Braille labels on medicines may soon be a reality

India’s drug regulator, CDSCO, is considering mandatory Braille embossing on medicine packaging to aid the visually impaired. Recommendations include voice-assisted QR codes, Braille cards for bulk packs, and retailer guidelines to ensure greater accessibility and independence in healthcare

Hyderabad: In a novel attempt to ensure healthcare is accessible and inclusive, especially for the visually challenged, India’s drug regulatory authorities are paving the way for mandatory Braille embossing on medicine packaging. The initiative will go a long way in helping the blind, who depend on their guardians and caretakers to take medication.

Going beyond just Braille packaging, attempts are on to introduce novel concepts like voice-assisted QR codes and other prevalent modern technologies aimed specifically to guide visually-impaired individuals to procure medicines on their own from the drug store.

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Embossing medicine packets with Braille to help blind people properly go through the labelling is mandatory in the European Union. The EU has standardised this approach, as Braille is typically embossed on the outer/secondary packaging of the medicine by drug manufacturers.

Recently, the Central Drugs Standards Control Organization (CDSCO), the regulatory body for drugs, medical devices and cosmetics in the country, released recommendations by a committee, which conducted a study on the matter.

The Committee in its report recommended that Braille should be implemented on a voluntary basis on drugs, such as eye drops, which are used in high numbers by the visually impaired.

The Committee also noted that Braille labels would not be required for products administered under professional supervision such as injections and vaccines. It added that Braille artwork must be validated by a nodal agency like the National Institute for the Empowerment of Persons with Intellectual Disabilities (NIEPID) or a similar approved body.

The recommendations referenced European Commission guidelines on font size for package leaflets, recommending a minimum of 9 points in ‘Times New Roman’ font.

“Manufacturers should be prepared to provide package information leaflets in formats suitable for the blind and partially sighted upon request. A guideline should be issued for retailers to verbally inform visually-impaired customers about the medicine’s dosage, name, uses, and expiry date,” the Committee said.

The Committee further recommended that secondary packaging containing more than 10 units of medicine should include Braille cards for distribution. It also proposed that medicines should feature QR codes linked with voice assistance to provide information. The CDSCO is expected to take a decision on the recommendations in the coming months.