Latest news with #DrugsControllerGeneralofIndia
Mint
17 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
Mint
09-06-2025
- Business
- Mint
Glenmark to launch cancer drug Zanubrutinib in India
New Delhi: Glenmark Pharmaceuticals on Monday said it will launch cancer treatment drug zanubrutinib in India following approval by the Drugs Controller General of India (DCGI). Zanubrutinib will be marketed in India under the brand name Brukinsa. It is the first and only Bruton's tyrosine kinase (BTK) inhibitor approved in India for the treatment of five distinct B-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma. "We look forward to bringing Brukinsa to India in the coming months as part of our ongoing partnership with BeiGene (now BeOne Medicines)," Glenmark Pharmaceuticals President and Business Head - India Formulations Alok Malik said. The launch marks a significant milestone in our innovative oncology portfolio, offering patients in India access to a globally trusted therapy with proven efficacy and safety, he added. Glenmark shares on Monday ended 0.68 per cent up at ₹ 1,600.85 apiece on BSE. In March, Glenmark Pharmaceuticals had launched a medication for glycemic control and weight-loss for diabetes patients. The Mumbai-based drug firm launched Empagliflozin, a widely recognised SGLT2 inhibitor, under the brand name Glempa (Empagliflozin 10/25 mg), along with its fixed-dose combinations (FDCs)''Glempa-L (Empagliflozin 10/25 mg Linagliptin 5 mg) and Glempa-M (Empagliflozin 12.5 mg Metformin 500/1000 mg). The medications are designed to improve glycemic control in adults with type 2 diabetes mellitus while also reducing cardiovascular outcomes in patients with cardiovascular risk. Studies have demonstrated several benefits of Empagliflozin, including effectively improving glycemic control, supporting weight-loss, and reducing cardiovascular-renal risks in patients with type 2 diabetes mellitus. Empagliflozin has also demonstrated benefits in heart failure patients by lowering the cardiovascular death or hospitalisation. "The launch of Glempa range reinforces this commitment by providing a comprehensive and affordable solution that empowers healthcare professionals and patients to manage type 2 diabetes mellitus with established cardiovascular disease more effectively," Glenmark Pharmaceuticals President and Head of India Formulations Business Alok Malik had said.
Time of India
09-06-2025
- Business
- Time of India
Glenmark to launch DCGI-approved cancer drug in India
Glenmark Pharmaceuticals on Monday said it will launch cancer treatment drug zanubrutinib in India following approval by the Drugs Controller General of India ( DCGI ). Zanubrutinib will be marketed in India under the brand name Brukinsa . It is the first and only Bruton's tyrosine kinase (BTK) inhibitor approved in India for the treatment of five distinct B-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Bank Owned Properties For Sale In Larantuka (Prices May Surprise You) Foreclosed Homes | Search ads Search Now Undo "We look forward to bringing Brukinsa to India in the coming months as part of our ongoing partnership with BeiGene (now BeOne Medicines)," Glenmark Pharmaceuticals President and Business Head - India Formulations Alok Malik said. The launch marks a significant milestone in our innovative oncology portfolio, offering patients in India access to a globally trusted therapy with proven efficacy and safety, he added. Glenmark shares on Monday ended 0.68 per cent up at Rs 1,600.85 apiece on BSE.
Business Standard
09-06-2025
- Business
- Business Standard
Glenmark Pharma rises after zanubrutinib launch in India
Glenmark Pharmaceuticals rose 1% to Rs 1605.80 after the drug maker announced the upcoming launch of zanubrutinib in India, following approval from the Drugs Controller General of India (DCGI). Co-developed with global oncology leader BeOne Medicines, zanubrutinib will be marketed under the brand name Brukinsa. It is the first and only Brutons tyrosine kinase (BTK) inhibitor approved in India for five types of B-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenstr macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL). Globally, Brukinsa is approved in over 70 countries, backed by robust clinical evidence from pivotal trials such as Alpine, Aspen, and Sequoia. The drug has shown a strong safety profile, high response rates, and durable disease control. With one Indian diagnosed with blood cancer every five minutes and around 70,000 deaths annually, Brukinsa addresses a critical treatment gap. Its flexible dosing (once or twice daily) supports personalized care. In the Alpine study for relapsed/refractory CLL, Brukinsa reported significantly fewer serious cardiac events (1.9% vs 7.7%) and lower treatment discontinuation (0.3% vs 4.3%) compared to ibrutinib. Glenmark Pharmaceuticals is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. On a consolidated basis, Glenmark Pharmaceuticals reported net profit of Rs 4.65 crore in Q4 March 2025 as against net loss of Rs 1218.28 crore in Q4 March 2024. Net sales rose 6.77% year-on-year to Rs 3220.13 crore in Q4 March 2025.
Business Standard
09-06-2025
- Health
- Business Standard
Glenmark receives DCGI approval to launch oncology drug BRUKINSA in India
Glenmark Pharmaceuticals has announced the upcoming launch of zanubrutinib in India following approval by the Drugs Controller General of India (DCGI). Zanubrutinib will be marketed in India under the brand name BRUKINSA, an innovative therapy developed by BeiGene (now BeOne Medicines), a global oncology leader committed to delivering advanced treatments for cancer patients worldwide. BRUKINSA is the first and only Bruton's tyrosine kinase (BTK) inhibitor approved in India for the treatment of five distinct B-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenstr macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL). Globally, BRUKINSA is approved in more than 70 countries, supported by compelling clinical evidence from pivotal trials including ALPINE, ASPEN, and SEQUOIA. This extensive clinical program underscores BRUKINSA's proven efficacy, strong safety profile, and broad therapeutic value. The introduction of BRUKINSA brings an innovative treatment option at a time when India continues to face a significant burden from serious and difficult-to-treat haematological malignancies. According to various sources, someone in India is diagnosed with blood cancer every five minutes, and an estimated 70,000 people die from the disease each year. BRUKINSA addresses a critical unmet need with its differentiated pharmacological profile, demonstrating high response rates and durable disease control across multiple B-cell malignancies as shown in pivotal clinical trials. BRUKINSA's flexible dosing regimen (once or twice daily) supports personalized care.1 In the head-to-head ALPINE study in relapsed/refractory chronic lymphocytic leukemia, BRUKINSA demonstrated a lower rate of serious cardiac events (1.9% vs. 7.7%) and fewer treatment discontinuations due to cardiac issues (0.3% vs. 4.3%) compared with ibrutinib.
