Braille Labels, QR Code Voice Assistance on Drugs? CDSCO Seeks Stakeholder Comments

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has invited public comments on a proposal to make medicines more accessible to blind and visually impaired patients by introducing Braille labelling and QR code-based voice assistance on drug packs, following recommendations of the Drugs Consultative Committee (DCC) and a subcommittee that examined the issue in detail.

The initiative comes in response to representations highlighting the difficulties faced by visually impaired people in identifying medicines and expiry details on strips, often leaving them dependent on others.

In view of the above, the issue was deliberated in the 58th Drugs Consultative Committee (DCC) meeting on 14.07.2020, which recommended constituting a subcommittee to examine the issue in detail for further consideration.

Also Read: Govt panel proposes braille cards voice enabled QR codes on medicine packs to aid visually impaired

In continuation, a subcommittee was constituted on DCC recommendation, which had submitted its report and recommended the following points for consideration:

1. 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.

2. 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.

3. Such braille labels are not applicable for the products dispensed/given under supervision of health care professional's e.g. Injectable, Vaccine etc.

4. The Braille artwork as developed by the manufacturer should be validated by the nodal agency, like the 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.

5. As per the European Commission guideline of the Readability of the Labelling and Package Leaflet of Medicinal Products for Human use Revision I, 12 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 mm, should be considered as a minimum.

6. The marketing authorization 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.

7. Issuance of advisory by the competent authority for the retailers under their jurisdiction to guide such population 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.

Further, discussion on the subcommittee's report took place during the 66th DCC meeting held on June 17, 2025.

The DCC, after deliberation, opined that the recommendations of the subcommittee may be placed on the CDSCO website for public comments along with the below-mentioned additional points:

1. Secondary packaging containing more than 10 units of medicines may have some Braille cards for giving to such a population as and when required.

2. Medicines can have QR codes linked with voice assistance.

The CDSCO has now uploaded the recommendations on its website, inviting feedback from stakeholders and stated,

"The recommendations of the subcommittee, etc., are uploaded on CDSCO website for seeking public comments in the matter and all stakeholders may send their comments to the email id's: dci@cdsco.nic.in., and dccdtab@cdsco.nic.in for further necessary action in the matter."

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/inviting-comments-wrt-visually-impaired-people-300497.pdf