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CDSCO affirms that all batches of 300 brands of drugs notified should carry QR code from August 1
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Gireesh Babu, New Delhi
July 27 , 2023
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With the rule on printing barcode or Quick Response (QR) code on the label of top 300 brand drugs to be implemented from August 1, 2023, the drug regulator affirmed that any batch of brands of drug formulations as specified in its notification and manufactured on or after the stipulated date, irrespective of the manufacturing site, shall have the barcode or QR code on its label.
On November 17, 2022, the Union health ministry had issued final notification amending the Drugs Rules, 1945, mandating barcode or Quick Response (QR) code on the label of top 300 brand of drugs from August 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 Central Drugs Standard Control Organisation (CDSCO) added that in case of imported products, they should preferably be imported with affixed or printed Barcode or QR code on the label. However, the code may be affixed on the label in the country after obtaining the permission from the licensing authority as required under the Drugs Rules, 1945, it added.
As per the notification, the manufacturers of drug formulation products as specified in the Schedule H2 shall print or affix barcode or QR code which shall have particulars including unique product identification code, proper and generic name of the drug or the brand name, name and address of the manufacturer, batch number, date of manufacturing, date of expiry and manufacturing licence number.
The unique product identification code shall be decided by the manufacturer as per their own Standard Operating Procedure to ensure the identification of the product. While it is mandatory to print the code on these 300 brands, if any manufacturer voluntarily wants to affix or print the code for any other brand, they are free to do so, said the regulator in a response to Frequently Asked Questions (FAQs) prior to the implementation of the amended rule.
“The notification is applicable for all the indigenous as well as foreign manufacturers who are manufacturing these brands of drug formulations for marketing in the country,” it added.
In case if the space in the primary packaging label is inadequate to carry the code, the same may be affixed or printed on the secondary package label.
It may be noted that 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, among others.
The DTAB, in its 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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