From Braille To Voiceover QR Labels - Drug Regulator Bats For Inclusion

(MENAFN- Live Mint) New Delhi: Over six million visually impaired Indians could soon access their medicine details through voiceovers. In addition to Braille labels--reported by Mint earlier--the Central Drugs Standard Control Organization (CDSCO) has proposed mandatory QR codes with voice assistance on medicine packs to help visually-impaired people, who struggle to identify crucial medication details.

The CDSCO, India's primary regulatory body for pharmaceuticals, initiated the move after receiving numerous complaints regarding the problems faced by visually-impaired people in accessing medicine details--including the name and expiry date, which often made them dependent on others.

The regulator has invited stakeholder feedback on the recommendations.

In a statement on 9 September, the Drugs Controller General (India), Dr Rajeev Singh Raghuvanshi said this is an important step towards greater accessibility and patient safety.

Also Read | India may soon have Braille labelling on medicines

The issue was first brought up for discussion at the 58th Drugs Consultative Committee (DCC) meeting in July, 2020. The advisory committee that works to ensure uniform drug administration across the country recommended forming a sub-committee to study the matter. In June this year, the sub-committee made several recommendations, including the one on an additional labeling in Braille to be implemented on a "voluntary basis" for drugs sold in mono-carton packs.

The suggestions added by the DCC at its June meeting are significant.“The secondary packaging for medicines containing more than ten units may have some Braille cards for giving to such a population as and when required. Medicines can have QR codes linked with voice assistance,” the DGCI communication said to all the relevant stakeholders.

“This comprehensive approach reflects the government's commitment to making medicines safer and more accessible for a large part of the population. By seeking public comments, the CDSCO aims to ensure that the final guidelines are well-rounded and effective, marking a major step forward for pharmaceutical safety and public health in India,” said an official familiar with the matter.

'Progressive step'

Dr Sanjiv Gupta, director and a senior eye surgeon at i Care Centre in New Delhi, said the CDSCO's initiative to introduce QR codes with voice assistance on medicines is a progressive step towards inclusive healthcare.

“A voice-enabled system to QR codes can provide real-time, accurate information about dosage, expiry date, and safety instructions. This will empower visually-impaired individuals in India to take medicines independently, reduce dependency, and most importantly, minimize the risk of medication errors," Dr Gupta said. "For healthcare providers, it offers greater assurance that patients are adhering to prescriptions safely. This initiative is not just about technology; it's about dignity, inclusivity, and patient safety.”

The DCGI said special attention would be given to medicinal products frequently used by visually-impaired people. These include certain eye drop preparations.

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The proposal, however, specifies that these labels would not apply to products given under the supervision of a healthcare professional. These include injectables and vaccines.

The sub-committee had also recommended that a minimum font size of 9 points, similar to European guidelines, should be considered for printed text on medicine packs to assist partially vision-impaired individuals.

On the Braille label proposal, it said the artwork developed by manufacturers would need to be validated by a nodal agency such as the National Institute for the Empowerment of Persons with Intellectual Disabilities (NIEPID).

Queries sent to the health ministry spokesperson on these proposals remained unanswered till press time.

Also Read | Why the drug regulator is looking to redesign medicine labels

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