Latest news with #CentralDrugsStandardControlOrganization
Bloomberg
26-06-2025
- Business
- Bloomberg
India Drug Regulator Approves Eli Lilly's Mounjaro in Pen Format
India's Central Drugs Standard Control Organization approved marketing of Eli Lilly & Co. 's Mounjaro in pen format for treatment of type-2 diabetes and obesity, the firm said in a statement Thursday.
Business Standard
24-06-2025
- Business
- Business Standard
Glenmark Pharma launches TEVIMBRA in India
Glenmark Pharmaceuticals announced that it had launched TEVIMBRA (tislelizumab) in India after receiving approval from the Central Drugs Standard Control Organization (CDSCO). The drug is a specially designed anti-PD-1 monoclonal antibody created by BeiGene, now BeOne Medicines, which focuses on oncology. TEVIMBRA is intended for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) when combined with chemotherapy. It is also approved for second-line treatment of locally advanced or metastatic NSCLC and esophageal squamous cell carcinoma (ESCC) as a standalone therapy. The launch signifies Glenmark's entry into the immuno-oncology market in India. This strategic step aims to expand its innovative oncology offerings. NSCLC represents more than 80% of lung cancer cases, while ESCC is the most common type of esophageal cancer in India. TEVIMBRA is already approved and available in major markets such as the US, the EU, Australia, and China. The therapy specifically targets PD-1 receptors, helping to restore T-cell function while reducing off-target immune suppression. It has shown strong effectiveness and a good safety profile in several key Phase 3 trials across a variety of solid tumors. Alok Malik, President and Business Head India Formulations, Glenmark Pharmaceuticals, said, At a time when the cancer burden is rising sharply, we are proud to enable oncologists and patients to access TEVIMBRA, a therapy with proven efficacy and safety outcomes, strong science, and meaningful impact. Immuno-oncology offers a promising future for the treatment of various types of advanced cancers that are difficult to treat. Our foray in this area marks a significant inflection point in our journey to build a world-class oncology portfolio that is innovative, inclusive and at the same time life-changing for patients. Glenmark Pharmaceuticals is a research-led, global pharmaceutical company, having a presence across branded, generic, and OTC segments, with a focus on therapeutic areas of respiratory, dermatology and oncology. On a consolidated basis, Glenmark Pharmaceuticals reported a net profit of Rs 4.65 crore in Q4 March 2025 as against a net loss of Rs 1,218.28 crore in Q4 March 2024. Net sales rose 6.77% year-on-year to Rs 3220.13 crore in Q4 March 2025. Shares of Glenmark Pharmaceuticals rose 0.78% to Rs 1,699.25 on the BSE.
Business Standard
24-06-2025
- Health
- Business Standard
Glenmark Pharmaceuticals launches TEVIMBRA in India
Glenmark Pharmaceuticals (Glenmark) launched TEVIMBRA (tislelizumab) in India following the approval by Central Drugs Standard Control Organization (CDSCO). TEVIMBRA is a uniquely designed anti-PD-1 monoclonal antibody developed by BeiGene (now BeOne Medicines), a global oncology leader committed to delivering advanced treatments for cancer patients worldwide. It is indicated for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy and second-line treatment of locally advanced or metastatic NSCLC and esophageal squamous cell carcinoma (ESCC) as monotherapy. This launch marks Glenmark's first foray into immune-oncology in India and is a major milestone in expanding its innovative oncology portfolio. NSCLC is the most common type of lung cancer, representing over 80% of all lung cancer cases. Similarly, ESCC is the most common histological subtype of esophageal cancer in India. TEVIMBRA caters to the needs of this significant patient population by offering a differentiated and proven treatment option for these cancers. TEVIMBRA is approved and marketed in multiple leading global markets including the United States, European Union, Australia and China. Designed to selectively bind to PD-1 receptors, TEVIMBRA restores T-cell function while minimizing off-target immune suppression and has demonstrated robust efficacy with a favorable safety profile across diverse solid tumor types in multiple pivotal Phase 3 studies and through a comprehensive global clinical development program.
Mint
13-05-2025
- Business
- Mint
India tightens export rules for medicines to check wide misuse as narcotics in overseas markets
New Delhi: The Centre has tightened the rules for exports to check the wide abuse of medicines manufactured in India, three officials aware of the matter said. The guidelines are applicable to unapproved and approved new drugs for exports purpose only and manufacturers have to comply with the legal procedures, two officials aware of the matter said. Also Read | India to boost production of combat medicines With some of these drugs being used in overseas markets as narcotics, the Central Drugs Standard Control Organization (CDSCO) has introduced a two-step verification for the manufacturer that will be checked at Indian ports. In addition, the apex drug regulator has made it mandatory for manufacturers to obtain regulatory approval from the importing country for medicines classed as narcotic drugs and psychotropic substances (NDPS). Also Read | E-pharmacies, chemists at odds as govt mulls a stop to home delivery of drugs The development comes against the backdrop of unapproved Indian-made drugs being exported to countries in Africa and being rerouted to other destinations. Under the new rules, a manufacturer has to first obtain a no-objection certificate (NOC) from the Central Licensing Authority. Once approved, the consignment and all related documents will be verified at the port before shipment. Also Read | You may soon get to buy non-prescription drugs at a friendly neighbourhood store Earlier, there was no detailed verification of the manufacturer at Indian ports. The manufacturers will have to submit the details of quality of products, manufacturer's name, name of the exporting country and details of the buyer. These regulations have been made under the relevant provisions of the Drugs and Cosmetics Act, 1940 and Drug Rule, 1945. A guidance document for manufacturers seen by Mint has been issued by CDSCO. In case of unapproved FDC (fixed dose combination), unapproved NDPS and banned drugs in India, the manufacturer is required to mandatorily get the approval of the importing country's regulator. 'This entire exercise will ensure that only approved consignment will be shipped from India to the destination country. This is one way to have greater vigilance for exports of unapproved and approved new drugs from India," said one of the officials cited above. Step two involves the procedure for release of consignment at the Indian port office. 'New guidelines have been issued and these requirements were not in place and divided in two steps. The first thing is online documentation to get the NOC and the second step is physical verification at the ports. This will have uniformity and create the system of traceability all throughout the process," said the second official. As per the department of pharmaceuticals, the Indian pharmaceutical industry is worth approximately $50 billion with over $25 billion of the value coming from exports. About 20% of the global exports in generic drugs are met by India. The country has 10,000 pharmaceutical companies, out of which 2,000 are MSME drug firms. Queries sent to the health ministry spokesperson remained unanswered.
Associated Press
02-04-2025
- Business
- Associated Press
Okogen Announces Regulatory Submission to CDSCO for EMERALD STUDY and Appointment of New Chief Medical Officer
Plano, Texas--(Newsfile Corp. - April 2, 2025) - Okogen Inc., a company specializing in innovative eyecare solutions, today announced the submission of a regulatory application to the Central Drugs Standard Control Organization (CDSCO) in India for its Phase IIb clinical trial, The Emerald Study. In conjunction with this regulatory milestone, Okogen is also pleased to announce the appointment of David A Hollander, MD, MBA as its new Chief Medical Officer (CMO). Dr. Hollander will serve a crucial role in Okogen's clinical development and regulatory initiatives, further strengthening the company's commitment to advancing innovative solutions for AIC. To view the full announcement, including downloadable images, bios, and more, click here. Key Takeaways: David A. Hollander, MD, MBA, has been appointed as Okogen's new Chief Medical Officer (CMO), bringing extensive experience in drug development and regulatory affairs to lead the company's clinical and regulatory initiatives. Okogen Inc. has submitted a regulatory application to the Central Drugs Standard Control Organization (CDSCO) in India for its Phase IIb clinical trial, The Emerald Study, which aims to evaluate the effectiveness of a triple-combination eyedrop for bacterial and viral conjunctivitis. The Emerald Study, set to begin during the 2025 Monsoon Season in India, will provide valuable data for Okogen's AI platform and aims to address the growing challenge of acute infectious conjunctivitis with innovative treatment solutions. [ This image cannot be displayed. Please visit the source: ] Click image above to view full announcement. About Acute Infectious Conjunctivitis Pink eye (acute infectious conjunctivitis) is when the conjunctiva is irritated by a viral or bacterial infection. The current conjunctivitis market is USD $4.2 billion annually and is estimated to grow beyond USD $6.0 billion by 2031. Bacterial and viral conjunctivitis are easily spread from person to person if left untreated or properly diagnosed. There are currently no approved treatments for adenoviral conjunctivitis, comprising +90% of all viral ocular infections. About Okogen, Inc. Okogen, Inc. is a cutting-edge eyecare product development company focused on delivering patient-centric solutions, with a current focus on acute infectious conjunctivitis. The company's lead product, OKG-0303, is a triple-active combination eyedrop designed to treat both forms of acute infectious conjunctivitis, bacterial and viral, safely and effectively. In addition to advancing its Phase 2b clinical program, Okogen is developing an AI-powered evaluation tool aimed at improving patient care. The company is committed to innovation and expects a Phase 2b data readout by Q4 2025. Contacts:
