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Hindustan Times
a day ago
- Health
- Hindustan Times
CDSCO flags 186 drugs that fail to meet quality standards
The Central Drugs Standard Control Organisation (CDSCO) has listed at least 186 drugs and formulations as not of standard quality (NSQ) in May , after both central and state testing laboratories across the country flagged these samples, according to the national drugs regulator's alert issued on Friday. CDSCO flags 186 drugs that fail to meet quality standards Two samples were found to be spurious. Data accessed by HT for the year so far, showed that at least 561 samples were labelled as NSQ by the national drugs regulator while three samples were found to be spurious. NSQ drugs are those that fail to meet the quality standards or specifications, including those pertaining to labelling, dissolution, weight uniformity, and sterility. According to a release issued by CDSCO, of the 186 samples that failed the quality test, 128 were identified by various state drugs testing laboratories, while the central drugs laboratories identified 58 . 'As per routine regulatory surveillance activity, the list of Not of Standard Quality (NSQ) and Spurious drugs are being displayed… Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters. The failure is specific to the drug products of the batch tested by the Govt. Laboratory and it does not warrant any concerns on the other drug products available in the market,'CDSCO said in the statement. 'Two dug samples from the State of Bihar are identified as spurious drugs, which were manufactured by an unauthorized manufacturer using brand name owned by another company, the matter is under investigation and action will be taken as per Act & Rules.' Last year, at least 900 samples were found to be of NSQ and 20 spurious from samples randomly lifted from across the country. As part of the continuous regulatory surveillance, drug samples are picked from sales or distribution points and analysed after which the regulator displays a list of NSQ drugs on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the batches of such drugs identified in the market. The Drugs Controller General of India, Rajeev Singh Raghuvanshi, earlier said that the CDSCO was taking all measures to drastically bring down the percentage of less efficacious drugs, noting that only around 1.5% of the total drugs being sampled were found less efficacious in recent surveys. Identification of drug samples as NSQ is done based on the failure of the drug sample in one or the other specified quality parameters. The regulator said the failure is specific to the drug products of the batch tested by the government laboratory and it does not warrant any concerns on the other drug products available in the market. Besides NSQs, some defective products related to quality are also categorised as adulterated or spurious drugs, which are considered to have potential to cause serious adverse reactions and even death. 'This action of identifying NSQ and Spurious medicines is taken on a regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from the market,' read the statement.
India Gazette
13-06-2025
- Business
- India Gazette
EAM Jaishankar holds talks on regional developments with Armenian FM
New Delhi [India], June 13 (ANI): External Affairs Minister S Jaishankar met Minister of Foreign Affairs of Armenia Ararat Mirzoyan in Marseille. The two discussed regional developments in their meeting on Thursday. In a post on X, he said, 'Pleased to meet FM Ararat Mirzoyan of Armenia in Marseille today. A useful discussion on our close cooperation and regional developments.' On March 11, India and Armenia signed two major Memoranda of Understanding during the visit of Armenian Foreign Minister Ararat Mirzoyan, to India. An MOU was signed between India's Central Drugs Standard Control Organisation (CDSCO) and Armenia's Center of Drug and Medical Technology Expertise (CDMTE) on cooperation in regulating medical products. Another MOU was signed between the Sushma Swaraj Institute of Foreign Service and the Diplomatic School of the Ministry of Foreign Affairs of Armenia on cooperation. Armenia FM Mirzoyan held a meeting with EAM S Jaishankar on Monday and exchanged views on regional and global matters of shared interest. During the meeting, the two leaders reviewed the whole range of growing India-Armenia bilateral cooperation, including in the areas of political exchanges, trade, economy, connectivity, education, culture, and people-to-people contacts. 'The two ministers held productive discussions where they reviewed the whole range of growing India-Armenia bilateral cooperation, including areas of political exchanges, trade, economic, connectivity, education, culture, and people-to-people contacts. They agreed to explore cooperation in digital technologies and pharmaceuticals. The discussions also focused on multilateral cooperation at the UN and other fora. The Ministers also exchanged views on regional and global matters of shared interest,' the Ministry of External Affairs stated. In his opening remarks at the meeting, Minister Mirzoyan thanked Jaishankar for the invitation and the warm welcome received in India. He said, 'It's always a great pleasure to have the opportunity to exchange views on our bilateral agenda and regional and global processes with you. Let me congratulate you on your cricket team's recent victory in the ICC. It's an important and quite symbolic event.' (ANI)
Business Standard
05-06-2025
- Health
- Business Standard
Servier India introduces 'Ivosidenib'(Tibsovo®), in India, First-in-class Targeted Therapy in Oncology for Rare IDH1-Mutated AML and Cholangiocarcinoma
VMPL Mumbai (Maharashtra) [India], June 5: Servier India, a subsidiary of the leading French pharmaceutical Servier Group, today announced the launch of Ivosidenib (Tibsovo®), an oral targeted therapy approved in the management of cancer patients with Acute Myeloid Leukemia (AML) and Cholangiocarcinoma, with an isocitrate dehydrogenase-1 (IDH1) mutation. Servier India received the approval on 14th May 2025, from Central Drugs Standard Control Organisation (CDSCO) for the import, sale, and distribution of the medication. Acute myeloid leukemia is a challenging hematological malignancy. Studies indicate that only about 30-40% of AML patients in India receive adequate treatment1, with high mortality rates due to rapid disease progression and infections. Cholangiocarcinomas (CCA) are rare tumours originating from bile duct. Due to their asymptomatic nature they are usually diagnosed when the disease is advanced.2 The announcement marks a significant advancement in management of the mentioned rare and difficult-to-treat cancers in India, addressing a critical unmet medical need. Speaking on the occasion, Mr. Aurelien Breton, Managing Director, Servier India, said, "Our focus is to advance oncology care by bringing innovative, precision medicines to patients who need them the most. By prioritizing access and working to make treatment options affordable to patients, we are dedicated to bridging critical gaps in cancer care across the country. This launch is a significant step forward in our mission to support healthcare providers with targeted treatment options and ultimately improve survival outcomes and quality of life for patients throughout India." IDH1 mutation occurs in approximately 7-14% of AML patients in India3, making targeted mechanisms especially relevant for this subset. "This therapy represents a significant therapeutic option in the treatment of AML and Cholangiocarcinoma. For healthcare professionals, this precision therapy offers a new, effective option that can improve patient outcomes where traditional treatments have limited success. It highlights the benefits of targeted therapy and caliber of innovation in enhancing lives and advancing cancer care in India.", highlighted Dr. Pranav Sopory, Medical and Patient Affairs Director, Servier India. Speaking on the importance of treatment access, Ms. Pratima Tripathi, Commercial Director, Servier India, said: "Our foremost priority is to ensure that the therapy is accessible and affordable to patients across India. We are actively collaborating with healthcare providers, patient advocacy groups, and policymakers to remove barriers and facilitate timely access to this important therapy. Through these partnerships, we are committed to expanding treatment options and making a meaningful difference in the lives of patients." By introducing these advanced therapies, Servier India reaffirms its commitment to advancing innovative cancer treatments that improve clinical outcomes and enhance the quality of life of patients. Disclaimer: This press release is intended solely to share regulatory and medical information regarding the launch; the reference to "Tibsovo" is not intended as a promotional or public advertisement. Use of the therapy is strictly based on a doctor's prescription and clinical discretion. About Servier India Servier India has been committed for over three decades to delivering innovative pharmaceutical solutions that improve the lives of patients and their families across India. Established in 1985 as an affiliate of the leading independent French pharmaceutical Servier Group, the company focuses on therapeutic areas such as Cardiometabolism, Neuroscience, Venous Diseases, and Oncology. Servier India has a strong pan-India presence and a dedicated workforce of around 580 that strives to address critical healthcare challenges with passion and purpose. As part of Servier group operating in over 150 countries, Servier India inherits a rich legacy of scientific excellence and patient-centric innovation. Globally, Servier invests heavily in research and development, focusing on our key therapeutic areas. About Servier Servier is a global pharmaceutical group governed by a Foundation that aspires to serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. As a world leader in cardiometabolism and venous diseases, Servier's ambition is to become a focused and innovative player in oncology by targeting rare cancers. Headquartered in France, Servier relies on a strong geographical footprint; its medicines are available in close to 140 group achieved a revenue of EUR5.9 billion in 2024. Additional Details on Ivosidenib Internationally, Ivosidenib has already received regulatory approvals in more than 42 countries, including the USA, Europe, China, UAE, and South Korea. In the United States, the US FDA approved it in 2019 as a monotherapy and later in May 2022 as a combination treatment with Azacitidine for patients aged 75 and above, or those who cannot tolerate intensive chemotherapy. The European Medical Agency (EMA) gave its approval in May 2023 for use in patients who are not fit for standard induction chemotherapy. In India, the process moved forward in April 2025, when the Subject Expert Committee (SEC) gave a positive recommendation for Ivosidenib. Following this, the DCGI granted approval for the marketing authorization in May 2025
Indian Express
05-06-2025
- Indian Express
Spurious cancer drug racket busted, 6 arrested in 3 raids: Delhi Police
The Delhi Police Crime Branch busted a well-organised racket that allegedly sold spurious, unauthorised, and unregistered cancer drugs to unsuspecting patients. Six people were arrested in three simultaneous raids — at Laxmi Nagar, Budh Vihar and Chandni Chowk — and counterfeit medication worth several lakhs was seized, police said Wednesday. Police said the accused targeted cancer patients via social media groups, claiming to offer expensive drugs at discounted rates. In Laxmi Nagar, Neeraj Kumar (23) and Anil Kumar (30) from a pharmaceutical firm were arrested with five counterfeit Opdivo injections lacking importer details. In Budh Vihar, police said Dhanesh Sharma (23) and Dheeraj Kumar were found with three boxes of Cetuximab, six Opdivo injections, and three boxes of Lenvatinib. In Chandni Chowk's Bhag-irath Palace, Rohit Bhatti (24) and Jyoti Grover (52) were arrested with a large haul of spurious medicines. Drug inspectors from the Central Drugs Standard Control Organisation confirmed these drugs were unauthorised for sale in India. 'During the inquiry, it was found that the owner of a shop (in Chandni Chowk), Naveen Arya, is the kingpin of the racket. He remained behind bars for about three months in a similar case. After he got out on bail, he activated this syndicate, as the profit margin is very high. The drugs, valued at several lakhs of rupees, were sealed as evidence. The accused were selling these counterfeit medications at discounted rates, exploiting vulnerable cancer patients and endangering their lives,' said DCP (Crime Branch) Vikram Singh. Arya is yet to be arrested. Police said their investigation revealed that the syndicate sourced the counterfeit drugs at low prices from illicit suppliers and sold them to unsuspecting patients at rates between Rs 50,000 to Rs 70,000 — far below the market value of Rs 1.5 to Rs 2 lakh. The accused allegedly admitted to exploiting desperate patients by offering counterfeit drugs marked as 'Not for Sale in India', said police. Technical analysis of seized mobile phones showed the accused were connected to multiple victims through social media groups, where patients often posted appeals for affordable medication. The Crime Branch is working to identify and contact affected victims, said police. A total of 66 spurious drug items were seized. A case has been registered under sections 276 (adulteration of drugs), 277 (sale of adulterated drugs), 278 (sale of drug as a different drug or preparation), 318(4) (cheating), 61(2) (criminal conspiracy), and 3(5) (common intent) of the BNS, police said.
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Business Standard
03-06-2025
- Business
- Business Standard
Biocon share price pops 2% on CDSCO nod for diabetes drug; key details here
Biocon share price: Bengaluru-based biopharmaceutical company Biocon shares were in demand in a weak market on Tuesday, June 3, 2025, with the stock rising up to 1.85 per cent to hit an intraday high of 340.25 per share. However, at 11:00 AM, Biocon share price was trading 0.49 per cent higher at 335.70 per share. What is the reason behind the uptick in Biocon share price? Biocon's share price saw an uptick following key regulatory approvals in India for its Liraglutide drug. The company received approval from the Central Drugs Standard Control Organisation (CDSCO) for its Liraglutide drug substance, while its wholly owned subsidiary, Biocon Pharma, secured approval for the Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge). Liraglutide is a synthetic analog of the GLP-1 peptide and is administered as a once-daily injection. It is a generic version of Victoza and is indicated for the treatment of Type 2 Diabetes Mellitus in adults, adolescents, and children aged 10 years and older, as an adjunct to diet and exercise. The original formulation was approved in the EU in 2009 and in the US in 2010. The approvals were granted under the CDSCO's recently introduced 101 route, which recognises approvals from established global regulatory authorities, streamlining the approval process in India. Siddharth Mittal, chief executive officer and managing director, Biocon, said: 'The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes. India has one of the highest numbers of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further. The approval enables us to address a critical need by making this drug available, and aligns with Biocon's mission to provide affordable, lifesaving medications to those who need it the most. We are now gearing up to launch the product expeditiously through our commercialization partners in India'' 'With GLP-1 therapies projected to be a substantive future growth driver for Biocon, the Company remains committed to reinforcing its position as a key player in this area,' Biocon said, in a statement. Biocon Q4 results Biocon reported a strong financial performance for the fourth quarter of FY25, with consolidated net profit surging 153 per cent year-on-year (Y-o-Y) to ₹344 crore, up from ₹136 crore in the same quarter last year. Profit before tax (PBT) rose 53 per cent Y-o-Y to ₹487 crore. The company's Board also approved plans to raise up to ₹4,500 crore through various funding options, including qualified institutional placement (QIP), rights issue, or other permissible methods. The robust growth was driven by solid performance across its generics, biologics, and research services segments. Total consolidated revenue for the quarter stood at ₹4,454 crore, compared to ₹3,966 crore in Q4 FY24. Ebitda rose 16 per cent to ₹1,115 crore, with the margin maintained at 25 per cent. READ MORE About Biocon Biocon is a global biopharmaceutical company focused on developing and supplying affordable therapies for chronic diseases such as diabetes, cancer, and autoimmune disorders. The company manufactures and markets novel biologics, biosimilars, complex small molecule APIs, and generic formulations across India, the US, Europe, and other key markets. It is also advancing a pipeline of novel immunotherapy assets.
