Glenmark receives DCGI approval to launch oncology drug BRUKINSA in India
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.
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Business Standard
02-08-2025
- Business Standard
India launches formal rules to fix, streamline drug and device clearances
India has released its first official set of guidelines on how expert panels should review and approve new drugs, medical devices, and biologics, Mint reported. This move is aimed at fixing problems of unclear and inconsistent approvals that have previously slowed down drug launches and weakened the pharmaceutical industry's trust in the system. These new rules, issued by the Central Drugs Standard Control Organisation (CDSCO), are designed to improve how India regulates new medical products. The goal is to make the approval process quicker, more transparent, and predictable, the news report said. The guidelines define how Subject Expert Committees (SECs) should be formed, how experts are chosen, and how they must review applications. These SECs play a key role in advising the Drugs Controller General of India (DCGI) on whether a product should be approved. The overhaul follows recommendations from the World Health Organisation (WHO), which last year conducted a regulatory review of CDSCO and the office of the DCGI, who heads the organisation. The WHO called for stronger transparency and data integrity to align India's system with global standards. Why this is important for India's pharma sector? India's pharmaceutical industry is the world's third-largest by volume and 14th by value. It supplies around 20 per cent of the global generic drug demand and manufactures over 60,000 products across 60 therapy areas. The sector includes generic medicines, vaccines, biologics, over-the-counter drugs, and more. In its review, the WHO had asked Indian authorities to better track low-quality or fake medical products, start a market monitoring programme, and ensure drug advertisements are not misleading. Many of these suggestions are now being followed by the DCGI and those involved in SEC meetings, the news report said. Stricter criteria and structured evaluations Each SEC has eight members — one pharmacologist and seven other experts from research or medical fields. At least four members must be present to make a decision. Earlier, the lack of formal rules often led to delays and confusion in the approval process. Now, SEC members must meet strict criteria, such as having at least 10 published research papers and a 2:1 citation ratio. They are appointed for three years and must follow rules on confidentiality, impartiality, and attendance. Those who miss meetings without good reason can be removed. The new document also says SECs must evaluate drug safety, effectiveness, and risks using strong scientific standards. Decisions like clinical trial waivers must be clearly justified, and discussions must only focus on scientific and regulatory issues — not pricing or business concerns, Mint reported. US hits Indian exports with blanket 25% tariffs The US government has decided to impose a 25 per cent tariff on all Indian exports starting August 7 — without any exemptions. This new order removes earlier tariff breaks given to products like pharmaceuticals, electronics, and energy goods. GTRI founder Ajay Srivastava said this is one of the toughest trade measures by the US against India, news agency PTI reported. India's top export items to the US — like smartphones ($10.9 billion), petroleum products ($4.1 billion), and pharmaceuticals ($9.8 billion) — will be hit hardest. Srivastava said these sectors have high import content and low local value addition, making them vulnerable to the tariff hike. USFDA actions slow down Indian drug approvals Meanwhile, Indian drugmakers are also facing regulatory challenges abroad. In the first quarter of FY25, the US Food and Drug Administration (USFDA) sharply reduced the number of abbreviated new drug application (ANDA) approvals for Indian firms, according to a report by The Times of India. Companies like Cipla, Sun Pharma, Dr Reddy's, Lupin, and Aurobindo Pharma are under increased inspection. Aurobindo's approvals dropped due to issues at its Unit III plant. In May, the company got seven observations from the USFDA at its Bhiwadi facility and earlier three more for its Andhra Pradesh site. Cipla also got six observations for its Goa plant in June. In a filing, the company said it was committed to addressing the concerns in time. A Business Standard report said that the USFDA's Centre for Drug Evaluation and Research recently found that 11 per cent of Indian drug manufacturing facilities had violations, including data integrity issues.
Mint
02-08-2025
- Mint
India unveils first formal rules for drug approval panels in regulatory overhaul
New Delhi: India has issued its first formal playbook for how expert panels should vet new drugs, biologics and medical devices—a move aimed at fixing long-standing concerns about inconsistent and opaque approvals that have delayed critical drug launches and eroded industry trust in the regulatory system. The guidelines, issued by the Central Drugs Standard Control Organization (CDSCO), represent a major overhaul of India's drug approval process and aim to make regulatory decisions faster, more predictable and transparent, according to two government officials and documents reviewed by Mint. The guidelines standardize how Subject Expert Committees (SECs) are formed, how members are selected, and how they must evaluate applications, including the scientific benchmarks and disclosure norms they must follow. The SECs advise the Drugs Controller General of India (DCGI) on whether to clear new drugs, and their decisions have long shaped the trajectory of India's pharmaceutical industry. The CDSCO finalized the guidelines about two weeks ago and circulated them to SEC members for immediate implementation, the officials said. The overhaul follows recommendations from the World Health Organization (WHO), which last year conducted a regulatory review of CDSCO and the office of the DCGI, who heads the organization. The WHO called for stronger transparency and data integrity to align India's system with global standards. India's pharmaceutical industry ranks third globally by volume and 14th by value. It accounts for roughly 20% of the world's generic drug supply and manufactures more than 60,000 products across 60 therapeutic areas. The sector also includes over-the-counter drugs, vaccines, contract manufacturing, biologics and biosimilars. As part of its findings, the WHO urged Indian authorities to implement stronger controls to prevent, detect, and respond to substandard and falsified medical products; to launch a market surveillance program for drug quality monitoring; and to ensure that promotional and advertising claims for medicines are not misleading. These steps are now being implemented by the DCGI and other stakeholders involved in the SEC meetings, according to the officials cited earlier. The SECs play a central role in India's drug approval process, advising the DCGI on whether to approve new drugs, biologics, and medical devices. Each committee includes eight experts—one pharmacologist and seven specialists from research, medical, or regulatory institutions—and requires a four-member quorum to issue recommendations. In the absence of formal guidelines, though, these decisions were often viewed as inconsistent or opaque, delaying product approvals. 'SECs are subject expert committees involved in evaluating approvals of new drugs. Simplification and streamlining the process will help industry in getting drugs approved with predictable speed and more transparency. We appreciate the step taken by DCGI," said Dr. Viranchi Shah, national spokesperson of the Indian Drugs Manufacturers Association (IDMA). Emailed queries to the spokesperson for the health ministry went unanswered at the time of publishing. Clearer mandate, tougher benchmarks According to the guidance document, SEC members must meet strict selection criteria, including a publication record of at least 10 peer-reviewed papers and a citation ratio of 2:1. Experts are appointed for a three-year term and are expected to maintain confidentiality, impartiality, and active participation. Those who fail to attend meetings regularly may be removed. The document specifies that SECs must offer rigorous, science-based evaluations on safety, efficacy, and risk-benefit balance. It outlines the dos and don'ts of deliberations: clinical trial waiver decisions must include clear yes/no recommendations with detailed justifications, and all discussions must remain focused on scientific and regulatory issues, excluding matters such as pricing. 'For new drug and clinical trial applications, the DCGI refers them to the SEC, an expert body that discusses proposals and offers recommendations for approval or rejection. These experts, being external to CDSCO, are not always fully aware of regulatory requirements. This often led to differing, sometimes subjective opinions, a lack of uniformity in decisions, and delays on straightforward matters. Therefore, it's important for the committee to provide uniform decisions, maintain transparency, and offer proper reasoning for approvals and rejections," said one of the two government officials cited earlier, who asked not to be named. The second official added, 'There were persistent discussions during SEC meetings about the absence of a guiding document to regulate or suggest proper functioning. This new guidance note outlines the 'do's and don'ts' for experts. Previously, some companies had even alleged that SEC meetings were not being conducted properly." While officials declined to cite specific past incidents, people familiar with the matter said the lack of consistency and alignment among SEC experts, who advise on key regulatory decisions, had severely affected the functioning of the DCGI in recent years. Industry seeks consistency For years, pharmaceutical companies have raised concerns over the unpredictability of SEC verdicts, especially around clinical trial waivers, which are critical for expediting the launch of generics and biosimilars. The new rules aim to reduce such uncertainty by standardizing decision-making across similar products, unless clear scientific reasons justify a deviation. The document states: 'The SECs are indispensable in the CDSCO's evaluation process due to their specialized expertise, independent perspective and commitment to quality assurance. These committees address complex scientific and regulatory challenges, fostering informed decision-making. By operating transparently and consistently across applications, SECs bolster public trust while safeguarding public health and promoting innovation in the healthcare sector." Public health experts have welcomed the reform. 'Any committee should operate under certain guidance, and it is always beneficial for all members of such a committee to have clarity and a common vision. It's akin to laying down the rules of the game," said Dr. Chandrakant Lahariya, a physician and public health expert. He added: 'The Subject Expert Committee (SEC) is an essential requirement for guiding the drug approvals and other processes in all regulatory bodies. When a new drug is needed, the SEC provides its recommendations to the apex drug regulator. CDSCO is a regulatory organization, and they need guidance from a technical expert committee to make decisions. A regulatory body needs guidance from those who deeply understand the subject."
Indian Express
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- Indian Express
France battles rapid spread of viral cattle disease in cheese regions
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