scan barcodes on medicine packs to check their authenticity and details like batch numbers and expiry dates. By linking these scans to e-prescription systems, they ensure every patient gets the correct medicine while automatically weeding out expired or counterfeit drugs. Adding a unique random number to each box could further prevent the distribution of fakes.
 

ii. Radiofrequency identification (RFID): This RFID tag uses a radio-frequency transponder chip, which is programmed with a permanent unique identification code and also programmed to contain the batch number and expiration date. This combination of a unique code and product information provides a high level of security against counterfeiting. 
 

It utilizes radio waves to identify and track products in real time. This technology can be overt or covert, i.e., either visible on the product itself or hidden in the packaging. Its advantage over traditional barcoding is its ability to detect several items simultaneously, unlike barcoding, where each tag must be visible and requires a separate device for reading. However, until this RFID technology matures and becomes more widespread across India, it will remain more expensive than traditional barcoding.
 

Emerging technologies to combat counterfeit medicines
 

While the technologies mentioned above offer some hope, eliminating counterfeits entirely is still challenging. Counterfeiters capitalize on information gaps and the need for more transparency in the supply chain. As a result, patients might unknowingly consume substandard or even dangerous products. To overcome this, one technology on the rise offers hope: blockchain.
 

Blockchain technology

Blockchain is a digital ledger that synchronizes records of even a single transaction and product information in a highly secure manner, spread throughout the entire supply chain. It works as a chain of interconnected nodes or blocks, where each block contains data linked to the previous one. This means the data is irreversible or unchangeable and forms a chronological record. 
 

Key features of blockchain:
 

1. Decentralization: Unlike traditional centralized servers, which are susceptible to breaches, blockchain works decentralized, where the data or records are distributed throughout the supply chain participants. This means any person from manufacturers, distributors, online pharmacies, and customers can check every transaction and product information, providing an advanced level of security against counterfeits.
 

2. Immutability: No single entity in the supply chain can manipulate the data on a blockchain. Each block contains a reference to the previous one, and altering it would require changing subsequent blocks of the network – something nearly impossible to achieve.
 

3. Transparency: Consumers of every medicinal product get access to the same information. All transactions are visible to everyone, making it easy to detect fraudulent activities.
 

4. Data security: Blockchain uses cryptographic techniques to secure data, enhancing protection against unauthorized access. This is crucial in the pharmaceutical industry to safeguard sensitive patient information and intellectual property.
 

5. Traceability: Due to the chronological and unalterable nature of blockchain records, it is possible to trace and alter a product's information throughout its process in the supply chain. In pharma, this means tracking the origin of raw materials, manufacturing processes, distribution, and even patient usage is hardly possible.
 

This transparency in the supply chain makes it far more challenging for counterfeiters to infiltrate the system, as each medicinal product is identified and verified throughout the supply chain. Hence, blockchain technology is a big boon in helping the accountability and trustworthiness of the entire pharmaceutical realm.
 

What is the current status of blockchain technology adoption in India?
 

The Indian government is showing great interest in blockchain technology and is planning strategies for using it in public services. In December 2021, they released the "National Strategy on Blockchain" to outline their plans. They want to use blockchain in areas like healthcare and other sectors. India is working on creating a national framework for it. 
 

The goal is to have Indian-made blockchain technology used worldwide by 2027, and they aim for it to work well with other technologies like IoT (Internet of Things), cloud, and AI (Artificial Intelligence).
 

As part of this plan, they have developed a Drug Authentication and Verification Application (DAVA) system to track medicines using barcodes. This will help ensure that drugs made in India are safe and can be tracked in real-time. The system will be rolled out in phases and eventually include all medicine manufacturers in India. 

While DAVA is a good start, unlike blockchain, it has limited features; however, it will be implemented soon. With blockchain, AI, and IoT, India can achieve even more in tracking medicines and ensuring their safety.

In addition to blockchain, the Indian government is revolutionizing elderly care through initiatives like the Ayushman Bharat Digital Mission and the launch of digital dispensaries, which are significantly improving healthcare accessibility for seniors, especially in rural areas.  
 

The Bottom Line

As the technologies mature and continuously adopt these authenticated technologies, we can assure authenticity in different aspects of the supply chain. These advanced technologies make product counterfeiting more difficult and expensive, ensuring safer medicines for everyone.