Traceability enables validation of vaccines to prevent counterfeits: S. Swaminathan, CEO, GS1

The government of India is facing one of the most significant challenges in history. It has to undertake a vaccination drive which encompasses an unprecedented rapid mass development, distribution, and administration of Covid-19 vaccines. This has made it imperative that there are some guidelines for the healthcare supply chain to enable fast, efficient, and safe distribution of coronavirus vaccines. Also to fight against the counterfeiting of Covid-19 vaccines, there is a need for adoption of common standards including barcode scanning, This is the most important and under-discussed element in preventing vaccine distribution failures and ensuring traceability and patient safety in the COVID-19 vaccination campaign. In an exclusive conversation with the Financial Express Online S. Swaminathan, CEO, GS1 India talked about  vaccine traceability and strengthening anti-counterfeiting measures. Excerpts:

Why is vaccine traceability important to detect counterfeit COVID-19 jabs?

Vaccine traceability enables end-to-end visibility of the supply chain. It tracks the movement of a vaccine from manufacturing to the vaccination centre and also helps in monitoring the temperature at which the vaccine needs to be stored. With vaccine traceability in place, healthcare professionals administering the vaccine can validate vaccines at the point of inoculation. This helps in detecting and preventing counterfeit vaccines being inoculated and ensuring safety of patients.

How will it ensure equity in vaccine availability, which will be vital to ending the acute phase of the pandemic?

Visibility in the supply chain makes sure that every stakeholder has accurate and real-time information of vaccine movement, stocks, and inventory conditions across different locations. This real-time information on stock availability can help various healthcare stakeholders, including the government, to efficiently allocate the inventory and plan better vaccination drives.

How Global Standards bring transparency to relevant healthcare stakeholders (regulators, Central and State governments) with essential information, like stock and temperature patterns, and temperature breaches, allowing them to make rapid and informed decisions?

All vaccine manufacturers need to uniquely identify, capture data in standardised manner using 1D or 2D barcodes, across the packaging levels. This information can be shared in a consistent manner to enable end-to-end visibility in the supply chain. Trading partners can share essential information on consignment, including batch numbers, expiry date and temperature, etc., with simple scan of barcodes, in real time. This would detect whether there has been a temperature breach somewhere along the channel, and would also enable targeted and efficient recalls whenever required.

How will traceability help in tracking whether someone has an adverse reaction, which means any potential issues with vaccine safety can be immediately investigated?

Vaccine tracking makes it easier to identify the batch that was administered to the person experiencing an adverse reaction. This will provide information about other people as well who were vaccinated with the same batch. Individual factors can be a reason for the adverse reaction, but something being wrong with the batch can’t be ruled out. Hence, all batches should be tracked properly and the supply chain should be recall-ready at all times. Manufacturers can also track raw materials going into the manufacturing of vaccines.

S Swaminathan – CEO, GS1 India

Why is counterfeiting of Covid-19 vaccines a concern in India? How a harmonised framework for facilitating supply chain visibility will help in strengthening anti-counterfeiting measures, and facilitate the sharing of data between parties?

India has one of the largest vaccine drives. There is a huge gap in supply and demand. These circumstances are ideal for counterfeiters to get in to earn profits. A harmonized way of tracking the vaccine supply chain provides greater control over the visibility and movement of vaccines. Validating vaccines at every stage eliminates counterfeiting attempts and prevents any tampering. Efficient data sharing is necessary for strengthening anti-counterfeiting measures.

How can GS1 India support vaccine manufacturers, regulators and the Government to enable supply chain visibility and ensure authentication of a patient’s jab in the COWIN portal?

GS1 India provides necessary training and knowledge transfer sessions to manufacturers on how to secure supply chains and enable visibility of vaccine movement. We further provide implementation assistance in adoption of global best practices.GS1 India also publishes whitepapers on a regular basis for sharing knowledge with the industry and other healthcare stakeholders.

What should be the role of Vaccine Manufacturers in implementing the safety aspects on each Covid-19 vaccine distributed in India?

Vaccine manufacturers should put appropriate tracking systems in place to capture and share unique identification, batch ID and expiry date, to enable validation of vaccine at the point of inoculation. This enables visibility to the movement of vaccines and enables validation of vaccines to prevent counterfeits.

Do we have examples of implementation of global standards for vaccine traceability?

Global procurement organisations, including WHO and UNICEF, have recognized the use of global standards for traceability for improving visibility in the supply chain. Vaccine tenders backed by GAVI financing and issued by UNICEF are required to have GS1 barcoding on the secondary packages latest by 31st December 2021.UNICEF is providing vaccines to 92 low and middle-income countries on behalf of COVAX. This could be the world’s largest procurement and supply of Covid-19 vaccines and has sparked collaboration with manufacturers and partners from around the world.Also, the EU Regulatory system has released a Memorandum of Understanding with its member states on the regulatory flexibility of labelling and packaging for Covid-19 vaccines. This includes the use of global standards in 2D barcodes.