In a significant move aimed at enhancing patient safety and awareness, the Drugs Consultative Committee (DCC) under the Union health ministry has recommended amendments to the regulation mandating Quick Response (QR) codes for the top 300 drug brands. The proposed change includes comprehensive information on all excipients used in the drug formulation.
Recognizing the importance of transparency in drug information, the DCC’s latest meeting considered the practical challenges associated with mentioning all excipients on the product label. In response, the committee proposed capturing this vital information through QR codes or by including it in the package insert.
The 62nd meeting of the DCC, held in late September 2023, recommended amending the November 17, 2022, notification that mandated barcodes or QR codes for the top 300 brands. This amendment aims to ensure that the QR codes of these top 300 brands encompass essential information about excipients, marking an initial step towards broader patient-centric drug information.
During the 61st DCC meeting on June 1, 2023, concerns were raised regarding the usage of parabens in pharmaceutical products as preservatives, posing challenges for patients allergic to such excipients. The absence of a clear indication of excipient composition on medicine strips in retail medical shops was identified as a source of inconvenience for patients.
To address this issue and alleviate the suffering of affected patients, the committee proposed adding details of excipients or International Numbering System (INS) codes on every strip of medicines. The committee recognized the absence of a mandatory provision for manufacturers to provide package inserts along with drugs in the country, emphasizing the need for evaluating criteria to mandate excipient details on drug formulations.
In light of the overall perspective, the 61st meeting recommended issuing an advisory for manufacturers to voluntarily include details of excipients on drug formulations through various means or modalities. This forward-thinking approach reflects the committee’s commitment to fostering transparency and ensuring patient safety in the pharmaceutical landscape.
Stay tuned for further developments as the DCC progresses in implementing these crucial recommendations to enhance drug information accessibility and patient well-being.
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