Experts express need for traceability of COVID-19 vaccines

Say it won’t add much to cost of vaccine, will bring end-to-end traceability in supply chain

Industry experts have urged the government bodies to consider the need to incorporate an end-to-end traceability mechanism on all COVID-19 vaccines. They reason that it is the need of the hour to build a supply chain that has visibility and enhanced effectiveness to ensure that the largest feasible portion of India’s population benefits from the initial limited supplies.

Experts are suggesting that the government makes it mandatory for vaccine manufacturers to implement serial numbers, bar codes and a systems driven end-to-end traceability and tracking system, which will monitor the distribution channel, quality of drug, patient safety, counterfeiting etc.

As per GS1, the benefits of linking a traceability mechanism with the product and patient id i.e, (Aadhaar/National Digital Health ID) are:

• Real-time knowledge and recording of what (batch number, vaccine unit and dosage) is administered to whom (patient) with the help of linking unit and dosage of vaccine with digital ID/Aadhaar number.

• Ability for swift and targeted recalls, whenever required

• Real-time knowledge of what stocks are lying where in the supply chain, from the point of manufacturing to point of dispensing

• Real-time monitoring and recording of temperature to ensure that the right temperature is maintained throughout the supply chain – storage as well as transportation.

• Enable counterfeit detection at the point of entry in the supply chain and mitigation of risks through investigating.

Emphasising on the need, S Swaminathan, COO, GS1 India said, “We need to implement IT-enabled traceability systems encompassing all supply chain stakeholders (manufacturers, distributors, stockists, chemists, hospitals, etc). This would enable all of them to capture and share consignment information to enable complete end-to-end visibility – from the point-of-manufacturing to the patient.”

Streesing on the need for a traceability mechanism for COVID-19 vaccine, Prof. Bejon Kumar Misra, Founder Director, Patient Safety and Access Initiative of India Foundation (PSAIIF) said, “Vaccines against corona virus must have a non-clonable tracing and tracking system embedded in the vials to ensure misuse, diversion, safety, counterfeiting and quality. Patient safety and quality of vaccines are paramount and distribution must adopt the best pharmacy and distribution practices. I do not find any conversation in this regard by the policy makers and on behalf of patients, we wish to intervene (and give the) heads up on distribution practices and accepted protocols prior to the arrival of the vaccines. It is not only who will get first but more on whoever gets vaccinated they must access the right vaccine and assured 100 per cent efficacy to the beneficiaries. In this regard, PSAIIF intends to facilitate the government in developing the right mechanism and fully insulated distribution on a fast track mode with use of technology and all stakeholders’ engagement.”

Sachin Taparia, Chairman and CEO, LocalCircles commented, “Tracing and tracking is critical to ensure quality and safety and eliminate black marketing and counterfeiting. LocalCircles had requested the Government in July this year to implement a unique serial number on every vial with barcode approach such that it can be tracked till the time it is administered to a citizen with their Aadhaar number. With such tracking unused vials in a hospital or public health facility can be re-routed back into the supply chain or alternate facility and prevent black marketing.”

He continued, “We had received a confirmation from the pharma department after our letter that they will be seriously considering this and that NPPA will be the evaluation agency. The recent announcement made about the digital platform for vaccine tracking is an initiative towards our ask. We are yet to hear from the Government about the exact stage that they are at. They however at the earliest must mandate unique serial number for each COVID-19 vaccine vial and vial tracking from factory to citizen administration for all manufacturers.”

Commenting on the cost aspect, Taparia added, “As per our estimates, the cold chain cost aside, the cost for just track and trace of vials with serial number and bar coding is less than a rupee per vial so it’s negligible. Many US pharma companies already do this at a global level.”

Swaminathan informed, “Vaccine manufacturers have already adopted track and trace systems using GS1 standards based on importing country requirements. They have to extend the same to their domestic supply chains. There is no additional cost to use standards in domestic market. All they have to do is to capture and share the information in a standardised format to enable supply chain visibility and traceability.”

Mahesh Bhalgat, Chief Operating Officer, Syngene International said, “Covid vaccine tracking is more complex than the usual track and trace. There is a need to address counterfeiting but also the need to ensure that people who get first dose from one company get the correct second dose. Then there is the need to make sure storage till the last mile is correctly done when the volumes being managed are so large. Then there is the component of who pays for the extra track and trace costs as well as Vaccine Vial Monitor costs where applicable.”