Glimepiride

New Delhi: During the routine quality review check in March, a total of 131 drug samples failed to meet the quality standards, while one sample of the popular hypertension brand Telma 40 has been flagged as spurious. The monthly drug quality review alert issued by the Central Drugs Standard Control Organization (CDSCO) flagged 131 drug samples as “ Not of Standard Quality ” (NSQ) and one sample as “spurious.” Making the announcement, the Union Health Ministry informed that of the total 131 NSQ samples, 70 were identified by the Central Drugs Laboratories and the remaining 61 samples were identified by the State Drugs Testing Laboratories. In addition to this, one drug sample flagged as spurious is of popular hypertension brand “Telma 40 (Telmisartan Tab I.P. 40mg),” manufactured in February 2024 and was plucked by the regulators from West Bengal. As per the Union Health Ministry, “the spurious sample was manufactured by an unauthorized manufacturer using a brand name owned by another company, and currently the matter is under investigation.” In its remark, the apex drug regulator CDSCO has said, “the product is purported to be spurious, however, the same is subject to the outcome of investigation.” Notably, last month a separate batch of the same brand picked from West Bengal was flagged as spurious. The sample was manufactured in 2022, and the reason for the drug test failure was notified as the sample “does not conform to I.P.” Telma (Telmisartan) is an angiotensin II receptor blocker that decreases high blood pressure and has been commercially marketed in India for the past two decades. The branded generic drug is marketed by Glenmark and, as per an analysis from market research firm Pharmarack, it features among the top 20 brands in the country, with a moving annual total (MAT) value of around ₹483 crore. The NSQ drug samples flagged by the central drug laboratories in March include Pantoprazole manufactured by Kolkata-based Shangrila Industries; Albendazole tablets by Mumbai-based Digital Vision; Telmisartan tablets manufactured by Guwahati-based Swiss Garnier Life Sciences; among 67 others. While the NSQ samples identified by state drug testing laboratories include Norfloxacin tablets manufactured by Revat Laboratories; Glimepiride tablets by Kerala State Drugs and Pharmaceuticals; Sucralfate by Legend Industries; among 58 others. Under Section 17-B of the Drugs and Cosmetics Act, 1940, a drug shall be deemed spurious if it is manufactured under a name belonging to another drug; an imitation of, or a substitute for, another drug; resembles another drug in a manner likely to deceive; or if it bears upon its label or container the name of another drug, among several other provisions. For NSQ samples, the drugs that fail to meet quality standards or specifications are notified as NSQ, a term defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. By Online Bureau ,

New Delhi: Several domestic drug companies are set to transform diabetes therapy by launching the blockbuster drug Empagliflozin at a fraction of the innovator’s price. Affordable generics will hit the market within days, following the expiry of Boehringer Ingelheim’s patent on Empagliflozin on March 11, industry sources told TOI. The launch of generic Empagliflozin , used to treat diabetes, related comorbidities, including heart failure, promises to slash therapy costs, making it more accessible to millions of diabetics and easing the financial strain of this debilitating disease. Those looking to launch the drug include Mankind Pharma , Torrent, Alkem, Dr Reddy’s and Lupin. Mankind Pharma, India’s fourth-largest firm by market share, plans to offer Empagliflozin at one-tenth the innovator’s Rs 60 per tablet, sources said. Most generic versions will cost Rs 9-14 per tablet, disrupting the high-growth diabetes therapy market valued at nearly Rs 20,000 crore, up 43per cent from Rs 14,000 crore in 2021. 10.1cr Indians live with diabetes, most end up paying out of pocket The market was further bolstered by Torrent Pharmaceuticals’ acquisition of three Empagliflozin brands from Boehringer Ingelheim last year. With India facing a staggering public health burden—10.1 crore people live with diabetes, according to International Diabetes Federation— this shift is critical. “This aligns with our philosophy of breaking cost barriers with a high-quality product (raw materials certified by regulators like the USFDA) at an affordable price. Using our own active pharmaceutical ingredient in bulk lowers costs, and we will deploy separate teams to promote two distinct brands, boosting distribution and market share,” said a Mankind Pharma executive. The market size of Empagliflozin and its combinations is estimated at Rs 640 crore. Experts highlight its ability to significantly reduce heart failure hospitalisations, slow chronic kidney disease progression and improve survival in both diabetic and non-diabetic patients, though high pricing has long limited access. Metformin remains the first-line treatment for type-2 diabetes, but as the disease progresses, additional medications—such as Sulfonylureas (glimepiride, glyburide, glipizide, chlorpropamide), DPP-4 Inhibitors (sitagliptin, vildagliptin), and SGLT2 Inhibitors (empagliflozin, dapagliflozin, canagliflozin)—are added. Now, newer therapies like semaglutide and tirzepatide enhance management, offering improved glycemic control and cardiovascular benefits. The economic burden of diabetes weighs heavily in India, where most patients pay out-of-pocket due to limited medical reimbursement. Treatment costs escalate with complications, magnifying the challenge. By Rupali Mukherjee ,