Mar 11,2024
The Drugs Technical Advisory Board (DTAB) has recommended affixing bar code or quick response (QR) code on all vaccine products, as part of obtaining the benchmarking maturity levels required under the upcoming World Health Organisation (WHO) Global Benchmarking of vaccines. It also recommended that the tracking mechanism be extended to all antimicrobials, and narcotic and psychotropic substances in a phased manner.
The recommendation comes at a time when the Indian drug regulator is preparing for the WHO benchmarking, which is a process of assessment of National Regulatory Authority (NRA) based on Global Benchmarking Tools (GBT) done by a team from WHO. Global Benchmarking of vaccines is the tool followed by WHO that involves the implementation of various regulatory functions at relevant institutes of India including CDSCO as NRA.
In India, the last NRA assessment was carried out by WHO in the year 2017. As a prerequisite of WHO prequalification programme of vaccine, the Organisation has communicated for benchmarking of Indian NRA and the Central Drugs Standard Control Organisation (CDSCO) and the State regulators in near future and the regulators has to prepare for the same at the earliest.
A DTAB meeting held in January, this year, observed thawt marketing surveillance and control is one of the important function amongst the nine functions of WHO Benchmarking tool audited by WHO NRA assessment team and one of the indicator is regarding the legal provisions or regulations exist in the country for placement of product’s unique identification number (UIN) on its outer packaging.
The Maturity Level 4 of the marketing and surveillance standards under GBT requires the NRA to make legal provision or regulations for affixing of UIN on outer packaging of each vaccine product.
“DTAB deliberated the matter and agreed for the proposal to affix Bar Code or Quick Response Code on all vaccine products. Further the same may be extended to all antimicrobials, narcotic & psychotropic substances in a phase wise manner,” said the Board after the latest meeting.
The Board also recommended that implementation of the existing system of QR code in the states for top 300 brands shall also be monitored.
It may be noted that the government has already mandated affixing QR code on labels of 300 brands of different products through a notification in November, 2022 and it was implemented from August 1, 2023.
“The manufacturers of drug formulation products as specified in Schedule H2 shall print or affix bar code or quick response code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication,” said the notification.
The list of 300 brands which has the QR code include seven vaccine brands including Pfizer’s Prevnar 13 injection 0.5 ml, Panacea Biotec’s Easy Six Prefilled Syringe 0.5 ml, GlaxoSmithkline Pharma’s Varilrix injection 0.5 ml, Synflorix injection 1, and Infanrix Hexa injection 0.5 ml, and Sanofi India’s Menactra injection 0.5 ml and Hexaxim injection 0.5 ml.
However, to fulfil the requirements of sub indicator 1.05 of function “Marketing Surveillance and Control” under Global Benchmarking Tools for Maturity Level 4, it is required to make legal provision/regulations for affixing of unique identification number on outer packaging” of each vaccine product, observed the DTAB.
Source: Pharmabiz