The Central Drugs Standard Standard Control Organization (CDSCO) has issued a notice inviting public comments on a proposal to introduce Braille inscriptions on medicine strips to assist blind and visually impaired people.
The initiative follows representations highlighting the difficulty these individuals face in independently identifying the name and expiry date of their medicines. The issue was deliberated in the 58th Drugs Consultative Committee (DCC) meeting, which recommended constituting a sub-committee for a detailed examination.
Sub-Committee Recommendations
The sub-committee submitted its report with the following key recommendations for consideration:
The additional Braille labeling should be implemented “initially on a voluntary basis” and only for drugs supplied in mono carton pack sizes.
Particular consideration should be given to medicinal products likely to be used by a high visually impaired target population, such as certain eye drop preparations.
Braille labels are not applicable to products dispensed or administered under the supervision of a healthcare professional, such as injectables and vaccines.
The Braille artwork developed by the manufacturer must be validated by a nodal agency like the National Institute for the Empowerment of Persons with Intellectual Disabilities (NIEPID) through the Braille Council of India (BCI) or another recommended agency.
Reference is made to the European Commission guideline, which suggests that the type size for labeling should be as large as possible to aid readers, with a minimum type size of 9 points (as measured in ‘Times New Roman’ font).