Training healthcare workers and pharmacists against fraudulent medicines is a must: ASPA

On December 4, 2020, the European Union’s crime agency Europol issued a warning about fake vaccines being sold online. Has something like this been reported in India?

Interpol and Europol had been issuing these global alerts to enforcement agencies across its 194 member countries for the last 12-15 months. One of the first alerts was released in March 2020 when global operations saw a rise in fake medical products related to COVID-19. They also noticed that criminals were taking advantage of COVID-19 anxiety to defraud victims online. Even in December 2020, an alert was issued that terrorist groups are using COVID-19 to reinforce power and influence. The latest one was issued in March 2021 as the public is warned against online vaccine scams after recent operations in China and South Africa.

A Twitter handle operated by the Ministry of Home Affairs (MHA) @Cyberdost has issued alerts on a regular basis. On-ground incidents of fake COVID vaccines have surfaced in India, but no incident of online counterfeit sales has been reported so far.

As several COVID-19 vaccines come closer to approval and global distribution, ensuring the safety of the supply chain and identifying illicit websites selling fake products will be essential. The need for coordination between law enforcement and health regulatory bodies will also play a vital role to ensure the safety of individuals and that the wellbeing of communities are protected.

As per a 2017 WHO report, 10.5 per cent of medicines sold in low and middle-income countries, including India, are substandard and falsified. What are the latest estimates about the extent of counterfeit medicines in India’s pharma supply chain?

Understanding the exact magnitude of the size of counterfeiting in the healthcare system is extraordinarily complex. Realising this, in 2013, the World Health Organization (WHO) launched a global surveillance and monitoring system. It encourages the member states to report substandard, spurious, falsely labelled, falsified and counterfeit medical products (SSFFC) incidents in a structured and systematic format, to assist in arriving at a more accurate and validated assessment of the scope, scale and harm caused by this issue. In between 2013 to July 2017, the system received 1,500 reports of cases of substandard or falsified products. Of these, antimalarials and antibiotics are the most reported. The findings you have mentioned are based on that alert system.

Globally, experts had noticed an increase in SSFFC from the last decade. The Pharmaceutical Security Institute (PSI), a trade group, had also reported that theft and counterfeiting of pharma products rose nearly 69 per cent over the past five years.

While varied statistics are reported, it is undoubtedly a huge issue threatening health and wellbeing. In the Indian scenario, as per ASPA Counterfeit News Repository, pharma products are among the top five categories which are at high risk of counterfeiting. Between March 2020 to December 2020 itself, over 50 cases were reported involving making SSFFC. There is more than one incident every week.

How can healthcare institutions and medical staff spot fake medicines/vaccines? Is there any way nurses and paramedical staff in hospitals, and pharmacists can be trained to identify counterfeit drugs and put a stop to them? Is such a thing happening anywhere at the moment?

There are two challenges – detecting counterfeit as well as stopping diversion. Healthcare workers and pharmacists make for our first line of defence, and are the most important part of our defence against fraudulent medicines and essential products.

Healthcare workers are amongst the few professionals who are well-versed and familiar with most medicine brands, usage and packaging. They can play a crucial role in detecting and preventing the distribution of counterfeit medicines. A continued immersive awareness and education programme is crucial for them so that they can be vigilant towards the presence of a counterfeit product and be informed of the protocol if they come across a fraudulent product. Information and reminder of a few simple, but crucial tips, can make a huge difference.

Many brands are using anti-counterfeiting solutions on their packaging. Sometimes, a close and careful look reveals authenticity. For example, checking if the security seal is intact, especially in bottled medicines or the unique code printed on medicine blister packing or carton can easily be verified by sending an SMS or WhatsApp or by scanning a QR code. A crucial requirement is to nurture the culture of due diligence to ensure that the products are authentic.

Almost seven years ago, the World Health Professions Alliance (WHPA) released a handbook titled, “All you need to know about spurious medicines” together with inputs from the Indian Nursing Council (INC), Indian Pharmaceutical Association (IPA) and the Indian Medical Association (IMA). The booklet aims to provide healthcare professionals with a ready reckoner and a “go-to” guide against spurious medicines in India.

There is a need to elevate and redesign the approach towards awareness on an ongoing basis, rather than a one-time opportunity. As per our information, the International Council of Nurses (ICN), WHPA and World Heart Foundation (WHF) have joined forces with the ‘Fight the Fakes’ campaign to raise awareness of the dangers of fake medicines.

What are the regulations to curb counterfeits, and what are the regulators like CDSCO and DCGI doing to combat this menace? Is any action being taken by pharma companies or pharma associations in this regard? What is ASPA’s role in combating counterfeit medicines and vaccines?

India has no legislation dealing specifically with counterfeiting and piracy, but the legislators, through various statutes, have provided statutory, civil, criminal and administrative remedies. However, counterfeiting has been majorly dealt with by the Intellectual Property (IP) Law as it directly invokes the IP Rights of the aggrieved.

In a meeting held in May 2018, the Drug Technical Advisory Body (DTAB) deliberated the matter and agreed to the introduction of trace and track mechanism for major 300 pharmaceutical brands on a voluntary basis. However, in the absence of mandates, often pharmaceutical companies prioritise other projects – this is a trend we have seen across the world, where regulatory drivers have sped up the implementation of anti-counterfeiting solutions. India is no different, but, in addition, we have another factor to consider – the price controls imposed on certain products as part of the National List of Essential Medicines (NLEM). While we fully support the government’s moves to make essential medicines more affordable for our citizens, we suggest that the quality and genuineness of the medicines should be factored in as well, and this can be done by having a dialogue with industry and ensuring that cost and margin pressures don’t put a dampener on the adoption of authentication and traceability solutions.

ASPA is committed to build the authentication ecosystems in the country and enhance our relationship with other across-sector industry associations and other bodies working in the same space. We had signed a Memorandum of Understanding (MoU) with GS1 India to create awareness about counterfeiting problems and build knowledge through various tools, including training, publishing of articles, enriching websites, etc., to drive adoption of global standards for detecting and controlling counterfeits. From time to time, we are conducting information awareness webinars. On June 11, 2021, we are conducting a webinar on “Protecting Pharmaceutical lives and securing pharmaceutical Supply Chain during COVID-19.”

Apart from this, we have built important tools for brand owners and policymakers. One such tool is the Counterfeit News Repository (https://www.counterfeitrepository.com/). The portal provides in-depth analysis and a one stop source for all counterfeiting incidents reported in India. This helps in the assessment of the problem areas and the magnitude of the issue the country is facing.

Very soon, we are going to release the first edition of “Authentication & Traceability Source Guide” and a new portal providing detailed information on authentication technologies and solutions. Brands and organisations can use these as a reference guide for framing their anti-counterfeiting strategy.

What technologies are the vaccine and pharma companies deploying to take on fake/falsified vaccines and medicines? How much do these technologies like holograms, barcodes, etc. add to the cost?

According to sources, vaccine makers are deploying authentication and traceability measures. Pfizer reported using GPS software on shipments, Johnson and Johnson is using a security seal on vials’ vaccine boxes, along with traceability measures on vials. Glassmaker Corning is equipping vials with black-light verification to curb counterfeiting. These are just some examples of various technologies, but the good news is that regulators around the world, including in India (for exports) have mandated the use of barcoding (also called serialisation) and traceability for protecting medicine and vaccine movement through the supply chain. Similar measures need to be adopted urgently for the domestic public and private supply chain to ensure patient safety.