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Mint
18 hours ago
- Health
- Mint
Drug regulator pushes for Braille labelling on medicines
New Delhi: India's top drug regulator is evaluating a plan for Braille labelling on medicine packaging to improve accessibility for India's 4.95 million blind and 70 million visually impaired citizens, who struggle to identify crucial medication details, said an official aware of the matter and documents reviewed by Mint. 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. Also read: Which private hospital is best for you? New grading system will help patients decide on treatment options 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. Also read: Centre moves to enhance organ transplant services in govt hospitals after review shows capacity constraints 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." Also read: Centre orders thorough safety review of painkiller Nimesulide for adults
Time of India
14-05-2025
- Health
- Time of India
Govt may mandate QR codes on vaccines, key drugs to curb counterfeits
New Delhi: Vaccines , antimicrobials, narcotic drugs and psychotropic substances, and additional cancer drugs would have to mandatorily print or affix bar codes or quick response (QR) codes on their labels. This follows the government mulling the possibility of bringing them under Schedule H2 of Drug Rules to track their movement to curb counterfeiting. Additionally, the government is considering inclusion of details of excipients on every medicine strip for 300 drug formulations that are under Schedule H2. Currently, the labels declare only those active substances added in the formulation. An excipient is a constituent of a medicine other than the active substances, added in the formulation for a specific purpose. While most excipients are considered inactive, some can have a known action or effect in certain circumstances. "The Drug Controller General of India (DCGI) will hold a meeting this week to deliberate on both the issues," people in the know told ET. Earlier the drug regulatory authority had included a few cancer drugs to help validate the authenticity of medicines following incidents of refilling of expensive anti-cancer drugs with counterfeit drugs . It came to light that criminals in collusion with hospital pharmacies were found refilling empty vials of expensive anti-cancer medicines with counterfeit drugs. These fake drugs were then mixed with genuine stocks and sold to unsuspecting cancer patients, putting their lives at risk. Live Events In a bid to weed out spurious drugs, the regulator had made it mandatory for companies to have a barcode on the top 300 brands, so that information such as manufacturing licence and batch number can be accessed upon scanning. These drugs included widely-used analgesics, pain relievers, anti-platelet, vitamin supplements, blood-sugar lowering medicines and contraceptive tablets.
