[Exclusive] Fake Drugs Are A Billion Dollar Problem, Killing Thousands Every Year: President of ASPA

Authentication Solutions Providers’ Association (ASPA), is an association that primarily focuses on the adoption and advancement of authentication technologies and solutions for Brand, Revenue and Document Protection. 

ASPA is a non-profit organisation which came into existence in 1998 and is recognised globally as a regulated and ethical organisation. It mainly aims to build up the authentication ecosystems & environment in the country against the counterfeiting activity and illicit economy.

We had an exclusive interview with Mr. Nakul Pasricha, President of ASPA, who has over 20 years’ rich experience and is a subject matter expert in digital authentication, serialization and traceability solutions.

On the issue of fake pharmaceutical products, he said, “Pharmaceuticals have consistently ranked among the top 10 counterfeited goods, with product risk varying from market to market. With the complex modern pharmaceutical supply chain, eliminating substandard and spurious drugs and creating an environment where patients receive quality and affordable medicines requires equal responsibility from all the stakeholders.”

Read to find out more about counterfeited products and their effects on individuals and the economy and much more…

1. What is counterfeiting and in which sectors is it observed majorly? 

In layman’s terms, the making of an imitation, copy of forgery of a genuine document, card, product, label, or package with the intention to deceive or defraud is counterfeiting. Counterfeiting has become the crime of the 21st century. It affects almost all sectors. We should examine the reasons why it is increasing. Counterfeiters capitalize on every opportunity which lies in front of them, especially in the absence of authentication solutions, problems in supply chains, inadequate surveillance of products, etc.

2. Are there any cost-effective yet fruitful anti-counterfeiting solutions to fight this crime?

All the anti-counterfeiting solutions are fruitful if implemented in a proper manner, understanding and countering the attack on the brand. An ideal combination of physical + digital technology always works best.

3. Has COVID -19 pandemic increased the counterfeiting in India due to imports? If yes, how?

It will be difficult to say that counterfeiting in India is increased due to imports. In the last few months, more than 30 incidents have been reported in India involved in making sub-standard PPE kits. Counterfeiters thrive in situations where there is enormous demand and restricted supply, and such a situation is now present, especially when it comes to specific categories of essential products such as pharmaceuticals and medical supplies like masks, gloves, and sanitizers.

4. How often does Indian pharma industry fall prey to sub-standardised or falsified products? Has it increased during the pandemic?

Pharmaceuticals have consistently ranked among the top 10 counterfeited goods, with product risk varying from market to market. With the complex modern pharmaceutical supply chain, eliminating substandard and spurious drugs and creating an environment where patients receive quality and affordable medicines requires equal responsibility from all the stakeholders. In the latest Operation Pangea XIII by Interpol, 90 countries took part in collective action against the illicit online sale of medicines and medical products, resulting in more than 121 arrests worldwide. Compared to the last operation action in 2018, this latest edition of the operation reported an increase of about 18 per cent in seizures of unauthorized antiviral medication, and an increase of more than 100 per cent in seizures of unauthorized chloroquine (an antimalarial medication), which could also be connected to the COVID-19 outbreak.

5.  What are the adverse effects of counterfeited drugs on the citizens and economy?

Falsified products in pharmaceuticals are a billion-dollar problem. The effects are beyond our imagination. For example, falsified medicine is one key reason that malaria still kills so many individuals. Falsified and substandard antimalarial drugs may contain no active ingredients, less than the required amount of active ingredients, or ingredients not described on the package label.

6. Are there any laws to help fight this counterfeiting crime? How well are they being implemented?

There are laws in place, but the penalties and enforcement should be made much stronger in order to ensure compliance.  More resources in terms of additional field personnel with central and state drug regulators would go a long way towards this.

7. Will anti-counterfeit goods remain a dream or someday become a reality?

The global pharmaceutical industry is moving towards a serialized world. In over 40 countries, regulatory mandates to secure the supply chain are already in place or in development. Regulatory mandates typically require serialization and verification or product tracking at a saleable unit level. There are two challenges – detecting falsified medicines as well as stopping diversion. While we need to ensure that the product cannot be replicated, we also need to ensure the product has not been removed from the supply chain, tampered with and then re-entered in the system at a different country and/or location.

8. How has the need for the authentication sector over the years been boosted by fraudsters, data breaches and illegal activities?

Authentication sector has evolved to new paradigms in the last few years with the advancement of new digital technologies. The new digital technologies in combination with physical security technologies are making an ideal form. For example, the European Union regulation which requires tamper evident label + serialisation. The global pharmaceutical industry is moving towards a serialized world. In over 40 countries, regulatory mandates to secure the supply chain are already in place or in development. 

In 2011, our government had determined that it needed to protect the reputation of its exports and of the pharmaceutical industry and they thus implemented serialization for all drugs leaving India. Following which customs officials stopped shipments that did not have serialization. So, we are doing a great job of implementing this and protecting the patients around the world, 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. Commitment from pharma companies and regulators is there but since guidelines are voluntary, the adoption is not yet as high as expected.

9. Furthermore, are companies investing more in authentication sectors worrying about their security and privacy as their employees work from home?

Brands need to take more responsibility, as a brand is built on trust. If that trust is eroded, especially at a time when consumers need it most, it could have long-term impacts on business. Yes, many brands are adopting authentication solutions and they must be encouraged by the government through some incentives. I think the government needs to play a bigger role, motivating genuine manufacturers and punishing illegitimate manufacturers.