Last Updated on January 6, 2024 by The Health Master
Download notification No. 448(E) dated 14-06-2022, link is given below: Centre has issued a draft Rule vide notification No. 448(E) dated 14-06-2022, amending a certain rule in the Drugs Rules, 1945, for mandating Barcode or Quick Response (QR) code on the label of top 300 brand of drugs from May 1, 2023.
The move is in line with the recommendation of the Drugs Technical Advisory Board (DTAB) in November last year, in the top 300 brands to track and trace them through the manufacturing and supply chain.
The draft Rule introduces a new Schedule H2 with a list of 300 top brands, and inserts a new sub-rule under the Rule 96, under the Drugs Rules, 1945, after the sub-rule (5).
According to the proposed new sub-rule named as (5A), the manufacturers of drug formulation products specified in the schedule H2 of the rule, shall print or affix Barcode or QR code on its primary packaging label or, in the 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.
The store data or information shall include the particulars including unique product identification code, proper and generic name of the drug, brand name, name and address of the manufacturers, batch number, date of manufacturing and date of expiry along with the manufacturing license number.
The list of 300 drugs included in the Schedule H2 include:
- Certain strengths of Aciloc,
- Actemra,
- Allegra,
- Amlokind,
- Ascoril D Plus New,
- Asthalin inhaler,
- Becosules Capsules,
- Betadine ointment,
- Solution and gargle,
- Calpol,
- Combiflam,
- Dolo 650 mg,
- Electral Sache,
- Fabiflu,
- Foracort,
- Gelusil,
- Glycomet,
- Janumet,
- Lantus.
Objections and suggestions from any person within a period of 30 days will be considered by the Central government, following which draft rule shall be taken for consideration and issueance of final notification.
The Drugs Technical Advisory Board (DTAB), in its last meeting held in November, 2021, 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.
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.
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