Download the notification: The Central government has mandated a Quick Response (QR) code on the label of all active pharmaceutical ingredients (APIs) manufactured or imported in India, at each level of packaging to enable tracking and tracing of the ingredients vide notification GSR No. 20(E) dt 18-01-2022.

Download the notification GSR No. 20(E) dt 18-01-2022.

The amendment Rule is scheduled to come into force from January 1, 2023.

The amendment to the Drugs Rules, 1945 in this regard was issued as final notification by the ministry of health and family welfare on January 18, 2022.

According to the notification, the new Rule, named Drugs (Amendment) Rules, 2022, inserts a sub-rule (5) after the existing sub-rule (4) under the Rule 96 of the Drugs Rules, 1945, related to the manner of labelling.

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The new sub-rule says, “Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store-data or information readable with software application to facilitate tracking and tracing”.

The stored data or information shall include the minimum particulars including unique product identification code, name of the API, brand name (if any), name and address of the manufacturer, batch number, batch size, date of manufacturing, date of expiry or retesting, serial shipping container code, manufacturing licence number or import licence number and special storage conditions required (if any).

The draft amendment to the Rule was published in the Gazette of India on August 8, 2019, inviting objections and suggestions from persons likely to be affected, within 30 days from the date of publication of the draft notification.

The copies of the Gazette were made available to the public on August 10, 2019 and the objections and suggestions received from the public on the Rules were considered by the Central government before publishing the final notification now.

The authorities have been considering options to implement technology to track and trace the drugs and raw materials in the last few years.

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The Drugs Technical Advisory Board (DTAB), in its meeting in November, 2021, has recommended the introduction of barcodes or QR codes 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.

In a meeting held in May, 2018 also, it deliberated the same matter and agreed for introduction of trace and track mechanism for major 300 pharmaceutical brands on a voluntary basis.

It was only based on its recommendations, the draft notification in August, 2019 was issued. However, a number of objections were raised from the industry, which were examined by the government.

Following this, 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.

In the DTAB meeting in November, it was also 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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