Authentication Solution Providers' Association (ASPA) is a body which provides an answer to the problem of counterfeiting of products in India and abroad with the help of various new technology. Nakul Pasricha, President, Authentication Solution Providers' Association (ASPA) says counterfeiting of Covid-19 vaccines is a real threat in India. Excerpts:
Q) Do you think counterfeiting of Covid-19 vaccines is a concern in India?
We need to understand that counterfeiters are not going to produce a vaccine, 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 & traceability measures is going to make their task easy. Incidents of vaccine falsification are not new for India and the world. In India, there have been incidents. Last year, a big racket was busted in Rajasthan that was 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. This year, itself, various agencies had issued alerts raising the concerns of fake incidents.
Q) How rampant is it in India and in other countries?
Recently, Interpol had issued the global alert to law enforcement agencies across its 194 member countries warning them to prepare for the organised crime networks possibly targeting Covid-19 vaccines, both physically and online. These concerns are justifiable and genuine, as from time-to-time various enforcement authorities had issued global alerts. Over the past five years, worldwide incidents such as theft and counterfeiting of pharmaceutical products rose nearly 69%, 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 the counterfeit incidents in the last two years.
Q) Don’t you think companies are aware of it and they will introduce safety aspects on each vial?
The Covid-19 vaccine can save lives but a falsified vaccine will kill human beings as well and erode the trust in our healthcare systems. Further, the world is also looking for us to provide cost-effective, safe, and quality vaccines. I think most pharma companies are aware of these risks as well as of solutions. For export, most large companies have already implemented serialization and traceability as per Directorate General of Foreign Trade (DGFT) guidelines. This is the best chance for them to implement these in the domestic market, and we would strongly encourage Drugs Controller General of India (DCGI) and Ministry of Health and Family Welfare to look into these measures.
Q) So isn’t the serialization and traceability mechanism mandatory in India?
Serialization is required for all exported medicines as per DGFT. However, for the domestic market, there is no regulation governing serialization, traceability or anti-counterfeiting in general. There should be one, and this is the need of the hour.
Q) What could be the reason for not implementing these safety measures?
I have heard many Drug Controllers, especially in states but also DCGI, refer to the lack of resources. It's a vast market and it is difficult for a limited number of inspectors to cover the entire market.
Q) But hasn’t the problem been existing for decades? Why can’t we have a robust mechanism in place?
Yes, It is something that has been there for many years. We have two tools at our disposal to help the situation.
One is technology and solutions - there are many that have been successfully implemented around the world and even in India also. Like serialization and traceability which I have talked about. But there are many more.
Two is our consumers, our people. Our PM is asking us to be atmanirbhar. Why can't we empower our consumers with awareness campaigns and the technological tools to help weed out falsified vaccines and medicines? Until we take this on as a national project, with strict regulations, better resources for our Drug Controllers, better awareness for our patients and consumers, adoption of proven technologies, and strict punishment for violators, the problem will persist and lives will be lost. I think Covid-19 is a perfect opportunity to tackle this once and for all.
Q) Finally, how can we ensure that a genuine vaccine reaches each and every needy person in the country?
Brands should contemplate putting in place a comprehensive anti-counterfeiting system that starts with adopting physical authentication & traceability solutions to eradicate tampering chances and secure supply chain integrity. A contingency plan should also be drawn up to alert customers, suppliers, the authorities, and the public in the event falsified products are discovered in the supply chain.