DCC Proposes QR Code Amendments for Comprehensive Drug Information

In its September 2023 meeting, the DCC suggested amending the November 17, 2022, notification mandating barcodes or QR codes for the top 300 drug brands. The proposed change aims to include information on all excipients within the QR code, starting with these top 300 brands.

In a recent development, the Drugs Consultative Committee (DCC) of the Union Health Ministry has recommended amendments to regulations mandating Quick Response (QR) codes for the top 300 drug brands. The proposed change aims to include information on all excipients used in the drug formulation, representing an initial step toward enhancing patient awareness and safety.

The move comes after the previous DCC meeting suggested issuing an advisory to drug manufacturers, encouraging them to voluntarily disclose details of excipients on drug formulations through various means. However, the latest DCC meeting acknowledged that mandating the inclusion of all excipients on product labels poses practical challenges and is not currently a mandatory requirement.

To address this concern, the committee proposed capturing information on excipients through QR codes or by incorporating the details in the package insert.

During its 62nd meeting in September 2023, the DCC recommended amending the November 17, 2022, notification that mandated barcodes or QR codes for the top 300 drug brands. The proposed amendment would ensure the QR code includes information on all excipients, at least for these top 300 brands initially.

The committee's decision was influenced by the acknowledgement of grievances related to the use of parabens, a type of preservative and excipient, in pharmaceutical products. Patients, particularly those with allergies to certain excipients, face inconvenience due to the lack of clear indications of excipient composition on medicine strips available in retail medical shops.

In response to these concerns, the DCC proposed adding details of excipients or International Numbering System (INS) codes of excipients on every medicine strip to alleviate the suffering of affected patients and consumers.

While the committee recognised the importance of providing details of excipients in package inserts, it noted the absence of a mandatory provision requiring manufacturers to include package inserts with drugs manufactured or marketed in the country. The criteria for mandating the inclusion of excipient details on drug formulations need thorough evaluation before implementation.

Taking an overall perspective, the committee, during its 61st meeting on June 1, 2023, recommended issuing an advisory to manufacturers, urging them to voluntarily disclose details of excipients on drug formulations through various means. This voluntary approach allows for flexibility while promoting transparency in providing crucial information to consumers.

As the DCC takes steps to enhance drug information disclosure, these proposed amendments reflect a balanced effort to address patient concerns, ensure safety, and maintain practicality within the pharmaceutical industry.

The potential inclusion of comprehensive excipient information through QR codes demonstrates a commitment to advancing transparency and empowering patients with essential knowledge about the medications they consume.