Fighting fakes with technology
Vinod Kumar Arora, Principal Advisor, Institute of Good Manufacturing Practices India (IGMPI) states that the time has come when all packs sold in India are encrypted, coded and the data is available at the CDSCO server to fight counterfeits
The COVID-19 pandemic has radically changed the way consumers behave when it comes to shopping. There has been a significant increase of ~70 per cent in online shopping after Mar 2020. The world is moving towards contactless purchase and delivery and the consumer wants to know more about the provenance and authenticity of the products before they buy it. Yet, as per WHO, 30-50 per cent of drugs bought online are fake.
Pharmaceuticals have consistently ranked among the top 10 counterfeited goods, with product risk varying from market to market. With the complex modern pharma 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.
The global counterfeit drugs industry is estimated to be worth up to $200 billion and growing. WHO says that exact figures may never be fully known due to the complexity of the distribution networks and the illegal nature of the trade and it is estimated that approximately 100,000 people across the continent die every year from taking counterfeit or sub-standard medication. Pharma products are especially attractive to counterfeiters due to high-profit margins and ease of avoiding detection and prosecution. Even for those who are caught, the penalties tend to be mild as compared to other drug offences.
With the ongoing increase of counterfeit pharma products putting countless people at risk of further illness or even death, it would be prudent to look into an effective anti-counterfeiting strategy which offers protection of your brand and ensures that these illicit goods are successfully removed from the market. The 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.
The global pharma industry is moving towards a serialised world. In over 40 countries, regulatory mandates to secure the supply chain are already in place or in development. Regulatory mandates typically require serialisation 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.
In 2011, our government determined that it needed to protect the reputation of its exports and of the pharma industry and they thus implemented serialisation for all drugs leaving India. Following which, customs officials stopped shipments that did not have serialisation. 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.
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 as current anti-counterfeit solutions – Barcode, QR, 2D Code, RFID etc., have certain limitations.
Many leading technology companies are also coming to the forefront with advanced solutions. For instance, IBM developed the Crypto Anchor Verifier, an Artificial Intelligence- and blockchain-based counterfeit detector that runs on a smartphone. VerifyMe and SmartGlyph are integrating their technologies for an advanced protection and engagement ecosystem. The combined offering will include VerifyMe global supply chain security and cutting-edge product authentication. VerifyMe technology solutions prevent counterfeiting and diversion through instant verification, enforcement and advanced cloud-based track and trace that integrates with security features. VerifyMe solution also encompasses visible and invisible codes, pre-printed serialized labels or an integrated label solution. SmartGlyph provides a patented, bridging technology enabling 2-way, interactive, rich-media experiences for advanced customer engagement. SmartGlyph transforms any existing identifier (barcode, QR code, data matrix, logo, NFC, RFID, serial#) into an intelligent, two-way communication channel with unlimited functionality and is designed for secure, incorruptible transactions and engagement in a closed-loop channel. Ennoventure, a Delaware-based start-up organisation having their R&D at Bengaluru has an anti-counterfeit solution. Their patented technology can encrypt any information transforming the existing packaging to digitally encrypted. The encrypted data is completely invisible to the naked eyes and can be retrieved using the app on any smartphone. It’s a plug and play, cloud-based solution that can be implemented within 48 hours with no process change or capital investment in machinery or scanner and is very cost-effective.
The time has come when all packs sold in India are encrypted, coded using India’s IT strength and data is available at CDSCO server and they are able to check whether a pack is genuine or fake. This will help the patient to genuine medicines and create trust in consumers. With the intervention of the Government of India, the Aadhaar Card is a reality and if the government plays a bigger role I am sure this can also happen using current anti-counterfeit measures + digital.