Latest news with #CDSCO
Time Business News
2 hours ago
- Health
- Time Business News
Emerging Frontiers in Non-Insulin Treatments for Diabetes Mellitus
Non-insulin remedies for diabetes include drugs and treatments that help control blood sugar levels without using insulin, such as GLP -1 receptor agonist, SGLT 2 inhibitors, DPP -4 inhibitors, and lifestyle or device -based intervention. The market for these remedies is increasing due to the spread of growing global diabetes, an increase in demand for easy-to-use and low aggressive remedies, innovation in oral and injectable drug formulations, and weight loss compared to insulin, heart safety and better patients such as their additional benefits. Key Growth Drivers and Opportunities Rising Global Prevalence of Diabetes: The increasing global proliferation of diabetes, sedentary lifestyle, unhealthy diet and aging population are promoting considerable demand for effective and convenient treatment options. As more patients are diagnosed especially with type 2 diabetes there is a growing requirement of treatments managing blood sugar without complications of insulin use. Non-insulin therapy provides benefits such as weight loss and heart safety, such as oral administration, low side effects, and additional health benefits, making them a favorite option and accelerates their market growth. Challenges Non-insulin therapy for diabetes market faces many challenges, including high treatment costs, limited access to low and medium-income countries, and concerns on long-term security and side effects of new drug classes. Additionally, the patient may be affected by complex doses regimens or gastrointestinal side effects, and competition from insulin-based treatments remains stronger in some segments. Regulatory barriers and extensive clinical trials also slow down the introduction of innovative remedies. Innovation and Expansion IDF Establishes a Working Group to Examined New Type 5 Diabetes In April 2025, A working group to create formal diagnostic criteria and treatment guidelines for a type of diabetes associated with malnutrition that was officially designated as 'type 5 diabetes' during an international meeting of experts in India earlier this year was announced by IDF President Professor Peter Schwarz at the recent International Diabetes Federation (IDF) World Diabetes Congress 2025 in Bangkok, Thailand. Additionally, the working group will create educational modules to teach healthcare professionals and a worldwide research registry. Between 20 and 25 million individuals globally are thought to have type 5 diabetes, mostly in Asia and Africa. This discovery represents a turning point in our knowledge of diabetes and its impact on undernourished and lean adolescents and young adults in low- and middle-income (LMIC) nations. Cipla Takes Center Stage as CDSCO Authorized the Launch of Inhaled Insulin In December 2024, Following the Central Drugs Standard Control Organization's (CDSCO) approval of Cipla's exclusive distribution and marketing of Afrezza, an inhalation human insulin, in India, the company's stock will continue to be closely watched. Unlike existing insulins that are administered as injections, Afrezza is a rapid-acting insulin that is administered via inhalation. When taken at the start of a meal, Afrezza dissolves swiftly in the lungs when inhaled orally and immediately gets insulin into the circulation. Inventive Sparks, Expanding Markets Through R&D innovation, strategic alliances, and entry into developing markets, non-insulin treatment firms are propelling growth. They concentrate on creating safer, more efficient medications, utilizing digital technologies to assist patients, and obtaining authorization for more extensive therapeutic applications. The key players operating the Non-Insulin Therapies for Diabetes Market include AstraZeneca, Bristol-Myers Squibb, BoehringerIngelheim GmbH, Eli Lilly and Company, and others. About Author: Prophecy is a specialized market research, analytics, marketing and business strategy, and solutions company that offer strategic and tactical support to clients for making well-informed business decisions and to identify and achieve high value opportunities in the target business area. Also, we help our client to address business challenges and provide best possible solutions to overcome them and transform their business. TIME BUSINESS NEWS
The Hindu
4 hours ago
- Health
- The Hindu
905 drug-manufacturing units inspected since 2022, action taken against 694: Centre to Rajya Sabha
Since 2022, 905 firm units have been inspected, resulting in actions being taken against 694 of those firms based on risk criteria like the number of drugs declared as not of standard quality and other complaints, the government informed Parliament on Tuesday, July 22, 2025. In a written reply to a question in the Rajya Sabha, Union Health Minister J. P. Nadda said isolated cases regarding spurious or adulterated or sub-standard drugs are received from time to time. As part of quality monitoring and in order to assess the regulatory compliance of drug-manufacturing premises in the country, the Central Drugs Standard Control Organisation (CDSCO), in collaboration with State regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022. Firms have been identified on the basis of risk criteria like the number of drugs declared as not of standard quality, complaints, criticality of products etc. "As of now, 905 units have been inspected, resulting in 694 actions being taken. These actions include Stop Production Orders (SPO), Stop Testing Orders (STO), licence suspensions/cancellations, warning letters, and showcause notices, depending on the severity of non-compliance," Mr. Nadda said. The initiative has provided valuable insights into manufacturing practices and led to relevant corrective actions, resulting in noticeable improvements in the regulatory framework, he added. All the drug manufacturers are required to comply with the conditions of their licence, including Good Manufacturing Practices (GMP) as prescribed under the Drugs Rules, 1945, to ensure the quality, safety and efficacy of drugs. Further, the CDSCO uploads a list of drugs of various companies, which are declared not of standard quality or spurious or misbranded or adulterated by the central drug-testing laboratories, on its website ( under the heading of "Drug Alert", Mr. Nadda said.
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Business Standard
a day ago
- Health
- Business Standard
Substandard quality in 3,104 drugs, 245 found spurious in FY25: JP Nadda
Since December 2022, the Central Drugs Standard Control Organisation (CDSCO) has inspected 905 drug manufacturing and testing units, resulting in 694 regulatory actions, Nadda said Rahul Goreja New Delhi Between April 2024 and March 2025, a total of 3,104 drug samples were declared not of standard quality, while 245 were found to be spurious or adulterated, the government informed the Rajya Sabha on Tuesday. These results came from 1,16,323 drug samples tested across the country during the period. The data was shared by Union Health Minister Jagat Prakash Nadda in response to a question on the prevalence of substandard and spurious drugs in the country. Nadda also stated that between April 2023 and March 2024, a total of 1,06,150 drug samples were tested, out of which 2,988 were found to be not of standard quality and 282 were identified as spurious. Risk-based inspections and regulatory action Since December 2022, the Central Drugs Standard Control Organisation (CDSCO) has inspected 905 drug manufacturing and testing units, resulting in 694 regulatory actions, including stop production or testing orders, licence suspensions or cancellations, warning letters, and show-cause notices, Nadda said. He further added that manufacturers whose drugs fail quality checks are required to immediately recall and halt further distribution of those batches. As for whether the government plans to publish a list of compliant drug manufacturers to rebuild public trust, Nadda said that CDSCO already uploads alerts about drugs declared not of standard quality, spurious, misbranded or adulterated on its website under the 'Drug Alert' section. Funding and policy initiatives To address broader challenges in drug quality, the government is implementing the Strengthening of Pharmaceutical Industry (SPI) scheme, which includes support for common facilities, technology upgrades for small and medium enterprises, and promotion of research and knowledge-sharing. The ministry of health and family welfare is also running a centrally sponsored scheme - Strengthening of States' Drug Regulatory System (SSDRS) - with an approved outlay of ₹850 crore, Nadda said, adding that the funding has supported the construction of 17 new drug testing labs and the upgradation of 24 existing labs.
The Hindu
a day ago
- Health
- The Hindu
Eliminate unnecessary animal studies, establish clear conditions for comparative clinical trials, say healthcare advocates
There is an urgent need to eliminate unnecessary animal studies, and establish clear conditions for requiring comparative clinical trials for affordable biosimilars without compromising safety and efficacy, members of civil society said in a letter to the Central Drugs Standard Control Organisation (CDSCO) on the draft guidelines on biosimilars. Also read:India takes first step to remove animals from drug-testing process A biosimilar is a biological medicine like another already approved biological medicine. While it is not an exact copy, it is clinically similar in terms of safety, purity, and potency. Biosimilars are developed to be a more affordable alternative to the reference biologic, increasing access to treatment options and potentially lowering healthcare costs. 'These guidelines mark a significant step toward making affordable, lifesaving biosimilars available to Indians suffering from serious illnesses like cancer, diabetes, and auto-immune disorders like arthritis. Biosimilars offer hope to patients by providing lower-cost alternatives to expensive biologic medicines. In India, where many struggle to afford basic healthcare, these drugs can transform lives. The draft guidelines are progressive as they have simplified the approval process, but we believe additional changes can make biosimilars even more accessible, ethical, and affordable, while maintaining safety and quality,'' the group, which includes patient advocates, healthcare organisations, and concerned citizens, said in its letter. 'The proposed guidelines on seeking reduced animal testing are encouraging. However, without a complete waiver, we are looking at increased costs and delayed access to affordable biosimilars. So, by eliminating these tests, India can lower production costs, speed up the biosimilar development, and uphold ethical standards, as well as make biosimilars more affordable for patients,' K.M. Gopakumar, co-convenor of the Working Group on Access to Medicines and Treatment, a civil society network for affordable healthcare, said. There is also a global trend to make clinical efficacy studies an exception rather than a rule, Mr. Gopakumar added. 'The draft guidelines' provision to skip clinical trials when a biosimilar is proven similar through lab tests is a positive step. But the language used grants significant discretion to the licensing authority and carries the risk of regulatory arbitrariness. Moreover, it could be exploited by originator companies to initiate legal action against biosimilar manufacturers, alleging potential compromises in safety and quality,'' he warned, adding that the group is demanding a clear definition for the situation where a biosimilar developer needs to carry out comparative clinical trials. Calling on the CDSCO to ensure the finalised guidelines on biosimilars remain free from any conflict of interest, the group said that the 2025 Draft Guidelines on Similar Biologics offer an opportunity to advance India's healthcare system. 'By removing animal studies, clarifying clinical trial waivers, and prioritising affordability, India can make biosimilars more accessible, reduce ethical concerns, and reinforce India's leadership in affordable medicine. We request that you incorporate these recommendations and engage with civil society, patient groups, and healthcare advocates as you finalise the guidelines,'' the group has urged the CDSCO.
News18
a day ago
- Health
- News18
900 Pharma Units Inspected In 3 Years, 700 Actions Taken; Himachal Key In Drug Quality Crackdown
In Himachal alone, 2,275 drug samples from local firms have been tested in the past two years, signalling the regulatory focus on pharma hotspots. In a crackdown that exposes lapses in the pharmaceutical manufacturing sector, India's drug regulator has ramped up scrutiny, issuing almost 700 regulatory actions following risk-based inspections across India. The Central Drugs Standard Control Organisation (CDSCO), India's apex drug regulator, has inspected 905 pharmaceutical units as part of its risk-based surveillance drive — and 694 actions have been taken, leading to enforcement measures ranging from stop production orders and license suspensions to show cause notices and warning letters. 'As of now, 905 units have been inspected, resulting in 694 actions being taken." The data has been shared by the Minister of State, Health and Family Welfare, Anupriya Patel, in Rajya Sabha on Tuesday. The scale of non-compliance, where roughly 3 actions were taken for every 4 units inspected — underscores concern about quality control in the country's pharma ecosystem. The actions on these firms include 'Stop Production Orders (SPO), Stop Testing Orders (STO), licence suspensions/cancellations, warning letters, and show cause notices, depending on the severity of non-compliance," the minister replied. 'This initiative has provided valuable insights into the ground reality of manufacturing practices and has led to relevant corrective actions, resulting in noticeable improvements in the regulatory framework," Patel said. In Himachal alone, 2,275 drug samples from local firms have been tested in the past two years, signalling the regulatory focus on pharma hotspots. 'In the last two years, CDSCO has tested 2275 drug samples of pharma companies situated in Himachal Pradesh. These drugs include vitamins, antipyretics, antibiotics, antihelminthics, antihistaminics, antineoplastics, corticosteroids, anticoagulants, analgesics, antacids, antidiabetics, anti-lipidemic and antihypertensives etc," she said while responding to the question on 'the details of drugs of pharmaceutical companies tested by the Central Drugs Standard Control Organisation (CDSCO) during the last two years in Himachal Pradesh…" The inspections, along with many other moves detailed by the minister in the Rajya Sabha, claim to be one of the most aggressive regulatory exercises in recent years to clean up India's drug manufacturing practices. According to the data shared by Patel, in the latest May 2025 drug alert released by CDSCO, 186 drug samples failed quality checks and were classified as Not of Standard Quality (NSQ). Among these, 49 products were manufactured in Himachal Pradesh, one of the largest pharmaceutical manufacturing hubs in India. The flagged samples, now publicly listed on CDSCO's website, include medicines used for a wide range of conditions — from common antibiotics and antihypertensives to corticosteroids, antidiabetics, and anticoagulants. She further added that the central government is providing regular residential, regional training and workshops to officials of CDSCO and state drug regulatory authorities on good manufacturing practices. 'In the financial year 2023-24, CDSCO has trained 22854 persons while in financial year 2024-25, 20,551 persons have been trained." Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
