Synopsis;

– The Drugs Technical Advisory Board (DTAB) has recommended introduction of barcode or QR code in the top 300 brands of drug products available in the Indian market to help track and trace these brands, in line with the discussions it has been carrying out in the last couple of years. It has also decided to withdraw the draft rules issued by the ministry of health and family welfare (MoHFW) on June 3, 2015, related to barcoding.

The Drugs Technical Advisory Board (DTAB) has recommended introduction of barcode or QR code in the top 300 brands of drug products available in the Indian market to help track and trace these brands, in line with the discussions it has been carrying out in the last couple of years. It has also decided to withdraw the draft rules issued by the ministry of health and family welfare (MoHFW) on June 3, 2015, related to barcoding.

The DTAB meeting held after it was reconstituted in October, 2021, while deliberating on the issue, “recommended for introduction of barcode/QR Code in the top 300 brands of the drug products and also to withdraw the earlier draft notification issued in this regard vide G.S.R 449(E) dated June 3, 2015”.
During the meeting, the Board was apprised of the draft rules, which could not be finalised as many of the pharmaceutical companies showed their inability to introduce this sophisticated technology in their manufacturing processes. It was however observed that some of the pharmaceutical companies have already introduced bar coding systems in some of the brands.

The DTAB, in an earlier meeting held in May, 2018, deliberated the matter and agreed for introduction of trace and track mechanism for major 300 pharmaceutical brands on a voluntary basis. The Board then informed that an order may be issued by the Drug Controller General (India) to all the concerned to this effect.
Following this, the MoHFW has published a draft notification August, 2019, mandating QR code for active pharmaceutical ingredients (APIs) only based on the recommendations of a DTAB meeting. A number of objections were raised from the industry, which are being examined, said the minutes of the 87th Board meeting held on November 8 through video conference. The meeting chaired by Dr Sunil Kumar, Director General of Health Services had other 12 members attended apart from a CDSCO representative.
The MoHFW constituted an Inter-Department Committee (IDC) on July 13, 2020 on the issue of implementation of barcode/QR code on packing of drugs including medical devices and as per its recommendations, the implementation of authentication mechanism for the top 300 drug formulation brands in the first phase was decided to be taken up
A roadmap was also prepared to complete identification of the top 300 brands using technologies that can be used including cost, procurement of hardware, changes in packing lines and packing materials etc., and complete stakeholder consultation, obtaining their comments and rollout for top 300 brands and all items meant for government procurement, in systematic manner. It has also decided to constitute a committee to execute these activities.

Accordingly, it was proposed to consider the introduction of QR code in phase-wise manner, so that trace and track mechanism by QR coding system on packaging may be implemented initially for the top 300 brands through amendment in the Drugs Rules, 1945.

Simultaneously, it was decided to withdraw the draft notification issued in 2015, regarding track and trace mechanism through two dimensional barcode encoding unique and universal global product identification code in the 14 digits global trade item number format along with batch number at primary level packaging, one or two dimensional barcoding in secondary level packaging and one dimensional barcoding at tertiary level packaging.

 

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