Counterfeit drugs, medical devices during Covid-19: Collective effort required to tackle menace- Nakul Pasricha, ASPA

What is the status of counterfeiting in the pharmaceutical industry? What is the Status in India?  Is counterfeiting affecting only the pharmaceutical industry? What are the latest trends? 

Substandard, spurious, falsely labelled, falsified, and counterfeit medical products collectively called as SSFFC medical products are by their very nature difficult to detect. They are often designed to appear identical to the genuine product and may not cause an obvious adverse reaction, however they will fail to treat the disease or condition for which they were intended.

In 2013, World Health Organisation (WHO) launched a global surveillance and monitoring system to encourage Member States to report 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-July 2017, the system received 1,500 reports of cases of substandard or falsified products. Of these, antimalarial and antibiotics are the most reported. (Source: who.int/medicines/regulation/ssffc/publications/GSMSreport_EN.pdf?ua=1) Similarly, Pharmaceutical Security Institute, a trade group had also reported that theft and counterfeiting of pharmaceutical products rose nearly 69% over the past five years.

In Indian scenario, as per ASPA Counterfeit News Repository, pharmaceutical products are among the top five categories which are under continuous risks. Between March 2020-December 2020, more than 50+ cases are reported involving making SSFFC.

Counterfeiting is a global problem and no economies in the world can overrule it. It is hurting Indian economy a great deal and in the last three years, the SSFFC incidents have increased by 20% on a year-to-year basis.

Why do we see rampant counterfeits in the form of injections/drugs/oximeters? Is there a possibility of fake vaccines being circulated? 

Counterfeiters are becoming successful because we are not making their tasks difficult. Or if we put it in another way, we are not making this business less profitable for them. History provides us with warnings. Quackery was rampant during the Great Plague of the 17th century. When cinchona bark became the treatment for malaria in the 17th century, they adulterated it on a vast scale. After World War 2, penicillin shortages led to widespread falsification. Reserving penicillin for British and US soldiers in post-war Berlin created a lucrative illicit trade.

Nakul Pasricha, President, ASPA

Scarcity breeds falsification and counterfeiting that is just a fact. One can reduce the crime rate, but so long as there is greed for more with the least efforts, it will be difficult to eliminate the criminal mind set. A weak anti-counterfeiting ecosystem and lack of awareness about how to identify fake products in the stakeholders further encourages frauds.

According to you, what are the reasons behind the increase of such activities? How do counterfeiters manage to make such perfect duplicates and fool people? Are there any laws/policies or guidelines to be followed for fighting this menace? If yes, are these being followed? If not, why?

One of the important is the absence of anti-tampering, anti-counterfeiting & traceability measures making their task quite easy. Apart from it, reasons that are triggering the growth of SSFFC are inadequate legal framework, weak administration measures, brand & consumer awareness, fragmented distribution channels, Govt. reluctance to acknowledge the existence of gravity of the problem, etc.

Counterfeiters are becoming smarter, and we need to stay one step ahead of them. The loopholes exist in our systems. In many incidents, we have noted that counterfeiters are fooling people simply by replicating the product packaging, while potentially putting inactive or even harmful contents inside the vial/packing. For instance in some cases, the accused was found preparing vials with COVID-19 vaccine stickers on them. There are solutions available that have proved successful and are cost effective, the gap unfortunately is in adopting and implementing.

Who is responsible for a counterfeit product? Consumer, Regulator, or Brands? Where do we have lacked? How can Government & Brands keep a check on these? How can the possibility of fake vaccines be checked well in advance? 

While COVID-19 is a current pandemic, Counterfeiting is an ongoing menace. In a country like ours to cover the massive scale, collective responsibilities/efforts are required. Ending any endemic disease is the pathway to strengthen fragile health systems and boosting resilience to better deal with current and future health threats. The most important thing is building an environment for Safety Culture.

There are two challenges – detecting counterfeit as well as stopping diversion. While we need to ensure that the product has not been 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. Anti-counterfeiting measures protect both the manufacturer and the end-user. So, manufacturers must adopt anti-counterfeiting solutions to protect their products and ensure the safety of consumers by creating awareness around the measures they are taking.

Global regulatory compliance issues have tarnished the image of Indian pharma companies in the global arena and counterfeit drugs are adding mileage to this damage. What according to your immediate steps needs to be done both by the government and pharma companies? 

India’s pharmaceutical industry is one of the most highly regulated industries in the country. We have become a pharmacy to the world. However, in terms of building strong measures to curb the spread of spurious and sub-standard medicines, much more work remains to be done.

In 2011, the Union government had determined that it needed to protect the reputation of its exports and the pharmaceutical industry and they thus implemented serialization for all drugs leaving India. While we (India) have made great strides toward requirements for exports, laid out in early 2011, the proposal for the domestic market is still pending for the last 5 years. If that would have been implemented in the last few years, we would have been in a better position to ensure safe, quality, and genuine to our citizens in this panic situation.

India is a Member State of the WHO policy group on eradicating falsified medicines and products, and this is the right time to show the global world our commitment towards high-quality products. Emergency responses require pragmatic, agile, and well-coordinated action.

At the immediate level, to secure the Vaccine Supply Chain, we recommend three steps:

a) Implementation of serialization-and-traceability authentication on product packaging

b) Training staff to differentiate genuine from Counterfeits

c) Contingency plan to alert stakeholders in case event falsified products are discovered in the supply chain.

What are the anti-counterfeiting solutions? There is a lot of talk about authentication, traceability, and blockchain systems? What is your opinion on that? 

There are many solutions available across the globe. Broadly classifying these can be divided into two categories – physical and digital solutions. While physical solutions eradicate product tampering, digital solutions ensure supply chain integrity along with data intelligence. In ideal conditions, the solutions must be a combination of physical + digital technology. While physical anti-counterfeiting solutions must ensure tamper resistance, digital will provide real-time data intelligence, transparency, and traceability. Examples of physical solutions are tamper evident packaging, holograms, labels, etc. Some digital solutions which are being effectively used are QR Codes, Smart Labels, Barcodes, etc.

Currently, 75 percent of the world has adopted Serialization including the USA, EU, Turkey, Russia, Gulf Countries, and India (for exports) which is going to help the pharmaceutical industry tracking medicines throughout the supply chain. I think a standardized approach is better. 

The approach adopted by European Union; falsified medicine directives is a good example. It introduced two new safety features that must be present on each individual pack or bottle of medicine: a unique identifier (a 2D barcode containing a unique 20-digit pack number, as well as other data), and a physical anti-tampering device (ATD).

What are your suggestions for handling Oxygen shortage/traceability? 

There are solutions and systems which can be added as GMP measures. Whilst the urgent supply of medical gases is necessary, we must be certain that appropriate standards must be followed for the production, control, storage, and distribution of oxygen and other medical gases to guarantee that gases for medical use are of assured quality when they reach the patients. Understanding the seriousness of the issue, WHO has suggested a few points for good manufacturing practices for medical gases, which can increase transparency in the system. These are:

• There should be a system in place to ensure traceability of cylinders, mobile cryogenic vessels, and valves.

• The maintenance and repair operations of cylinders, mobile cryogenic vessels, and valves are the responsibility of the manufacturer of the medical product. If subcontracted, they should only be carried out by approved subcontractors. This will avoid black marketing and hoarding.

• Each filled cylinder should be traceable to significant aspects of the production and filling operations.

• There should be documented, detailed procedures for the dispatch of medical gases.

• Records for the dispatch should include relevant information to allow traceability. Such records should facilitate the recall of a batch of medical gas when necessary.

In what ways regulating the intermediaries can lead to the safety of the pharmaceutical supply chain in India as compared to other countries? 

Online selling of products like medicines need clear regulatory guidelines, strong enforcement as well as the adoption of solutions that can empower consumers to check the authenticity of medicines for themselves. For example, the easy availability of these products without prescription. These syrups are easily available at the website including Indiamart which is not a health e-platform.

How can awareness be increased? 

Consumer awareness has become an important part of the anti-counterfeiting strategy in developed economies. On the flipside, in developing countries, it is still a major challenge. The ‘Jaago Grahak Jaago’ campaign of the Indian Government has received reasonable success with urban consumers looking out for the safety and genuineness of the product. But we still have a long way to go to inculcate and develop a sense of responsibility amongst the rural consumer base.

In countries like India, where health and medicine literacy in society is not yet fully developed, healthcare professionals have an even bigger role to play compared to their counterparts in the developed world.

To battle counterfeit medicines circulation, nurses, and pharmacist associations in several countries in collaboration with their national drug regulatory authorities, have developed useful continuing awareness modules and education tools to inform nurses and pharmacists about counterfeit medicine issues. Also, the new generation technocrat nurses assisted with innovative authentication and traceability solutions can help in the authentication process and eliminate falsified medicines from the systems.

Our nurses and healthcare community are doing a tremendous job in the fight against this pandemic, we are confident that they can be instrumental in the fight against falsified medicines as well.

Can we completely eradicate counterfeiting? 

Why should even one life be lost or compromised due to counterfeit medicines? However, at the end of the day, counterfeiters are criminals with no regard or concern for public safety. According to some statistics, counterfeiting medicines is a more profitable industry in some places than in dealing heroin. Hence, we must be alert, have awareness and technology solutions in place to stay one step ahead.

Even if we were to say that we have achieved 100 percent anti-counterfeiting, one or two years later, counterfeiters will find some other ways to create the menace. So, it is a constant battle. We must constantly stay one step ahead. Moreover, a solution that worked 10 years ago might not work today. So, we must keep looking at the new advances and solutions in the market to stay alert.