Chetan Verma’s Post

India Waives Local Clinical Trials for Approved Drugs The Indian government has taken a significant step to waive off mandatory local clinical trials for certain drugs that have already been approved in countries like the US, UK, Japan, Australia, Canada, and the European Union. Key Points: 1. Expedited Drug Approval: The move is expected to reduce the time taken for new and advanced drugs to reach Indian patients. 🤐Launching a new drug in India takes up to 4 years compared to the developed market. 2. Focus on Advanced Therapies: The waiver applies to drugs that are considered more advanced than the current standards available in India, such as treatments for cancer, rare diseases, and other complex conditions. 3. Aim for Improved Healthcare: The ultimate goal is to enhance healthcare access and outcomes for Indian citizens by providing them with quicker access to life-saving treatments. Is a complete waiver of clinical trials viable, given India's diverse genetic profiles that impact drug metabolism, efficacy, and safety? #medical #doctors #AIIMS #Pharma #News

India has removed clinical trial requirements for new drugs that make significant therapeutic advancements and have already been approved in the US, UK, Japan, Australia, Canada, or the EU. The Central Drugs Standard Control Organization (CDSCO) stated that this change is designed to expedite the approval process and availability of drugs, especially for rare diseases, pandemics, and special defence purposes. This policy is anticipated to improve access to essential treatments in India. Read more: https://lnkd.in/d__aiXuF #BiotechIndia #BiotechIndustry  #BiotechUpdate

A recent publication in The Lancet has drawn attention to the pervasive issue of look-alike, sound-alike (#LASA) #drugs in #India, shedding light on the potential risks and implications for #patientsafety within the country's #healthcaresystem. The study underscores the urgent need for #regulatorymeasures and heightened awareness to mitigate the hazards posed by LASA medications. #LASAdrugs, characterized by similar packaging, names, or appearance, pose a significant challenge to #medicationsafety, often leading to #medicationerrors, #adversereactions, and #patient harm. In the context of India's vast and diverse #pharmaceuticalmarket, where numerous brands and #genericformulations coexist, the prevalence of LASA drugs exacerbates these risks, posing formidable challenges for #healthcareproviders and #patients alike. In India, poor drug regulation is not a recent problem. The Indian drug market is full of look-alike, sound-alike drugs that have not yet caught the attention of the medical community or the media. The viewpoint by Parth Sharma, Association for Socially Applicable Research (ASAR), Pune, Maharashtra, India, and colleagues highlights the problem of LASA drugs and poor prescription practices, proposes solutions for involving all stakeholders in this unaddressed issue which is a huge public health problem in #India.

“Through US Pharmacopeia's collaboration with India's government, industry, and healthcare leaders, we are making strides to address quality challenges, establish India’s role in global healthcare, and safeguard the world’s supply of medicines.” 💬 Chris Colwell | USP VP, International Government & Regulatory Affairs USP staff recently welcomed Dr. Rajeev Raghuvanshi, Drug Controller General of India, and Rajiv Wadhawan, Joint Secretary, Ministry of Health and Family Welfare, Government of India, along with other key Government of India Officials to our offices in Rockville. The dignitaries met with USP leadership, toured a lab, and signed a memorandum of understanding between the Indian Pharmacopoeia Commission and USP. The MOU signals the start of collaboration on a detailed workplan between the two organizations. Read more from Chris about the visit in a new USP Quality Matters blog ⤵ and share your insights about the visit or our collaboration in a comment or repost below. #Collaboration #PublicHealth #India #WednesdayWisdom

While reading the story about 𝐀𝐬𝐭𝐫𝐚𝐙𝐞𝐧𝐞𝐜𝐚 𝐈𝐧𝐝𝐢𝐚'𝐬 𝐌𝐃 𝐚𝐝𝐦𝐢𝐫𝐢𝐧𝐠 𝐌𝐚𝐧𝐤𝐢𝐧𝐝 𝐏𝐡𝐚𝐫𝐦𝐚’𝐬 𝐞𝐟𝐟𝐨𝐫𝐭𝐬 to make Symbicort (used to treat asthma and COPD) widely accessible in India, my heart was filled with gratitude. 𝐈𝐭 𝐫𝐞𝐚𝐟𝐟𝐢𝐫𝐦𝐞𝐝 𝐦𝐲 𝐛𝐞𝐥𝐢𝐞𝐟 𝐢𝐧 𝐭𝐡𝐞 𝐩𝐨𝐰𝐞𝐫 𝐨𝐟 𝐜𝐨𝐥𝐥𝐞𝐜𝐭𝐢𝐯𝐞 𝐞𝐟𝐟𝐨𝐫𝐭𝐬 𝐭𝐨 𝐜𝐡𝐚𝐧𝐠𝐞 𝐥𝐢𝐯𝐞𝐬. Dr. Sanjeev Panchal ji, this achievement wouldn’t have been possible without your support and our shared vision. 𝐋𝐞𝐚𝐝𝐞𝐫𝐬 𝐥𝐢𝐤𝐞 𝐲𝐨𝐮 𝐡𝐞𝐥𝐩 𝐟𝐨𝐬𝐭𝐞𝐫 𝐚𝐧 𝐞𝐜𝐨𝐬𝐲𝐬𝐭𝐞𝐦 𝐨𝐟 𝐭𝐫𝐮𝐬𝐭, 𝐩𝐫𝐨𝐠𝐫𝐞𝐬𝐬, 𝐚𝐧𝐝 𝐥𝐚𝐬𝐭𝐢𝐧𝐠 𝐢𝐦𝐩𝐚𝐜𝐭. From combining AstraZeneca's groundbreaking research with Mankind's extensive reach to delivering innovative medicines on such a broad scale, 𝐢𝐭’𝐬 𝐭𝐫𝐮𝐥𝐲 𝐜𝐨𝐦𝐦𝐞𝐧𝐝𝐚𝐛𝐥𝐞 𝐭𝐨 𝐰𝐢𝐭𝐧𝐞𝐬𝐬 𝐭𝐡𝐞 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐓𝐨𝐠𝐞𝐭𝐡𝐞𝐫, 𝐛𝐨𝐭𝐡 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐚𝐫𝐞 𝐛𝐫𝐢𝐝𝐠𝐢𝐧𝐠 𝐜𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐠𝐚𝐩𝐬 𝐢𝐧 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐜𝐜𝐞𝐬𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐲. Partnerships like these don’t just make a difference in urban centers—they extend hope and healing across the nation. Our vision remains steadfast: to make lifesaving medicines accessible while driving innovation and operational excellence. Through purposeful collaborations and shared determination, we are confident in shaping a healthier future for India. https://lnkd.in/gBcpiWrd #HealthcareInnovation #AccessToMedicine #PharmaPartnerships #MakingADifference #CollectiveEfforts #HealthcareAccessibility #AsthmaCare #TransformingLives

Small changes (+free riding) can have outsized impact. Last month, the Indian Drug control authority waived the need for clinical trials for some types of medicines if they have been approved by USA, UK, Japan, Australia, Canada and EU. The news went mostly unnoticed but can have huge implications. Here is how an Indian official put it “Presently, the delay in launching a new or novel medicine in India is anywhere between 5-20 years when compared to western markets. With the waiver of Rule 101, the scope of parallel launches of medicines in India along with the West will be opened up,”. Read more here: https://lnkd.in/g6KSJzbG Vijay Kelkar and Ajay Shah in their brilliant book “In Service of the Republic”(https://lnkd.in/gCYi-E6X) have previously written about opportunities that India and other LMICs can use to free ride on state capacity outside their countries. If the US-FDA and the EMA have invested significant resources to test drugs, LMICs may not want to waste limited resources to reinvent the wheel. They could focus on ensuring whether the drugs are safe for their populations.  By the way, Alessio Damato and I at Alstonia Impact have been working on the topic on greater and faster access to medicines. Reach out if you want to have a discussion! Cc: Chandni Goel Manjot Kaur Steve Kretschmer Heather Vahdat

Read our latest article by Parth Sharma (from ASAR for India) with Murali Neelakantan and Ashish Kulkarni in The Lancet Regional Health-Southeast Asia where they shed light on the issue of look-alike and sound-alike drugs in India and the knowledge gaps and propose solutions from policy to patient level to address this problem. https://lnkd.in/gH6PifiJ

Professor Kim Van Oorschot Calls for Systems Thinking to Address Drug Shortages at Global Health Norway Conference At the Global Health Norway Conference, Professor Kim Van Oorschot (BI Norwegian Business School) tackled a critical issue: drug shortages. Her presentation, "A systems view – drug shortage as a case," argued that solving this problem requires moving beyond isolated solutions. Professor Van Oorschot proposes a systemic approach. She developed a framework that considers the actions of various stakeholders (manufacturers, governments, healthcare providers) and the resulting outcomes. This framework, based on European data, helps us understand the cause-and-effect relationships behind drug shortages. While some common approaches exist – letting the market handle it, finding alternatives, or relaxing regulations – Professor Van Oorschot warns of unintended consequences. These approaches can interact, making the problem more complex. The solution lies in developing "higher-level solution archetypes" that account for these interactions. By understanding the system as a whole, we can design more effective and sustainable solutions for drug shortages. Professor Van Oorschot's work emphasizes the importance of systems thinking in global health. A holistic approach is crucial for building stronger and more equitable health systems for all. #GlobalHealth #DrugShortages #SystemsThinking #HealthEquity #MIAproject https://lnkd.in/g943jZKU

Pharmaceutical companies often attribute high medicine prices to R&D costs. But Cipla shatters this myth. Founded in 1935 by Dr. Khwaja Abdul Hamied, Cipla aimed to make healthcare accessible to all. Dr. Hamied’s vision was clear: affordable healthcare. As the years passed, the torch was handed over to his son, Yusuf Hamied, who continues to build on this legacy. Cipla grew into a pharmaceutical titan. Could Cipla revolutionize healthcare with affordable treatments? Their crowning achievement: Triomune. This life-saving HIV/AIDS medication brought hope to millions at a fraction of international prices. Today, nearly 90 years later, Cipla is a global force with a presence in over 80 countries and an impressive portfolio of more than 1,500 offerings. This reflects the power of the family’s vision to transcend boundaries. Cipla’s story isn’t just about innovation. It’s about staying true to its roots. At its core, it remains a family-managed business, guided by the same principles of care and quality that have been its hallmark for nearly 9 decades. From humble beginnings to global impact, Cipla’s journey proves that transformative change is possible without losing sight of purpose. As you reflect on the role of legacy and purpose in driving a business forward, what legacy do you aspire to leave? #familyoffice #familybusiness #entrepreneurship #vision #fmb Photo credit: Cipla Archives

The TELUS Health 2024 Drug Data Trends and National Benchmarks Report is now available. The Report provides comprehensive insights into the evolving landscape of private drug plans, highlighting trends and shedding light on emerging areas to watch.