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Incidents of vaccine falsification are not new for India and the world: Nakul Pasricha

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India’s immunisation supply chain has been breached before and besides counterfeit PPE kits, there are already reports of fake COVID-19 vaccines, warns Nakul Pasricha, President, Authentication Solution Providers’ Association. In an interaction with Viveka Roychowdhury, he lists out how hospitals can secure their pharmacies and supply agencies with cutting edge authentication and traceability solutions and by training staff to spot the fakes

As there are signs that the COVID-19 vaccination campaign will be a public-private-partnership (PPP) effort, at least for some part of the population, how can healthcare management of hospitals gear up to ensure that fake vaccines do not enter their end of the supply and delivery chain?

Every stakeholder’s role is important in combating COVID-19. The role of healthcare management of hospitals is particularly important not only for providing effective, secure, and safe vaccines, but also for creating awareness.

There are concerns related to product security, falsification, theft and counterfeiting of vaccines. Healthcare management of hospitals need to ensure a preventive mechanism by which they can identify any irregularities during vaccine pre procurement and post vaccination. They must do the following:

Evaluation: Evaluate their procurement systems and check for ethical and reliable distributions, and vendors.

Assurance: When the vaccine (product) reaches them, one needs to ensure that there are no signs of product tampering. If tampering is found, they must inform their partners immediately.

Maintaining supply: It has been noted that substandard drugs / medicines are driven by cost reduction, whereas falsified agents (because of fraud) thrive on shortages, particularly when buyers divert from regulated supply chains. For example, in December 2018, because of global shortage of supply a large, tertiary, university-affiliated hospital in the Philippines switched to another vendor and later discovered that their legitimate supply chain was infiltrated with counterfeit rabies vaccines (Verorab).

Awareness: Healthcare management can / appraise their professionals including doctors, nurses, and paramedical staff to become key players to increase vigilance and reporting of possible falsified vaccines / medicines.

What kind of collaborations will be required between stakeholders like national authorities, private players like pharma/vaccine manufacturers and healthcare staff to put such a secure supply chain in place? Do we already have some parts of this in place, via our ational immunisation programme? 

Identifying and tracking the path of a COVID-19 vaccine will be of great importance. This will make supply chain security vital to address as we plan how to distribute the product. Countries not yet incorporated in a traceability system will need a mobile and cloud-based infrastructure. Private actors can be relied on to provide technological solutions to adapt mobile technologies. All stakeholders need to be aware to identify and participate in the authentication process.

Apps that facilitate services like contact tracing, pharmacovigilance and vaccination certifications could use the marking (QR Code/2D Code) on the vaccine pack to capture the product code, serial number, as well as batch and expiry data. This way there is a record that an individual has been vaccinated with a verified pack and the batch and expiry data is available for aspects such as recall management and pharmacovigilance reporting.

Currently, under the Universal Immunisation Program (UIP), vaccine distribution is based on Electronic Vaccine Intelligence Network (eVIN) system, which is an internet-based digital system to track routine immunisation, vaccine stocks, storage temperature in about 25,000 dedicated cold chain storage points across the country as well as movement of vaccine. The vaccine is distributed to health facilities and outreach station sites, to reach all areas. The eVIN system is regularly monitored by health authorities at state and district level.

India has a strong immunisation network for newborns and mothers. Have there been previous incidents of fakes within this supply chain and if so, how were they discovered and tackled? Likewise, there have been reports of fake PPE kits etc. What are the learnings?

Yes, we have a strong immunisation network, however, one needs to be extra vigilant in this case, as any adverse situation will have a long impact. Incidents of vaccine falsification are not new for India and the world. There are ample recent examples of alarming situations. We need to address the issue of regulated supply chains. Panicked global populations are desperate to buy products that might prevent and treat COVID-19, and it is critical that only the right product reaches them.

In October 2018, a Chinese vaccination firm was fined $1.3 billion after it was found to have illegally produced the human rabies vaccines. In December 2018, a large university-affiliated hospital in the Philippines discovered that their legitimate supply chain was infiltrated with counterfeit rabies vaccines (Verorab). In May 2020, fake Israeli coronavirus vaccines were being sold in South America.

In India also there have been incidents. Last year, a big racket was busted in Rajasthan involved in counterfeit Meningitis vaccines. Fraudulent people have already started their malpractices.

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. In this year, itself, various agencies had issued alerts raising the concerns of fake incidents.

Protecting COVID-19 vaccines and other essential products from falsification and diversion require cutting edge authentication and traceability solutions, public-private collaboration, and national level support. One way everyone can prevent falsified products entering their supply chain is to put in place a robust authentication and traceability mechanism. Brands should contemplate 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.

Are hospital pharmacies part of track and trace initiatives? 

 In India, a major part of the vaccine programme is led and controlled by the Government. There have been reports in the media highlighting involvement of fake drug rackets in Government hospitals.

One of the major supplies agency of a big state in India has continuously been accused of supplying substandard personal protection equipment (PPE) to state-run-hospitals. These PPE kits supplied by them allegedly bore two stamps-those of an Indian PSU and “Made in China”. Even the viral transport vials, supplied by the agency came in different colours.

With the connivance of the corrupt officials, the agents of the illegal drug industry manage to get a diversion letter. Instead of the original company to whom the order was issued, the unscrupulous company supplies the consignment of drugs and even draws the payment.

Before pharmacies, we need to ensure that these supply agencies must have an integrated authentication and traceability systems, further linked with pharmacies.

Ironically, 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 five years. If that had been implemented, we would have been in a better position ensuring safe, quality, and genuine medicines to our citizens  in this panic situation.

Do hospitals in India have a contingency plan for hospital/pharmacy staff to alert patients, their management, government authorities etc. about possible fake/falsified products? 

According to news, some private hospitals are preparing their contingency plans. Apollo Hospitals Healthcare Chain is gearing up to administer 1 million COVID-19 vaccine and training its staff at 4,000 pharmacies on inoculation through a certification course which is scheduled for next month.

Most of the hospitals / administrations are talking about patient traceability which is good. But apart from that we also need to ensure the authenticity of vaccines and for that we need to take bold decisions, which are pending from the last few years such as domestic pharmaceutical serialisation regulation.

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