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The CDSCO has invited public comments on the proposal, marking a significant step towards improving accessibility for the visually impaired population
To support easier access to medication for visually impaired persons, the guideline on additional labelling in Braille is proposed to be implemented ‘initially voluntarily’ for drugs supplied in mono carton pack size—one of the most common packaging formats in the pharma, FMCG, and cosmetics industries. Representational image
Drug products likely to be used by a larger visually impaired patient group, such as certain “eye drop preparations”, could soon carry Braille labels, QR codes linked to voice assistance, or Braille cards in their packaging. The Central Drugs Standard Control Organisation (CDSCO) has invited public comments on the proposal suggested by the apex panel, marking a significant step towards improving accessibility for the visually impaired population.
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The move, earlier reported by News18, follows long-standing concerns that such patients struggle to identify medicines and expiry dates on strips, forcing them to depend on others for safe usage. To support easier access to medication for visually impaired persons, the guideline on additional labelling in Braille is proposed to be implemented “initially voluntarily” for drugs supplied in mono carton pack size—one of the most common packaging formats in the pharma, FMCG, and cosmetics industries.
What order says
“This directorate has received representations regarding problems faced by blind or visually impaired people in reading the strips of medicines. These special people face difficulty to know the name/expiry of the medicines and depend on others; therefore, they requested for a provision under the Drugs and Cosmetics Act and Rules to label the drugs with Braille inscriptions,” said the order issued by Drug Controller General of India, Rajeev Singh Raghuvanshi, on September 9.
The regulator is now inviting public comments on the proposal, which was heavily discussed by the apex panel, the Drugs Consultative Committee, in 2020 and 2025. The panel proposed that 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”.
“Such Braille labels are not applicable for the products dispensed or given under the supervision of a health care professional, for e.g. injectable, vaccine etc,” said Raghuvanshi’s order, quoting the proposals suggested by the Drugs Consultative Committee in 2020.
Apart from the DCC’s proposals, the DCGI has offered additional options for public consideration, including the use of QR codes linked with voice assistance and the inclusion of Braille cards in secondary packaging of medicines containing more than 10 units.
Proposal for easing drug choices for blind, partially blind people
According to the DCC recommendations, 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.
“Braille is not simply embossed dots—it follows a strict code. Any mistake in spacing, dot placement, or transcription can completely change the meaning. For medicines, errors could be dangerous, such as a wrong drug name or a wrong strength. Validation ensures the Braille printed is correct and readable by trained users,” said a senior government official, explaining the reason behind the recommendations, while requesting anonymity as he was not authorised to speak to the media officially.
Citing the European Commission guideline of the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use, the order issued by DCGI said, “The type size should be as large as possible to aid readers.”
It also added that the marketing authorisation holder—the one who will hold rights to market the drug or medicinal product—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.
“On a medicine pack, only limited information (usually the drug name and strength) can be embossed in Braille because of space constraints. Patients still need access to the detailed package leaflet—dosage instructions, side effects, storage conditions, warnings, etc—which is far too long to fit in Braille on a carton,” the officer said while adding that providing the leaflet in accessible formats (Braille booklet, large print, audio, or digital screen-reader compatible versions) ensures they have the same level of drug safety information.
The panel has also proposed the “issuance of an 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.”
However, the industry officials News18 spoke with were sceptical about whether every drugmaker would invest in it. “Since the move is not mandatory, drugmakers may be reluctant to adopt it given the added costs and design changes, though some larger firms could still view it as a step toward patient trust and corporate responsibility,” an industry veteran said.
About the Author
Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective. She is particularly pass…Read More
Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective. She is particularly pass… Read More
September 10, 2025, 07:00 IST
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