AstraZeneca gets CDSCO nod for lung cancer drug
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News18
15 hours ago
- News18
Are Indian Drug Makers Doing Enough? The Fight Against Fake Medicines Needs More Muscle
Last Updated: Counterfeit and 'not of standard quality' drugs are more than a regulatory headache -- they erode patient trust, compromise treatment outcomes, and can even endanger lives Are India's leading drug makers doing enough to fight counterfeit medicines? Month after month, the Central Drugs Standard Control Organisation releases its list of 'not of standard quality' drugs. And month after month, pharma giants whose brand names appear on it are quick to distance themselves – terming the flagged products as counterfeit or disowning them altogether. Now, the regulatory body's own alerts include comments from manufacturers stating that the failed products did not originate from them. In fact, in 2023, the Centre made QR codes mandatory for 300 pharmaceutical brands allowing consumers to verify the authenticity of medicines. Despite the move, counterfeit drugs continue to circulate – partly due to limited public awareness and the absence of a robust system to sensitise consumers. When News18 reached out, only a handful of companies shared details of the steps they are taking to trace and curb fake brands. Others chose not to respond despite reminders. This raises a sharp question: are drug makers truly committed to tackling counterfeits, or is silence simply a safer route – one that shields them from reputational damage and regulatory scrutiny while the problem festers in the market? DRUGS FLAGGED IN QUALITY CHECKS Over the past year, several widely used medicines sold under popular brand names have figured in the 'not of standard quality' (NSQ) alerts issued by Central Drugs Standard Control Organisation (CDSCO), which is India's apex drug regulator. Cipla's Tamsulosin Hydrochloride and Dutasteride tablets (Urimax D, May 2025) and Tofacitinib (Tofajak, November 2024) were flagged, as was Glenmark's Telma 40 (March and May 2025). Alkem's Ondem (January 2025), Pan D (October 2024) and Taxim, as well as Sun Pharma's Rosuvas (October 2024), Pantocid (August 2024) also appeared on the list. Among multinationals, GSK's Augmentin 625 Duo and dermatology creams Betnovate-N and Betnovate-C were named in November 2024. Pharmaceutical companies typically inform regulators that the listed batches were not manufactured by them and, therefore, are in the category of spurious or counterfeit drugs. BUT, WHAT'S NEXT? Several drug makers have outlined the steps they are taking to address the issue. A GSK spokesperson told News18 that its most recognised product, 'Augmentin 625 Duo and dermatology products Betnovate-N and Betnovate-C", have been targeted by the counterfeit market. The company said 'detection and prevention are two different topics which require different technical solutions". It utilises overt and covert anti-counterfeit features on its packaging – both Augmentin 625 Duo and Betnovate-N and Betnovate-C incorporate these features. 'In line with legislation that requires capturing the details of the product, we overprint QR codes on these products for easier detection," GSK said. To stop the proliferation of counterfeit drugs, the spokesperson said: 'We believe enforcement must be strengthened. In addition, there is low adoption of scanning at the retail and consumer level, weak integration of the tracking system across the supply chain, along with the presence of informal or unregulated distribution channels. Until compliance is universal and verification is routine at every stage – from manufacturing to the point of sale – counterfeiters will exploit such loopholes." GSK said it is actively working with different Indian law enforcement agencies, including CDSCO (DCGI), state FDAs (Food and Drug Administration), and the police. In fact, it said, it is constantly surveying and investigating valuable targets under a global anti-counterfeiting programme. 'We regularly send notifications to relevant FDA offices when we receive consumer complaints of counterfeit goods," the company added. Another drugmaker, Alkem, whose popular brands Pan D and Taxim-O have also been targeted, described counterfeit medicines as a persistent public health risk. 'We are consistently enhancing our security measures, adopting innovative packaging technologies to prevent counterfeiting. Today, Alkem's key brands, including Pan, Clavam, A to Z and Taxim-O, incorporate unique security features in addition to QR codes to verify product authenticity," the company said. Alkem said it regularly engages with industry bodies, healthcare professionals, and government authorities to address the problem of counterfeiting and drive awareness about the security measures taken by the company on its product packs. 'We believe counterfeit drugs is a national issue and all stakeholders involved should tackle it collaboratively to ensure that patients receive approved and genuine medicines developed by authentic manufacturers," it said. Similarly, Mankind Pharma's CEO Sheetal Arora called counterfeit drugs a 'direct threat to patient safety" and public trust in branded medicines. 'Counterfeit and spurious drugs are a grave concern, given the recent spate of incidents reported in the media, as they directly threaten patient safety and trust," Arora said. Mankind Pharma implements safeguards, including QR codes, holograms, security labels and tamper-proof packaging across our top-selling products. 'These measures enable consumers to instantly verify authenticity and access essential product details. We also change packaging periodically to make duplication more challenging," Arora added. Despite these safeguards, counterfeit products can still infiltrate the supply chain. 'This is why we have adopted multiple preventive measures and continuously monitor our supply chain processes. Alongside enforcement, we work closely with chemists, distributors and consumers through public awareness initiatives to help them identify genuine medicines." The company has designed a way to create awareness around fake medicines. 'In August, we rolled out our public awareness campaign #AsliDawaKhushalZindagi and launched a podcast on our social media platform Docflix. This is our way of sensitising the public and combating counterfeit medicines through organic advocacy, stakeholder collaborations and sustained awareness campaigns," the CEO said. The company recognises that curbing this menace requires stronger policy-level support, including joint task forces, stricter implementation of good distribution practices and investments in secure, distinctive and hard-to-replicate packaging. However, Cipla, Abbott and Sun Pharma – the top three pharmaceutical companies in the chronic segment drugs – did not respond to queries about the safeguards they have in place to protect patients from fake versions of their brands. Glenmark, maker of one of the most popular high blood pressure drug Telma, told News18: 'We won't be able to take it further." IN SHORT… Counterfeit and NSQ drugs are more than a regulatory headache – they erode patient trust, compromise treatment outcomes, and can even endanger lives. top videos View all While some companies have introduced technological fixes, the scale of the problem goes beyond packaging and security features. Weak enforcement, gaps in drug distribution, and limited awareness among consumers allow fakes to persist. India needs a stronger, coordinated strategy where regulators, law enforcement, pharma companies and healthcare providers act in concert. Without this, the monthly NSQ alerts risk becoming a ritual – doing little to protect patients in reality. About the Author Himani Chandna Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India's COVID-19 battle, she brings a seasoned perspective. She is particularly More Click here to add News18 as your preferred news source on Google. Get breaking news, in-depth analysis, and expert perspectives on everything from politics to crime and society. Stay informed with the latest India news only on News18. Download the News18 App to stay updated! tags : health matters Pharmaceuticals view comments Location : New Delhi, India, India First Published: August 18, 2025, 08:00 IST News india Are Indian Drug Makers Doing Enough? The Fight Against Fake Medicines Needs More Muscle 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.
The Print
5 days ago
- The Print
Health Ministry launches SHRESTH index to strengthen state drug regulatory systems
The initiative, proposed by the Central Drugs Standard Control Organisation (CDSCO), aims to improve the performance of state drug regulatory authorities, ensuring that drug safety and quality standards are consistently met, the ministry said in a statement. The index was launched on Tuesday by Union Health Secretary Punya Salila Srivastava virtually in the presence of Drug Controller General of India Dr Rajeev Singh Raghuvanshi. New Delhi, Aug 13 (PTI) The Union Health Ministry has launched the State Health Regulatory Excellence Index, a first-of-its-kind national initiative to benchmark and strengthen state drug regulatory systems through a transparent and data-driven framework. In a meeting attended virtually by the health secretaries, principal health secretaries and the drugs controllers from states and Union Territories, Srivastava reiterated that the health of all citizens begins with the safety, quality, and efficacy of the medicines they consume. Ensuring their quality is the government's commitment, she said. 'Our federal structure is designed to regulate a complex and globally significant pharmaceutical industry. The only way forward is cooperative action to ensure medicines made in India are trusted everywhere, starting with every citizen in India,' the Union health secretary said. Srivastava highlighted the crucial role played by states and Union Territories in ensuring quality manufacturing and distribution in India and the need for recognising and supporting their best practices and growth. 'States have strong regulatory certification. State Health Regulatory Excellence Index (SHRESTH) is a virtual gap assessment tool for states to assess their current position and help towards maturity certification,' she added. Highlighting India's achievement of WHO ML3 status for vaccines, Srivastava stressed the next step is to elevate medicines to the same global standard, advancing international harmonisation and reinforcing India's role as the 'pharmacy of the world'. Several upcoming initiatives were also outlined, including the extension of the Not of Standard Quality (NSQ) dashboard to all states, the proposed symposium on Drug Regulatory Systems, and the expansion of joint training and audits. Speaking on the occasion, Dr Raghuvanshi highlighted that states will be divided into two categories — manufacturing and primarily distribution — and will be ranked accordingly on the SHRESTH index. SHRESTH will have 27 indices for Manufacturing States across five key themes — human resources, infrastructure, licensing activities, surveillance activities and responsiveness — and 23 indices for primarily distribution states. States will submit the data on predefined metrics to CDSCO, which will be collected by the 25th day of every month, and these metrics will be scored on the first day of next month and shared with all states and Union Territories, Dr Raghuvanshi said. PTI PLB NSD NSD This report is auto-generated from PTI news service. ThePrint holds no responsibility for its content.
Time of India
6 days ago
- Time of India
CDSCO notifies draft standard evaluation protocols for issuing IVD licenses
New Delhi: India's medical device regulator, CDSCO in collaboration with the Indian Council of Medical Research (ICMR) has issued draft standard protocols for evaluating In-Vitro Diagnostics (IVDs) devices quality and performance, to be used for issuing licenses. The protocols are meant to be followed by the country's IVD manufacturers testing labs and the regulator has sought stakeholders' comments over the notified draft by August 25. 'These protocols are now being placed in the public domain for comments from relevant stakeholders. This window of opportunity will close on 25th August 2025, and, once finalized, there will be minimal scope for change in these documents,' the notice reads. The 180-page document details the standard performance evaluation and field evaluation protocol for 15 types of IVDs including Dengue, Malaria, Influenza virus, Nipah virus, Chandipura virus, SARS-CoV-2 molecular detection differentiation assay, among several others. In Vitro Diagnostics (IVDs) are medical devices used to test samples such as blood, urine, or tissue outside the human body, to diagnose diseases, conditions, or infections, and to monitor a person's health based on predefined bio markers. Under the Medical Device Rules of 2017, 'Licensure of In-Vitro Diagnostics (IVDs) requires a detailed evaluation protocol for the performance evaluation of IVDs to evaluate their quality and performance.' The evaluation protocol helps to test the device safety, sensitivity, and accuracy, to validate the device clinical and analytical performance, required for issuing the product license, thereby allowing its usage in the country. In India the ICMR develops evaluation protocols to standardize the process of assessing the performance of diagnostic kits, particularly In Vitro Diagnostics (IVDs) and the CDSCO oversees the evaluation and enforcement of the protocols.
