|
DTAB recommends excipients causing high sensitivity to be mentioned on drug labels
|
|
Gireesh Babu, New Delhi
March 28 , 2024
|
|
|
The Drugs Technical Advisory Board (DTAB) has suggested to the drug regulator to prepare a list of excipients causing hypersensitivity, to be considered for mentioning on the label of medicines while agreeing to an earlier recommendation of the Drugs Consultative Committee (DCC) to capture the details of the excipients in the Quick Response (QR) code for the top 300 brands.
The DTAB, in its 90th meeting in January, was considering a proposal to incorporate provision for inclusion of details of excipients on every strip of medicine.
The latest recommendation is initiated after a grievance was received by the authorities that the parabens are used in pharmaceutical products as preservatives, which is one of the products used as excipients.
There is no clear cut indication of composition of excipient on strips of medicines available on retails medical shops and he is unable to find paraben free antihypertensive medicines. Many other people may also be allergic to other excipient also. The applicant has requested to rectify this problem to stop suffering of many people like him and suggested to add details of excipient or INS codes of excipient on every strip of medicines.
The proposal was deliberated in the 61st DCC meeting where the committee deliberated the matter that details of the excipients should be in the package inserts of the medicines. However, presently there is no provision which makes it mandatory for the manufacturers to provide package inserts along with the drugs manufactured/marketed in the country. 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 after detailed deliberation recommended issuing an advisory for mentioning details of excipients on drug formulation by various means/ modality on a voluntary basis.
However, DCC in its 62nd meeting held in September, 2023 while reviewing the Action Taken Report of 61st DCC recommended that mentioning of all the excipients on the product label is a practical challenge and there is no mandatory requirement.
DCC deliberated and suggested for capturing this information through the QR code or by capturing this information in the package insert. DCC recommended that the notification issued on November 17, 2022 mandating barcode 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.
DTAB, in its latest meeting, deliberated the matter and opined that it is difficult to include the details of all excipients on every strip of medicines. Further the Board also suggested preparing a list of excipients causing hypersensitivity which may be considered for mention on the label.
“However, DTAB agreed for the proposed amendment with regard to capturing the requisite information in QR code for top 300 brands,” it added.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|