The Central Drugs Standard Control Organization (CDSCO) has initiated deliberations on a proposal to mandate Braille labelling on medicine strips. The move aims to address long-standing challenges faced by blind and visually-impaired individuals in identifying medications and reading critical information such as expiry dates.

Representations received by the Directorate highlighted the heavy reliance of visually-impaired persons on others to access basic information about medicines, potentially putting their health and safety at risk. In response, stakeholders have called for regulatory amendments under the Drugs and Cosmetics Act and Rules to include Braille inscriptions on drug packaging.

The matter was discussed during the 58th meeting of the Drugs Consultative Committee (DCC) held on 14 July, 2020. The committee, acknowledging the seriousness of the issue, recommended the formation of a sub-committee to study the proposal in depth.

Following the DCC’s recommendation, a sub-committee was constituted, which has since submitted its report. The report includes a series of recommendations aimed at improving medicine accessibility for the visually impaired, and is currently under consideration by the Directorate.

Officials say the move is in line with broader efforts to ensure inclusive healthcare and uphold the rights of persons with disabilities. Further announcements are expected following the review of the sub-committee’s findings as mentioned below:

• To support the ease of access of medication to the visually-impaired persons, this guideline regarding additional labeling in Braille language is proposed to 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 eyedrop preparations.
• Such braille labels are not applicable for the products dispensed/given under supervision of healthcare professionals e.g. injectable, vaccine, etc.
• The Braille artwork, as developed by manufacturer, should be got 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 l. 12 January, 2009, the type size should be as large as possible to aid readers. A type size of nine points, as measured in font 'Times New Roman' not narrowed with a space between lines of at least three nun, should be considered as a minimum.

The marketing authorisation holder may ensure that the package information leaflet is made available on request from patients/stakeholders in formats appropriate for the blind and the partially sighted. Issuance of advisory by the competent authority retailers jurisdictiontoguidesuchpopulationverballyaboutdosagenameindication and uses, along with other information, date,etc.that can be routinely followed up the by Enforcement Officers. Further, discussion on the sub-committee's report took place during the 66th DCC meeting held on 17 June, 2025. The DCC, after deliberation, opined that the recommendations of the sub-committee may be placed on the CDSCO website for public comments along with the points mentioned below:

• Secondary packaging containing more than 10 units of medicines may have some braille cards for giving to such population as and when required. 
• Medicines can have QR code linked with voice assistance.

The CDSCO has uploaded the sub-committee’s recommendations, along with additional suggestions, on its official website to seek public comments. All stakeholders are encouraged to review the proposals and submit their feedback via email to dci@cdsco.nic.in and de.dcita@cdsco.nic.in for further necessary action.