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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
5 days ago
- Health
- Time of India
Online pharmacies could face stricter check-ups
Amid rising concerns over unverified prescriptions and a surge in online pharmacies, the government is intensifying regulation and scrutiny on platforms promising medicine delivery within minutes. Complaints regarding bypassed safeguards like age verification have prompted this action. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads New Delhi: The government is working on tightening regulation and scrutiny on online pharmacy platforms delivering medicines within 10-60 minutes amid increasing complaints over unverified prescriptions and mushrooming of such platforms, officials said."The surge in complaints about various e-pharmacy platforms bypassing safeguards such as verification of prescriptions, age-gating and lack of supervision has increased in alarming proportions," an official at the health and family welfare ministry told has been a proliferation of e-pharmacy platforms in recent months. PhonePe's Pincode introduced 10-minute medicine deliveries in Bengaluru, Pune, and Mumbai in April. Private pharmacy chain Davaindia has started 60-minute deliveries in Pune. Zeelab Pharmacy, which raised $2.4 million from OTP Ventures earlier this year, has started 60-minute deliveries in are in addition to rapid expansion of large platforms such as Tata 1mg, PharmEasy and some of these platforms connect consumers with medical stores in the vicinity, others deliver the medicines and drugs through dark stores (or warehouses where stocks are stored and delivered to consumers) similar to quick-commerce grocery reported by ET last week, dark stores selling grocery products and daily essentials are under the scrutiny of the Food Safety and Standards Authority of India (FSSAI) and Maharashtra food and drug administration (FDA) amid mounting incidents of hygiene and storage foods companies, too, have flagged urgent concerns over hygiene standards at such dark present, there are no specific regulations that exclusively govern e-pharmacies. The Drugs and Cosmetics Act and Rules don't explicitly legalise online pharmacies The government is preparing a new law to replace the existing drug regulations, which are not clearly latest move by the government on e-pharmacies is over and above the Drugs Technical Advisory Board planning to set up a sub-committee to examine withdrawal of doorstep delivery of drugs , following a demand by industry body All-India Organisation of Chemists and Druggists ( AIOCD ).The association has demanded withdrawal of a government notification that allows doorstep delivery of drugs, a facility which was allowed during the Covid-19 pandemic in 2020. "Emergency phase of the pandemic no longer exists, therefore, the notification is no longer relevant and should be revoked immediately," it said in a letter to health minister JP represents 1.24 million chemists and Ministry of Health and Family Welfare had in 2018 issued draft amendments to the Drugs and Cosmetics Rules, 1945, for inclusion of rules to regulate online sale of drugs, inviting objections and suggestions from all chemists' body challenged the notification before the Delhi High Court. In December 2018, the court, in an interim order, had stayed the sale of drugs without licence by online pharmacies. Crisil report on the online pharmacy market estimated that e-pharmacies currently contribute 3-5% of the country's retail pharmacy market, compared to 22-25% in some developed countries. The report valued the overall retail pharmacy market at close to '2.4 lakh crore, led by an unorganised sector with 85% report said online pharmacies "have immense growth potential given their under-penetration in the country." E-pharmacies selling wellness products, medical equipment and other such high-margin products to their mix will add to their growth and profitability, it added.
Time of India
12-06-2025
- Health
- Time of India
HC quashes FIR against doctor, nurse accused of administering expired vaccine to infant
Chhatrapati Sambhajinagar: The Aurangabad bench of the Bombay High Court has quashed the FIR and criminal proceedings against a doctor and nurse from Beed district who were accused of administering an expired vaccine to an infant in Nov 2022. The division bench of Justice Vibha Kankanwadi and Justice Sanjay Deshmukh passed the order on Monday in a criminal application filed by Dr Sharad Madhukar Pawar, who runs Pawar Hospital at Majalgaon in Beed district, and his subordinate nurse, Sonali Chandrasen Gore. The FIR in the case, registered by the Majalgaon city police on Dec 26, 2022, and the subsequent criminal case before the Judicial Magistrate First Class, Majalgaon, invoked Section 336 (act endangering life or personal safety of others) with Section 34 (acts done by several persons in furtherance of common intention) of the Indian Penal Code, as well as provisions of the Drugs and Cosmetics Act and Rules. The case originated from a complaint by drug inspector Ashok Dharak, who acted on a news report claiming an expired rotavirus vaccine was administered to an infant at Dr Pawar's hospital. The complaint alleged that the vaccine administered on Nov 7, 2022, expired in March that year. The child, however, remained in good health and did not suffer any adverse effects. In the case, lawyer Mayur Salunke represented Dr Pawar, while nurse Gore was represented by lawyer Pawan Gore, appointed by legal aid. During the hearing, the bench noted that the child's maternal grandfather and mother both gave statements affirming that the doctor took immediate remedial measures. According to their statements, Dr Pawar kept the infant under observation at his hospital the entire dayto check for any side-effects. The vaccine manufacturer, Pune-based Serum Institute of India, in its communication dated Nov 21, 2022, stated that ROTASIIL, the vaccine in question, was considered safe even after expiry if stored properly and that no adverse effects were documented in post-marketing studies. The court emphasised that there was no criminal intent or gross medical negligence involved. It relied heavily on the Supreme Court's guidelines in Jacob Mathew vs State of Punjab (2005), which underlined that medical professionals should not be prosecuted under criminal law unless there was prima facie evidence of gross negligence, backed by an independent expert medical opinion. "It is the mistake. No element of criminality is involved," the bench observed. It further stated that the FIR was registered by the drug inspector without obtaining any opinion from a qualified medical expert, a key procedural requirement under the Jacob Mathew judgment. Even the medical board of Swami Ramanand Teerth Rural Govt Medical College, Ambajogai, could not provide any conclusive opinion on adverse effects of expired ROTASIIL on a one-and-a-half month child. The court noted that the offences under the Drugs and Cosmetics Act required a formal complaint to be filed directly before a court by the designated authority. "In other words, the FIR as per Section 154 of CrPC is not maintainable for the said violations," the bench observed. Calling the continuation of proceedings "an abuse of process of law", the bench quashed the FIR and the criminal case against both Dr Pawar and nurse Gore.
