Fighting counterfeiting requires a long-term battle and we need to start somewhere

COVID-19 vaccines are here but there are reports about a surge in the cyber attacks in the pharma sector as well. How can a data breach become a critical, serious event?

Yes, there are concerns related to cybersecurity also. According to a report published in the Wall Street Journal, hackers from North Korea are trying to infiltrate companies in the US, the UK and South Korea working on COVID-19 treatments including the leading COVID-19 vaccine makers. Further, cybercriminals are creating fake websites related to COVID-19 to entice victims and dupe innocent consumers. Trend Micro reported that nearly one million spam messages are linked to COVID-19 since January 2020. There are incidents reported across the globe, criminals making fraud because of supply shortages. In one instance, German health authorities caught an elaborate international scam-paying million for masks that do not exist.

What measures need to be taken by pharma companies involved in developing COVID-19 vaccine to ensure product quality till it reaches the last mile? 

Brands should contemplate putting in place a comprehensive anti-counterfeiting system that starts with adopting physical authentication and traceability solutions to eradicate tampering chances and secure supply chain integrity. A contingency plan should also be drawn to alert customers, suppliers, authorities, and the public in the event falsified products are discovered in the supply chain. Globally, companies are deploying measures to ensure product supply chain integrity, safety, and security.

Some solution providers have taken the initiative of providing robust authentication solutions to pharma companies making COVID-19 vaccines. How will they benefit the pharma companies as well as people? Will such solutions add cost to the finished product? 

The safety initiatives are welcomed and a much-needed step in the right direction. Investment in robust authentication solutions creates a win-win situation for each stakeholder. Escalating incidents of counterfeiting, tampering and diversion are threats to the integrity of global drug supply. According to a recent report by IDC, while surveying 532 global supply chain leaders it found that 75 per cent of them believe that COVID-19 will greatly increase problems with drug diversion, including theft and counterfeiting of critical products (such as test kits, vaccines, and antiviral medicines). There are ample benefits including maintaining brand integrity, the trust of consumers, preventing liability clauses, recouping lost revenue etc., that provide a great return on investment to pharma companies. Even, authentication systems also help companies and regulators in saving enforcement cost as these facilitate easy identification. More than that, from a country perspective, fighting fakes will plug criminals funding. At the consumer point, he receives genuine medicine, which he is assured of.

Can you give us a brief update about tech-enabled, advanced solutions used in ensuring the quality of COVID-19 vaccines in the supply chain? 

Today, there are many solutions available across the globe. Broadly classifying these can be divided into two categories: physical and digital solutions. While physical solutions ensure tamper-evident facility, digital solutions ensure supply chain integrity and traceability along-with data intelligence. In the case of the pharma industry with global supply chain complexities, a standard based phygital (combination of physical+digital) approach is the future. There is no silver bullet. Fighting counterfeiting requires a long-term battle and we need to start somewhere.

What kind of tracing system needs to be implemented to authenticate a product?

Globally, there are proven models working in the European Union and the US for pharma. In fact, in India, almost 22 States Excise Departments are using systems ensuring the genuineness of liquor products as well as ensuring revenue enhancement. Every year more than 22 billion liquor bottles are secured with authentication and technological measures. As a country, we are fully capable of adopting these proven systems. Regulators can learn from these and adopt any one of them according to ours and global requirements.

Do you have data on fake, counterfeit medicines used for the treatment of COVID-19 and what were the loopholes? 

Over the past five years, worldwide incidents such as theft and counterfeiting of pharma products rose nearly 69 per cent, according to the Pharmaceutical Security Institute, a trade group. In the Indian scenario, as per ASPA study, pharma and healthcare products are amongst the top 10 sectors reported with the highest number of counterfeit incidents reported in the last two years. Time to time, worldwide renowned authorities have issued global alerts. Recently, Interpol had issued a global alert to law enforcement across its 194 member countries warning them to prepare for the organised crime networks possibly targeting COVID-19 vaccines, both physically and online.

Incidents of vaccine falsification are not new for India and the world. In India also there have been incidents. Last year, a big racket was busted in Rajasthan involved in counterfeit Meningitis vaccines. Three months ago, in September 2020, Odisha’s drug enforcement agency arrested a man on charges of trying to sell fake COVID-19 vaccines in the Bargarh district. The accused was found preparing vials with COVID-19 vaccine stickers on them. In this year itself, various agencies had issued alerts raising concerns of fake incidents.

The loopholes are existing in our systems. It is very unfortunate that we have systems to protect liquor, currency, but not medicines. We need to understand that counterfeiters are not going to produce vaccines, they are going to fool people by replicating the vaccine packaging, while potentially putting inactive or even harmful contents inside the vial. The absence of anti-counterfeiting and traceability measures is going to make their task easy.

On behalf of Authentication Solution Providers Association (ASPA) have you initiated a conversation with the government, regulatory authorities to strengthen the COVID-19 vaccine supply chain?

In 2011, our Government implemented the traceability solutions for exports, but the question is what about our own citizens. In 2018, the Drugs Technical Advisory Board (DTAB) recommended that the top 300 pharma brands in India should have an anti-counterfeiting solution, namely application of a unique code to each consumer-level pack coupled with SMS-based authentication of that code. However, they made it voluntary, not compulsory, and so far, it has not progressed much. For a long time, we have been raising this matter with regulators, stakeholders, and media. This is the best chance for them to implement and enforce these in the domestic market and we would strongly encourage DCGI and MoHFW to look into these measures.