Drug regulator pushes for Braille labelling on medicines
The Drugs Controller General of India (DCGI) is considering these changes based on a report of a subcommittee that recommended introducing Braille labelling for drugs packaged in mono cartons and for those frequently used by the visually impaired, such as eye drops.
'Currently, there is no labelling provision in the Drugs and Cosmetics Act and Rules that considers the needs of blind or visually impaired people," the panel recommended. 'As a result, this special category of people finds it difficult to know the name and expiry date of medicines. Therefore, a provision should be made to label drugs with Braille inscriptions."
The recommendations stem from a 2020 representation highlighting the difficulties visually-impaired individuals faced when trying to read medicine strips. The subcommittee was first constituted in 2020 and then reconstituted in October 2024 under KR Chawal, Drug Controller and Licensing Authority of Delhi, along with three more members.
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An added benefit
The committee report also said that Braille labelling will help combat counterfeit drugs. 'Braille fonts on drug pack labels are unique and difficult to copy, which could significantly reduce the incidence of drug duplication and spurious products in the market," according to the documents of the 66th Drugs Consultative Meeting (DCC) reviewed by Mint.
India's spurious or counterfeit medicine drug sales are valued at $3 billion. The country's overall medicine market is currently valued at $50 billion, with domestic consumption at $23.5 billion, according to the department of pharmaceuticals.
Queries emailed to the spokespersons of the health and family ministry and the DCGI remained unanswered till press time.
Voluntary rollout, initially
The subcommittee's recommendations presented to the Drugs Consultative Committee (DCC) on 17 June are currently under consideration to make the implementation voluntary or mandatory to start with through legislative amendments to the Drug Rules, 1945," said the official aware of the matter, requesting anonymity.
"Initially, it has been proposed on a voluntary basis because people (drug makers) would take time to switch over to Braille labelling. We also have to see how the Indian industry is going to adapt to change. That is why it is being proposed for additional labelling in Braille language to be implemented 'initially on a voluntary basis' for drugs supplied in mono carton pack sizes," the official said.
To ensure the accuracy of Braille labels, the subcommittee's report has recommended that drug manufacturers have their Braille artwork validated by nodal agencies such as the National Institute for the Empowerment of Persons with Intellectual Disabilities (NIEPID) through the Braille Council of India (BCI) or other NIEPID-recommended bodies.
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The report has excluded Braille labelling for medicines and other pharmaceutical items dispensed under direct healthcare professional supervision, including injectables and vaccines. Also, the report recommends that the competent authority issue an advisory to retailers, instructing them to verbally guide visually impaired customers about medicine names, dosage, indications, uses, and expiry dates. This guidance would be routinely monitored by enforcement officers.
'Putting Braille labelling on drug making is a good idea. Even if a 1% population gets benefits, it's worth doing, especially for life-saving drugs which are of significant use, and not just limiting it to certain eye drops," said Dr. J.S. Titiyal, head of Dr. Aggarwal's Eye Institute in New Delhi and former chief of RP Eye Centre at the All India Institute of Medical Sciences. He said that visually impaired individuals may have other health complications beyond eye issues.
Dr. Manipal S. Sachdeva, chairman and managing director at Centre for Sight, said Braille labelling should be on all kinds of important life-saving medicines, not just eye drops. But he expressed reservations about making it a voluntary requirement.
'We don't know how the voluntary initiative will be picked up by the manufacturers, because it will add to their expense and logistic issues."
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