India weighs braille labels and QR codes on medicines to aid visually impaired

India’s drug regulatory authority has invited public comments on improving access to medicine by introducing braille cards and voice-assisted QR codes on pharma packaging.

The country’s Central Drugs Standard Control Organization (CDSCO) proposes the initiative due to the difficulties faced by blind and visually impaired people in identifying medicines as well as tablet and capsule strips. 

In India, nearly eight million individuals are blind and 62 million are visually impaired, accounting for almost a quarter of the global total of vision impairment, according to the National Medical Journal of India.

“These special peoples face difficulty to know the name and expiry of the medicines and depend on others. We request for a provision under the Drugs and Cosmetics Act and Rules to label the drugs with braille inscriptions,” says CDSCO.

Standard formats

A sub-committee was constituted on the Drugs Consultative Committee to examine the issue. Its report suggests several measures, such as including braille cards to secondary packaging of medicines with more than 10 units (where required) and providing QR code linked to voice assistance.

The use of braille labeling on medications may reduce medications errors.The Braille artwork developed by the manufacturer should also be validated from the nodal agencies, such as the National Institute for the Empowerment of Persons with Intellectual Disabilities through the Braille Council of India.

The recommendations suggest drawing lessons from the European Commission’s Guideline of the Labelling and Package Leaflet of Medicinal Products for Human Use, ensuring larger type sizes and a standardized format for space between lines.

Improving user-friendliness

Marketing authorization holders need to ensure that the package information leaflet is made available on request from patients or stakeholders in accessible formats for the blind and partially sighted, according to recommendation.

“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 a voluntary basis’ for the drugs, which are supplied in mono carton pack size,” says CDSCO.

Patient-centric design is becoming a key trend in global pharma packaging as the industry witnesses a rise in self-medication. 

For medicinal products likely to be used by a high visually impaired population, such as certain eye drop preparations, the sub-committee suggests that particular consideration should be given in the label and packaging design. 

However, the recommendations state that the products dispensed or given under supervision of health care professional’s, including injectable and vaccine solutions, braille labels should not be applicable.