Recently, several incidents of fake COVID vaccines being administered to the population of various countries were reported. For instance, the World Health Organization (WHO) had identified counterfeit versions of Covishield (manufactured by the Serum Institute of India), which became a major cause of concern for stakeholders across the world. Apart from it, Pfizer’s fake vaccine vials were also found in some parts of the US, along with other parts of the globe.
Since vaccines are key in the fight against the COVID-19 virus which has held the world at ransom, the circulation of fake vaccines is a disaster in making.
Speaking in this regard, Nakul Pasricha, President, Authentication Solution Providers’ Association (ASPA), highlights that the consumers need to be assured that they are receiving a genuine and safe product that is manufactured with the highest standards of quality.
He states, “Secured pharma packaging plays a vital role in protecting the integrity and inviolability of drug packaging, facilitating authentication, verification and product traceability in the supply chain. Several pharma companies already use authentication and traceability measures. For example, Johnson & Johnson is using security seals on vaccine boxes along with traceability measures on vials. Glassmaker Corning is equipping vials with black-light verification to curb counterfeiting. Apart from these authentication measures, most vaccine vials now come with a vaccine vial monitor (VVM) attached to them. These smart labels are time-temperature indicators that contain a colourless chemical that irreversibly reacts in proportion to heat and time, becoming darker to give a visual indication of cumulative heat exposure. Currently, 230 of the 248 vaccines that have been pre-qualified by WHO are required to carry a VVM.”
Adding to it, Siddhartha Mitra, a pharma veteran notifies that counterfeit medicines in the Indian market are nothing new. However, vaccines made with saline solution, mineral water or with Amikacin during the pandemic is a serious issue. He adds, “High and instant demand and outstripping the supply during the pandemic initiated the possibility of production of fake vaccines. Further, R&D and the cost behind vaccine production and ensuring its safety created a huge demand-supply gap, especially in developing and poor countries. This is another reason for counterfeit vaccines.”
According to Sudesh Anand Shetty, Partner, KPMG, for any fraud to occur, there has to be an incentive, an opportunity, capability and rationalisation. He says that during the pandemic, what the world saw was a booming trade in counterfeits for products used from diagnosis to treatment such as pharma consumables (counterfeit PPE and masks), drugs (fake medicines for prevention, treatment and recovery), diagnosis kits (fake COVID-19 testing kits, pulse, pressure and oximeters), treatment (scarcity of hospital beds, oxygen supply and vaccines), fake websites and apps (used to steal personal information as also to cause financial loss to individuals).
The challenges around the third wave
The vaccination drive facing India remains colossal and reported instances of fake vaccines only add to public distrust of the vaccine programme. It is critical to mitigate fears of the efficacy of the vaccines as well as assure the public of the authenticity of the vaccines to withstand the onslaught of the expected third wave, points out Arvind Sharma, Partner, Shardul Amarchand Mangaldas & Co.
He suggests, “Access to basic healthcare facilities, including testing centres, should be addressed before the third wave hits. The aim should be to increase COVID-19 testing centres which deliver results on time to ensure treatment can begin for COVID-19 positive patients at the earliest.
“Grass-root level mobilisation of resources should be carried out to create awareness regarding testing and vaccinations. Community healthcare centres should be equipped with facilities such as beds, ventilators, medicines, electricity, toilets, etc. to cater to local communities. Localised treatment will help in calming the patients’ nerves since they will be in known surroundings. They can be moved to better facilities should the community centre be ill-equipped or specialised treatment is required. Increasing emphasis on vaccination drives ensures most of the population is administered with at least one dose of vaccine before the third wave hits. Clear strategy and information around storage, transportation and cost of oxygen cylinders should be devised to ensure it is available at short notice wherever and whenever required,” he emphasises.
Besides, Pasricha points out that in the current system, the CoWIN app maintains data of people-to-be-vaccinated, but it is not designed to protect the vaccine supply chain from the risks of counterfeiting. “Protecting COVID-19 vaccines and other essential products from falsification and diversion requires cutting-edge authentication and traceability solutions, public-private collaboration and national-level support,” he highlights.
He also advises implementation of authentication, serialisation-and-traceability method on the product packaging, like provisions pharmaceutical companies are already using for export regulation and market; putting in place a comprehensive anti-counterfeiting system that starts with training staff to spot and test for counterfeit products, buying only from trusted sources, monitor the flow of goods, and report the entry of fake goods into the supply chain; and a contingency plan to alert customers, suppliers, the authorities, and the public in the event falsified products are discovered in the supply chain.
Decoding the Health Ministry’s guidelines
Talking about the advantages of putting the guidelines released by the Ministry of Health and Family Welfare (MoH&FW) for identifying the original vials of Covishield, Covaxin and Sputnik V in the public domain, Sharma says, “The guidelines serve as an important instruction to the general public, not only for tackling counterfeiting of vaccines, but also for allaying vaccine hesitancy concerns. Dissemination of the latest information on authentic and counterfeit vaccines is vital to increase levels of vaccine delivery to achieve wide-scale immunisation of the population.
Sharing similar views, Shetty also opines that putting the guidelines in public domain will help the healthcare institutions administering the vaccines and general public to identify the counterfeit version of the vaccines. “The doctors and medical staff in charge of performing the vaccination may also benefit from knowing these subtle differences to provide an additional layer of safety to the general public. The service providers and monitoring teams for COVID-19 vaccination may be informed about these details
and to ensure due diligence towards recognition of counterfeit vaccines,” he says.
Pasricha also agrees that releasing the guidelines in public domain is important since “awareness plays a vital role in eliminating sub-standard, spurious, falsely-labelled, falsified, and counterfeit (SSFFC) medical products from the system.”
He adds, “Fighting counterfeiting is everyone’s responsibility, and policymakers must involve all stakeholders in this. Our healthcare workers, nurses and pharmacists can play an important role in enhancing awareness amongst genuine products.”
In addition, he also elaborates on the role of consumers in preventing the distribution of fake vaccines. “Before and after buying any product, they must participate in completing the authentication process. Consumers should buy from trusted places and always ask for a bill. Post-purchase, they should participate in the authentication process provided by brands. If none is provided, they must ask why. If a consumer unwittingly purchases a counterfeit, he/she must report it to the brand or a consumer rights forum. Consumers should not allow such incidents to go unreported as it may encourage those who profit from illegal acts. They could be our whistle-blowers in identifying and rooting out counterfeiters. However, policymakers need to ensure their safety and they must be rewarded for it,” he opines.
In Mitra’s view, there is no cent per cent process to stop counterfeit medicines, other than strict vigilance. However, consumer education/surveillance without creating panic or doubt can help in preventing the same.
“Proper logistics of the supply chain, manufacturers increasing their supply chain vigilance, collaborative supply chain and intelligence sharing are indeed important. Further, random batch testing by responsible officers at all the vaccination centres, innovative use of digital platforms and QR codes, innovative screen printing on the pack, elevated engrossing of confidential code, preferably on the neck of the container and intermittent change of the colour of the pack with confidential information to the suggested stakeholders only can also help in preventing the distribution of fake vaccines,” he informs.
Using indelible and invisible magnetic inks, and cryptoglyphs can be effective monitoring measures for the pharmaceutical companies, as per Sharma.
Pasricha indicates that brands should contemplate putting in place a comprehensive anti-counterfeiting system that starts with training the staff to spot and test for counterfeit products, buying only from trusted sources, monitor the flow of goods, and report the entry of fake goods into the supply chain.
“Vaccination via private camps becomes susceptible to fake vaccines with no monitoring or checks being performed previously. However, now states have been coming up with their SOPs/guidelines on private vaccination camps such as approvals required before setting up, source of procuring the vaccines should be displayed, etc. Even the manufacturers have to evolve with time and introduce different measures in packaging and technology solutions to stay alert and combat counterfeits. Consumer awareness campaigns on multiple platforms on identifying the fake vaccines and measures taken by the manufacturers should be clearly communicated – be it direct reach to consumers or via medical fraternity/circulations in collaboration with drug authorities – so that it reaches out to the public at large,” stresses Shetty.
Counterfeiters have evolved over the period and we need to stay ahead of them at every step. They have started to exactly replicate the packaging that makes it resemble the original product. This poses multiple challenges right from detecting counterfeits to ensure it is removed out of the supply chain. Combating counterfeits would entail efforts from the manufacturers, industry and government agencies who need to collaborate and educate the public at large on the anti-counterfeiting measures and dos and don’ts on fake vaccines.
Although multiple measures have been taken by the manufacturers and Health Ministry, are they enough or do we need more measures? The onus also lies on healthcare providers and end-users to be vigilant and identify/report the availability of fake goods.