DTAB was apprised that WHO Benchmarking is a process of assessment of National Regulatory Authority (NRA) based on Global Benchmarking Tools (GBT) done by team from WHO. Global Benchmarking of vaccine is the tool followed by WHO that involves the implementation of various regulatory functions at relevant institute 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, WHO has communicated for benchmarking of Indian NRA. Therefore, it is required to prepare for the same by CDSCO and State Regulators.
Marketing Surveillance and Control is one of the important function amongst the nine functions of WHO Benchmarking tool audited by WHO NRA assessment team. Under the above function, there is sub-indicator MC 1.05 which is as below; - “MC01.05: Legal provisions and/or regulations exist for placement of a product’s unique identification number on its outer packaging” under first indicator “MC01: - Legal provisions, regulations and guidelines required to define regulatory framework of market surveillance and control activities”.
In this regard, Government of India vide Gazette notification GSR 449 (E) dated 3rd June 2015 published a draft rule for tracking and tracing of product which was not finalized. Further, gazette notification vides no. GSR 20 (E) was published on 18th Jan, 2022 for bearing “Quick Response Code” on label at each level of packing for Active Pharmaceutical Ingredients.
Further, draft gazette notification vide no. GSR 448 (E) was published on 14th June, 2022 which was finalised vide no. GSR 823 (E) dated 17th November, 2022 which is reproduced as below: - “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.
This is applicable for 300 brands of different products, inserted as Schedule H2 after Schedule H1 and this includes 7 brands of vaccines as EASY SIX PREFILLED SYRINGE 0.5 ML; HEXAXIM INJECTION 0.5 ML; INFANRIX HEXA INJECTION 0.5 ML; MENACTRA INJECTION 0.5 ML; PREVENAR 13 INJECTION 0.5 ML; SYNFLORIX INJECTION; VARILRIX INJECTION 0.5 ML
This rule has become effective from 1st August 2023. 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.
In view of the above, it has been proposed to meet the WHO expectation in the GBT and obtain Maturity Level 4 in the sub indicator 1.05 of function “Marketing Surveillance and Control” under Global Benchmarking Tools, it is required to affix unique identification number 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. The Board also recommended that implementation of the existing system of QR Code in the states for top 300 brands shall also be monitored.
