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DCGI seeks public comments on proposal to add braille language on drug labels
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Our Bureau, New Delhi
September 11 , 2025
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The Central drug regulator is contemplating inclusion of labelling in braille language, starting on a voluntary basis, on the packaging of medicines in order to help the visually impaired people.
The Drugs Controller General (India), Dr Rajeev Singh Raghuvanshi, has released proposals in this regard, including one for inclusion of Quick Response (QR) code linked with voice assistance, seeking public comments, especially from the stakeholders.
The proposals were put forward by a sub-committee appointed by the DCGI following a recommendation from the Drugs Consultative Committee meeting on July 14, 2020, to come up with possible solutions.
The sub-committee proposed additional labelling in braille language, to support the ease of access of medication to the visually impaired persons, be implemented "initially on voluntary basis" for the drugs which are supplied in mono carton pack size.
"Particular consideration should be given to medicinal products likely to be used by a high visually impaired target population, e.g. certain eye drop preparations," proposed the sub-committee in its report submitted to the DCC.
The DCC in its recent meeting, directed the DCGI to publish the recommendations along with two additional points, and seek public comments.
Such braille labels are not applicable for the products dispensed under supervision of health care professional's - such as injectable, vaccine etc.
The Braille artwork as developed by the manufacturer should be validated from the nodal agency like National Institute for the Empowerment of Persons with Intellectual Disabilities (NIEPID) through the Braille Council of India (BCI) or any other agency recommended by the NIEPID.
As per the European Commission guideline of the Readability of the Labelling and Package Leaflet of Medicinal Products for Human use Revision I. 12 of January 2009, the type size should be as large as possible to aid readers.
"A type size of 9 points, as measured in font 'Times New Roman' not narrowed, with a space between lines of at least 3 nun, should be considered as a minimum," it added.
The marketing authorisation holder may ensure that the package information leaflet is made available on request from patients or stakeholders in formats appropriate for the blind and the partially sighted.
Competent authority should issue an advisory to the retailers under their jurisdiction to guide the population who are visually impaired, verbally about the dosage form, name of the medicines, indication and uses along with any other information like expiry date etc., that can be routinely followed up by the Enforcement Officers.
Considering the sub-committee report in its latest meeting held on June 17, 2025, the DCC added that the secondary packaging containing more than 10 units of medicines may have some braille cards for giving to such population as and when required. Besides, medicines can have QR code linked with voice assistance, it added.
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