New Delhi: The Drugs Consultative Committee (DCC) of the Union health ministry has recommended to the national drug regulator to amend the regulation mandating Quick Response (QR) code for the top 300 brands in order to include the information on all the excipients used in the drug formulation.
This is expected to be an initial step to mandate mentioning of all the excipients along with the product package, in order to help the patients.
While the previous DCC meeting recommended issuance of an advisory to the manufacturers for mentioning details of excipients on drug formulation by various means/modality on voluntary basis, the latest meeting of the DCC considered the point that mentioning of all the excipients on the product label is a practical challenge and there is no mandatory requirement.
The Committee, considering the point, suggested for capturing this information through the QR code or by capturing these information in the package insert.
As part of this, the DCC in its 62nd meeting held in the end of September, 2023, recommended that the notification issued on November 17, 2022 mandating bar code or QR code for all top 300 brands may be amended for capturing the requisite information in the QR code at least for these top 300 brands initially.
In the 61st meeting of the DCC, held on June 1, 2023, it was apprised about the grievance received on the usage of parabens in pharmaceutical products as preservatives, which is one of the product used as excipients.
There is no clear cut indication of composition of excipient on strips of medicines available on retails medical shops which causes inconvenience to the patients who are allergic to such excipients, it noted.
The proposal requested the Committee to rectify this problem to stop suffering of such patients/consumers and suggested to add details of excipient or INS codes of excipient on every strip of medicines, it added.
The Committee deliberated that the details of the excipients should be in the package inserts of the medicines. However, presently there is no provision which make it mandatory for the manufacturers to provide package inserts along with the drugs manufactured/marketed in the country, it observed.
The criteria to mandate mentioning of the details of excipients on drug formulations have to be evaluated at length for its implementation.
Considering overall perspective, the committee in the 61st meeting recommended to issue an advisory for mentioning details of excipients on drug formulation by various means/modality on voluntary basis.
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